Drug Class Description
Immunomodulating agent
Generic Name
Lenalidomide
Drug Description
Each Revlimid 5 mg hard capsule contains 5 mg of lenalidomide.Excipient: Each capsule contains 147 mg of anhydrous lactose.Each Revlimid 10 mg hard capsule contains 10 mg of lenalidomide.Excipient: Each capsule contains 294 mg of anhydrous lactose.Each Revlimid 15 mg hard capsule contains 15 mg of lenalidomide.Excipient: Each capsule contains 289 mg of anhydrous lactose.Each Revlimid 25 mg hard capsule contains 25 mg of lenalidomide.Excipient: Each capsule contains 200 mg of anhydrous lactose
Presentation
Hard capsule.Revlimid 5 mg hard capsules: White capsules marked “REV 5 mg”.Revlimid 10 mg hard capsules: Blue-green/pale yellow capsules marked “REV 10 mg”.Revlimid 15 mg hard capsules: Pale blue/white capsules marked “REV 15 mg”.Revlimid 25 mg hard capsules: White capsules marked “REV 25 mg”.
Indications
Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.
Adult Dosage
Treatment must be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma (MM).AdministrationRevlimid capsules should be taken at about the same time each day. The capsules should not be broken or chewed. The capsules should be swallowed whole, preferably with water, either with or without food. If less than 12 hours has elapsed since missing a dose, the patient can take the dose. If more than 12 hours has elapsed since missing a dose at the normal time, the patient should not take the dose, but take the next dose at the normal time on the following day.Recommended doseThe recommended starting dose of lenalidomide is 25 mg orally once daily on days 121 of repeated 28day cycles. The recommended dose of dexamethasone is 40 mg orally once daily on days 14, 912, and 1720 of each 28day cycle for the first 4 cycles of therapy and then 40 mg once daily on days 14 every 28 days. Dosing is continued or modified based upon clinical and laboratory findings.Lenalidomide treatment must not be started if the Absolute Neutrophil Counts (ANC) < 1.0 x 109/l, and/or platelet counts < 75 x 109/l or, dependent on bone marrow infiltration by plasma cells, platelet counts < 30 x 109/l.Recommended dose adjustments during treatment and restart of treatmentDose adjustments, as summarised 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.•Dose reduction stepsStarting dose25 mgDose level 115 mgDose level 210 mgDose level 35 mg•Platelet countsThrombocytopeniaWhen plateletsRecommended CourseFirst fall to < 30 x 109 /lInterrupt lenalidomide treatmentReturn to 30 x 109 /lResume lenalidomide at Dose Level 1For each subsequent drop below 30 x 109 /lInterrupt lenalidomide treatmentReturn to 30 x 109 /lResume lenalidomide at next lower dose level (Dose Level 2 or 3) once daily. Do not dose below 5 mg once daily.•Absolute Neutrophil counts (ANC)NeutropeniaWhen neutrophilsRecommended CourseFirst fall to < 0.5 x 109 /lInterrupt lenalidomide treatmentReturn to 0.5 x 109 /l when neutropenia is the only observed toxicityResume lenalidomide at Starting Dose once dailyReturn to 0.5 x 109 /l when dose-dependent haematological toxicities other than neutropenia are observedResume lenalido