Drug Interaction Report

MONITOR: The use of omacetaxine with other immunosuppressive or myelosuppressive agents may increase the risk of infections. Omacetaxine alone may cause severe myelosuppression, neutropenia, lymphopenia, and opportunistic infections. In clinical trials, infections/infestations (bacterial, viral, fungal, and nonspecified) were reported in up to 56% of patients, and grade 3 or 4 infections/infestations in up to 20% of patients. The risk may theoretically increase when coadministered with other hematotoxic therapy. Agents that may be significantly myelo- or immunosuppressive include antineoplastic agents, radiation, zidovudine, linezolid, some antirheumatic agents, high dosages of corticosteroids or adrenocorticotropic agents (greater than 10 mg/day to 1 mg/kg/day, whichever is less, of prednisone or equivalent for more than 2 weeks), and long-term topical or inhaled corticosteroids.

MANAGEMENT: Caution is advised if omacetaxine must be used in patients who have recently received or are receiving treatment with other immunosuppressive or myelosuppressive drugs, and vice versa. Close clinical and laboratory monitoring for the development of severe hematologic adverse effects is recommended both during and after discontinuation of therapy. Patients should be advised to seek medical attention if they experience symptoms such as fever, chills, shortness of breath, fatigue, and any unusual bleeding or bruising.

GENERALLY AVOID: Alcohol may potentiate some of the pharmacologic effects of CNS-active agents. Use in combination may result in additive central nervous system depression and/or impairment of judgment, thinking, and psychomotor skills.

MANAGEMENT: Patients receiving CNS-active agents should be warned of this interaction and advised to avoid or limit consumption of alcohol. Ambulatory patients should be counseled to avoid hazardous activities requiring complete mental alertness and motor coordination until they know how these agents affect them, and to notify their physician if they experience excessive or prolonged CNS effects that interfere with their normal activities.