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Revlimid
lenalidomide
Black Box Warnings .
Appropriate Use
restricted distribution program, Lenalidomide REMS, to minimize fetal exposure; prescribers, pharmacies, and pts must enroll at 1-888-423-5436 or www.lenalidomiderems.com
Embryo-Fetal Toxicity
contraindicated in pregnancy; females of reproductive potential must have 2 negative pregnancy tests prior to tx start and use 2 reliable contraceptive methods or continuously abstain from heterosexual sex x4wk prior to tx start, during tx and dose interruptions, and x4wk after D/C; lenalidomide caused limb abnormalities in a developmental monkey study and may cause birth defects or embryo-fetal death; lenalidomide is analog of thalidomide, a known human teratogen that causes severe life-threatening human birth defects
Hematologic Toxicity
incl. significant neutropenia and thrombocytopenia; Grade 3 or 4 hematologic toxicity observed in 80% of pts w/ del 5q myelodysplastic syndromes (MDS); monitor CBC in pts w/ del 5q MDS qwk x1st 8wk, then at least qmo; monitor CBC in pts w/ multiple myeloma qwk x1st 8wk, then q2wk x4wk, then q4wk; monitor CBC in pts w/ mantle cell lymphoma qwk x1st 4wk, then q2wk x12wk, then qmo; monitor CBC in pts w/ follicular lymphoma or marginal zone lymphoma qwk x1st 3wk for cycle 1, then q2wk x12wk, then qmo; may require dose interruption and/or reduction as well as blood product support and/or growth factors
Venous and Arterial Thromboembolic Events
significant incr. risk of DVT, PE, MI, and stroke in pts w/ multiple myeloma receiving lenalidomide and dexamethasone; monitor for thromboembolism s/sx incl. SOB, chest pain, arm or leg swelling, advise pts to seek immediate medical care if they occur; thromboprophylaxis recommended, choice of regimen based on assessment of pt's underlying risk factors
Adult Dosing .
Dosage forms: CAP: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg
Restricted Distribution in US
- [1-888-423-5436 or www.celgeneriskmanagement.com for more info]
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments
multiple myeloma
- [newly diagnosed dz]
- Dose: 25 mg PO qd on days 1-21 of 28-day cycle; Info: for pts not eligible for autologous HSCT; use w/ dexamethasone + daratumumab or daratumumab/hyaluronidase; do not open cap
- [relapsed or refractory dz]
- Dose: 25 mg PO qd on days 1-21 of 28-day cycle; Info: use w/ dexamethasone +/- carfilzomib, elotuzumab, daratumumab, or daratumumab/hyaluronidase; do not open cap
- [post-auto-HSCT maintenance tx]
- Dose: 10 mg PO qd on days 1-28 of 28-day cycle; Start: upon hematologic recovery from autologous HSCT; Info: may incr. dose to 15 mg PO qd after 3 cycles; do not open cap
myelodysplastic syndrome, deletion 5q type
- [10 mg PO qd]
- Info: for pts w/ transfusion-dependent anemia d/t low- or intermediate-1-risk MDS; do not open cap
mantle cell lymphoma, relapsed or refractory
- [25 mg PO qd on days 1-21 of 28-day cycle]
- Info: for pts whose dz relapsed or progressed after 2 prior tx, incl. bortezomib; do not open cap
follicular lymphoma, previously treated
- [20 mg PO qd on days 1-21 of 28-day cycle]
- Info: use w/ rituximab; give up to 12 cycles; do not open cap
marginal zone lymphoma, previously treated
- [20 mg PO qd on days 1-21 of 28-day cycle]
- Info: use w/ rituximab; give up to 12 cycles; do not open cap
diffuse large B-cell lymphoma, relapsed or refractory (off-label)
- [25 mg PO qd on days 1-21 of 28-day cycle]
- Info: use w/ tafasitamab; give up to 12 cycles; do not open cap
renal dosing
- [multiple myeloma, combination tx]
- CrCl 30-60: start 10 mg qd for 1st 2 cycles, may incr. to 15 mg qd for subsequent cycles; CrCl <30: start 15 mg qod
- HD: start 5 mg qd, on dialysis days admin. after dialysis; no supplement; PD: not defined
- [multiple myeloma, maintenance tx]
- CrCl 30-60: start 5 mg qd; CrCl <30: start 2.5 mg qd
- HD: start 2.5 mg qd, on dialysis days admin. after dialysis; no supplement; PD: not defined
- [myelodysplastic syndrome]
- CrCl 30-60: start 5 mg qd; CrCl <30: start 2.5 mg qd
- HD: start 2.5 mg qd, on dialysis days admin. after dialysis; no supplement; PD: not defined
- [mantle cell lymphoma]
- CrCl 30-60: start 10 mg qd; CrCl <30: start 15 mg qod
- HD: start 5 mg qd, on dialysis days admin. after dialysis; no supplement; PD: not defined
- [follicular lymphoma, relapsed or refractory]
- CrCl 30-60: start 10 mg qd for 1st 2 cycles, may incr. to 15 mg qd for subsequent cycles; CrCl <30: start 5 mg qd
- HD: start 5 mg qd, on dialysis days admin. after dialysis; no supplement; PD: not defined
- [marginal zone lymphoma, relapsed or refractory]
- CrCl 30-60: start 10 mg qd for 1st 2 cycles, may incr. to 15 mg qd for subsequent cycles; CrCl <30: start 5 mg qd
- HD: start 5 mg qd, on dialysis days admin. after dialysis; no supplement; PD: not defined
- [diffuse large B-cell lymphoma, relapsed or refractory (off-label)]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- mild impairment: no adjustment; moderate-severe impairment: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.