Siklos® (hydroxyurea) now available through ProCare Pharmacy Care's Siklos At Home™ program

ROSEMONT, PA, Sept. 12, 2018 /PRNewswire/ - Medunik USA announced today that Siklos® (hydroxyurea), the first and only hydroxyurea-based treatment FDA-approved for pediatric patients with sickle cell anemia, is now available through the Siklos At Home™ program.

"The recent launch of Siklos® represents an important milestone in Medunik USA's mission to support patients with rare diseases - in this case, sickle cell anemia," said Dean Hopkins, the company's General Manager. "We are looking forward to introducing this treatment to pediatric patients with sickle cell anemia and committed to providing Siklos® at the lowest possible cost to all patients, whether they are cash-paying or have commercial or Medicaid healthcare coverage, through the Siklos At Home™ program, offered through our specialty pharmacy, ProCare Pharmacy Care."

Through Siklos At Home™, commercially insured patients can receive Siklos® for as little as $0 copay per prescription. Patients who are not insured or whose insurance does not cover Siklos® can pay as little as $99 for 60 tablets or $149 for 90 tablets.

In addition to providing savings on the cost of a prescription, the Siklos At Home™ program offers home delivery at no additional charge, as well as insurance benefit verification, monthly refill reminders, prior authorization support and pharmacists to answer product questions.

For physicians' offices, the Siklos At Home™ program offers the convenience of patient benefit verification, assistance with prior authorizations, monthly refill reminders for patients, as well as three easy ways to prescribe Siklos®: by telephone, by fax or by e-prescription.

Children with sickle cell anemia have abnormal red blood cells that become stuck in the blood vessels, blocking blood flow. These blockages can cause crippling pain and organ damage, which begins early in life and worsens over time.¹ That is why early treatment and a medication like Siklos®, specifically indicated for a pediatric population, are so important.

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.²

Thanks to the Siklos At Home™ program, filling a prescription for Siklos® is now more affordable and convenient for families whose time and resources are best spent caring for their child.

About 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.

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

• 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 Sickle Cell Anemia
Sickle cell anemia, also known as sickle cell disease, is a hereditary genetic disease caused by a mutation in gene encoding hemoglobin, the molecule in red blood cells that transports oxygen from the lungs to other parts of the body. Red blood cells with normal hemoglobin (hemoglobin-A) are smooth, round and flexible therefore, they glide through blood vessels, even in tight capillary beds. People with sickle cell anemia have abnormal hemoglobin molecules (hemoglobin-S) that can form long, rod-like structures and clump together. This causes red blood cells to become stiff, assuming a sickle shape. These sickled red blood cells tend to pile together, creating clots, and blocking the flow of blood through vessels. This can cause a number of complications, including vaso-occlusive crises with damage to several organs and disabling pain episodes. Problems due to sickle cell anemia can begin at a very young age.³ Therefore, an early and adapted management of the disease in children is crucial to minimize the impact of these complications.

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.

References

     1 Platt, OS and al., Mortality in sickle cell disease. Life expectancy and risk
         factors for early death., N Engl J Med. 1994 Jun 9;330(23):1639-44.



     2 Siklos(R) (hydroxyurea) tablets, for oral use [Prescribing Information].
         Addmedica, May 2018.



     3 Sickle Cell Disease, <https://www.nhlbi.nih.gov/health-topics/sickle-
         cell-disease>

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SOURCE Medunik USA