osis (DVT) and Pulmonary Embolism (PE) occur in patients with multiple myeloma treated with Pomalyst. Prophylactic anti-thrombotic measures were employed in the clinical trial. Consider prophylactic measures after assessing an individual patient’s underlying risk factors [see Warnings and Precautions (5.3)].
Indications and Usage for Pomalyst
Multiple Myeloma
Pomalyst is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval is based on response rate [see Clinical Studies (14.1)]. Clinical benefit, such as improvement in survival or symptoms, has not been verified.
Pomalyst Dosage and Administration
Multiple Myeloma
Females of reproductive potential must have negative pregnancy testing and use contraception methods before initiating Pomalyst [see Warnings and Precautions (5.1) and Use in Specific Populations (8.6)].
The recommended starting dose of Pomalyst is 4 mg once daily orally on Days 1-21 of repeated 28-day cycles until disease progression. Pomalyst may be given in combination with dexamethasone [see Clinical Studies (14.1)].
Pomalyst may be taken with water. Inform patients not to break, chew or open the capsules. Pomalyst should be taken without food (at least 2 hours before or 2 hours after a meal).
Dose Adjustments for Toxicity
Table 1: Dose Modification Instructions for Pomalyst for Hematologic Toxicities *Note: ANC = Absolute Neutrophil Count
Toxicity Dose Modification
Neutropenia
•ANC* < 500 per mcL or Febrile neutropenia (fever more
than or equal to 38.5°C and ANC < 1,000 per mcL)
•ANC return to more than or equal to 500 per mcL
Interrupt Pomalyst treatment, follow CBC weekly.
Resume Pomalyst at 3 mg daily.
•For each subsequent drop < 500 per mcL
•Return to more than or equal to 500 per mcL
Interrupt Pomalyst treatment
Resume Pomalyst at 1 mg less than the previous dose
Thrombocytopenia
•Platelets < 25,000 per mcL
•Platelets return to > 50,000 per mcL
Interrupt Pomalyst treatment, follow CBC weekly
Resume Pomalyst treatment at 3 mg daily
•For each subsequent drop < 25,000 per mcL
•Return to more than or equal to 50,000 per mcL
Interrupt Pomalyst treatment
Resume Pomalyst at 1 mg less than previous dose.
For other Grade 3 or 4 toxicities hold treatment and restart treatment at 1 mg less than the previous dose when toxicity has resolved to less than or equal to Grade 2 at the physician’s discretion.
To initiate a new cycle of Pomalyst, the neutrophil count must be at least 500 per mcL, the platelet count must be at least 50,000 per mcL. If toxicities occur after dose reductions to 1 mg, then discontinue Pomalyst.
Dosage Forms and Strengths
Pomalyst is available in the following capsule strengths:
1 mg: Dark blue opaque cap and yellow opaque body imprinted “POML” on the cap in white ink and “1 mg” on the body in black ink
2 mg: Dark blue opaque cap and orange opaque body imprinted “POML” on the cap and “2 mg” on the body in white ink
3 mg: Dark blue opaque cap and green opaque body, imprinted, “POML” on the cap and “3 mg” on the b |
