Select therapeutic use:

Kaposi's sarcoma:

Indications for POMALYST:

AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) in adults. Kaposi sarcoma in HIV-negative adults.

Adult:

Confirm negative pregnancy status before initiation. Swallow whole; may be taken with water (with or without food). 5mg once daily on Days 1–21 of each 28-day cycle until disease progression or unacceptable toxicity; continue HAART in AIDS patients. Concomitant strong CYP1A2 inhibitors (if unavoidable): reduce Pomalyst dose to 2mg. Severe renal impairment requiring dialysis: 4mg daily; give dose after dialysis session on hemodialysis days. Hepatic impairment: 3mg daily. Dose modifications for adverse reactions, other Grade 3/4 toxicities: see full labeling.

Children:

Not established.

Contraindications:

Pregnancy.

Boxed Warning:

Embryo-fetal toxicity. Venous and arterial thromboembolism.

Warnings/Precautions:

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); withhold, reduce dose, or permanently discontinue based on severity of reaction. Obtain CBCs weekly for first 8 weeks (for MM) or every 2 weeks for first 12 weeks (for KS), and monthly thereafter. 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). Permanently discontinue if angioedema, anaphylaxis, Grade 4 rash, skin exfoliation, bullae, or other severe cutaneous reactions occur (eg, SJS, TEN, DRESS). Nursing mothers: not recommended.

Pharmacologic Class:

Immunomodulator.

Interactions:

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.

Adverse Reactions:

Fatigue, asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper respiratory tract infections, back pain, pyrexia, rash, elevated creatinine, glucose, or ALT, decreased hemoglobin, platelets, phosphate, albumin, or calcium; thrombocytopenia, hepatotoxicity, dizziness, confusion, neuropathy, pneumonia, tumor lysis syndrome, severe cutaneous or hypersensitivity reactions.

Note:

Available only through Pomalyst REMS program.

Metabolism:

Hepatic (CYP1A2, CYP3A4).

Elimination:

Renal (major), fecal.

REMS:

YES

Generic Availability:

NO

How Supplied:

Caps—21, 100

Pricing for POMALYST

4mg capsule (Qty: 21)
Appx. price $20239
GoodRx

Leukemias, lymphomas, and other hematologic cancers:

Indications for POMALYST:

In combination with dexamethasone for multiple myeloma (MM), 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.

Adult:

Confirm negative pregnancy status before initiation. Swallow whole; may be taken with water (with or without food). 4mg once daily on Days 1–21 of each 28-day cycle until disease progression; give with dexamethasone. Concomitant strong CYP1A2 inhibitors (if unavoidable): reduce Pomalyst dose to 2mg. Severe renal impairment requiring dialysis: 3mg daily; give dose after dialysis session on hemodialysis days. Hepatic impairment (mild or moderate): 3mg daily; (severe): 2mg daily. Dose modifications for adverse reactions, other Grade 3/4 toxicities: see full labeling.

Children:

Not established.

Contraindications:

Pregnancy.

Boxed Warning:

Embryo-fetal toxicity. Venous and arterial thromboembolism.

Warnings/Precautions:

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); withhold, reduce dose, or permanently discontinue based on severity of reaction. Obtain CBCs weekly for first 8 weeks (for MM) or every 2 weeks for first 12 weeks (for KS), and monthly thereafter. 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). Permanently discontinue if angioedema, anaphylaxis, Grade 4 rash, skin exfoliation, bullae, or other severe cutaneous reactions occur (eg, SJS, TEN, DRESS). Nursing mothers: not recommended.

Pharmacologic Class:

Immunomodulator.

Interactions:

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.

Adverse Reactions:

Fatigue, asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper respiratory tract infections, back pain, pyrexia, rash, elevated creatinine, glucose, or ALT, decreased hemoglobin, platelets, phosphate, albumin, or calcium; thrombocytopenia, hepatotoxicity, dizziness, confusion, neuropathy, pneumonia, tumor lysis syndrome, severe cutaneous or hypersensitivity reactions.

Note:

Available only through Pomalyst REMS program.

Metabolism:

Hepatic (CYP1A2, CYP3A4).

Elimination:

Renal (major), fecal.

REMS:

YES

Generic Availability:

NO

How Supplied:

Caps—21, 100

Pricing for POMALYST

4mg capsule (Qty: 21)
Appx. price $20239
GoodRx