Source: FDA, National Drug Code (US) Revision Year: 2020
POMALYST, in combination with dexamethasone, is indicated for adult patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
POMALYST is indicated for the treatment of:
This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.2)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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 (8.1, 8.3)].
The recommended dosage of POMALYST is 4 mg once daily orally with or without food on Days 1 through 21 of each 28-day cycle until disease progression. Give POMALYST in combination with dexamethasone [see Clinical Studies (14.1)].
The recommended dosage of POMALYST is 5 mg once daily taken orally with or without food on Days 1 through 21 of each 28-day cycle until disease progression or unacceptable toxicity. Continue HAART as HIV treatment in patients with AIDS-related Kaposi sarcoma (KS) [see Clinical Studies (14.2)].
Initiate a new cycle of POMALYST in patients with multiple myeloma (MM) when the neutrophil count is at least 500 per mcL and the platelet count is at least 50,000 per mcL.
Dosage modification for POMALYST for hematologic adverse reactions in patients with MM are summarized in Table 1.
Table 1. Dosage Modifications for POMALYST for Hematologic in MM:
| Adverse Reaction | Severity | Dosage Modification |
|---|---|---|
| Neutropenia [see Warnings and Precautions (5.5)] | • ANC less than 500 per mcL or febrile neutropenia (fever greater than or equal to 38.5°C and ANC less than 1,000 per mcL) | • Withhold POMALYST until ANC is greater than or equal to 500 per mcL; follow CBC weekly. • Resume POMALYST dose at 1 mg less than the previous dose.?footnote? |
| • For each subsequent drop of ANC less than 500 per mcL | • Withhold POMALYST until ANC is greater than or equal to 500 mcL. • Resume POMALYST dose at 1 mg less than the previous dose.?footnoteRef? | |
| Thrombocytopenia [see Warnings and Precautions (5.5)] | • Platelets less than 25,000 per mcL | • Withhold POMALYST until platelets are greater than or equal to 50,000 per mcL; follow CBC weekly. • Resume POMALYST dose at 1 mg less than the previous dose?footnoteRef? |
| • For each subsequent drop of platelets less than 25,000 per mcL | • Withhold POMALYST until platelets are greater than or equal to 50,000 per mcL. • Resume POMALYST at 1 mg less than the previous dose?footnoteRef? |
ANC= absolute neutrophil count
Initiate a new cycle of POMALYST in patients with KS when the neutrophil count is at least 1000 per mcL and the platelet count is at least 75,000 per mcL.
Dose modifications for POMALYST for hematologic adverse reactions in patients with KS are summarized in Table 2.
Table 2. Dosage Modifications for POMALYST for Hematologic Adverse Reactions in KS:
| Adverse Reaction | Severity | Dosage Modification |
|---|---|---|
| Neutropenia [see Warnings and Precautions (5.5)] | ANC 500 to less than 1,000 per mcL | Day 1 of cycle• Withhold POMALYST until ANC is greater than or equal to 1,000 per mcL. • Resume POMALYST at the same dose.During cycle• Continue POMALYST at the current dose. |
| ANC less than 500 per mcL | • Withhold POMALYST until ANC is greater than or equal to 1,000 per mcL. • Resume POMALYST at the same dose. | |
| Febrile Neutropenia [see Warnings and Precautions (5.5)] | ANC less than 1,000 per mcL and single temperature greater than or equal to 38.3°C or ANC less than 1,000 per mcL and sustained temperature greater than or equal to 38°C for more than 1 hour | • Withhold POMALYST until ANC is greater than or equal to 1,000 per mcL. • Resume POMALYST at dose 1 mg less than the previous dose.?footnote? |
| Thrombocytopenia [see Warnings and Precautions (5.5)] | Platelet count 25,000 to less than 50,000 per mcL | Day 1 of cycle• Withhold POMALYST until platelet count is greater than or equal to 50,000 per mcL. • Resume POMALYST at the same dose.During cycle:• Continue POMALYST at the current dose. |
| Platelet count less than 25,000 per mcL | Permanently discontinue POMALYST. |
ANC= absolute neutrophil count
Permanently discontinue POMALYST for angioedema, anaphylaxis, Grade 4 rash, skin exfoliation, bullae, or any other severe dermatologic reaction [See Warnings and Precautions (5.7, 5.12)].
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.
Avoid concomitant use of POMALYST with strong CYP1A2 inhibitors. If concomitant use of a strong CYP1A2 inhibitor is unavoidable, reduce POMALYST dose to 2 mg [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
Take POMALYST after completion of dialysis procedure on hemodialysis days [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
For patients with MM with mild or moderate hepatic impairment (Child-Pugh A or B), reduce the recommended dosage to 3 mg orally daily.
For patients with MM with severe hepatic impairment (Child-Pugh C), reduce the recommended dosage to 2 mg [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
For patients with KS with mild, moderate, or severe hepatic impairment (Child-Pugh A, B, or C), reduce the recommended dosage to 3 mg orally daily [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
Swallow capsules whole with water. Do not break, chew, or open the capsules.
POMALYST may be taken with or without food.
Hemodialysis can remove pomalidomide from circulation.
Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].
Care should be exercised in handling of POMALYST. Do not open or crush POMALYST capsules. If powder from POMALYST contacts the skin, wash the skin immediately and thoroughly with soap and water. If POMALYST contacts the mucous membranes, flush thoroughly with water.
Follow procedures for proper handling and disposal of hazardous drugs.1
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