Generic Name and Formulations:
Lenalidomide 2.5mg, 5mg, 10mg, 15mg, 25mg; caps.
Company:
Celgene Corp
Transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality.
Do not break, chew, or open caps. Swallow whole with water. ≥18yrs: initially 10mg per day; adjust dose based on response. Renal impairment: Moderate (CrCL 30-60mL/min): 5mg per day. Severe (CrCL <30mL/min without dialysis): 2.5mg per day. ESRD (CrCL <30mL/min with dialysis): 2.5mg once daily; administer after dialysis (on dialysis days). Dose adjustments if thrombocytopenia or neutropenia develops: see literature.
<18yrs: not recommended.
Immunomodulator.
Pregnancy (Cat. X). Women who may become pregnant.
Must register patient in RevAssist program; patient must understand toxicity with fetal exposure. Counsel patient on need for contraception; female: use 2 forms of contraception 1 month before, during, and 1 month after therapy; male: use condom during and 1 month after therapy; obtain 2 negative pregnancy tests (one within 10–14 days, and then another within 24 hours prior to starting therapy), repeat at least weekly for 1st month then every 4 weeks; get informed consent. Monitor for signs/symptoms of thromboembolic events. Obtain CBCs weekly for first 8 weeks, then monthly. Renal impairment (monitor). Monitor for tumor lysis syndrome in those with high tumor burden. Maximum 1 month per ℞. Nursing mothers: not recommended.
Monitor digoxin. Concomitant warfarin; monitor PT, INR. May increase risk of thrombosis with erythropoietic agents or estrogen containing therapies.
Birth defects, thrombocytopenia, neutropenia, GI upset, pruritus, rash, fatigue, arthralgia, pyrexia, back pain, cough, dizziness, headache, dyspnea, blurred vision, muscle cramp; thrombosis/embolism, allergic reactions (discontinue if occurs; do not resume), tumor flare reaction, hepatotoxicity.
Available only through RevAssist program. Report any suspected fetal exposure to the FDA at (800) FDA-1088 and Celgene at (888) 423-5436.
Caps 2.5mg, 5mg, 10mg—28, 100
15mg, 25mg—21, 100
Multiple myeloma (in combination with dexamethasone) in patients who have received at least one prior therapy.
Do not break, chew, or open caps. Swallow whole with water. ≥18yrs: initially 25mg once daily on Days 1–21 of each 28-day cycle. Renal impairment: Moderate (CrCL 30-60mL/min): 10mg per day. Severe (CrCL <30mL/min without dialysis): 15mg every 48 hrs. ESRD (CrCL <30mL/min with dialysis): 5mg once daily; administer after dialysis (on dialysis days). Dose adjustments if thrombocytopenia or neutropenia develops: see literature.
<18yrs: not recommended.
Immunomodulator.
Pregnancy (Cat. X). Women who may become pregnant.
Must register patient in RevAssist program; patient must understand toxicity with fetal exposure. Counsel patient on need for contraception; female: use 2 forms of contraception 1 month before, during, and 1 month after therapy; male: use condom during and 1 month after therapy; obtain 2 negative pregnancy tests (one within 10–14 days, and then another within 24 hours prior to starting therapy), repeat at least weekly for 1st month then every 4 weeks; get informed consent. Monitor for signs/symptoms of thromboembolic events. Obtain CBCs every 2 weeks for first 3 months, then monthly. Renal impairment (monitor). Monitor for tumor lysis syndrome in those with high tumor burden. Monitor for second primary malignancies. Maximum 1 month per ℞. Nursing mothers: not recommended.
Monitor digoxin. Concomitant warfarin; monitor PT, INR. May increase risk of thrombosis with erythropoietic agents or estrogen containing therapies.
Birth defects, thrombocytopenia, neutropenia, GI upset, pruritus, rash, fatigue, arthralgia, pyrexia, back pain, cough, dizziness, headache, dyspnea, blurred vision, muscle cramp; thrombosis/embolism, allergic reactions (discontinue if occurs; do not resume), tumor flare reaction, hepatotoxicity.
Available only through RevAssist program. Report any suspected fetal exposure to the FDA at (800) FDA-1088 and Celgene at (888) 423-5436.
Caps 2.5mg, 5mg, 10mg—28, 100
15mg, 25mg—21, 100