Medunik USA announced the launch of Siklos (hydroxyurea) tablets indicated to reduce the frequency of painful crises and need for blood transfusions in patients aged ≥2 years with sickle cell anemia with recurrent moderate to severe painful crises. This is the first hydroxyurea-based treatment for use in pediatric patients with sickle cell anemia. 

Hydroxyurea, an antimetabolite, is thought to cause an immediate inhibition of DNA synthesis by acting as a ribonucleotide reductase inhibitor, without interfering with the synthesis of ribonucleic acid or of protein. It may contribute to clinical benefit by increasing fetal hemoglobin (hemoglobin F) levels in red blood cells, decreasing neutrophils, increasing water content of red blood cells, increasing deformability of sickled cells, and altering the adhesion of red blood cells to endothelium. 

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The approval was supported by tolerability and efficacy data from a European sickle cell disease cohort study (N=405). Treatment with Siklos increased the concentration of hemoglobin F and the number of patients having ≥1 painful crisis in the 12 months prior to treatment was significantly reduced after 12 months of treatment. 

Siklos carries a Boxed Warning regarding the risks of myelosuppression and malignancies. It is available as 100mg strength tablets in 60-count bottles.

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