Siklos® is the first and only FDA-approved 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.
Sickle cell disease is an inherited disease that affects the red blood cells. Individuals with the disease have abnormal red blood cells that are stiff and half-moon-shaped, causing them to become stuck in the blood vessels, blocking blood flow. These blockages can cause crippling pain and organ damage, which require hospitalization.
Science does not fully understand how hydroxyurea works, but studies suggest that it increases the amount of fetal hemoglobin (HbF), as well as the amount of water, in red blood cells. In this way, Siklos® helps keep red blood cells round and flexible so they can travel more easily through the blood vessels. This may help reduce painful crises and some of the complications of the disease.
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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.
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.
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.
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.
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 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.SIKLOSusa.com
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.
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.
