DOSAGE AND ADMINISTRATION
Myelodysplastic Syndromes
The recommended starting dose of REVLIMID® (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 Platelets | Recommended Course |
| Fall to <50,000/mcL | Interrupt REVLIMID® treatment |
| Return to ≥50,000/mcL | Resume REVLIMID® at 5 mg daily |
| If baseline <100,000/mcL |
| When Platelets | Recommended Course |
| Fall to 50% of the baseline value | Interrupt REVLIMID® treatment |
If baseline ≥60,000/mcL and
returns to ≥50,000/mcL | Resume REVLIMID® at 5 mg daily |
If baseline <60,000/mcL and
returns to ≥30,000/mcL | Resume REVLIMID® at 5 mg daily |
If thrombocytopenia develops AFTER 4 weeks of starting treatment at 10 mg daily | When Platelets | Recommended Course |
<30,000/mcL or <50,000/mcL
and platelet transfusions | Interrupt REVLIMID® treatment |
Return to ≥30,000/mcL
(without hemostatic failure) | Resume REVLIMID® 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 Platelets | Recommended Course |
<30,000/mcL or <50,000/mcL
and platelet transfusions | Interrupt REVLIMID® treatment |
Return to ≥30,000/mcL
(without hemostatic failure) | Resume REVLIMID® 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 Neutrophils | Recommended Course |
| Fall to <750/mcL | Interrupt REVLIMID® treatment |
| Return to ≥1,000/mcL | Resume REVLIMID® at 5 mg daily |
| If baseline ANC <1,000/mcL | |
| When Neutrophils | Recommended Course |
| Fall to <500/mcL | Interrupt REVLIMID® treatment |
| Return to ≥500/mcL | Resume REVLIMID® at 5 mg daily |
If neutropenia develops AFTER 4 weeks of starting treatment at 10 mg daily | When Neutrophils | Recommended Course |
<500/mcL for ≥7 days or <500/mcL
associated with fever (≥38.5°C) | Interrupt REVLIMID® treatment |
| Return to ≥500/mcL | Resume REVLIMID® 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 | + Absolute neutrophil count |
| When Neutrophils | Recommended Course |
<500/mcL for ≥7 days or <500/mcL
associated with fever (≥38.5°C) | Interrupt REVLIMID® treatment |
| Return to ≥500/mcL | Resume REVLIMID® at 5 mg every other day |
Multiple Myeloma
The recommended starting dose of REVLIMID® (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 REVLIMID®(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 REVLIMID® treatment, follow CBC weekly |
| Return to ≥30,000/mcL | Restart REVLIMID® at 15 mg daily |
| For each subsequent drop <30,000/mcL | Interrupt REVLIMID® treatment |
| Return to ≥30,000/mcL | Resume REVLIMID® 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 REVLIMID® treatment, add G-CSF, follow CBC weekly |
| Return to ≥1,000/mcL and neutropenia is the only toxicity | Resume REVLIMID® at 25 mg daily |
Return to ≥1,000/mcL and if
other toxicity | Resume REVLIMID® at 15 mg daily |
| For each subsequent drop <1,000/mcL | Interrupt REVLIMID® treatment |
| Return to ≥1,000/mcL | Resume REVLIMID® 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.
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HOW SUPPLIED
REVLIMID® (lenalidomide) 5 mg, 10 mg, 15 mg and 25 mg capsules will be supplied through the RevAssist® program. (See INFORMATION FOR PATIENTS)
REVLIMID® (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
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