Generic Name and Formulations:
Pomalidomide 1mg, 2mg, 3mg, 4mg; caps.
Indications for POMALYST:
In combination with dexamethasone for multiple myeloma, in patients who have received at least two prior therapies (including lenalidomide and a proteasome inhibitor), and have shown disease progression on or within 60 days of completion of the last therapy.
Swallow whole; may be taken with water (with or without food). 4mg once daily on Days 1–21 of repeated 28-day cycles until disease progression; give with dexamethasone. Concomitant strong CYP1A2 inhibitors: consider alternatives, if necessary, reduce Pomalyst dose by 50%. Severe renal impairment requiring dialysis: initially 3mg daily; give dose after dialysis session on hemodialysis days. Hepatic impairment (mild or moderate): initially 3mg daily; (severe): 2mg daily. Dose modification for hematologic and other Grade 3/4 toxicities: see full labeling.
Embryo-fetal toxicity. Venous and arterial thromboembolism.
Embryo-fetal toxicity: females of reproductive potential must avoid pregnancy, commit either to abstain from heterosexual sex or to use two methods of reliable contraception, at least 4 weeks prior to initiating, during therapy, dose interruptions and for at least 4 weeks after discontinuation. Obtain two negative pregnancy tests prior to initiating therapy: perform first test within 10–14 days, and second test within 24hrs prior to prescribing, and then weekly during first month, then monthly thereafter in women with regular menstrual cycles or every 2 weeks if irregular cycles. Males: must use latex or synthetic condom during therapy and up to 4 weeks after discontinuing, even after successful vasectomy; do not donate sperm. Patients must not donate blood during therapy and for 1 month after discontinuation. Venous and arterial thromboembolism; consider anticoagulation prophylaxis. Monitor for hematologic toxicities (esp. neutropenia); obtain CBCs weekly for first 8 weeks and monthly thereafter; may need dose interruption and/or modification. Hepatic or severe renal impairment on hemodialysis: adjust doses (see Adults). Monitor LFTs monthly; discontinue and evaluate if elevated liver enzymes occur; consider using lower dose when restarting. Risk of second primary malignancies. High tumor burden (monitor). Discontinue if angioedema, skin exfoliation, bullae, or other severe dermatologic reactions occur; do not restart. Nursing mothers: not recommended.
Increased mortality when PD-1 or PD-L1 blocking antibody (eg, pembrolizumab) is added to thalidomide analogue plus dexamethasone regimen in multiple myeloma: not recommended. Potentiated by strong CYP1A2 inhibitors (eg, ciprofloxacin, fluvoxamine); avoid (see Adults). Smoking may reduce efficacy.
Fatigue, asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper respiratory tract infections, back pain, pyrexia; thromboembolism, thrombocytopenia, hepatotoxicity, dizziness, confusion, neuropathy, pneumonia, tumor lysis syndrome, severe skin or hypersensitivity reactions.
Available only through Pomalyst REMS program.
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