REMS restricted

Lenalidomide

REVLIMID

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Pronunciation: len-a-LID-oe-mide

Lenalidomide ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Lenalidomide ballicule

What it isThalidomide analog and cereblon modulator; multiple myeloma and del(5q) myelodysplastic syndrome.

Why this oneThe 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.

Lenalidomide molecular structure (skeletal formula) — Molecular structure: Lenalidomide

Lenalidomide prescription history

Animated chart of estimated U.S. prescriptions per year, Oral anticancer meds (1953–2026). Lenalidomide enters in 2006 (estimated).

FDA-approved for

multiple myeloma (2006)
myelodysplastic syndrome with del(5q)

Classes and tags

Clinical profile

Therapeutic safety burden4 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk4 / 4

Legacy pregnancy categoryX

Defining liabilityExtreme teratogenicity, myelosuppression and thromboembolism.

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Embryo-fetal toxicity (thalidomide analogue — do not use in pregnancy; 2 negative pregnancy tests and 2 contraception forms; REMS program). Hematologic toxicity (neutropenia, thrombocytopenia — monitor CBC). Venous and arterial thromboembolism (DVT/PE, MI, stroke).

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

Available strengths

cap 2.5, 5, 10, 15, 20, 25 mg

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

Cost

Lenalidomide (REVLIMID)

Strength		#/mo	CostPlus
2.5 mg	cap	30 qd	not offered
5 mg	cap	30 qd	not offered
10 mg	cap	30 qd	not offered
15 mg	cap	30 qd	not offered
20 mg	cap	30 qd	not offered
25 mg	cap	30 qd	not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Lenalidomide is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entry2026

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Self-check

Which MDS subgroup can gain transfusion independence with lenalidomide?
Del(5q) MDS.
What reproductive monitoring is mandatory with lenalidomide?
Pregnancy testing under a REMS.