Usual Adult Dose for Thrombocythemia

Initial: 0.5 mg orally 4 times a day, or 1 mg orally twice a day, for a minimum of 7 days.

Maintenance: titrate to the lowest effective dosage required to reduce and maintain the platelet count at less than 600,000 cells/microliter, ideally down to normal levels. Increase the dosage by no more than 0.5 mg/day in any 1 week period.

The dosage should not exceed 10 mg/day or 2.5 mg in any single dose.

Usual Pediatric Dose for Chronic Myelogenous Leukemia

Initial dose: 0.5 mg orally daily (recommended) to 0.5 mg orally 4 times daily

Maintenance: titrate to the lowest effective dosage required to reduce and maintain the platelet count at less than 600,000 cells/microliter, ideally down to normal levels. Increase the dosage by no more than 0.5 mg/day in any 1 week period.

The dosage should not exceed 10 mg/day or 2.5 mg in any single dose.

Usual Pediatric Dose for Thrombocythemia

Initial dose: 0.5 mg orally daily (recommended) to 0.5 mg orally 4 times daily

Maintenance: titrate to the lowest effective dosage required to reduce and maintain the platelet count at less than 600,000 cells/microliter, ideally down to normal levels. Increase the dosage by no more than 0.5 mg/day in any 1 week period.

The dosage should not exceed 10 mg/day or 2.5 mg in any single dose.

Renal Dose Adjustments

Moderate hepatic impairment: Single 1 mg dose showed an 8-fold increase in total exposure (AUC) to anagrelide
Severe renal impairment (creatinine clearance less than 30 mL/min): Single 1 mg dose showed no significant effects on the pharmacokinetics of anagrelide

Liver Dose Adjustments

Use of anagrelide in patients with severe hepatic impairment is contraindicated. Patients with moderate hepatic impairment should receive a starting dose of 0.5 mg/day and be maintained at that dose for a minimum of 1 week (careful monitoring of cardiovascular effects should be instituted during this time). Incremental increases should not exceed more than 0.5 mg/day in any 1 week.

Dose Adjustments

Most patients will experience an adequate response at a dose of 1.5 to 3 mg/day.

Typically, platelet count begins to respond within 7 to 14 days at the proper dosage.

Precautions

• Anagrelide has not been studied in pediatric patients less than 7 years of age.
• Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

General: An increase in platelet count can be seen within 4 days after sudden discontinuation of this drug and a decrease to pretreatment levels occurs within 10 to 14 days.

Monitoring:

• Hematologic: Platelet count (every 2 days during the first week of treatment and at least weekly thereafter until the maintenance dosage is established); hemoglobin and white blood cells (during the first 2 weeks of treatment)
• Hepatic: ALT and AST (during the first 2 weeks of treatment)
• Renal: Serum creatinine and BUN (during the first 2 weeks of treatment)