Revlimid
INDICATIONS
REVLIMIDÃ? (lenalidomide) is indicated for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
REVLIMIDÃ? (lenalidomide) in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.
DOSAGE AND ADMINISTRATION
Myelodysplastic Syndromes
The recommended starting dose of REVLIMIDÃ? (lenalidomide) is 10 mg daily with water. Patients should not break, chew or open the capsules. Dosing is continued or modified based upon clinical and laboratory findings.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it would be prudent to monitor renal function.
Dose Adjustments During Treatment:
Patients who are dosed initially at 10 mg and who experience thrombocytopenia should have their dosage adjusted as follows:
Platelet counts
| If thrombocytopenia develops WITHIN 4 weeks of starting treatment at 10 mg daily | |
| If baseline ≥100,000/mcL | |
| When | Recommended |
| Platelets | Course |
| Fall to <50,000/mcL | Interrupt REVLIMIDÃ? treatment |
| Return to ≥50,000/mcL | Resume REVLIMIDÃ? at 5 mg daily |
| If baseline <100,000/mcL | |
| When | Recommended |
| Platelets | Course |
| Fall to 50% of the baseline value | Interrupt REVLIMIDÃ? treatment |
| If baseline ≥60,000/mcL and returns to ≥ 50,000/mcL | Resume REVLIMIDÃ? at 5 mg daily |
| If baseline <60,000/mcL and returns to ≥ 30,000/mcL | Resume REVLIMIDÃ? at 5 mg daily |
| If thrombocytopenia develops AFTER 4 weeks of starting treatment at 10 mg daily | |
| When | Recommended |
| Platelets | Course |
| <30,000/mcL or <50,000/mcL and platelet transfusions | Interrupt REVLIMIDÃ? treatment |
| Return to≥30,000/mcL (without hemostatic failure) | Resume REVLIMIDÃ? at 5 mg daily |
| Patients who experience thrombocytopenia at 5 mg daily should have their dosage adjusted as follows: | |
| If thrombocytopenia develops during treatment at 5 mg daily | |
| When | Recommended |
| Platelets | Course |
| <30,000/mcL or <50,000/mcL and platelet transfusions | Interrupt REVLIMIDÃ? treatment |
| Return to ≥30,000/mcL (without hemostatic failure) | Resume REVLIMIDÃ? at 5 mg every other day |
| Patients who are dosed initially at 10 mg and experience neutropenia should have their dosage adjusted as follows: | |
| Neutrophil counts (ANC)+ | |
| If neutropenia develops WITHIN 4 weeks of starting treatment at 10 mg daily | |
| If baseline ANC ≥ 1,000/mcL | |
| When | Recommended |
| Neutrophils | Course |
| Fall to <750/mcL | Interrupt REVLIMIDÃ? treatment |
| Return to ≥ 1,000/mcL | Resume REVLIMIDÃ? at 5 mg daily |
| If baseline ANC <1,000/mcL | |
| When | Recommended |
| Neutrophils | Course |
| Fall to <500/mcL | Interrupt REVLIMIDÃ? treatment |
| Return to ≥ 500/mcL | Resume REVLIMIDÃ? at 5 mg daily |
| If neutropenia develops AFTER 4 weeks of starting treatment at 10 mg daily | |
| When | Recommended |
| Neutrophils | Course |
| <500/mcL for ≥ 7 days or <500/mcL associated with fever (≥38.5°C) | Interrupt REVLIMIDÃ? treatment |
| Return to ≥ 500/mcL | Resume REVLIMIDÃ? at 5 mg daily |
| Patients who experience neutropenia at 5 mg daily should have their dosage adjusted as follows: | |
| If neutropenia develops during treatment at 5 mg daily | |
| When | Recommended |
| Neutrophils | Course |
| <500/mcL for ≥7 days or <500/mcL associated with fever (≥ 38.5°C) | Interrupt REVLIMIDÃ? treatment |
| Return to ≥ 500/mcL | Resume REVLIMIDÃ? at 5 mg every other day |
| + Absolute neutrophil count | |
Multiple Myeloma
The recommended starting dose of REVLIMIDÃ? (lenalidomide) is 25 mg/day with water orally administered as a single 25 mg capsule on Days 1-21 of repeated 28-day cycles. Patients should not break, chew or open the capsules. The recommended dose of dexamethasone is 40 mg/day on Days 1-4, 9-12, and 17-20 of each 28-day cycle for the first 4 cycles of therapy and then 40 mg/day orally on Days 1-4 every 28 days. Dosing is continued or modified based upon clinical and laboratory findings.
The effect of substituting lesser strengths of REVLIMIDÃ?(lenalidomide) to achieve a 25 mg capsule dose is unknown.
Dose Adjustments During Treatment:
Dose modification guidelines, as summarized below are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged to be related to lenalidomide.
| Platelet counts | |
| Thrombocytopenia | |
| When Platelets | Recommended Course |
| Fall to <30,000/mcL | Interrupt REVLIMIDÃ? treatment, follow CBC weekly |
| Return to ≥ 30,000/mcL | Restart REVLIMIDÃ? at 15 mg daily |
| For each subsequent drop <30,000/mcL Return to ≥ 30,000/mcL | Interrupt REVLIMIDÃ? treatment Resume REVLIMIDÃ? at 5 mg less than the previous dose. Do not dose below 5 mg daily |
| Neutrophil counts (ANC) | |
| Neutropenia | |
| When Neutrophils | Recommended Course |
| Fall to <1000/mcL | Interrupt REVLIMIDÃ? treatment, add G-CSF, follow CBC weekly |
| Return to ≥ 1,000/mcL and neutropenia is the only toxicity | Resume REVLIMIDÃ? at 25 mg daily. |
| Return to ≥ 1,000/mcL and if other toxicity | Resume REVLIMIDÃ? at 15 mg daily |
| For each subsequent drop <1,000/mcL Return to ≥ 1,000/mcL | Interrupt REVLIMIDÃ? treatment Resume REVLIMIDÃ? at 5 mg less than the previous dose. Do not dose below 5 mg daily |
Other Grade 3/4 Toxicities
For other Grade 3/4 toxicities judged to be related to lenalidomide, hold treatment and restart at next lower dose level when toxicity has resolved to Grade 2.
HOW SUPPLIED
REVLIMIDÃ? (lenalidomide) 5 mg, 10 mg, 15 mg and 25 mg capsules will be supplied through the RevAssistSM program. (See INFORMATION FOR PATIENTS)
REVLIMIDÃ? (lenalidomide) is supplied as:
White opaque capsules imprinted "REV" on one half and "5 mg" on the other half in black ink:
5 mg bottles of 30 (NDC 59572-405-30)
5 mg bottles of 100 (NDC 59572-405-00)
Blue/green and pale yellow opaque capsules imprinted "REV" on one half and "10 mg" on the other half in black ink:
10 mg bottles of 30 (NDC 59572-410-30)
10 mg bottles of 100 (NDC 59572-410-00)
Powder blue and white opaque capsules imprinted "REV" on one half and "15 mg" on the other half in black ink:
15 mg bottles of 21 (NDC 59572-415-21)
15 mg bottles of 100 (NDC 59572-415-00)
White opaque capsules imprinted "REV" on one half and "25 mg" on the other half in black ink:
25 mg bottles of 25 (NDC 59572-425-25)
25 mg bottles of 100 (NDC 59572-425-00)
Storage and Dispensing
Dispense no more than a 28-day supply.
Store at 25°C (77 °F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature].
Rx only.
Manufactured for Celgene Corporation
86 Morris Avenue Summit,
NJ 07901
FDA rev date: 06/29/06
Generic Name: Lenalidomide
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