Usual Adult Dose for Chronic Myelogenous Leukemia

Induction dose: 1.25 mg/m2 subcutaneously twice daily for 14 consecutive days of a 28 day cycle.

Maintenance dose: 1.25 mg/m2 subcutaneously twice daily for 7 consecutive days of a 28 day cycle.

Use: Chronic or accelerated phase CML with resistance and/or intolerance to two or more tyrosine kinase inhibitors.

Comments: There are no trials verifying an improvement in disease-related symptoms or increased survival with omacetaxine.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

• For hematologic toxicities, omacetaxine treatment cycles may be delayed.
• If a patient experiences Grade 4 neutropenia (absolute neutrophil count (ANC) less than 0.5 x 10(9)/L) or Grade 3 thrombocytopenia (platelet counts less than 50 x 10(9)/L) during a cycle, delay starting the next cycle until ANC is greater than or equal to 1.0 x 10(9)/L and platelet count is greater than or equal to 50 x 10(9)/L. Also, for the next cycle, reduce the number of dosing days by 2 days (e.g. to 12 or 5 days).
• For other clinically significant nonhematologic toxicity manage symptomatically. Interrupt and/or delay omacetaxine until toxicity is resolved.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For subcutaneous injection
• May be administered in the home setting. The manufacturer's product information should be consulted for further information.

• Reconstitute with 1 mL of 0.9% sodium chloride injection, USP.
• The manufacturer's product information should be consulted for detailed reconstitution information.

• Room Temperature: Use within 12 hours of reconstitution.
• Refrigerated: Use within 6 days of reconstitution.
• Protect reconstituted solution from light.