Posted from: Tuesday, January 16, 2018 - 12:22 PM - Present

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.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Monday, September 16, 2019 - 08:45 AM.