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Revlimid (Lenalidomide) - Indications and Dosage

 
 



INDICATIONS AND USAGE

REVLIMID® (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.

REVLIMID® (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 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 PlateletsRecommended Course
Fall to <50,000/mcLInterrupt REVLIMID® treatment
Return to ≥50,000/mcLResume REVLIMID® at 5 mg daily
If baseline <100,000/mcL
When PlateletsRecommended Course
Fall to 50% of the baseline valueInterrupt 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 PlateletsRecommended 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 PlateletsRecommended 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 NeutrophilsRecommended Course
Fall to <750/mcLInterrupt REVLIMID® treatment
Return to ≥1,000/mcLResume REVLIMID® at 5 mg daily
If baseline ANC <1,000/mcL
When NeutrophilsRecommended Course
Fall to <500/mcLInterrupt REVLIMID® treatment
Return to ≥500/mcLResume REVLIMID® at 5 mg daily

If neutropenia develops AFTER 4 weeks of starting treatment at 10 mg daily
When NeutrophilsRecommended Course
<500/mcL for ≥7 days or <500/mcL
associated with fever (≥38.5°C)
Interrupt REVLIMID® treatment
Return to ≥500/mcLResume 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 NeutrophilsRecommended Course
<500/mcL for ≥7 days or <500/mcL
associated with fever (≥38.5°C)
Interrupt REVLIMID® treatment
Return to ≥500/mcLResume 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 PlateletsRecommended Course
Fall to <30,000/mcLInterrupt REVLIMID® treatment, follow CBC weekly
Return to ≥30,000/mcLRestart REVLIMID® at 15 mg daily
For each subsequent drop <30,000/mcLInterrupt REVLIMID® treatment
Return to ≥30,000/mcLResume REVLIMID® at 5 mg less than the previous dose. Do not dose below 5 mg daily

Neutrophil counts (ANC)

Neutropenia
When NeutrophilsRecommended Course
Fall to <1000/mcLInterrupt REVLIMID® treatment, add G-CSF, follow CBC weekly
Return to ≥1,000/mcL and neutropenia is the only toxicityResume 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/mcLInterrupt REVLIMID® treatment
Return to ≥1,000/mcLResume REVLIMID® at 5 mg less than the previous dose. Do not dose below 5 mg daily

Starting Dose Adjustment for Renal Impairment:

Since lenalidomide is primarily excreted unchanged by the kidney, adjustments to the starting dose of REVLIMID® (lenalidomide) are recommended to provide appropriate drug exposure in patients with moderate or severe renal impairment and in patients on dialysis. Based on a pharmacokinetic study in patients with renal impairment due to nonmalignant conditions, lenalidomide starting dose adjustment is recommended for patients with CLcr < 60 mL/min. Non-dialysis patients with creatinine clearances less than 11 mL/min, and dialysis patients with creatinine clearances less than 7 mL/min, have not been studied. The recommendations for initial starting doses for patients with multiple myeloma (MM) and myelodysplastic syndromes (MDS) are as follows:

Starting Dose Adjustment for Renal Impairment
CategoryRenal Function (Cockcroft-Gault CLcr)Disease
Multiple MyelomaMyelodysplastic Syndromes
Moderate Renal Impairment30 ≤ CLcr < 60 mL/min10 mg
Every 24 hours
5 mg
Every 24 hours
Severe Renal ImpairmentCLcr < 30 ml/min (not requiring dialysis)15 mg
Every 48 hours
5 mg
Every 48 hours
End Stage Renal DiseaseCLcr < 30 mL/min (requiring dialysis)5 mg
Once daily. On dialysis days the dose should be administered following dialysis
5 mg
3 times a week following each dialysis

After initiation of REVLIMID® (lenalidomide) therapy, subsequent REVLIMID® (lenalidomide) dose modification should be based on individual patient treatment tolerance, as described elsewhere in this section.


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

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 28       (NDC 59572-405-28)

            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 28     (NDC 59572-410-28)

            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 21     (NDC 59572-425-21)

            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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