SIKLOS® (hydroxyurea) is now covered by State Medicaid programs in 19 states

PRINCETON, N.J., Sept. 21, 2023 (GLOBE NEWSWIRE) —

Medunik USA (member of Duchesnay Pharmaceutical Group) is pleased to announce that government coverage of Siklos^® (hydroxyurea, HU) under State Medicaid programs is now available in 19 states: 5 states with preferred coverage: FL, TX, WI, & WY as well as on the Contract Drug List in California (for pediatric patients), and covered in another 14 states (NY, GA, MI, NC, SC, NJ, MS, VA, MO, PA, TN, MA, AZ, & NE) with prior authorizations*, in addition to the expanding commercial coverage for the benefit of Americans with sickle cell anemia (SCA).

Siklos^® is the only FDA-approved hydroxyurea-based treatment indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult and pediatric patients, 2 years of age and older, with sickle cell anemia with recurrent moderate to painful crises.

The most common side effects to Siklos^® include infections and low white blood cells in children and infections, headache and dry skin in adults. Siklos^® has a Boxed Warning regarding low blood cell counts and cancer; please read Important Safety Information below.

Being the only formulation of hydroxyurea available in 100 mg & 1,000 mg scored tablets that allow for body-weight adjusted dosing, Siklos^® can also be dissolved in a small amount of water for those who have difficulty swallowing pills or capsules. It is an affordable alternative to compounded HU with a longer shelf life of up to 36 months. Distributed through retail pharmacies, Siklos^® will not be affected by the upcoming USP compounding standards which are expected to take effect in November.

“Since launching Siklos^® five years ago, Medunik USA has been focusing its efforts on easing access to this valuable treatment option which is now covered by State Medicaid programs in 19 states,” said Tanya Carro, Executive Vice-President of Medunik USA. “We, at Medunik USA, are aware of the challenges SCA patients may face in securing affordable and effective medication for their health condition and are committed to expanding our network of commercial and government insurers in the months to come.”

Sickle cell anemia is the most common inherited blood disorder, resulting in the production of abnormal hemoglobin, known as hemoglobin-S, responsible for the sickling of red blood cells. This disease affects nearly 100,000 Americans, decreases life expectancy by 25 to 30 years, induces significant morbidity and, may therefore, reduce quality of life^1,2. Most of those affected are of African ancestry; a minority are of Hispanic or southern European, Middle Eastern or Asian Indian descent³.

*usually requires diagnosis & patient being of appropriate age

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 adults and 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 every 2 weeks 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^®.

HOW SHOULD I TAKE SIKLOS^®?

Read the Instructions for Use for step-by-step instructions on how to prepare a dose of SIKLOS^®.

• Take SIKLOS^® exactly as your healthcare provider tells you to take it.
• Take SIKLOS^® 1 time a day at the same time each day.
• Swallow the tablets with a glass of water. If you are not able to swallow SIKLOS^® tablets, you can dissolve your prescribed dose in a small amount of water in a teaspoon and swallow right away.
• SIKLOS^® tablets must be handled with care.

WHAT SHOULD YOU TELL YOUR HEALTHCARE PROVIDER BEFORE TAKING SIKLOS^®?

Tell your healthcare provider about all of your medical conditions, including if you:

• have kidney problems or are receiving hemodialysis
• have liver problems
• have human immunodeficiency virus (HIV) or take HIV medicines. Taking SIKLOS^® with certain HIV medicines can cause serious reactions and may lead to death.
• have increased levels of uric acid in your blood (hyperuricemia)
• have a history of receiving interferon therapy or are currently receiving interferon therapy
• have leg wounds or ulcers
• plan to receive any vaccinations. You should not receive “live vaccines” during treatment with SIKLOS^®.
• are pregnant or plan to become pregnant. See “What is the most important information I should know about SIKLOS^®?”
• are breastfeeding or plan to breastfeed. It is not known if SIKLOS^® can pass into your breast milk. Do not breastfeed during treatment with SIKLOS^®. 

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^®?”

• Skin ulcers, including leg ulcers, and death of skin tissue (gangrene) have happened in people who take SIKLOS^®. This has happened most often in people who receive interferon therapy or have a history of interferon therapy. Your healthcare provider will decrease your dose or stop treatment with SIKLOS^® if you develop any skin ulcers.
• Enlarged red blood cells (macrocytosis). Macrocytosis is common in people who take SIKLOS^® and can make it difficult to detect a decrease of folic acid. Your healthcare provider may prescribe a folic acid supplement for you.
• Hemolytic Anemia, the fast breakdown of red blood cells, has happened in people who take SIKLOS^®. Tell your healthcare provider if you develop yellowing of your skin (jaundice) or blood in your urine. Your healthcare provider may do blood tests if you have persistent or worsening anemia not related to sickle cell anemia.

The most common side effects of SIKLOS^® in children include: infections and low white blood cells.

The most common side effects of SIKLOS^® in adults include: infections, headache, and dry skin.

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 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 www.SIKLOS^®usa.com. 

About Medunik USA
Based in Princeton, New Jersey, Medunik USA is part of Duchesnay Pharmaceutical Group and 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.

About Duchesnay Pharmaceutical Group

Duchesnay Pharmaceutical Group (DPG), with its affiliated companies, is headquartered in Blainville, Quebec, Canada. The Group consists of five pharmaceutical companies to meet the needs of patients in Canada, the U.S. and abroad. The companies are Duchesnay (Canada) and Duchesnay USA, both dedicated to women’s health; Médunik Canada and Medunik USA, which provide treatments for rare diseases; and Analog Pharma, an American generic drugs company, specializing in authorized generics and orphan drugs. From its state-of-the-art manufacturing plant, DPG exports its innovative treatments to more than 50 countries.

The Group, through its proprietary research and development, and through exclusive partnerships, offers innovative treatments for a variety of medical conditions in women’s health, urology, oncology as well as for rare diseases. DPG recognizes the dedication and professionalism of its employees and promotes an inclusive culture and flexible work environment. It is deeply committed to environmental responsibility and to giving back to the community through the support of various charitable organizations. For more information, visit duchesnaypharmaceuticalgroup.com.

References

1. Platt OS et al. Mortality in sickle cell disease. Life expectancy and risk factors for early death. The New England Journal of Medicine 330, 1639-1644, doi:10.1056/NEJM199406093302303 (1994).
2. McGann PT and Ware RE, Hydroxyurea therapy for sickle cell anemia. Expert opinion on drug safety 14, 1749-1758, doi:10.1517/14740338.2015.1088827 (2015).
3. National Heart, Lung, and Blood Institute, National Institutes of Health, Sickle Cell Disease, https://www.nhlbi.nih.gov/health-topics/sickle-cell-disease
4. Prescribing information https://files.medunik.com/usa/siklos/prescribing-information.pdf 

Media contact:
Mariia Savchuk
Senior Communication Advisor
Email: msavchuk@duchesnay.com
Telephone: 1-877-833-7734 ext. 149

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/fdd06472-cd99-437b-a7a9-c3177912aa4d