Siklos® now available in 1,000 mg triple-scored tablets to help optimize dosing

ROSEMONT, PA, November 13, 2018 – Medunik USA, a company dedicated to improving the health and quality of life of Americans with rare diseases by making orphan drugs available in the U.S., is proud to announce today that Siklos® (hydroxyurea), an FDA-approved orphan drug, is now available in 1,000 mg triple-scored tablets to help optimize dosing.

Siklos® is the first and only FDA-approved hydroxyurea-based treatment indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in pediatric patients two years of age and older with sickle cell anemia with recurrent moderate to severe painful crises.1 Siklos has a boxed warning, please see important safety information below.

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.

“Medunik is proud to offer pediatric SCA patients a new option that helps optimize daily dosing. Given that the new triple-scored Siklos® 1,000 mg tablets can be divided into four equal parts of 250 mg each, when combined with the 100 mg tablets, it is now possible to adjust dosing in increments as small as 50 mg (starting at a 200 mg dose),” affirmed Dany Hallé, Vice President, Commercial Affairs, at Medunik.

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

For more information about prescribing Siklos® tablets, which are dissolvable in water for patients who are unable to swallow tablets whole, please visit siklosusa.com 

WARNING: LOW BLOOD CELL COUNT AND CANCER

  • Low blood cell counts are common with Siklos®, including low red blood cells, white blood cells, and platelets, and can be severe and life threatening. If your white blood cell count becomes very low, you are at increased risk for infection. Your healthcare provider will check your blood cell counts before and during treatment with Siklos®. Your healthcare provider may change your dose or tell you to stop taking Siklos® if you have low blood cell counts. Tell your healthcare provider right away if you get any of the following symptoms: fever or chills; shortness of breath; body aches; unusual headache; feeling very tired; bleeding or unexplained bruising.
  • Cancer. Some people have developed cancer, such as leukemia and skin cancer, after taking Siklos® for a long time. Your healthcare provider will check you for cancer. You should protect your skin from the sun using sunblock, hats, and sun-protective clothing.


WHAT IS THE MOST IMPORTANT INFORMATION YOU SHOULD KNOW ABOUT SIKLOS®?
• Siklos® can harm your unborn baby.

• For females taking Siklos® who can become pregnant:

  • You should talk with your healthcare provider about the risks of Siklos® to your unborn baby.
  • You should use effective birth control during treatment with Siklos® and for at least 6 months after treatment with Siklos®.
  • Your healthcare provider will perform a pregnancy test before you start treatment with Siklos®. Tell your healthcare provider right away if you become pregnant or think you  may be pregnant.
  • For males taking Siklos®. Siklos® can affect your sperm. If you have a female sexual partner who can become pregnant, you should use effective birth control during treatment with Siklos® and for at least 6 months after treatment.

Siklos® may cause fertility problems in males. Talk to your healthcare provider if this is a concern for you.

WHO SHOULD NOT TAKE SIKLOS®?
Do not take Siklos® if you are allergic to hydroxyurea or any of the ingredients in Siklos®. See the Medication Guide for a list of the ingredients in Siklos®.

Siklos® may cause serious side effects, including skin ulcers (including leg ulcers) and enlarged red blood cells (macrocytosis).

The most common side effects of Siklos® include: infections, headache, fever, skin problems, stomach and intestine problems, decrease in vitamin D and weight gain. These are not all the possible side effects of Siklos®.

Please consult full Prescribing Information, including Boxed Warning.

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

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

References
1. Siklos® (hydroxyurea) tablets, for oral use [Prescribing Information]. Addmedica, May 2018
2. 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): 365–371.

About Medunik USA
Based 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: www.medunikusa.com 

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