Other Grade 3 / 4 Toxicities in MDS

For other Grade 3/4 toxicities judged to be related to REVLIMID, hold treatment and restart at the physician's discretion at next lower dose level when toxicity has resolved to ≤ Grade 2.

Starting Dose Adjustment for Renal Impairment in MDS

[see Dosage and Administration (2.4)].

2.3 Mantle Cell Lymphoma
 
The recommended starting dose of REVLIMID is 25 mg/day orally on Days 1-21 of repeated 28-day cycles for relapsed or refractory mantle cell lymphoma. Treatment should be continued until disease progression or unacceptable toxicity.

Treatment is continued, modified or discontinued based upon clinical and laboratory findings.

Dose Adjustments for Hematologic Toxicities During MCL Treatment

Dose modification guidelines as summarized below are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicities considered to be related to REVLIMID.

Platelet counts

Thrombocytopenia during treatment in MCL 

When Platelets Recommended Course
Fall to <50,000/mcL Interrupt REVLIMID treatment and follow
CBC weekly
Return to ≥50,000/mcL Resume REVLIMID at 5 mg less than the
previous dose. Do not dose below 5 mg daily

Absolute Neutrophil counts (ANC)

Neutropenia during treatment in MCL

When Neutrophils Recommended Course
Fall to <1000/mcL for at least 7 days
OR
Falls to < 1,000/mcL with an associated temperature ≥ 38.5°C
OR
Falls to < 500 /mcL Interrupt REVLIMID treatment and follow
CBC weekly
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 in MCL

For other Grade 3/4 toxicities judged to be related to REVLIMID, hold treatment and restart at the physician’s discretion at next lower dose level when toxicity has resolved to ≤ Grade 2.

Starting Dose Adjustment for Renal Impairment in MCL

[see Dosage and Administration (2.4)].

2.4 Starting Dose for Renal Impairment
 
The recommendations for starting doses for patients with renal impairment are shown in the following table [see Clinical Pharmacology (12.3)].

Table 3: Starting Dose Adjustments for Patients with Renal Impairment

Renal Function
(Cockcroft-Gault) Dose in REVLIMID Combination
Therapy for MM and for MCL Dose in REVLIMID Maintenance
Therapy Following Auto-HSCT for
MM and for MDS 
CLcr 30 to 60 mL/min 10 mg once daily 5 mg once daily
CLcr < 30 mL/min (not requiring dialysis) 15 mg every other day 2.5 mg once daily
CLcr < 30 mL/min (requiring dialysis) 5 mg once daily. On dialysis days, administer the dose following dialysis. 2.5 mg once daily. On dialysis days, administer the dose following dialysis.

REVLIMID Combination Therapy for MM: For CLcr of 30 to 60 mL/min, consider escalating the dose to 15 mg after 2 cycles if the patient tolerates the 10 mg dose of lenalidomide without dose-limiting toxicity.

REVLIMID Maintenance Therapy Following Auto-HSCT for MM and for MCL and MDS: Base subsequent REVLIMID dose increase or decrease on individual patient treatment tolerance [see Dosage and Administration (2.1- 2.3)].

3 DOSAGE FORMS AND STRENGTHS

REVLIMID 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules will be supplied through the REVLIMID REMS program.