ROSEMONT, PA, April 9th, 2019 – Medunik USA, a company dedicated to improving the health and quality of life of Americans with rare diseases, is pleased to announce that Siklos® (hydroxyurea) is now available to safety-net provider locations served by Apexus, the 340B Pricing Program Prime Vendor.
Effective today, Siklos® will be provided at a discounted price to all public health clinics and organizations that participate in the 340B Prime Vendor Program (PVP), thus expanding access to Siklos® to young sickle cell anemia patients in the U.S.
Sub-WAC (below wholesale acquisition cost) pricing will be available for patients not eligible for 340B product dispensing, disproportionate share hospitals (DSH), children’s hospitals (PED) and freestanding cancer clinics (CAN).
Siklos® is the first and only FDA-approved hydroxyurea-based treatment for pediatric patients with sickle cell anemia. It is indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in children two years of age and older with sickle cell anemia with recurrent moderate to severe painful crises. Low blood cell counts are common with Siklos® and can be severe and life threatening.
“Because Siklos® is the only treatment of its kind with a pediatric indication, we are committed to making it accessible to every child who needs it. That is why it was so important to us to be able to offer Siklos® through the 340B drug pricing program”, explained Dean Hopkins, Medunik USA’s General Manager.
The importance of optimal hydroxyurea dosing based on patient body weight has been well established. Siklos® tablets are available in 100 mg film-coated tablets and 1,000 mg triple-scored tablets to allow dose adjustments in increments as small as 50 mg (beginning at a 200 mg dose). Siklos® tablets are dissolvable in water for patients who are unable to swallow them whole. For more information about Siklos®, please visit siklosusa.com
IMPORTANT SAFETY INFORMATION
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
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.