Lenalidomide

Preview FDA label, Amneal Pharmaceuticals NY LLC, oral, effective 2026-05-14. Full label on DailyMed

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using. Not yet reviewed by a ClinDose pharmacist.

Dosing in kidney impairment

Recommended Dosage for Patients with Renal Impairment The recommendations for dosing patients with renal impairment are shown in the following table [see Clinical Pharmacology ] . Table 3: Dose Adjustments for Patients with Renal Impairment [See table below.] 2.5 mg once daily. On dialysis days, administer the dose following dialysis.

Lenalidomide Capsules Combination Therapy for MM: For CL cr of 30 mL/min 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. Lenalidomide Capsules Maintenance Therapy Following Auto-HSCT for MM: Base subsequent lenalidomide capsules dose increase or decrease on individual patient treatment tolerance [see Dosage and Administration ] .

Renal Function(Cockcroft-Gault)Dose in Lenalidomide Capsules Combination Therapy for MMDose in Lenalidomide Capsules Maintenance Therapy Following Auto-HSCT for MM
CLcr 30 mL/min to 60 mL/min10 mg once daily5 mg once daily
CLcr below 30 mL/min (not requiring dialysis)15 mg every other day2.5 mg once daily
CLcr below 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.

Preparation and administration

Administration Advise patients to take lenalidomide capsules orally at about the same time each day, either with or without food. Advise patients to swallow lenalidomide capsules whole with water and not to open, break, or chew them.