Lenalidomide
REVLIMID
What it isThalidomide analog and cereblon modulator; multiple myeloma and del(5q) myelodysplastic syndrome.
Why this oneIt is the backbone of myeloma maintenance and produces transfusion independence in del(5q) MDS.
What limits itPowerfully teratogenic under a REMS with mandatory pregnancy testing. Myelosuppression and venous thromboembolism requiring prophylaxis.
FDA-approved for
- multiple myeloma (2006)
- myelodysplastic syndrome with del(5q)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Multiple myeloma — combination therapy | Adults | 25 mg QD, Days 1-21 of 28-day cycles | 25 mg QD (Days 1-21) | 25 mg QD |
| MM maintenance after auto-HSCT | Adults | 10 mg QD continuously, Days 1-28 | 10 mg QD | per tolerability |
| MDS with del 5q | Adults | 10 mg QD | 10 mg QD | 10 mg QD |
| Mantle cell lymphoma | Adults | 25 mg QD, Days 1-21 of 28-day cycles | 25 mg QD (Days 1-21) | 25 mg QD |
| Follicular / marginal zone lymphoma | Adults | 20 mg QD, Days 1-21 of 28-day cycles, up to 12 cycles | 20 mg QD (Days 1-21) | 20 mg QD |
Renal Adjust starting dose based on creatinine clearance
Hepatic Undefined
Cyclic dosing on Days 1-21 of 28-day cycles (except MM maintenance and MDS)
Instructions
- Available only through the Lenalidomide REMS program
- Take at about the same time each day
- Swallow capsules whole with water; do not open, break, or chew
Contraindications
- Pregnancy
Cautions
- Increased mortality in CLL
- Second primary malignancies
- Increased mortality when pembrolizumab added
- Hepatotoxicity (fatal hepatic failure)
- Severe cutaneous reactions
- Tumor lysis syndrome
- Tumor flare reaction
- Impaired stem cell mobilization
- Early mortality in MCL
- Thyroid disorders
- Hypersensitivity (angioedema/anaphylaxis)
Adverse reactions
- Diarrhea
- Fatigue
- Anemia
- Constipation
- Neutropenia
- Thrombocytopenia
- Peripheral edema
- Nausea
- Muscle cramp/spasms
Pregnancy Contraindicated — thalidomide analogue causes severe birth defects and embryo-fetal death
Lactation Advise not to breastfeed during treatment
⚠ BOXED WARNINGS
- Embryo-fetal toxicity
- Hematologic toxicity
- Venous and arterial thromboembolism
Cost, est. cash$100–$5,000/month
Generic entry2026
Classes and tags
Clinical profile
Legacy pregnancy categoryX
Defining liabilityExtreme teratogenicity, myelosuppression and thromboembolism.
Mechanism of action: Lenalidomide ballicule
