REVLIMID Rx

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REVLIMID

Anemias
Leukemias, lymphomas, and other hematologic cancers
Only 4 drugs may be compared at once

Generic Name and Formulations:

Lenalidomide 2.5mg, 5mg, 10mg, 15mg, 20mg, 25mg; caps; contains lactose.

Company:

Celgene Corp

Select therapeutic use:

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.

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, bleeding, or bruising. Obtain CBCs weekly for first 8 weeks, then monthly; dose interruption and/or reduction may be needed. May require blood product support and/or growth factors. 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.

Interactions:

Monitor digoxin. Concomitant warfarin; monitor PT, INR. May increase risk of thrombosis with dexamethasone, erythropoietic agents, or estrogen-containing therapies.

Pharmacological Class:

Immunomodulator.

Adverse Reactions:

Thrombocytopenia, neutropenia, diarrhea, pruritus, rash, fatigue, constipation, nausea, nasopharyngitis, arthralgia, pyrexia, back pain, peripheral edema, cough, dizziness, headache, muscle cramp, dyspnea, pharyngitis, epistaxis; birth defects, thromboembolism, allergic reactions (discontinue if severe; do not resume), hepatotoxicity, impaired stem cell mobilization, thyroid disorders.

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

REVLIMID 10mg capsules (Qty:28)

appx. price $17099.00

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.

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 (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. 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 dose based on patient tolerance. Auto-HSCT eligible: refer for hematopoietic cell mobilization within 4 cycles; if non-eligible, continue therapy until disease progression or unacceptable toxicity. Dose adjustments for hematologic toxicities: see full labeling.

Children:

Not established.

Contraindications:

Pregnancy.

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, bleeding, or bruising. For MM: obtain CBCs weekly for the first 2 cycles, on Days 1 and 15 of Cycle 3, and every 28 days thereafter; for MCL: obtain CBCs weekly for the first cycle, every 2 weeks during Cycles 2–4, and then monthly thereafter; both: dose interruption and/or reduction may be needed. May require blood product support and/or growth factors. 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. Monitor for second primary malignancies. Lactose intolerance. Max 28-day supply per ℞. Nursing mothers: not recommended.

Interactions:

Monitor digoxin. Concomitant warfarin; monitor PT, INR. May increase risk of thrombosis with dexamethasone, erythropoietic agents, or estrogen-containing therapies.

Pharmacological Class:

Immunomodulator.

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, allergic reactions (discontinue if severe; do not resume), hepatotoxicity, tumor flare reaction (monitor; esp. in MCL), impaired stem cell mobilization, thyroid disorders.

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

REVLIMID 10mg capsules (Qty:28)

appx. price $17099.00