Category Archives: Hormone Replacement Therapy

Tired sick woman in grey homewear sitting on bed, keeping hands on stomach, suffering from pain, looking aside. Illness, stomach ache concept

Did you know that in Mexico there are more than 7.5 million women in menopause? This number is still growing up. For many women, this stage of life is troublesome, complicated, or awkward. However, its important to recognize that menopause is a natural part of womens reproductive cycle. This stage of womens reproductive life cant be delayed, nevertheless, it can be more bearable if you know what is going on with your body. Coping with these symptoms can give women a hard time, making it important to have the proper knowledge of this life period.

What is menopause?

Menopause literally means when the menstrual cycles stop and never return after a year. The menopausal transition is a natural process that normally occurs at 45 to 50 years old. With menopausal transition many symptoms such as hot flashes, irregular menstrual periods, vaginal dryness, diminishing sexual desire, and others like cognitive impairment start. These aforementioned symptoms continue when you properly enter menopause, which occurs after a year of your last menstrual cycle.

In this stage of womens reproductive life the ovaries (endocrine glands) which normally produce estrogen (womens main sexual hormone) stops its function, this leads to all symptoms associated with menopause.

One of the most troublesome symptoms associated with menopausal transition and menopause are the hot flashes. This symptom (hot flashes) can happen even in cold weather as many women describe them as a heat sensation in all of her bodies that cause sweating. Hot flashes can be bothersome and socially disturbing for many women but specially those whose jobs implies meetings.

These hot flashes are the sole indication for giving hormone replacement therapy.

This hormone replacement therapy uses estrogen as the main pharmacologic choice, nevertheless, if you choose to start hormone replacement therapy it must be prescribed by a board certified Gynecologist, for it is not recommended to all women with menopausal transition, menopause or for treating all of the symptoms.

Symptoms

It is important to state that not all women may experience the same symptoms. Even some women dont seem to have any symptoms at all, while others may experience some severe and uncomfortable symptoms such as the hot flashes. The symptoms usually start at the menopausal transition, and can be such as vaginal dryness, diminished sexual desire, hot flashes. Difficulty in sleeping is one controversial symptom, because it can be associated with hot flashes and not necessarily with circadian cycle disorder. The approach to the symptoms may need the assessment of not only a board certified gynecologist but other medical specialists, such as a rheumatologist to treat the diminished bone mineral density and a psychiatrist to manage sleep cycle disorders not associated with hot flashes.

When to see a doctor?

You may want to consult your Gynecologist every once a year (in some cases more frequent than that) to get proper surveillance not only to treat bothersome symptoms but to get some important routine studies such as a Pap smear, mammography scan, and bone densitometry. Remember that nowadays it is more and more important to get proper medical surveillance, for many cancers seem to be increasing in frequency such as endometrial and breast cancer.

How can I cope with menopause?

The first thing you should know about is that you are not alone, many women experience these troublesome symptoms along with you. As an auxiliary relief for hot flashes you may want to wear light dresses, exercise and a healthy diet may also aid.

You must also know that nowadays if you get the proper therapy by a board certified gynecologist you may get through menopause transition or menopause symptoms as smooth as day in the park! Remember that symptoms such as diminished sexual desire can be managed with pharmacological interventions. Other symptoms as hot flashes may also be amenable to treatment. Nowadays you may not need to suffer each and every menopausal symptom, but remember to always get proper medical advice from a professional board certified Gynecologist.

With the collaboration of Dr. Andres T. Flores y Flores, obstetrician gynecologist. Graduated from Universidad Nacional Autnoma de Mxico, where he also successfully completed his Bachelors Degree as a Surgeon. He has 20 years of experience where he has focused on endometriosis care and minimally invasive gynecological surgery, among others.

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Menopause: How to cope with it? - The Yucatan Times

SAN FRANCISCO (KPIX 5) Artists on Haight Street have found an unusual way to try to save their housing a weekly drag show. Large crowds are fanning out in front of The Red Victorian every Saturday night, but the real drama is whats taking place off-stage.

(CBS)

The Red Victorian is a historic hotel near San Franciscos Haight-Ashbury district. It got the name The Red Victorian in the 1970s when Sami Sunchild of the Peaceful World Foundation created a space for international travelers to have peace talks. Today, marginalized groups are fighting each other over who has the right to stay there.

Back in March, all hotels across the city were forced to halt operations due to COVID-19. The hotel went from making roughly $80,000 a month, to zero. Thats when the employees of the hotel had the idea to use the front windows to perform drag shows every Saturday night.

I would say its unconventional, I hesitate to even call it drag, I would say its trans or gender nonconforming performance art, drag adjacent, Adam Rice a former employee and organizer for the show said.

From the crowd in the street to the performers on stage, its a lot of people who consider themselves others.

I love that its people you dont typically see in drag transgender non-conforming, Johnny Nguyen said.

Many of the performers worked at this hotel and then started living here during the pandemic, they thought they had an understanding with the nonprofit that leases the space that they could stay, but District Commons says these artists are trespassing and that its time for them to go.

My stomach dropped, you know, I felt like I had been injected with ice water, Rice said when he heard the news.

Ill be homeless. Ill be homeless and a lot of the other people who live here will be homeless, as well, Sam Hogan a performer whose stage name is Bussy Dad said.

Hogan along with the majority of the other performers are BIPOC transgender artists like Gia Regalado.

Im currently going through hormone replacement therapy so Im transitioning from male to female and its just so great having a space that I can share that with like-minded people, Regalado said, If we were to be displaced from this fight, from the house here, I dont know where any of us would go.

The show started as a way to raise money to replace the lost funding from the hotel. The artists say they had an understanding that they could stay here. Their dream is to turn this into a housing collective for black, indigenous, people of color who are transitioning. The show is popular, pack-the-sidewalk-every-Saturday-night popular, but it doesnt appear to be enough.

We cant afford, you know, 40, $50,000 a month, Zarinah Agnew said.

Agnew is the co-director for District Commons, a nonprofit that helps house formerly incarcerated people and supports community events and art shows like whats going on at the Red Vic. It leases this building from The Peaceful World Foundation, another nonprofit, and says the artists were given permission to put together a show, but not to live there.

So they were given permission to run events there for free, with much love and excitement, you know? But they decided to stay and thats when things got difficult, Agnew said.

Agnew says this standoff could put the nonprofit out of business.

Were not the Hilton, were not the Salesforce tower, this is not sticking it to the man. Were a tiny nonprofit, Peaceful World is a nonprofit and I dont think this is, like, how we get to the utopia that were all seeking, Agnew said.

For now, theyre at an impasse. It comes down to money, which has been the motivator for why artists and others have struggled to stay in the city that once masqueraded as their safe haven.

I dont think we should blame individuals for these things, we should blame systems maybe the city of San Francisco can look to support some of its most marginalized people, so they dont hurt each other, Agnew said.

With everything thats going on politically this space and spaces like it that people like us can safely exist are shrinking by the day, Hogan said.

The artists have paid $5,000 toward utilities but they do not have a formal lease. District Commons plans to file a forcible detainer in court, which is like an eviction, but because theyre not violating a lease, its for trespassing.

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BIPOC Trans Artists At Odds With Non-Profit Over Future Of SFs Red Victorian Hotel - CBS San Francisco

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According to a recent data from breast cancer research foundation (BCRF) it is anticipated that in 2019, around 272000 new patients of breast cancer is projected to be diagnosed in US woman population alone. The rapidly growing patient pool of normal and amplified level of HER2 in breast cancer is fuelling the growth of the HER2 testing market. Signifying high growth opportunities for the HER2 testing kit manufacturers and HER2 testing service providers. Subsequently the increase in adoption of histopathology testing is anticipated to boost the market share of HER2 testing market. The growing aid from nongovernment and government organizations, reimbursement policies for breast biopsy and diagnosis is estimated to surge the adoption of HER2 testing for breast cancer screening. The addition of SPoT-Light HER2 CISH test and Inform HER2 Dual ISH test is anticipated to offer accuracy and cost effective solution for Breast HER2 testing. However, lower rate of regulatory approvals for HER2 testing and higher cost is anticipated to impede the growth of the HER2 testing market.

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Furthermore, the substantial demand for HER2 testing is arising from diagnosis centers and tertiary healthcare facilities is anticipated to propel the growth of global HER2 testing Market. Manufacturers in HER2 testing market are considering cost effective solutions and occupied on the technological foreground of the HER2 testing performance and results. The growing demand for HER2 testing is primarily arising from developed nations such as UK U.S., Australia, and Germany concerning to high level of awareness about HER2 positive breast cancer and advanced breast cancer diagnostic standards. The increasing demand for HER2 testing is primarily attributed to growth in the woman healthcare sector and is anticipated to propel the demand for the global HER2 testing market.

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The HER2 Testing market to witness explicit growth from 2019 and 2029 - PRnews Leader

Oct. 27, 2020 05:02 UTC

ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (NASDAQ: EXEL) today announced that Takeda Pharmaceutical Company Limited (Takeda), its partner responsible for the clinical development and commercialization of CABOMETYX (cabozantinib) in Japan, and Ono Pharmaceutical Co., Ltd. (Ono), have submitted a supplemental application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for Manufacturing and Marketing approval of CABOMETYX in combination with OPDIVO (nivolumab) for the treatment of patients with unresectable, advanced or metastatic renal cell carcinoma (RCC).

Takeda and Onos application is based on the results of CheckMate -9ER, a phase 3 pivotal trial evaluating CABOMETYX in combination with OPDIVO in previously untreated patients with advanced or metastatic RCC compared with sunitinib. In CheckMate -9ER, CABOMETYX in combination with OPDIVO demonstrated superior overall survival, doubled median progression-free survival and objective response rate, and demonstrated a favorable safety profile versus sunitinib. These results were presented as a Proffered Paper during a Presidential Symposium at the European Society for Medical Oncology Virtual Congress 2020.

Following our recent announcement that the U.S. FDA accepted and granted Priority Review to our supplemental new drug application for CABOMETYX in combination with OPDIVO for the treatment of advanced renal cell carcinoma, were excited that our partner Takeda along with Ono have also advanced this combination regimen toward potential regulatory approval in Japan, said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. The results of the CheckMate -9ER trial suggest CABOMETYX in combination with OPDIVO may become an important new treatment option for patients with advanced kidney cancer in need of new therapies.

Per the terms of Exelixis and Takedas collaboration and license agreement, Exelixis is eligible to receive a $10 million milestone payment from Takeda as a result of this latest submission for RCC. Following the milestone associated with this regulatory filing, Exelixis will be eligible to receive a first-sale milestone payment of $20 million from Takeda related to the combination of CABOMETYX and OPDIVO for the treatment of RCC. Exelixis continues to be eligible to receive additional development, regulatory and first-sale milestones for potential future cabozantinib indications, and is also eligible for sales revenue milestones and royalties on net sales of cabozantinib in Japan. Takeda fully funds cabozantinib development activities that are exclusively for the benefit of Japan and has the opportunity to share the costs associated with global cabozantinib clinical trials, providing the company opts into those trials.

Takeda received approval in March 2020 from the Japanese MHLW to manufacture and market CABOMETYX as a treatment for patients with curatively unresectable or metastatic RCC.

About CheckMate -9ER

CheckMate -9ER is an open-label, randomized, multi-national phase 3 trial evaluating patients with previously untreated advanced or metastatic RCC. A total of 651 patients (23% favorable risk, 58% intermediate risk, 20% poor risk; 25% PD-L11%) were randomized to receive OPDIVO plus CABOMETYX (n=323) vs. sunitinib (n=328). The primary endpoint is progression-free survival. Secondary endpoints include overall survival and objective response rate. The primary efficacy analysis is comparing the doublet combination vs. sunitinib in all randomized patients. The trial is sponsored by Bristol Myers Squibb and Ono Pharmaceutical Co. and co-funded by Exelixis, Ipsen and Takeda Pharmaceutical Company Limited.

About RCC

The American Cancer Societys 2020 statistics cite kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.1 Clear cell RCC is the most common type of kidney cancer in adults.2 If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 12%.2 Approximately 32,000 patients in the U.S. and 71,000 worldwide will require systemic treatment for advanced kidney cancer in 2020.3

About 70% of RCC cases are known as clear cell carcinomas, based on histology.4 The majority of clear cell RCC tumors have below-normal levels of a protein called von Hippel-Lindau, which leads to higher levels of MET, AXL and VEGF.5,6 These proteins promote tumor angiogenesis (blood vessel growth), growth, invasiveness and metastasis.7,8,9,10 MET and AXL may provide escape pathways that drive resistance to VEGF receptor inhibitors.6,7

About CABOMETYX (cabozantinib)

In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC and for the treatment of patients with HCC who have been previously treated with sorafenib. CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the United States.

CABOMETYX in combination with OPDIVO is not indicated for advanced RCC.

CABOMETYX Important Safety Information

Warnings and Precautions

Hemorrhage: Severe and fatal hemorrhages occurred with CABOMETYX. The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies. Discontinue CABOMETYX for Grade 3 or 4 hemorrhage. Do not administer CABOMETYX to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.

Perforations and Fistulas: Gastrointestinal (GI) perforations, including fatal cases, occurred in 1% of CABOMETYX patients. Fistulas, including fatal cases, occurred in 1% of CABOMETYX patients. Monitor patients for signs and symptoms of perforations and fistulas, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a Grade 4 fistula or a GI perforation.

Thrombotic Events: CABOMETYX increased the risk of thrombotic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients. Fatal thrombotic events occurred in CABOMETYX patients. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic event requiring medical intervention.

Hypertension and Hypertensive Crisis: CABOMETYX can cause hypertension, including hypertensive crisis. Hypertension occurred in 36% (17% Grade 3 and <1% Grade 4) of CABOMETYX patients. Do not initiate CABOMETYX in patients with uncontrolled hypertension. Monitor blood pressure regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Diarrhea: Diarrhea occurred in 63% of CABOMETYX patients. Grade 3 diarrhea occurred in 11% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 diarrhea, Grade 3 diarrhea that cannot be managed with standard antidiarrheal treatments, or Grade 4 diarrhea.

Palmar-Plantar Erythrodysesthesia (PPE): PPE occurred in 44% of CABOMETYX patients. Grade 3 PPE occurred in 13% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.

Proteinuria: Proteinuria occurred in 7% of CABOMETYX patients. Monitor urine protein regularly during CABOMETYX treatment. Discontinue CABOMETYX in patients who develop nephrotic syndrome.

Osteonecrosis of the Jaw (ONJ): ONJ occurred in <1% of CABOMETYX patients. ONJ can manifest as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration or erosion, persistent jaw pain, or slow healing of the mouth or jaw after dental surgery. Perform an oral examination prior to CABOMETYX initiation and periodically during treatment. Advise patients regarding good oral hygiene practices. Withhold CABOMETYX for at least 3 weeks prior to scheduled dental surgery or invasive dental procedures, if possible. Withhold CABOMETYX for development of ONJ until complete resolution.

Impaired Wound Healing: Wound complications occurred with CABOMETYX. Withhold CABOMETYX for at least 3 weeks prior to elective surgery. Do not administer CABOMETYX for at least 2 weeks after major surgery and until adequate wound healing is observed. The safety of resumption of CABOMETYX after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by characteristic findings on MRI, can occur with CABOMETYX. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.

Embryo-Fetal Toxicity: CABOMETYX can cause fetal harm. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to initiating CABOMETYX and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

The most commonly reported (25%) adverse reactions are: diarrhea, fatigue, decreased appetite, PPE, nausea, hypertension, and vomiting.

Drug Interactions

Strong CYP3A4 Inhibitors: If coadministration with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage. Avoid grapefruit or grapefruit juice.

Strong CYP3A4 Inducers: If coadministration with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage. Avoid St. Johns wort.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed during CABOMETYX treatment and for 4 months after the final dose.

Hepatic Impairment: In patients with moderate hepatic impairment, reduce the CABOMETYX dosage. CABOMETYX is not recommended for use in patients with severe hepatic impairment.

Please see accompanying full Prescribing Information https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.

OPDIVO INDICATIONS

OPDIVO (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO (nivolumab) is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

OPDIVO (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).

OPDIVO (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

OPDIVO (nivolumab) is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

OPDIVO IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not be inclusive of all possible severe and fatal immune-mediated adverse reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur at any time after starting or discontinuing YERVOY. Early identification and management are essential to ensure safe use of YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue YERVOY depending on severity. In general, if YERVOY requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less followed by corticosteroid taper for at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroid therapy. Institute hormone replacement therapy for endocrinopathies as warranted.

Immune-Mediated Pneumonitis

OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In patients receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 6% (25/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 10% (5/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 4.4% (24/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 1.7% (2/119) of patients. In NSCLC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%) immune-mediated pneumonitis. Four patients (0.7%) died due to pneumonitis. The incidence and severity of immune-mediated pneumonitis in patients with NSCLC treated with OPDIVO 360 mg every 3 weeks in combination with YERVOY 1 mg/kg every 6 weeks and 2 cycles of platinum-doublet chemotherapy were comparable to treatment with OPDIVO in combination with YERVOY only. The incidence and severity of immune-mediated pneumonitis in patients with malignant pleural mesothelioma treated with OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks were similar to those occurring in NSCLC.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO: Grade 3 (n=1) and Grade 2 (n=12).

Immune-Mediated Colitis

OPDIVO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. When administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated colitis occurred in 26% (107/407) of patients including three fatal cases. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated colitis occurred in 10% (5/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 10% (52/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 7% (8/119) of patients.

In a separate Phase 3 trial of YERVOY 3 mg/kg, immune-mediated diarrhea/colitis occurred in 12% (62/511) of patients, including Grade 3-5 (7%).

Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Addition of an alternative immunosuppressive agent to the corticosteroid therapy, or replacement of the corticosteroid therapy, should be considered in corticosteroid-refractory immune-mediated colitis if other causes are excluded.

Immune-Mediated Hepatitis

OPDIVO can cause immune-mediated hepatitis. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. For patients without HCC, withhold OPDIVO for Grade 2 and permanently discontinue OPDIVO for Grade 3 or 4. For patients with HCC, withhold OPDIVO and administer corticosteroids if AST/ALT is within normal limits at baseline and increases to >3 and up to 5 times the upper limit of normal (ULN), if AST/ALT is >1 and up to 3 times ULN at baseline and increases to >5 and up to 10 times the ULN, and if AST/ALT is >3 and up to 5 times ULN at baseline and increases to >8 and up to 10 times the ULN. Permanently discontinue OPDIVO and administer corticosteroids if AST or ALT increases to >10 times the ULN or total bilirubin increases >3 times the ULN. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 13% (51/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 20% (10/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 7% (38/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 8% (10/119) of patients.

In Checkmate 040, immune-mediated hepatitis requiring systemic corticosteroids occurred in 5% (8/154) of patients receiving OPDIVO.

In a separate Phase 3 trial of YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 4.1% (21/511) of patients, including Grade 3-5 (1.6%).

Immune-Mediated Endocrinopathies

OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency, thyroid function prior to and periodically during treatment, and hyperglycemia. Withhold for Grades 2, 3, or 4 endocrinopathies if not clinically stable. Administer hormone replacement as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia.

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypophysitis occurred in 9% (36/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypophysitis occurred in 4% (2/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypophysitis occurred in 4.6% (25/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hypophysitis occurred in 3.4% (4/119) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, adrenal insufficiency occurred in 5% (21/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, adrenal insufficiency occurred in 18% (9/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal insufficiency occurred in 7% (41/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal insufficiency occurred in 5.9% (7/119) of patients. In patients receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (89/407) of patients. Hyperthyroidism occurred in 8% (34/407) of patients receiving this dose of OPDIVO with YERVOY. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (11/49) of patients. Hyperthyroidism occurred in 10% (5/49) of patients receiving this dose of OPDIVO with YERVOY. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (119/547) of patients. Hyperthyroidism occurred in 12% (66/547) of patients receiving this dose of OPDIVO with YERVOY. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 15% (18/119) of patients. Hyperthyroidism occurred in 12% (14/119) of patients. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, diabetes occurred in 1.5% (6/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, diabetes occurred in 2.7% (15/547) of patients.

In a separate Phase 3 trial of YERVOY 3 mg/kg, severe to life-threatening endocrinopathies occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. Six of the 9 patients were hospitalized for severe endocrinopathies.

Immune-Mediated Nephritis and Renal Dysfunction

OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 2.2% (9/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 4.6% (25/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 1.7% (2/119) of patients.

Immune-Mediated Skin and Dermatologic Adverse Reactions

OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and refer the patient for specialized care for assessment and treatment; if confirmed, permanently discontinue. In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated rash occurred in 22.6% (92/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated rash occurred in 35% (17/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated rash occurred in 16% (90/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated rash occurred in 14% (17/119) of patients.

YERVOY can cause immune-mediated rash or dermatitis, including bullous and exfoliative dermatitis, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous exfoliative rashes. Withhold YERVOY until specialist assessment for Grade 2 and permanently discontinue for Grade 3 or 4 exfoliative or bullous dermatologic conditions.

In a separate Phase 3 trial of YERVOY 3 mg/kg, immune-mediated rash occurred in 15% (76/511) of patients, including Grade 3-5 (2.5%).

Immune-Mediated Encephalitis

OPDIVO can cause immune-mediated encephalitis. Fatal cases have been reported. Evaluation of patients with neurologic symptoms may include, but not be limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. In patients receiving OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of patients. Fatal limbic encephalitis occurred in one patient after 7.2 months of exposure despite discontinuation of OPDIVO and administration of corticosteroids. Encephalitis occurred in one melanoma patient receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg (0.2%) after 1.7 months of exposure. Encephalitis occurred in one RCC patient receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg (0.2%) after approximately 4 months of exposure. Encephalitis occurred in one MSI-H/dMMR mCRC patient (0.8%) receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg after 15 days of exposure.

Other Immune-Mediated Adverse Reactions

Based on the severity of the adverse reaction, permanently discontinue or withhold OPDIVO, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy. Dose modifications for YERVOY for adverse reactions that require management different from these general guidelines are summarized as follows. Withhold for Grade 2 and permanently discontinue YERVOY for Grade 3 or 4 neurological toxicities. Withhold for Grade 2 and permanently discontinue YERVOY for Grade 3 or 4 myocarditis. Permanently discontinue YERVOY for Grade 2, 3, or 4 ophthalmologic adverse reactions that do not improve to Grade 1 within 2 weeks while receiving topical therapy OR that require systemic therapy. Across clinical trials of OPDIVO monotherapy or in combination with YERVOY , the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1.0% of patients receiving OPDIVO: myocarditis, rhabdomyolysis, myositis, uveitis, iritis, pancreatitis, facial and abducens nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, Guillain-Barr syndrome, hypopituitarism, systemic inflammatory response syndrome, gastritis, duodenitis, sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), motor dysfunction, vasculitis, aplastic anemia, pericarditis, myasthenic syndrome, hemophagocytic lymphohistiocytosis (HLH), and autoimmune hemolytic anemia. In addition to the immune-mediated adverse reactions listed above, across clinical trials of YERVOY monotherapy or in combination with OPDIVO, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1% of patients unless otherwise specified: autoimmune neuropathy (2%), meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis, nerve paresis, angiopathy, temporal arteritis, pancreatitis (1.3%), arthritis, polymyositis, conjunctivitis, cytopenias (2.5%), eosinophilia (2.1%), erythema multiforme, hypersensitivity vasculitis, neurosensory hypoacusis, psoriasis, blepharitis, episcleritis, orbital myositis, scleritis, and solid organ transplant rejection. Some cases of ocular IMARs have been associated with retinal detachment.

If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, which has been observed in patients receiving OPDIVO and YERVOY and may require treatment with systemic steroids to reduce the risk of permanent vision loss.

Infusion-Related Reactions

OPDIVO can cause severe infusion-related reactions, which have been reported in <1.0% of patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4 infusion-related reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2. Severe infusion-related reactions can also occur with YERVOY. Discontinue YERVOY in patients with severe or life-threatening infusion reactions and interrupt or slow the rate of infusion in patients with mild or moderate infusion reactions. In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients. In a separate trial in which patients received OPDIVO monotherapy as a 60-minute infusion or a 30-minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, experienced adverse reactions within 48 hours of infusion that led to dose delay, permanent discontinuation or withholding of OPDIVO. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 2.5% (10/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, infusion-related reactions occurred in 8% (4/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 5.1% (28/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 4.2% (5/119) of patients. In MPM patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, infusion-related reactions occurred in 12% (37/300) of patients.

In separate Phase 3 trials of YERVOY 3 mg/kg and 10 mg/kg, infusion-related reactions occurred in 2.9% (28/982).

Complications of Allogeneic Hematopoietic Stem Cell Transplantation

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1 receptor blocking antibody or YERVOY. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1 or CTLA-4 receptor blockade and allogeneic HSCT.

Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1 receptor blocking antibody or YERVOY prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

Based on mechanism of action, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO or YERVOY and for at least 5 months after the last dose.

Increased Mortality in Patients with Multiple Myeloma when OPDIVO is Added to a Thalidomide Analogue and Dexamethasone

In clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

Lactation

It is not known whether OPDIVO or YERVOY is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from OPDIVO or YERVOY, advise women not to breastfeed during treatment and for at least 5 months after the last dose.

Serious Adverse Reactions

In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in 2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (74% and 44%), adverse reactions leading to permanent discontinuation (47% and 18%) or to dosing delays (58% and 36%), and Grade 3 or 4 adverse reactions (72% and 51%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.2%), colitis (10% and 1.9%), and pyrexia (10% and 1.0%). In Checkmate 227, serious adverse reactions occurred in 58% of patients (n=576). The most frequent (2%) serious adverse reactions were pneumonia, diarrhea/colitis, pneumonitis, hepatitis, pulmonary embolism, adrenal insufficiency, and hypophysitis. Fatal adverse reactions occurred in 1.7% of patients; these included events of pneumonitis (4 patients), myocarditis, acute kidney injury, shock, hyperglycemia, multi-system organ failure, and renal failure. In Checkmate 9LA, serious adverse reactions occurred in 57% of patients (n=358). The most frequent (>2%) serious adverse reactions were pneumonia, diarrhea, febrile neutropenia, anemia, acute kidney injury, musculoskeletal pain, dyspnea, pneumonitis, and respiratory failure. Fatal adverse reactions occurred in 7 (2%) patients, and included hepatic toxicity, acute renal failure, sepsis, pneumonitis, diarrhea with hypokalemia, and massive hemoptysis in the setting of thrombocytopenia. In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in 2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 032, serious adverse reactions occurred in 45% of patients receiving OPDIVO (n=245). The most frequent serious adverse reactions reported in 2% of patients receiving OPDIVO were pneumonia, dyspnea, pneumonitis, pleural effusion, and dehydration. In Checkmate 743, serious adverse reactions occurred in 54% of patients receiving OPDIVO plus YERVOY. The most frequent serious adverse reactions reported in 2% of patients were pneumonia, pyrexia, diarrhea, pneumonitis, pleural effusion, dyspnea, acute kidney injury, infusion-related reaction, musculoskeletal pain, and pulmonary embolism. Fatal adverse reactions occurred in 4 (1.3%) patients and included pneumonitis, acute heart failure, sepsis, and encephalitis. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in 2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 214, serious adverse reactions occurred in 59% of patients receiving OPDIVO plus YERVOY. The most frequent serious adverse reactions reported in 2% of patients were diarrhea, pyrexia, pneumonia, pneumonitis, hypophysitis, acute kidney injury, dyspnea, adrenal insufficiency, and colitis. In Checkmate 205 and 039, adverse reactions leading to discontinuation occurred in 7% and dose delays due to adverse reactions occurred in 34% of patients (n=266). Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions reported in 1% of patients were pneumonia, infusion-related reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash. Eleven patients died from causes other than disease progression: 3 from adverse reactions within 30 days of the last OPDIVO dose, 2 from infection 8 to 9 months after completing OPDIVO, and 6 from complications of allogeneic HSCT. In Checkmate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO (n=236). The most frequent serious adverse reactions reported in 2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis. In Checkmate 275, serious adverse reactions occurred in 54% of patients receiving OPDIVO (n=270). The most frequent serious adverse reactions reported in 2% of patients receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small intestine obstruction, and general physical health deterioration. In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY, serious adverse reactions occurred in 47% of patients. The most frequent serious adverse reactions reported in 2% of patients were colitis/diarrhea, hepatic events, abdominal pain, acute kidney injury, pyrexia, and dehydration. In Checkmate 040, serious adverse reactions occurred in 49% of patients receiving OPDIVO (n=154). The most frequent serious adverse reactions reported in 2% of patients were pyrexia, ascites, back pain, general physical health deterioration, abdominal pain, pneumonia, and anemia. In Checkmate 040, serious adverse reactions occurred in 59% of patients receiving OPDIVO with YERVOY (n=49). Serious adverse reactions reported in 4% of patients were pyrexia, diarrhea, anemia, increased AST, adrenal insufficiency, ascites, esophageal varices hemorrhage, hyponatremia, increased blood bilirubin, and pneumonitis. In Checkmate 238, Grade 3 or 4 adverse reactions occurred in 25% of OPDIVO-treated patients (n=452). The most frequent Grade 3 and 4 adverse reactions reported in 2% of OPDIVO-treated patients were diarrhea and increased lipase and amylase. Serious adverse reactions occurred in 18% of OPDIVO-treated patients. In Attraction-3, serious adverse reactions occurred in 38% of patients receiving OPDIVO (n=209). Serious adverse reactions reported in 2% of patients who received OPDIVO were pneumonia, esophageal fistula, interstitial lung disease and pyrexia. The following fatal adverse reactions occurred in patients who received OPDIVO: interstitial lung disease or pneumonitis (1.4%), pneumonia (1.0%), septic shock (0.5%), esophageal fistula (0.5%), gastrointestinal hemorrhage (0.5%), pulmonary embolism (0.5%), and sudden death (0.5%).

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Exelixis Announces Takeda and Ono Submit Supplemental Application for CABOMETYX (cabozantinib) in Combination with OPDIVO (nivolumab) for the...

Menopause is a natural occurrence that takes place in a womans life around the age of 50. Menopause is marked by bodily changes that represent the end of a womans ability to bear children.

Like puberty, menstrual periods and pregnancy, menopause involves fluctuations in hormones, notably estrogen and progesterone. These fluctuations can cause symptoms that may make women uncomfortable, such as hot flashes, vaginal dryness, mood swings, and difficulty sleeping. As a result, many women discuss options that can make them feel more comfortable. Hormone replacement therapy may be a consideration.

What is hormone replacement therapy?

Estrogen levels fall during menopause. The online medical resource WebMD says that hormone replacement therapy, or HRT, involves taking small doses of estrogen alone or estrogen combined with progestin, the synthetic form of progesterone. Women who have undergone a hysterectomy or the surgical removal of their ovaries may only take estrogen, while a woman who still has her uterus typically takes the combination HRT. Many women find that HRT can relieve most of the troubling symptoms of menopause and help them feel more comfortable.

In addition, HRT has been proven to prevent bone loss and reduce fracture in postmenopausal women, according to the Mayo Clinic.

There are different types of HRT. HRT may involve taking a pill or applying a patch, gel or vaginal cream. HRT also may include a slow-releasing suppository or a vaginal ring. The delivery method will depend on the symptoms to minimize the amount of medication taken.

Risks of HRT

While there are many benefits to HRT, there are some risks associated with the therapy. These risks depend on the dose, the length of time taking HRT and individual health risks.

The Mayo Clinic says that, in the largest clinical trial to date, HRT that consisted of an estrogen-progestin pill increased the risk of certain serious conditions, such as heart disease, stroke, blood clots, and breast cancer. Women who begin at age 60 or older or more than 10 years from the onset of menopause are at greater risk of the these conditions. If HRT is started before the age of 60 or within 10 years of menopause, the benefits appear to outweigh the risks.

In addition, unless the uterus has been removed, doctors typically prescribe estrogen taken with progesterone because estrogen alone can stimulate the growth of the lining of the uterus, increasing the risk of endometrial cancer.

The American Cancer Society says that estrogen-progestin therapy also is linked to a higher risk of breast cancer the longer the therapy is used.

Minimizing risk

Doctors can work with their patients to minimize the risk of developing adverse affects from HRT. Tactics include finding the best product and delivery method, seeking regular follow-up care, making healthy lifestyle choices to reduce other health conditions, and taking the lowest effective dose for the shortest amount of time needed.

Hormone replacement therapy may be an option to help manage the symptoms of menopause. Women can discuss the pros and cons of HRT with their doctors.

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Hormone replacement therapy and menopause | | tctimes.com - Fenton Tri County Times

The crime writer made the revelation in a new collection of stories from women who are experiencing or have been through menopause. Here, we look at the science behind it.

Finding natural solutions to help ease your way through the menopause is a high priority for a lot of women at that time of life.

The symptoms can range from hot flushes, to night sweats, anxiety and mood swings to difficulty sleeping and even memory problems.

And while womens experiences of menopause can vary, few report coming through it without any issues.

Treatments include hormone replacement therapy (HRT) and oestrogen creams, with diet believed to play an important part.

Now, Scottish crime writer Val McDermid, has added to the list of potentially beneficial nutritional therapies by revealing her partners symptoms improved after drinking Indian pale ale (IPA).

The writer made the revelation in a new collection of stories from women who are experiencing or have been through menopause, written by presenter Kaye Adams and her co-author Vicky Allan.

Other contributors to the book, Still Hot!, include the artist Tracey Cox, presenters Carol Smillie and Anthea Turner, Trinny Woodall and Lorraine Kelly.

In an extract published in The Sunday Times, Val McDermid revealed: We had a very interesting experience last year with my partner, who is currently menopausal. We were in New Zealand for two-and-a-half months and after about a month she said: My menopausal symptoms seem to be so much easier here.

She was discussing it with a friend of hers who is a medic and he said: Have you been drinking the beer? Apparently IPA which is the principal beer in New Zealand and especially unpasteurised IPA has a lot of phytoestrogens in it. So there is a strong supposition that it could have a very positive effect on the menopause. So keep drinking the beer! My partner has discovered non-alcoholic IPAs, now a regular feature of our evening meal.

IPAs (Indian Pale Ale) are made using hops which carry plant-based compounds known as phytoestrogens. These compounds have been marketed as a natural alternative to oestrogen replacement therapy. Theyre present in soybeans, which is why soya, too, is suggested as being beneficial for women experiencing menopause.

Several years ago men were warned that drinking IPAs could contribute to man boobs because of their phytoestrogen content. But though that may have been a negative for affected males, it was a positive for women struggling with their hormones.

And while heavy drinking of alcohol has been linked with multiple health risks, moderate drinking of beer could be beneficial. As Val McDermid herself points out, alcohol-free versions are available and are at least just as good for menopause.

The results of a study carried out in Spain and published in 2012 looked at the effects of non-alcoholic hoppy beers. The researchers found that women who drank the beers with dinner had lower levels of anxiety and better sleep quality.

Drinking alcohol has been shown to increase anxiety levels and disrupt sleep quality, suggesting non-alcoholic options could be best for the insomnia that often accompanies menopause.

Menopause is caused by changes in the balance of hormones, with the ovaries producing less oestrogen and progesterone, the two key hormones that control the reproductive system.

According to the NHS website, menopause (when a woman stops having periods completely) usually occurs between 45 and 55 years of age, with the average age for a woman to reach the menopause in the UK being 51.

Symptoms can begin months or years before women stop menstruating and include night sweats, hot flushes, vaginal dryness, difficulty sleeping, low mood, anxiety, and reduced sex drive.

Eating a healthy and balanced diet is thought to play an important role in managing symptoms, and phytoestrogens appear to be particularly beneficial. If youre eating a healthy diet of fruits, vegetables, legumes (such as peas, lentils and beans) and some grains, you will already be eating them.

In addition to IPA drinks and soya-based foods, other notable sources of phytoestrogens include broccoli, carrots, coffee and tea, evening primrose oil and oranges.

Studies suggest phytoestrogens can also help prevent the bone-density loss in ageing women that is linked to menopause, with oestrogen known to help maintain normal bone density.

The web is awash with great recipe ideas for phytoestrogen-rich dishes and snacks, including Liz Earles menopause cake.

Most of the major supermarkets now carry alcohol-free IPA options. There are also several Scottish brewers producing alcohol-free IPAs to try out, including Ellon-based Brewdog, which offers this 0.5% Punk drink (carried by a couple of the major supermarekts), alongside their Nanny-State alcohol-free hoppy ale.

Edinburgh-based Jump Ship Brewing, which is dedicated to producing alcohol-free beers, also has a 0.5% Flying Colours pale ale.

Another Edinburgh-based alcohol-free brewer is Coast Beer which produces a range of IPAs available in mixed and single cases.

Gut doctor on why adding more fibre to your diet could transform your health

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Why author Val McDermid recommends drinking pale ale to help with menopause symptoms - Press and Journal

Future Market Insights (FMI) presents its new, comprehensive study on the Gobal Hormone Replacement Therapy Marketspanning from 2020 to 2027. Researches at FMI have no left no stone unturned in bestowing readers a comprehensive view of the market, by studying the drivers, trends, challenges, and restraints. Backed by historical data and projected data, the report breaks down the vast study into numerous geographies and end-use segments, among others to condense the research. The report also considers production and consumption analysis, value chain analysis, key findings, important suggestions and recommendations, and other aspects

Analysts at FMI have employed in-depth analysis to offer a lucid understanding of the market and the factors shaping its growth trajectory. Ranging from macro socio-economic factors to micro geography-specific trends, the research has taken into consideration every facet that is likely to play a vital role in the growth of the market in the years to come. Presenting a plethora of valuable information, the report will serve as an effective tool, guiding the market players in making fruitful decisions in the forthcoming years.

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Impact of COVID-19 on Hormone Replacement Therapy Market

The unforeseen outbreak of COVID-19, which swiftly metamorphosed into the pandemic of unexpected proportions, has shifted the worlds focus towards the healthcare sector. National governments are closely working with healthcare institutions and pharmaceutical companies to provide effective treatment to patients suffering with the infection. As a result, there has been a reorientation of medical priorities across healthcare institutions with treatment for COVID-19 patients being the utmost priority. This is sure to impact the growth of the Hormone Replacement Therapy market through the pandemic period.

FMIs report includes a dedicated section expounding both the short-term and long-term impact of the pandemic on the Hormone Replacement Therapy market. The study is shaped to bolster stakeholders in making the right decisions to mitigate challenges and leverage opportunities through the pandemic.

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Hormone Replacement Therapy Market: Segmentation

To simply the gargantuan study, the report is segregated on the basis of different segments.

Based on Therapy Type,

Based on Application

By Region:

The aforementioned segments are studied with respect to each individual region, considering the region-specific trends, drivers and restraints.

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Key Questions Answered in FMIs Hormone Replacement Therapy Market Report

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Future Market Insights is the premier provider of market intelligence and consulting services, serving clients in over 150 countries. FMI is headquartered in London, the global financial capital, and has delivery centers in the U.S. and India.

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Hormone Replacement Therapy Market Research Conclusions|Business Plans|Strategies with Forecast 20 - PharmiWeb.com

Hormone Replacement Therapy Market report would come handy to understand the competitors in the market and give an insight into sales, volumes, revenues in the Hormone Replacement Therapy Industry & will also assists in making strategic decisions. The report also helps to decide corporate product & marketing strategies. It reduces the risks involved in making decisions as well as strategies for companies and individuals interested in the Hormone Replacement Therapy industry. Both established and new players in Hormone Replacement Therapy industries can use the report to understand the Hormone Replacement Therapy market.

In Global Market, the Following Companies Are Covered:

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Analysis of the Market:

Hormone replacement therapy refers to the treatment of the patients with hormone deficiency due to conditions such as dwarfism or women nearing menopause, which requires replacement of hormones in the body whose levels have become low.

Market competition is intense. Eli Lilly, Pfizer, AbbVie, Novo Nordisk, etc. are the leaders of the industry, and they hold key technologies and patents, with high-end customers. Top 5 players combined 45.13% market share in all.

The global Hormone Replacement Therapy market is valued at 15950 million USUSD in 2020 is expected to reach 17720 million USUSD by the end of 2026, growing at a CAGR of 1.5% during 2021-2026.

This report focuses on Hormone Replacement Therapy volume and value at the global level, regional level and company level. From a global perspective, this report represents overall Hormone Replacement Therapy market size by analysing historical data and future prospect. Regionally, this report focuses on several key regions: North America, Europe, China, Japan and Middle East et

Hormone Replacement Therapy Market Breakdown by Types:

s

Hormone Replacement Therapy Market Breakdown by Application:

Critical highlights covered in the Global Hormone Replacement Therapy market include:

The information available in the Hormone Replacement Therapy Market report is segmented for proper understanding. The Table of contents contains Market outline, Market characteristics, Market segmentation analysis, Market sizing, customer landscape & Regional landscape. For further improving the understand ability various exhibits (Tabular Data & Pie Charts) has also been used in the Hormone Replacement Therapy Market report.

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Reasons for Buy Hormone Replacement Therapy Market Report:

In the end, Hormone Replacement Therapy Industry report provides the main region, market conditions with the product price,profit, capacity, production, supply, demand and market growth rateand forecast etc. This report also Present newproject SWOT analysis,investment feasibility analysis, andinvestment return analysis.

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Name: Mr. Ajay More

Email: [emailprotected]

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Hormone Replacement Therapy Market anticipates revenue will hit up to XX% CAGR by 2026: Segmentation by Revenue, Gross margin, Industrial Analysis,...

Dataintelo publishes a detailed report on Hormone Replacement Therapy (HRT) market providing a complete information on the current market situation and offering robust insights about the potential size, volume, and dynamics of the market during the forecast period, 2020-2026. This report offers an in-depth analysis that includes the latest information including the current COVID-19 impact on the market and future assessment of the impact on Global Hormone Replacement Therapy (HRT) Market. The report contains XX pages, which will assist clients to make informed decision about their business investment plans and strategies for the market. As per the report by Dataintelo, the global Hormone Replacement Therapy (HRT) market is projected to reach a value of USDXX by the end of 2026 and grow at a CAGR of XX% during the forecast period.

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The Hormone Replacement Therapy (HRT) market report also covers an overview of the segments and sub-segmentations including the product types, applications, and regions. In the light of this harsh economic condition as prompted by the COVID-19 outbreak, the report studies the dynamics of the market, changing competition landscape, and the flow of the global supply and consumption.

The report exclusively deals with key areas such as market size, scope, and growth opportunities of the Hormone Replacement Therapy (HRT) market by analyzing the market trend and data available for the period from 2020-2026. Keeping 2019 as the base year for the research study, the report explains the key drivers as well as restraining factors, which are likely to have major impact on the development and expansion of the market during the forecast period.

The report, published by Dataintelo, is the most reliable information as the study relies on a concrete research methodology focusing on both primary as well as secondary sources. The report is prepared by relying on primary source including interviews of the company executives & representatives and accessing official documents, websites, and press release of the private and public companies.

The report, prepared by Dataintelo, is widely known for its accuracy and factual figures as it consists of a concise graphical representations, tables, and figures which displays a clear picture of the developments of the products and its market performance over the last few years. It uses statistical surveying for SWOT analysis, PESTLE analysis, predictive analysis, and real-time analytics.

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Furthermore, the scope of the growth potential, revenue growth, product range, and pricing factors related to the Hormone Replacement Therapy (HRT) market are thoroughly assessed in the report in a view to entail a broader picture of the market. The report also covers the recent agreements including merger & acquisition, partnership or joint venture and latest developments of the manufacturers to sustain in the global competition of the Hormone Replacement Therapy (HRT) market.

Competition Landscape:

The report covers global aspect of the market, covering

Global Hormone Replacement Therapy (HRT) market by Types:

OralParenteralTransdermalOthers

Global Hormone Replacement Therapy (HRT) market by Applications:

MenopauseHypothyroidismMale HypogonadismGrowth Hormone DeficiencyOthers

Key Players for Global Hormone Replacement Therapy (HRT) market:

Abbott LaboratoriesNovartisPfizerMylan LaboratoriesMerck & Co.AmgenNovo NordiskBayerEli LilyWyethGenentech

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Dataintelo offers attractive discounts on customization of reports as per your need. This report can be personalized to meet your requirements. Get in touch with our sales team, who will guarantee you to get a report that suits your necessities.

About US:

DATAINTELO has set its benchmark in the market research industry by providing syndicated and customized research report to the clients. The database of the company is updated on a daily basis to prompt the clients with the latest trends and in-depth analysis of the industry.

Our pool of database contains various industry verticals that include: IT & Telecom, Food Beverage, Automotive, Healthcare, Chemicals and Energy, Consumer foods, Food and beverages, and many more. Each and every report goes through the proper research methodology, validated from the professionals and analysts to ensure the eminent quality reports.

Contact US:Name Alex MathewsPhone No.: +1 909 545 6473Email [emailprotected] Website https://dataintelo.com/ Address 500 East E Street, Ontario, CA 91764, United States.

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Hormone Replacement Therapy (HRT) Market 2020 Determined By Manufacturing Summary, Business Profile And Estimate To 2026 - PRnews Leader

Hormone Replacement Therapy Market

IndustryGrowthInsights, 18-10-2020: The research report on the Hormone Replacement Therapy Market is a deep analysis of the market. This is a latest report, covering the current COVID-19 impact on the market. The pandemic of Coronavirus (COVID-19) has affected every aspect of life globally. This has brought along several changes in market conditions. The rapidly changing market scenario and initial and future assessment of the impact is covered in the report. Experts have studied the historical data and compared it with the changing market situations. The report covers all the necessary information required by new entrants as well as the existing players to gain deeper insight.

Furthermore, the statistical survey in the report focuses on product specifications, costs, production capacities, marketing channels, and market players. Upstream raw materials, downstream demand analysis, and a list of end-user industries have been studied systematically, along with the suppliers in this market. The product flow and distribution channel have also been presented in this research report.

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The Major Manufacturers Covered in this Report:Eli LillyPfizerAbbVieNovo NordiskMerck KGaAMylanBayerTevaNovartisAbbottRocheEndo InternationalIpsenANI PharmaceuticalsTherapeuticsMD

The Research Study Focuses on:

By Types:Estrogen HormoneGrowth HormoneThyroid HormoneTestosterone HormoneThe proportion of estrogen hormone in 2018 is about 50%, and the proportion is in increasing trend from 2014 to 2018.

By Applications:MenopauseHypothyroidismGrowth Hormone DeficiencyMale HypogonadismOther DiseasesThe most proportion of hormone replacement therapy is used in menopause, and the proportion in 2018 is 46.2%.

By Regions:

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The Hormone Replacement Therapy Market Report Consists of the Following Points:

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In conclusion, the Hormone Replacement Therapy Market report is a reliable source for accessing the research data that is projected to exponentially accelerate your business. The report provides information such as economic scenarios, benefits, limits, trends, market growth rate, and figures. SWOT analysis is also incorporated in the report along with speculation attainability investigation and venture return investigation.

About IndustryGrowthInsights:IndustryGrowthInsights has set its benchmark in the market research industry by providing syndicated and customized research report to the clients. The database of the company is updated on a daily basis to prompt the clients with the latest trends and in-depth analysis of the industry. Our pool of database contains various industry verticals that include: IT & Telecom, Food Beverage, Automotive, Healthcare, Chemicals and Energy, Consumer foods, Food and beverages, and many more. Each and every report goes through the proper research methodology, validated from the professionals and analysts to ensure the eminent quality reports.

Contact Info:Name: Alex MathewsAddress: 500 East E Street, Ontario,CA 91764, United States.Phone No: USA: +1 909 545 6473 | IND: +91-7000061386Email: [emailprotected]Website: https://industrygrowthinsights.com

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Hormone Replacement Therapy Market 2020 Industry Size, Trends, Global Growth, Insights And Forecast Research Report 2025 - PRnews Leader