Generic name: POMALIDOMIDE 1mg
Dosage form: capsule
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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 (8.3)].
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 should 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 may be taken with or without food.
Dose Adjustments for Toxicities
|ANC, absolute neutrophil count|
To initiate a new cycle of POMALYST, the neutrophil count must be at least 500 per mcL and the platelet count must be at least 50,000 per mcL. If toxicities occur after dose reductions to 1 mg, then discontinue POMALYST.
Permanently discontinue POMALYST for angioedema, skin exfoliation, bullae, or any other severe dermatologic reaction [see Warnings and Precautions (5.6)].
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.
Dosage Adjustment for Strong CYP1A2 Inhibitors
Avoid concomitant use of POMALYST with strong inhibitors of CYP1A2. Consider alternative treatments. If a strong CYP1A2 inhibitor must be used, reduce POMALYST dose by 50% [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
Dosage Adjustment for Patients with Severe Renal Impairment on Hemodialysis
For patients with severe renal impairment requiring dialysis, the recommended starting dose is 3 mg daily (25% dose reduction). Take POMALYST after completion of dialysis procedure on hemodialysis days. [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Dosage Adjustment for Patients with Hepatic Impairment
For patients with mild or moderate hepatic impairment (Child-Pugh classes A or B), the recommended starting dose is 3 mg daily (25% dose reduction). For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose is 2 mg (50% dose reduction) [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
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