Siklos, the first and only hydroxyurea-based treatment for pediatric patients with sickle cell anemia, now available in 100 mg scored tablets to help…

ROSEMONT, Pa., Oct. 19, 2020 /PRNewswire/ - Medunik USA is proud to announce that Siklos (hydroxyurea), indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in children, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises1, is now available in a 100 mg scored tablet in addition to the 1,000 mg triple-scored tablets.

Siklos has a Boxed Warning regarding low blood cell counts and cancer; please read Important Safety Information below.

"Medunik USA is proud to offer pediatric SCA patients a new option that helps optimize daily dosing. With the newly available Siklos 100 mg scored tablets, dose adjustments can now be made in 50 mg increments. Coupled with Siklos 1,000 mg triple-scored tablets (4 x 250 mg), this will offer more accurate dose adjustmentsand may make it more convenient than compounded hydroxyurea," affirmed Tanya Carro, General Manager, at Medunik USA.

The importance of optimal dosing of hydroxyurea in sickle cell anemia (SCA) patients, based on patient body weight and biological and clinical response, has been well established.2,3 This is particularly relevant in pediatric populations, where patient weight is constantly changing.

In addition to its flexible dosing, Siklos may help increase patient compliance, as it is dissolvable in water for patients who are unable to swallow tablets whole.4 Siklos tablets should be taken once daily, at the same time every day, with a glass of water. For patients who are not able to swallow the tablets, they can be dispersed immediately before use in a small quantity of water in a teaspoon.

"I can't stress enough the importance of treating pediatric patients as early as possible. Why wait for painful episodes to occur and risk complications when you can give a child Siklos and reduce the frequency of recurrent painful crises once they turn 2? There's no reason to wait. Physicians and parents need to know about Siklos!," said Dr. Corey Hebert, MD, Chief Medical Officer at Dillard University and well-known medical broadcast journalist.

Medunik is committed to providing Siklos at the lowest possible cost to all patients. That is why the company continues to offer cost savings and free home delivery through the Siklos At Home program.

For more information about prescribing Siklos tablets, please visit siklosusa.com.

SIKLOS (hydroxyurea) tablets, for oral use

WHAT IS SIKLOS?

SIKLOS is a prescription medicine that is used to reduce the frequency of painful crises and reduce the need for blood transfusions in children, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises.

It is not known if SIKLOS is safe and effective in children less than 2 years of age.

IMPORTANT SAFETY INFORMATION

WARNING: LOW BLOOD CELL COUNT and CANCERSee full prescribing information for complete Boxed Warning.

WHAT IS THE MOST IMPORTANT INFORMATION YOU SHOULD KNOW ABOUT SIKLOS?

WHO SHOULD NOT TAKE SIKLOSDo not take SIKLOS if you are allergic to hydroxyurea or any of the ingredients inSIKLOS.See the Medication Guide for a list of the ingredients inSIKLOS.

WHAT SHOULD YOU TELL YOUR HEALTH CARE PROVIDER BEFORE TAKING SIKLOS?Tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF SIKLOS?

SIKLOS may cause serious side effects, including:

See "What is the most important information I should know about SIKLOS?"

The most common side effects of SIKLOS include:

These are not all the possible side effects of SIKLOS.

You are encouraged to report negative side effects of prescription drugs to the FDA at http://www.fda.gov/medwatch, or 1-800-FDA-1088.

Please read the Full Prescribing Information, including Boxed Warning, Medication Guide and Instructions for Use, at http://www.SIKLOSusa.com.

For more information about SIKLOS, we invite you to contact our Medical Information Service at 1 844-884-5520 or https://www.medunikusa.com/en/medical-information-service.

About Medunik USABased in Pennsylvania, Medunik USA works to improve the health and quality of life of Americans living with rare diseases by making orphan drug therapies available in the United States. With strategic partnerships at the global level, the company has critical experience in approval and market access processes as well as the marketing of orphan drug therapies. Medunik USA makes critical medications to treat rare diseases available to American patients who might not otherwise have access to these medications. For more information, visit: http://www.medunikusa.com.

References1. Siklos (hydroxyurea) tablets, for oral use [Prescribing Information]. Addmedica, May 20182. Optimizing hydroxyurea therapy for sickle cell anemia, Ware et al. Hematology Am Soc Hematol Educ Program. 2015;2015:436-432.3. Hydroxyurea for the Treatment of Sickle Cell Disease: Efficacy, Barriers, Toxicity, and Management in Children, Strouse et al. Pediatric Blood Cancer. 2012 August; 59(2): 365371.4. Parental and Other Factors Associated with Hydroxyurea Use for Pediatric Sickle Cell Disease, Oyeku et al. Pediatr Blood Cancer. 2013 April ; 60(4): 653658.

SOURCE Medunik USA

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Siklos, the first and only hydroxyurea-based treatment for pediatric patients with sickle cell anemia, now available in 100 mg scored tablets to help...