Lenalidomide

Pronunciation: len-a-LID-oh-mide.

Generic name
lenalidomide
Drug class
Immunomodulatory antineoplastic agent (thalidomide analogue)
Form
Capsule (2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, depending on market and indication)
Route
Oral
Legal status
Prescription-only, restricted/controlled distribution program required in every market

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Revlimid (5) · Full directory

What lenalidomide is and how it works

Lenalidomide is a prescription oral cancer/blood-disorder medicine (an immunomodulatory agent related to thalidomide) used to treat multiple myeloma, certain myelodysplastic syndromes, mantle cell lymphoma, and follicular or marginal zone lymphoma. It works by helping the immune system attack abnormal cells and by blocking the growth of new blood vessels that tumours need. (1) (2)

Lenalidomide carries a genuinely serious FDA boxed warning covering three separate risks: severe birth defects if used in pregnancy (it is a thalidomide-related medicine), significant drops in white blood cells and platelets, and a real increased risk of dangerous blood clots, heart attack, and stroke. Because of the pregnancy risk specifically, lenalidomide can only be prescribed and dispensed through a mandatory controlled program in every country -- you cannot get it through an ordinary prescription and pharmacy visit alone. Never take lenalidomide without being enrolled in your country's required program, and never share it with anyone else.

Mechanism of action: how lenalidomide works

Lenalidomide is an immunomodulatory antineoplastic agent structurally related to thalidomide. It is thought to work through several mechanisms: enhancing T-cell and NK-cell-mediated immunity against abnormal/malignant cells, direct cytotoxic and anti-proliferative effects on malignant cells (including deletion-5q clones), and anti-angiogenic effects that reduce blood vessel growth within tumours. (1) (4)

What lenalidomide is used for

Multiple myeloma

Used in combination with dexamethasone (and, in some regimens, bortezomib and dexamethasone, or melphalan and prednisone) to treat multiple myeloma, including as maintenance treatment after an autologous stem cell transplant. (1) (2)

Myelodysplastic syndromes (deletion 5q)

Used to treat transfusion-dependent anemia caused by low- or intermediate-1-risk myelodysplastic syndromes with a deletion 5q chromosomal abnormality. (1) (4)

Mantle cell lymphoma

Used to treat mantle cell lymphoma that has relapsed or not responded to prior treatment. (1) (2)

Follicular lymphoma and marginal zone lymphoma

Used in combination with rituximab to treat previously treated follicular lymphoma or marginal zone lymphoma. (1) (2)

Before taking lenalidomide

Do not take / not appropriate for

  • Do not take lenalidomide if you are pregnant, or if you cannot commit to the pregnancy-prevention requirements of your country's controlled program -- lenalidomide is contraindicated in pregnancy and may cause severe birth defects or loss of the pregnancy. (all confirmed countries) (1) (2)
  • Do not take lenalidomide if you have had a severe allergic reaction to it, including angioedema, Stevens-Johnson syndrome, or toxic epidermal necrolysis. (all confirmed countries) (1)
  • Do not take lenalidomide as a single agent for first-line chronic lymphocytic leukaemia outside of a controlled clinical trial -- this specific use increased the risk of death compared to chlorambucil in a clinical trial. (all confirmed countries) (1)

Tell your clinician about

  • Whether you are, or could become, pregnant, or whether you could father a pregnancy -- and your ability to reliably follow the pregnancy-prevention program in your country.
  • Any personal or family history of blood clots, heart attack, or stroke.
  • Any history of liver problems.
  • Any history of thyroid problems.
  • All other medicines, especially digoxin, warfarin, erythropoiesis-stimulating agents, or estrogen-containing medicines.
  • Your kidney function, since your dose may need to be adjusted.
(1) (2)

How to take lenalidomide

  • You can only receive lenalidomide if you, your prescriber, and your dispensing pharmacy are all registered with your country's mandatory controlled program (REMS in the US, RevAid in Canada, a Pregnancy Prevention Programme in the UK/EU, or the equivalent New Zealand programme).
  • Take exactly as prescribed, on the specific days of your cycle set by your oncologist/haematologist -- lenalidomide is usually taken on a cycle (for example, days 1-21 of a 28-day cycle), not continuously, for most indications.
  • Swallow capsules whole with water; do not open, break, or chew them.
  • Female patients of reproductive potential must have required pregnancy tests and use two reliable forms of contraception (or commit to continuous abstinence) exactly as your program requires.
  • Male patients must use condoms during treatment and for a defined period afterwards (even after a vasectomy), and must not donate sperm.
(1) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

If you miss a dose and remember with 12 or more hours still to go before your next scheduled dose, take the missed dose as soon as you remember. If less than 12 hours remain before your next dose, contact your prescriber or pharmacist for guidance on the missed dose entirely and take your next dose at its normal scheduled time -- never take an extra dose to make up for a missed one.

Overdose

Seek urgent medical attention if you think you have taken too much lenalidomide. There is no specific antidote; treatment is supportive and based on your symptoms and blood counts. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Diarrhoea, constipation, and nausea.

What to notice: Diarrhoea, constipation, and nausea.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Fatigue and muscle cramps.

What to notice: Fatigue and muscle cramps.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Anaemia, neutropenia (low white blood cells), and thrombocytopenia (low platelets) -- monitored with regular blood tests.

What to notice: Anaemia, neutropenia (low white blood cells), and thrombocytopenia (low platelets) -- monitored with regular blood tests.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Peripheral swelling (oedema), insomnia, and rash.

What to notice: Peripheral swelling (oedema), insomnia, and rash.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Signs of pregnancy or possible pregnancy — boxed_warning

Symptoms: A missed period, or any reason to suspect pregnancy in yourself or a partner.

Action: Contact your clinician immediately and let them advise on whether to continue or stop $1 and your country's controlled-distribution program without delay. Lenalidomide is a thalidomide-related medicine that can cause severe birth defects or death of an unborn baby. (1) (2)

Signs of low blood cell counts (infection, bleeding, or bruising) — boxed_warning

Symptoms: Fever, chills, or other signs of infection; unusual bruising; bleeding gums; nosebleeds; or unusually heavy bleeding from a small cut.

Action: Contact your clinician promptly -- lenalidomide can cause significant drops in white blood cells (neutropenia) and platelets (thrombocytopenia), and regular blood tests are required throughout treatment. (1) (6)

Signs of a blood clot, heart attack, or stroke — boxed_warning

Symptoms: Swelling, pain, redness, or warmth in one leg (possible deep vein thrombosis); sudden shortness of breath or chest pain (possible pulmonary embolism or heart attack); sudden weakness or numbness on one side, slurred speech, or vision changes (possible stroke).

Action: Seek emergency medical help immediately. Lenalidomide significantly increases the risk of these blood clot events, especially in multiple myeloma treated with combination therapy. (1)

Signs of liver injury — serious

Symptoms: Yellowing of the skin or eyes (jaundice), dark urine, severe fatigue, or pain in the upper right abdomen.

Action: Contact your clinician promptly for liver blood tests. Severe, including fatal, liver injury has been reported with lenalidomide combination therapy. (4)

Signs of a severe skin reaction — serious

Symptoms: Widespread blistering or peeling skin, painful rash, or mouth/eye sores.

Action: Seek emergency medical help immediately -- lenalidomide has been associated with severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, which require permanent discontinuation directed by your clinician. Let the clinician you see advise whether to continue or stop treatment. (1) (2)

Symptoms of tumour lysis syndrome or tumour flare reaction — serious

Symptoms: New or worsening lymph node swelling and tenderness, fever, pain, or rash (tumour flare); or muscle weakness, confusion, irregular heartbeat, or reduced urination (possible tumour lysis syndrome), especially with a high existing tumour burden.

Action: Contact your clinician promptly -- fatal cases of both tumour lysis syndrome and tumour flare reaction have been reported. (1)

Interactions

  • Digoxin: lenalidomide can raise digoxin blood levels; monitoring is required. (1)
  • Erythropoiesis-stimulating agents and estrogen-containing medicines (including the combined oral contraceptive pill): additive risk of blood clots -- your prescriber will weigh the benefits and risks carefully. (1) (6)
  • Warfarin: a possible interaction exists; your clinician will monitor you closely if you take both. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Contraindicated. Lenalidomide is a thalidomide analogue and can cause severe birth defects or death of an unborn baby. Two negative pregnancy tests are required before starting, with ongoing testing during treatment, and two reliable methods of contraception (or continuous abstinence) are required from before treatment starts until a defined period after it ends. (1) (2) (3) (4) (5) (6)

Elderly

Used with the same core precautions as in younger adults; kidney function (which commonly declines with age) is a key factor in dose selection. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

Severe, including fatal, liver injury has been reported with lenalidomide combination therapy; liver function should be monitored, with dose adjustment or discontinuation as directed by your clinician if abnormalities occur. (1) (2) (3) (4) (5) (6)

Renal_impairment

Dose must be reduced according to creatinine clearance, with further reduction for patients on dialysis -- always individualised by your prescriber. (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Two negative pregnancy tests for female patients of reproductive potential
  • Baseline full blood count (white blood cells, platelets, haemoglobin)
  • Baseline kidney function (creatinine clearance)
  • Baseline liver function tests
  • Thyroid function tests
  • Enrollment in the country's mandatory controlled distribution program

During treatment

  • Weekly full blood counts for at least the first 8 weeks, then at least monthly thereafter
  • Ongoing pregnancy testing for female patients (for example, every 4 weeks) throughout treatment and for a defined period after stopping
  • Periodic liver function and thyroid function testing
  • Ongoing assessment for signs of blood clots, infection, bleeding, and skin reactions
(1) (2)

Storage

Store in the original container at room temperature, out of reach of children and pets. Do not transfer capsules to a pillbox or other container. Do not use after the expiry date.

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information, UK EMC SmPC, and Health Canada Product Monograph; verify against the current full label before prescribing.

United States / United Kingdom / European Union / Canada / Australia / New Zealand

Indication: Multiple myeloma (combination therapy)

Dose summary: 25 mg once daily, days 1-21 of 28-day cycles, adjusted for haematologic toxicity and renal function.

Renal context: Reduced per creatinine clearance; further reduced on dialysis (dose given post-dialysis). (1) (2)

United States / United Kingdom / European Union / Canada / Australia / New Zealand

Indication: Myelodysplastic syndromes (deletion 5q)

Dose summary: 10 mg once daily.

Renal context: Reduced per creatinine clearance. (1) (4)

Mechanism of action

Hepatic guidance

Severe, including fatal, hepatotoxicity has been reported with combination therapy; monitor liver enzymes regularly and adjust or discontinue treatment for significant abnormalities.

Overdose note

No specific antidote; manage supportively with close monitoring of blood counts and clinical status. (1) (4)

Frequently asked questions

Is lenalidomide available in the US, UK, Europe, Canada, Australia, and New Zealand?

Yes. Lenalidomide (Revlimid) is confirmed authorised in all six of these markets, though in every one it can only be prescribed and dispensed through a mandatory controlled program (REMS in the US, RevAid in Canada, a Pregnancy Prevention Programme in the UK/EU, and a comparable New Zealand programme). (1) (2) (3) (4) (5) (6)

Why does lenalidomide require a special controlled program to get it?

Because lenalidomide is chemically related to thalidomide and can cause severe birth defects or death of an unborn baby if taken during pregnancy. Every country where it is authorised requires prescribers, pharmacies, and patients to be registered in a controlled distribution program (with mandatory pregnancy testing and contraception requirements for patients who could become or cause a pregnancy) before the medicine can be dispensed. (1) (2) (4)

What are the three parts of lenalidomide's boxed warning?

(1) Embryo-fetal toxicity -- it is a thalidomide analogue and can cause severe birth defects or pregnancy loss. (2) Hematologic toxicity -- it can cause significant drops in white blood cells and platelets, requiring regular blood tests. (3) Venous and arterial thromboembolism -- it significantly increases the risk of blood clots (deep vein thrombosis, pulmonary embolism), heart attack, and stroke. (1)

What is the mechanism of action of lenalidomide?

Lenalidomide is an immunomodulatory antineoplastic agent structurally related to thalidomide. It is thought to work through several mechanisms: enhancing T-cell and NK-cell-mediated immunity against abnormal/malignant cells, direct cytotoxic and anti-proliferative effects on malignant cells (including deletion-5q clones), and anti-angiogenic effects that reduce blood vessel growth within tumours. (1) (4)

What is the generic name of Lenalidomide?

The generic name is lenalidomide. (1) (3)

What class of drug is lenalidomide?

Lenalidomide is classed as: Immunomodulatory antineoplastic agent (thalidomide analogue). (1) (3)

References

  1. REVLIMID (lenalidomide) capsules, for oral use -- full prescribing informationDailyMed (U.S. National Library of Medicine) -- FDA prescribing information · United States · accessed 2026-07-30 · source 1
  2. Revlimid 20 mg Hard Capsules -- Summary of Product Characteristics (SmPC)electronic medicines compendium (emc), United Kingdom -- Summary of Product Characteristics · United Kingdom · accessed 2026-07-30 · source 2
  3. Revlimid (lenalidomide) -- EPAR medicine overviewEuropean Medicines Agency (EMA) -- European Public Assessment Report (EPAR) · European Union · accessed 2026-07-30 · source 3
  4. REVLIMID (lenalidomide capsules) -- Health Canada Product Monograph; RevAid controlled-distribution programHealth Canada -- Product Monograph and RevAid controlled distribution program · Canada · accessed 2026-07-30 · source 4
  5. REVLIMID lenalidomide capsules -- ARTG registrations (multiple strengths: 2.5mg, 5mg, 10mg, 15mg, 25mg)Therapeutic Goods Administration (TGA), Australia -- ARTG entries · Australia · accessed 2026-07-30 · source 5
  6. Lenalidomide (Revlimid) -- Healthify medicines A-ZHealthify (Te Whatu Ora / Health New Zealand-funded national health information service) · New Zealand · accessed 2026-07-30 · source 6

Brand names by country

Single-ingredient lenalidomide names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Revlimid15 mg, 10 mg, 25 mg, 20 mg, 2.5 mg, 5 mg · celgene corporation

United Kingdom

  • Revlimid (2)MHRA licensed confirmed via EMC SmPC · 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg · Bristol-Myers Squibb

Canada

  • REVLIMID

Australia

  • Revlimid (5)TGA ARTG registered 2007-12-20 confirmed · 2.5 mg, 5 mg, 10 mg, 15 mg, 25 mg · Bristol-Myers Squibb Australia Pty Ltd (formerly Celgene Pty Ltd)

New Zealand

  • Revlimid (6)Healthify confirmed publicly funded for eligible patients · not itemised in the source reviewed · not itemised in the source reviewed
View brands in additional countries.

European Union

Revlimid (3), Lenalidomide Accord / Lenalidomide Krka / Lenalidomide Mylan (generics) (3)

This page provides general reference information about lenalidomide and is not a substitute for advice from the oncology/haematology team managing your treatment. All dosing, monitoring, and controlled-program requirements must be followed exactly as directed by your prescriber and your country's program.

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