Select therapeutic use:

Anemias:

Indications for REVLIMID:

Transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality.

Adult:

Swallow whole with water. Initially 10mg once daily; adjust dose based on response. Renal impairment (CrCL 30–60mL/min): initially 5mg/day; (CrCL <30mL/min without dialysis): initially 2.5mg/day; (CrCL <30mL/min with dialysis): initially 2.5mg/day (administer after dialysis on dialysis days); adjust subsequent dose based on patient tolerance. Dose adjustments for hematologic toxicities: see full labeling.

Children:

Not established.

Contraindications:

Pregnancy.

Boxed Warning:

Embryo-fetal toxicity. Hematologic toxicity. Venous and arterial thromboembolism.

Warnings/Precautions:

Must register patient in Revlimid REMS program; patient must understand toxicity with fetal exposure. Counsel patient on need for contraception; females: use 2 forms of contraception 1 month before, during therapy, during dose interruptions, and 1 month after therapy; males: use condom during and 1 month after therapy. Obtain 2 negative pregnancy tests (one within 10–14 days, and then another within 24hrs prior to starting therapy), repeat at least weekly for 1st month then every 4 weeks (regular menstrual cycles) or every 2 weeks (irregular cycles); get informed consent. Patients must not donate blood during and for 1 month after therapy; males must not donate sperm. Monitor for signs/symptoms of thromboembolic events; base thromboprophylaxis on patient's risks. Monitor for signs of infection, second primary malignancies, bleeding, or bruising. Obtain CBCs as follows: for MDS: weekly for first 8 weeks, then monthly thereafter; for MM: weekly for first 2 cycles, on Days 1 and 15 of Cycle 3, and every 28 days thereafter; for MCL: weekly for the first cycle, every 2 weeks during Cycles 2–4, and then monthly thereafter; for FL, MZL: weekly for first 3 weeks of Cycle 1, every 2 weeks during Cycle 2–4, and then monthly thereafter; all: dose interruption and/or reduction may be needed. May require blood product support and/or growth factors. Avoid in patients with a prior history of Grade 4 rash with thalidomide; consider interrupting or discontinuing for Grade 2–3 rash. Permanently discontinue if angioedema, anaphylaxis, Grade 4 rash, exfoliative or bullous rash, Stevens-Johnson syndrome, toxic epidermal necrolysis or DRESS occurs. Renal impairment (monitor). Monitor for tumor lysis syndrome in those with high tumor burden. Monitor liver enzymes (discontinue if elevation occurs), thyroid function before and during therapy. Lactose intolerance. Max 28-day supply per ℞. Nursing mothers: not recommended.

Pharmacologic Class:

Immunomodulator.

Interactions:

Increased mortality when PD-1 or PD-L1 blocking antibody (eg, pembrolizumab) in combination with a thalidomide analogue plus dexamethasone regimen in multiple myeloma: not recommended. Monitor digoxin. Concomitant warfarin; monitor PT, INR. May increase risk of thrombosis with dexamethasone, erythropoietic agents, or estrogen-containing therapies.

Adverse Reactions:

Diarrhea, fatigue, anemia, constipation, neutropenia, leukopenia, peripheral edema, insomnia, muscle cramp/spasms, abdominal pain, back pain, nausea, asthenia, pyrexia, upper RTI, bronchitis, nasopharyngitis, gastroenteritis, cough, rash, dyspnea, dizziness, decreased appetite, thrombocytopenia, tremor, pruritus; birth defects, thromboembolism, hypersensitivity reactions, hepatotoxicity, tumor flare reaction (monitor; esp. in MCL, FL, MZL), impaired stem cell mobilization, thyroid disorders. Also for MCL: early mortality.

Note:

Available only through Revlimid REMS program. Report any suspected fetal exposure to the FDA at (800) FDA-1088 and Celgene at (888) 423-5436.

REMS:

YES

How Supplied:

Caps 2.5mg, 5mg, 10mg—28, 100; 15mg, 20mg, 25mg—21, 100

Pricing for REVLIMID

10mg capsule (Qty: 21)
Appx. price $17781
GoodRx

Leukemias, lymphomas, and other hematologic cancers:

Indications for REVLIMID:

Multiple myeloma (MM): for combination treatment with dexamethasone; or for maintenance therapy following autologous hematopoietic stem cell transplantation (auto-HSCT). Mantle cell lymphoma (MCL) in patients whose disease has relapsed or progressed after 2 prior therapies, one of which included bortezomib. In combination with a rituximab product, for previously treated follicular lymphoma (FL) or previously treated marginal zone lymphoma (MZL).

Limitations of Use:

Not for treating patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

Adult:

Swallow whole with water. MM (combo therapy), MCL: initially 25mg once daily on Days 1–21 of each 28-day cycle until disease progression or unacceptable toxicity. >75yrs: may reduce dexamethasone initial dose. MM (auto-HSCT eligible): refer for hematopoietic cell mobilization within 4 cycles; if non-eligible, continue therapy until disease progression or unacceptable toxicity. MM (post auto-HSCT): ensure ANC ≥1000/mcL and/or platelets ≥75,000/mcL. Initially 10mg once daily on Days 1–28 of each 28-day cycle until disease progression or unacceptable toxicity; may increase to 15mg once daily after 3 cycles, if tolerated. FL, MZL: initially 20mg once daily on Days 1–21 of each 28-day cycle for up to 12 cycles; give in combination with a rituximab product. Renal impairment: MM (combo therapy), MCL: (CrCl 30–60mL/min): initially 10mg/day; for MM, consider increasing to 15mg after 2 cycles, if tolerant; (CrCl <30mL/min without dialysis): initially 15mg every other day; (CrCl <30mL/min with dialysis): initially 5mg/day; administer after dialysis on dialysis days. MM (auto-HSCT): (CrCl 30–60mL/min): initially 5mg/day; (CrCl <30mL/min without dialysis): initially 2.5mg/day; (CrCl <30mL/min with dialysis): initially 2.5mg/day; administer after dialysis on dialysis days. Adjust subsequent dose based on patient tolerance. FL, MZL: (CrCl 30–60mL/min): initially 10mg/day; may increase to 15mg after 2 cycles, if tolerant; (CrCl <30mL/min without dialysis): initially 5mg/day; (CrCl <30mL/min with dialysis): initially 5mg/day; administer after dialysis on dialysis days. Dose adjustments for hematologic toxicities: see full labeling.

Children:

Not established.

Contraindications:

Pregnancy.

Boxed Warning:

Embryo-fetal toxicity. Hematologic toxicity. Venous and arterial thromboembolism.

Warnings/Precautions:

Must register patient in Revlimid REMS program; patient must understand toxicity with fetal exposure. Counsel patient on need for contraception; females: use 2 forms of contraception 1 month before, during therapy, during dose interruptions, and 1 month after therapy; males: use condom during and 1 month after therapy. Obtain 2 negative pregnancy tests (one within 10–14 days, and then another within 24hrs prior to starting therapy), repeat at least weekly for 1st month then every 4 weeks (regular menstrual cycles) or every 2 weeks (irregular cycles); get informed consent. Patients must not donate blood during and for 1 month after therapy; males must not donate sperm. Monitor for signs/symptoms of thromboembolic events; base thromboprophylaxis on patient's risks. Monitor for signs of infection, second primary malignancies, bleeding, or bruising. Obtain CBCs as follows: for MDS: weekly for first 8 weeks, then monthly thereafter; for MM: weekly for first 2 cycles, on Days 1 and 15 of Cycle 3, and every 28 days thereafter; for MCL: weekly for the first cycle, every 2 weeks during Cycles 2–4, and then monthly thereafter; for FL, MZL: weekly for first 3 weeks of Cycle 1, every 2 weeks during Cycle 2–4, and then monthly thereafter; all: dose interruption and/or reduction may be needed. May require blood product support and/or growth factors. Avoid in patients with a prior history of Grade 4 rash with thalidomide; consider interrupting or discontinuing for Grade 2–3 rash. Permanently discontinue if angioedema, anaphylaxis, Grade 4 rash, exfoliative or bullous rash, Stevens-Johnson syndrome, toxic epidermal necrolysis or DRESS occurs. Renal impairment (monitor). Monitor for tumor lysis syndrome in those with high tumor burden. Monitor liver enzymes (discontinue if elevation occurs), thyroid function before and during therapy. Lactose intolerance. Max 28-day supply per ℞. Nursing mothers: not recommended.

Pharmacologic Class:

Immunomodulator.

Interactions:

Increased mortality when PD-1 or PD-L1 blocking antibody (eg, pembrolizumab) in combination with a thalidomide analogue plus dexamethasone regimen in multiple myeloma: not recommended. Monitor digoxin. Concomitant warfarin; monitor PT, INR. May increase risk of thrombosis with dexamethasone, erythropoietic agents, or estrogen-containing therapies.

Adverse Reactions:

Diarrhea, fatigue, anemia, constipation, neutropenia, leukopenia, peripheral edema, insomnia, muscle cramp/spasms, abdominal pain, back pain, nausea, asthenia, pyrexia, upper RTI, bronchitis, nasopharyngitis, gastroenteritis, cough, rash, dyspnea, dizziness, decreased appetite, thrombocytopenia, tremor, pruritus; birth defects, thromboembolism, hypersensitivity reactions, hepatotoxicity, tumor flare reaction (monitor; esp. in MCL, FL, MZL), impaired stem cell mobilization, thyroid disorders. Also for MCL: early mortality.

Note:

Available only through Revlimid REMS program. Report any suspected fetal exposure to the FDA at (800) FDA-1088 and Celgene at (888) 423-5436.

REMS:

YES

How Supplied:

Caps 2.5mg, 5mg, 10mg—28, 100; 15mg, 20mg, 25mg—21, 100

Pricing for REVLIMID

10mg capsule (Qty: 21)
Appx. price $17781
GoodRx