From the Guidelines
Lenalidomide is recommended for multiple myeloma and myelodysplastic syndromes with specific dosing regimens for each condition, prioritizing the most recent and highest quality study from 2020 1. For multiple myeloma, lenalidomide is typically given at 25 mg orally once daily on days 1-21 of repeated 28-day cycles, in combination with dexamethasone. For maintenance therapy after stem cell transplantation, the dose is usually 10-15 mg daily. Some key points to consider when using lenalidomide include:
- Dosage adjustments are necessary for patients with renal impairment: for creatinine clearance 30-60 mL/min, reduce to 10 mg daily; for clearance below 30 mL/min, reduce to 15 mg every 48 hours or 5 mg daily.
- Regular blood count monitoring is essential as lenalidomide can cause neutropenia and thrombocytopenia.
- Thromboprophylaxis with aspirin or anticoagulants is required due to increased risk of blood clots.
- Lenalidomide works by modulating the immune system, inhibiting angiogenesis, and directly affecting tumor cells.
- Women of childbearing potential must use effective contraception due to the drug's teratogenic effects, and the medication should be taken at approximately the same time each day. Key regimens that include lenalidomide for multiple myeloma are:
- Lenalidomide/dexamethasone (category 1) 1
- Bortezomib/lenalidomide/dexamethasone (category 1) 1
- Carfilzomib/lenalidomide/dexamethasone (category 1) 1
- Daratumumab/lenalidomide/dexamethasone (category 1) 1
- Elotuzumab/lenalidomide/dexamethasone (category 1) 1
- Ixazomib/lenalidomide/dexamethasone (category 1) 1 For myelodysplastic syndromes with deletion 5q cytogenetic abnormality, the starting dose is 10 mg orally once daily. Lenalidomide has been shown to be effective in patients with myelodysplastic syndromes, with a significant reduction in transfusion requirements and an improvement in overall survival 1. However, the use of lenalidomide in myelodysplastic syndromes should be carefully considered, taking into account the potential risks and benefits, as well as the individual patient's characteristics and medical history.
From the FDA Drug Label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1676-7 Lenalidomide Capsules, 2.5 mg 28 Capsules Rx only NDC 70771-1677-7 Lenalidomide Capsules, 5 mg 28 Capsules Rx only NDC 70771-1678-7 Lenalidomide Capsules, 10 mg 28 Capsules Rx only NDC 70771-1679-8 Lenalidomide Capsules, 15 mg 21 Capsules Rx only NDC 70771-1680-8 Lenalidomide Capsules, 20 mg 21 Capsules Rx only NDC 70771-1681-8 Lenalidomide Capsules, 25 mg 21 Capsules Rx only
The FDA drug label does not answer the question.
From the Research
Recommended Use of Lenalidomide
- Lenalidomide is approved for the treatment of multiple myeloma and myelodysplastic syndromes, specifically deletion 5q myelodysplastic syndromes 2, 3, 4, 5, 6.
- It is also being investigated for use in other hematologic malignancies, including chronic lymphocytic leukemia, non-Hodgkin lymphoma, and mantle cell lymphoma 3, 6.
Dosage of Lenalidomide
- The recommended starting dose of lenalidomide varies by malignancy, with lower doses used for chronic lymphocytic leukemia than for multiple myeloma or non-Hodgkin lymphoma 3.
- The dose of lenalidomide should be adjusted based on renal function, with a reduction in dose recommended for patients with renal impairment 2, 4, 5.
- No dose adjustment is needed based on age, ethnicity, mild hepatic impairment, or drug-drug interactions 2.
Administration and Pharmacokinetics
- Lenalidomide is orally administered and rapidly absorbed, with a high bioavailability of over 90% under fasting conditions 2.
- Food can affect the absorption of lenalidomide, reducing the area under the concentration-time curve (AUC) by 20% and the maximum concentration (Cmax) by 50% 2.
- Lenalidomide has a short half-life of 3-4 hours and does not accumulate in plasma upon repeated dosing 2.
Safety and Adverse Events
- Common adverse events associated with lenalidomide include neutropenia, thrombocytopenia, fatigue, and venous thromboembolic complications 3, 4, 5.
- Effective management of adverse events requires awareness of these differences and appropriate prophylaxis, monitoring, and treatment 3.
- Lenalidomide is generally well tolerated, with most adverse events occurring early in the course of treatment and being manageable 4, 5.