Siklos®

Drug - Siklos® (hydroxyurea) [Medunik]

April 2019

Therapeutic Area - Sickle cell anemia

Approval criteria

Patient has diagnosis of sickle cell anemia with recurrent moderate to severe painful crises AND
Patient is ≥ 2 years of age AND
Patient does NOT have a myeloproliferative disorder (for which Siklos is not approved) AND
Negative pregnancy status in female patients prior to starting Siklos therapy AND
Patient (female and male) attest to use of effective contraception during therapy, and for ≥ 6 months after discontinuation of Siklos AND
Patient has adequate functioning bone marrow at start of therapy as indicated by:
- Absolute neutrophil count (ANC) ≥ 1,250/mm3 AND
- Platelet count ≥ 80,000 mm3 AND
- Hemoglobin (Hb) ≥ 4.5 g/dL AND
- Reticulocyte count ≥ 80,000 mm3 if Hb < 9 g/dL AND
The patient’s blood counts will be monitored at baseline and every 2 weeks during therapy AND
Prescriber attests to patient counseling regarding sun protection and will monitor for malignancies

Quantity limits

35 mg/kg/day; and patient’s most current weight must be provided at time of request
Calculate the rounded doses to the nearest 50 mg or 100 mg strength; and provide clinical rationale for rounding dosages taking into consideration that Siklos 100 mg tablets cannot be split; and Siklos 1000 mg tablets can be split into four 250 mg parts

Background

Siklos is an antimetabolite, FDA-approved to reduce the frequency of painful crises and to reduce the need for blood transfusions in pediatric patients, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises.

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411