Pomalyst (pomalidomide)

Temporary interruption of therapy, dosage reduction, and/or permanent discontinuance of pomalidomide may be necessary in patients experiencing adverse effects (see Table 2).

If angioedema, anaphylaxis, grade 4 rash, skin exfoliation, bullae, or any other severe dermatologic reaction occurs, pomalidomide should be permanently discontinued.

Table 2. Dosage Modifications for Adverse Effects in Patients with Kaposi Sarcoma

Adverse Reaction and Severity Pomalidomide Dosage Modification (Starting Dosage = 5 mg daily on days 1-21 of each 28-day cycle) Neutropenia: ANC 500 to <1000/mm3 Day 1 of cycle: Withhold therapy; when ANC >=1000/mm3, resume at same dosage During cycle: Continue current dosage ANC <500/mm3 Withhold therapy; when ANC >=1000/mm3, resume at same dosage Febrile neutropenia (ANC <1000/mm3 Withhold therapy; when ANC and single temperature of >=1000/mm3, then resume at a dosage >=38.3degreesC or sustained reduced by 1 mg temperature of >=38degreesC for >1 hour) If a daily dosage of 1 mg is not tolerated, permanently discontinue pomalidomide Thrombocytopenia: Platelet count Day 1 of cycle: Withhold therapy; 25,000 to <50,000/mm3 when platelet count >=50,000/mm3, resume at same dosage During cycle: Continue current dosage Platelet count <25,000/mm3 Permanently discontinue pomalidomide Non-hematologic adverse reactions: Withhold therapy; when toxicity Grade 3 or 4 (excluding resolves or improves to grade 2 or hypersensitivity or dermatologic less, then resume at a dosage reactions) reduced by 1 mg

Temporary interruption of therapy, dosage reduction, and/or permanent discontinuance of pomalidomide may be necessary in patients experiencing adverse effects (see Table 1).

Table 1. Dosage Modifications for Toxicity in Patients with Multiple Myeloma

Adverse Reaction and Severity Pomalidomide Dosage Modification (Starting Dosage = 4 mg daily on days 1-21 of each 28-day cycle) Neutropenia: ANC <500/mm3 First occurrence: Withhold therapy and monitor CBCs weekly; when ANC >=500/mm3, then resume at a dosage reduced by 1 mg Subsequent occurrence: Withhold therapy until ANC >=500/mm3, then resume at a dosage reduced by 1 mg If a daily dosage of 1 mg is not tolerated, permanently discontinue pomalidomide Febrile neutropenia (temperature of Withhold therapy and monitor CBCs >=38.5degreesC and ANC <1000/mm3) weekly; when ANC >=500/mm3, then resume at a dosage reduced by 1 mg Thrombocytopenia: Platelet count First occurrence: Withhold therapy <25,000/mm3 and monitor CBCs weekly; when platelet count >=50,000/mm3, then resume at a dosage reduced by 1 mg Subsequent occurrence: Withhold therapy until platelet count >=50,000/mm3, then resume at a dosage reduced by 1 mg If a daily dosage of 1 mg is not tolerated, permanently discontinue pomalidomide Non-hematologic adverse reactions: Withhold therapy; when toxicity Grade 3 or 4 (excluding resolves or improves to grade 2 or hypersensitivity or dermatologic less, then resume at a dosage reactions) reduced by 1 mg

Pomalidomide capsules should be administered orally with water once daily. The drug can be administered without regard to food. The capsules should be swallowed intact and should not be broken, chewed, or opened. No more than a 28-day supply of pomalidomide should be prescribed and dispensed at one time.

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Metabolism of pomalidomide is mediated primarily by cytochrome P-450 (CYP) isoenzymes 1A2 and CYP3A4, and to a lesser extent by CYP isoenzymes 2C19 and 2D6.

Pomalidomide does not inhibit or induce CYP isoenzymes in vitro.

Pomalidomide is a substrate of P-glycoprotein (P-gp).

Pomalidomide does not inhibit or induce transporters in vitro.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Pregnancy.

*Known hypersensitivity (e.g., angioedema, anaphylaxis) to the drug or any ingredient in the formulation.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects reported in at least 30% of patients with multiple myeloma receiving pomalidomide in combination with low-dose dexamethasone include fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper respiratory tract infection, back pain, and pyrexia.

Adverse effects reported in at least 30% of patients with Kaposi sarcoma receiving pomalidomide include decreased absolute neutrophil count (ANC), decreased white blood cell count (WBC), decreased hemoglobin concentrations, decreased platelet count, decreased serum phosphate concentrations, decreased serum albumin concentrations, decreased serum calcium concentrations, increased serum creatinine concentrations, increased serum glucose concentrations, increased serum ALT concentrations, rash, constipation, fatigue, nausea, and diarrhea.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

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Safety and efficacy of pomalidomide have not been established in pediatric patients.

Safety and efficacy of pomalidomide in pediatric patients (4 to less than 17 years of age) were assessed, but not established, in 2 open-label studies. New safety concerns were not observed in pediatric patients in these studies. When pomalidomide was administered at the same dose by body surface area, exposure in patients 4 to <17 years of age was similar to adult patients with multiple myeloma, but higher than exposure observed in adults with Kaposi sarcoma.

Pomalidomide is a thalidomide analogue and is contraindicated for use during pregnancy. Based on animal studies, female fertility may be impaired with pomalidomide treatment.

Pomalidomide is distributed into milk in rats; it is not known whether pomalidomide is distributed into milk in humans. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions to pomalidomide in nursing infants, women should not breast-feed during therapy with pomalidomide.

The manufacturer makes no specific dosage recommendations for geriatric patients.

In clinical trials evaluating pomalidomide in patients with multiple myeloma, 44% of patients were 65 years of age or older and 10% were 75 years of age or older. Although no overall differences in efficacy were observed between geriatric and younger patients, pneumonia occurred more frequently in patients 65 years of age or older compared with younger patients.

In patients with Kaposi sarcoma, experience in patients 65 years of age or older is insufficient to determine whether they respond differently to pomalidomide than younger patients.