|Active substance||Lenalidomide (C13H13N3O3)|
|Manufacturing by India||Natco|
|Strength||5mg, 10mg, 15mg, 25mg|
|Form release||bottle 30 capsules|
|Estimated shipping time||7 – 18 days (Depending from the Country)|
|Availability, Prices & Order||through request form|
It was initially intended as a treatment for multiple myeloma, for which thalidomide is an accepted therapeutic treatment. Lenalidomide has also shown efficacy in the class of hematological disorders known as myelodysplastic syndromes (MDS). Along with several other drugs developed in recent years, lenalidomide has significantly improved overall survival in myeloma (which formerly carried a poor prognosis), although toxicity remains an issue for users. It costs $163,381 per year for the average patient.
In 2006, lenalidomide, an orally administered thalidomide analogue, received FDA approval for use with dexamethasone in patients with multiple myeloma who received at least one prior therapy. In 2015, the indication was expanded for use in combination with dexamethasone for the treatment of patients with multiple myeloma, to include newly diagnosed multiple myeloma patients who are not eligible for autologous stem cell transplant. Lenalidomide is also approved in myelodysplastic syndromes and mantle cell lymphoma.
The current approval was based on two randomized, controlled trials evaluating the efficacy and safety of lenalidomide maintenance therapy for the treatment of multiple myeloma patients after autologous stem cell transplant (CALGB 100104 and IFM 2005-02 trials). These trials demonstrated approximately a 15-month (CALGB) and 18-month (IFM) progression-free survival advantage, at the time of the primary analysis, in patients treated with lenalidomide compared with patients receiving placebo (hazard ratio (HR) in CALGB=0.38; 95% CI: 0.27, 0.54; p<0.001 and HR in IFM=0.50; 95% CI: 0.39, 0.64; p<0.001). The median overall survival was 111 and 106 months for patients treated with lenalidomide compared with 84 and 88 months for patients receiving placebo in the CALGB and IFM trials, respectively.
The types, frequency, and severity of adverse events (AEs) observed in the two trials were similar to those previously described in the product label. Neutropenia, affecting 56% of the 517 patients treated with lenalidomide in both trials, was the most frequently reported grade 3/4 AE. An increased incidence of second primary malignancies was reported among patients treated with lenalidomide compared with those receiving placebo. The lenalidomide product label notes an increase in second primary malignancies in patients with multiple myeloma treated with lenalidomide.
The recommended dose and schedule for lenalidomide is 10mg once daily continuously on days 1-28 of repeated 28-day cycles.
Usual Adult Dose for Myelodysplastic Disease
10 mg orally once daily
Approved indication: Treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
25 mg/day of lenalidomide with water orally as a single 25 mg capsule on days 1 through 21 of repeated 28 day cycles.
(The recommended dose of dexamethasone is 40 mg/day on days 1 through 4, 9 through 12, and 17 through 20 of each 28 day cycle for the first 4 cycles of therapy and then 40 mg/day orally on days 1 through 4 every 28 days.)
The effects of substituting lesser strengths of lenalidomide to equal a 25 mg capsule dose is unknown.
25 mg orally once a day on Days 1 to 21 of repeated 28 day cycles.
Duration of therapy: Treatment should be continued until disease progression or unacceptable toxicity.
Approved indication: Treatment of mantle cell lymphoma (MCL) in patients whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
- Gastrointestinal effects (diarrhea, constipation, or nausea)
- Fatigue or loss of strength
- Low red blood cell or white blood cell counts
- Swelling in the arms and legs (peripheral edema)
- Muscle cramps
- Back pain
- Low white blood cell, red blood cell, or platelet counts
- Blood clots