Siklos Becomes First Sickle Cell Drug with Pediatric Indication
December 21, 2017 – The U.S. FDA has approved Siklos (hydroxyurea) tablets, manufactured by Addmedica, to reduce the frequency of painful sickle cell crises and the need for blood transfusions in pediatric patients at least two years of age who have sickle cell anemia with recurrent moderate to severe painful crises. Siklos, an antimetabolite, is the first drug to receive FDA approval for use in pediatric patients diagnosed with sickle cell disease.
Recommended dosing with Siklos is based on weight, starting at 20mg/kg once daily. The daily dosage can be increased by 5mg/kg once every eight weeks until blood counts reach an acceptable range. If the patient experiences a severe painful crisis, the dosage may be increased ahead of schedule. Dosage should not exceed 35mg/kg per day. Siklos will be available in two tablet forms: 100mg and 1,000mg. The 1,000mg tablets will be triple-scored to allow them to be divided as needed for proper dosage.
A black box warning cautions that Siklos may cause severe myelosuppression and is a known carcinogen. Patients should not be prescribed Siklos if they have depressed bone marrow function. While taking Siklos, patients should be monitored for malignancies and to assess blood counts. Patients should also be advised to use sun protection.
Addmedica has not yet announced plans for pricing or launch.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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