lenalidomide
Lenalidomide (Revlimid) is an oral anticancer medication. It’s taken by mouth daily and treats a variety of blood cancers, such as multiple myeloma and myelodysplastic syndromes. It’s commonly taken in combination with other medications, like dexamethasone and Rituxan (rituximab). Lenalidomide (Revlimid) can raise your risk of serious side effects, such as liver damage and blood clots, as well as severe birth defects. Because of these risks, lenalidomide (Revlimid) is only available under a restricted distribution program called a Risk Evaluation and Mitigation Strategy (REMS) program.
What is Lenalidomide (Revlimid)?
What is Lenalidomide (Revlimid) used for?
Blood cancers:
Multiple myeloma, with dexamethasone or after stem cell transplant
Myelodysplastic syndromes (deletion 5q)
Mantle cell lymphoma, relapsed or refractory after 2 prior therapies, including Velcade (bortezomib)
Follicular lymphoma, previously treated
Marginal zone lymphoma, previously treated
How Lenalidomide (Revlimid) works
Lenalidomide (Revlimid) works by stimulating the immune system to fight cancer cells. It also targets specific proteins within cancer cells and stops the cancer cell from growing. In addition, lenalidomide (Revlimid) works by blocking the blood supply to certain tumor cells, which helps lower the growth of new cancer cells.
Drug Facts
More on Lenalidomide (Revlimid) essentials
What are the side effects of Lenalidomide (Revlimid)?
Common Side Effects
- Diarrhea (up to 45%)
- Low red blood cell count (up to 44%)
- Low neutrophil count (up to 35%)
- Tiredness (up to 33%)
- Back pain (up to 32%)
- Weakness (up to 28%)
- Difficulty sleeping (up to 28%)
- Rash (up to 26%)
- Cough (up to 23%)
- Lowered appetite (up to 23%)
- Trouble breathing (up to 22%)
- Fever (up to 21%)
- Low platelet count (up to 20%)
- Stomach pain (up to 20%)
- Muscle spasms (up to 20%)
Other Side Effects
- Heartburn
- Joint pain
- Bone and muscle pain
- Pain in the hands, arms, legs, feet
- Cough, runny nose, sore throat, and other symptoms of a respiratory infection
- Pain while urinating and other symptoms of a urinary tract infection
- Headache
- Itchy skin
- Depression
Serious Side Effects
- Serious liver problems: tiredness, loss of appetite, nausea or vomiting, dark urine, right-side stomach pain, easy bruising or bleeding, or yellowing of the eyes or skin
- Blood clot in the brain: weakness or numbness in your arms, legs, or face on one side of the body, trouble speaking, blurred vision, dizziness, loss of balance, trouble walking, confusion
- Heart attack: feeling tired, dizziness, chest pain, sweating, nausea
- Blood clot in the lungs: dizziness, cough, coughing up blood, trouble breathing, chest pain, pounding heart
- Blood clot in the legs: cramps, swelling, pain, or muscle tightness
- Severe skin reactions: painful blisters, skin wounds, peeling skin, painful sores in your mouth or around your eyes
- Tumor lysis syndrome: fever, chills, nausea or vomiting, confusion, trouble breathing, seizures, irregular heartbeat, dark or cloudy urine, muscle or joint pain, unusual tiredness
- Serious infections: fever, sore throat, chills, headache, body aches, cough
- Serious bleeds: bleeding that’s difficult to stop, bruises that don’t go away, dark or tarry stool
Source: DailyMed
The following side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Black, tarry stools
bleeding gums
blood in the urine or stools
chills
decreased urine
difficult or labored breathing
increased thirst
irregular heartbeat
loss of appetite
lower back or side pain
mood changes
muscle pain or cramps
numbness or tingling in the hands, feet, or lips
painful or difficult urination
pale skin
pinpoint red spots on the skin
seizures
sores, ulcers, or white spots on the lips or in the mouth
swollen glands
tightness in the chest
unusual bleeding or bruising
unusual tiredness or weakness
vomiting
Less common
Burning or stinging of the skin
chest discomfort
confusion
difficulty with speaking
dilated neck veins
double vision
extreme tiredness or weakness
headache
inability to move the arms, legs, or facial muscles
inability to speak
irregular breathing
pain or discomfort in the arms, jaw, back or neck
painful cold sores or blisters on the lips, nose, eyes, or genitals
slow speech
sweating
swelling of the face, fingers, feet, or lower legs
Incidence not known
blistering, peeling, or loosening of the skin
clay-colored stools
dark urine
depressed mood
difficulty having a bowel movement
dizziness or lightheadedness
dry skin and hair
fainting
fast heartbeat
feeling cold
general feeling of tiredness or weakness
hoarseness or husky voice
itching or rash
joint pain, stiffness, or swelling
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
muscle cramps and stiffness
pain, redness, or swelling in the arm or leg
red skin lesions, often with a purple center
red, irritated eyes
sensitivity to heat
slowed heartbeat
stomach pain, continuing
swelling of the feet or lower legs
trouble sleeping
troubled breathing
unpleasant breath odor
vomiting of blood
yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Abnormal or decreased touch sensation
bloody nose
blurred vision
body aches or pain
bruising
burning feeling while urinating
burning, numbness, tingling, or painful sensations
change in taste
cough-producing mucus
difficulty with moving
drowsiness or tiredness
ear congestion
fast, slow, irregular, pounding, or racing heartbeat or pulse
flushing or redness of the skin
increased sweating or night sweats
irritability
itching, pain, redness, swelling, tenderness, or warmth on the skin
lack or loss of strength
large, flat, blue or purplish patches in the skin
loose stools
loss of interest or pleasure
muscle spasms or twitching
pain or tenderness around the eyes and cheekbones
shivering
tender, swollen glands in the neck
trembling
trouble concentrating
trouble swallowing
unsteadiness or awkwardness
upper abdomen or stomach pain
voice changes
weakness in the arms, hands, legs, or feet
Incidence not known
Feeling of constant movement of self or surroundings
sensation of spinning
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Pros and cons of Lenalidomide (Revlimid)
Pros
Taken once a day with or without food
A first-choice treatment option for people with multiple myeloma
Available as a lower-cost generic
Cons
Can't take during pregnancy
Commonly causes diarrhea, rash, and itching
Must be enrolled in and meet the terms of the lenalidomide (Revlimid) REMS program to fill each prescription
Pharmacist tips for Lenalidomide (Revlimid)
You can take lenalidomide (Revlimid) with or without food. Swallow the capsule whole with water. Don’t chew, crush, or break open the capsule. Make sure to take it at the same time everyday.
If the lenalidomide (Revlimid) capsule breaks on accident and powder gets on your skin, wash the skin area with soap and water right away. If the powder gets in your eye, flush your eyes with water.
If you have kidney problems and are on hemodialysis, you should take lenalidomide (Revlimid) after your hemodialysis session on hemodialysis days.
If you miss a dose of lenalidomide (Revlimid) or vomit after taking a dose, you can take the missed dose if you still have more than 12 hours before your next dose. However, if there’s less than 12 hours before your next dose, you can skip the missed dose. Just continue your next dose at the normally scheduled time. Don’t take 2 doses of lenalidomide (Revlimid) to make up for the lost dose.
Because lenalidomide (Revlimid) raises your risk for blood clots, your healthcare provider will most likely prescribe medications to help prevent blood clots. Depending on your risk for blood clots this can include medications like aspirin, warfarin (Coumadin), or enoxaparin (Lovenox). Ask your provider if you’re not sure whether you’ve been prescribed a blood-thinning medication.
Don’t donate blood while you’re taking lenalidomide (Revlimid) and for at least a month after your last dose. This is because the donated blood might go to a person who’s pregnant and cause harm to their unborn baby.
If you’re able to become pregnant, your provider will ask you to do pregnancy tests before you start treatment with lenalidomide (Revlimid) and regularly (either once or twice a month) throughout treatment. Set reminders for yourself of when you need to take a pregnancy test so that you can continue receiving this medication safely.
Lenalidomide (Revlimid) contains lactose. You shouldn’t take lenalidomide (Revlimid) if you have lactose intolerance. Let your healthcare provider know if you have lactose intolerance before starting lenalidomide (Revlimid).
Ask your provider or pharmacist about the best way to handle and throw away lenalidomide (Revlimid) safely. Anticancer medications can be very harmful to people who handle or come into contact with them.
Frequently asked questions about Lenalidomide (Revlimid)
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What are the risks and warnings for Lenalidomide (Revlimid)?
Lenalidomide (Revlimid) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Harm to unborn baby
Lenalidomide (Revlimid) can’t be used in pregnancy because it can cause very serious birth defects and death to the unborn baby. If you’re a female who’s able to become pregnant, you either need to avoid heterosexual intercourse or use 2 types of birth control for at least a month before starting lenalidomide (Revlimid) treatment, during treatment, and for at least a month after your last dose. You also need to have 2 negative pregnancy tests — one test 2 weeks before, then another test within 24 hours of starting lenalidomide (Revlimid). You’ll also need to take pregnancy tests biweekly or monthly while on treatment. If you become pregnant while taking lenalidomide (Revlimid), stop taking it right away and let your healthcare provider know.
Lenalidomide (Revlimid) is also present in the semen of males who take lenalidomide (Revlimid). Because of this, males with female partners who can become pregnant should use a condom during sexual intercourse while taking lenalidomide (Revlimid) and for a month after the last dose. This is recommended even if you’ve had a vasectomy. Males taking lenalidomide (Revlimid) must not donate sperm for up to a month after the last dose.
Everyone who take lenalidomide (Revlimid) shouldn't donate blood or blood products, such as platelets, during treatment and for a month after the last dose. This is because the donated blood might go to someone who’s pregnant.
lenalidomide (Revlimid) REMS program
Due to the risk of harm to an unborn baby, lenalidomide (Revlimid) is only available through a restricted program called lenalidomide (Revlimid) REMS. This program is set so that people who are being treated with lenalidomide (Revlimid), providers who prescribe lenalidomide (Revlimid), and select certified pharmacies that dispense this medication are all aware of the serious risks it has. There are a list of requirements that must be followed to minimize the risk of harm to pregnant females and their unborn babies. For females who are able to become pregnant, this includes complying with pregnancy testing, contraception requirements, and monthly telephone surveys. For males, this includes complying with contraception requirements. If you have questions about the REMS program, talk with your provider.
Blood clots
Risk factors: History of blood clots | High cholesterol | Smoking | High blood pressure | Taking lenalidomide (Revlimid) with dexamethasone for multiple myeloma
Lenalidomide (Revlimid) can raise your risk of blood clots. These clots can occur anywhere in your body, including your lungs (pulmonary embolism or PE), legs (deep vein thrombosis or DVT), brain (stroke), and heart (heart attack). Get emergency help right away if you have any signs of a blood clot:
Brain: weakness or numbness in your arms, legs, or face on one side of the body, trouble speaking, blurred vision, dizziness, loss of balance, trouble walking, or confusion
Heart: chest pain, sweating, nausea, or dizziness
Lungs: trouble breathing, chest pain, or cough
Legs: cramps, swelling, pain, or muscle tightness
Due to the higher risk of blood clots while taking lenalidomide (Revlimid), your healthcare provider might also recommend that you also take a blood thinner medication or aspirin to help prevent blood clots.
Bruising and serious infections (from low blood cell count)
Lenalidomide (Revlimid) can cause your white blood cells, red blood cells, and platelets to drop significantly. When these cell counts are lower than normal, you have a higher risk of anemia, bleeding, bruising, and infections. Your provider will check your blood counts weekly to monthly while you’re receiving lenalidomide (Revlimid). If your blood cell count drops too low, your provider might lower your dose of lenalidomide (Revlimid) or stop this medication altogether. Let your provider know if you develop a fever or start to feel sick or have any unusual bruising or bleeding.
Risk of new cancers
Although rare, some people who took lenalidomide (Revlimid) during clinical trials did develop other cancers, such as certain types of blood cancers or skin cancers. Speak with your healthcare provider about your risk of developing new cancers while taking lenalidomide (Revlimid).
Liver damage
Risk factors: History of liver problems, including infections | High liver enzyme levels | Taking other medications that can cause liver damage
Lenalidomide (Revlimid) can cause liver damage. Rarely, this can lead to life-threatening liver failure. Your provider will monitor your liver health through lab work at the start of treatment as well as monthly while you’re taking lenalidomide (Revlimid). If you experience higher levels of liver enzymes, your provider might ask you to stop lenalidomide (Revlimid) (either temporarily or permanent) or switch you to a different medication. Let your provider know if you experience tiredness, loss of appetite, nausea or vomiting, dark urine, right-side stomach pain, or yellowing of the eyes or skin, as these can be signs of liver problems.
Serious skin reactions
Lenalidomide (Revlimid) can cause severe skin reactions, like Stevens-Johnson syndrome (SJS). In some cases, it can become life-threatening. If you experience any skin reaction, your provider might as you to temporarily stop taking lenalidomide (Revlimid) or switch you to a different medication, depending on how serious your reaction is. Tell your provider immediately if you develop fever, painful blisters, skin wounds, or peeling skin, as you might need immediate medical attention.
Tumor lysis syndrome
Risk factors: High tumor burden
Treatment with lenalidomide (Revlimid) can cause a very rare, but serious reaction called tumor lysis syndrome (TLS). TLS is a condition where many cancer cells die quickly and suddenly break down in your body. In the process, these cells release their inner contents, like uric acid, potassium, and phosphorus, into your blood. High levels of uric acid and electrolytes in your body can cause serious problems, such as kidney damage and abnormal heart rhythms.
Your provider will order labs for you regularly to check for signs of TLS. Tell your provider right away if you’re urinating less than usual or have dark urine, muscle cramps, or a racing heartbeat.
Tumor flare reaction
Tumor flare reaction is a rare, but serious reaction that has happened in people who took lenalidomide (Revlimid) in clinical trials. Tumor flare reaction is a worsening of your tumor. If you experience a moderate to severe tumor flare reaction, your healthcare provider might lower your dose or ask you to stop taking lenalidomide (Revlimid) altogether. They might also recommend you take other supportive medications like corticosteroids, anti-inflammatory medications, or other pain medications to help manage the symptoms of tumor flare reaction.
Let your healthcare provider know right away if you have tender lymph node swelling, low grade fever, pain, and rash.
Impaired stem cell mobilization
Taking lenalidomide (Revlimid) might lower the number of stem cells that can be collected for a stem cell transplantation. If you're a candidate for an auto-HSCT, your healthcare provider should refer you to a transplant center early on in your treatment to undergo stem cell collection at the most appropriate time.
Risk of death (MCL)
In a clinical study for the treatment of MCL, there were more early deaths among people who took lenalidomide (Revlimid) than people who took placebo. It's unclear whether the deaths are linked to lenalidomide (Revlimid) or not. Speak with your healthcare provider about the risk associated with taking lenalidomide (Revlimid) if you have MCL.
Lenalidomide (Revlimid) dosage forms
Typical dosing for Lenalidomide (Revlimid)
Multiple myeloma and mantle cell lymphoma: The typical dose is 25 mg by mouth once daily for 21 days of a 28-day treatment cycle. If you’re being treated for multiple myeloma, you’ll take lenalidomide in combination with dexamethasone.
Follicular lymphoma and marginal zone lymphoma: The typical dose is 20 mg by mouth once daily for 21 days of a 28-day treatment cycle, in combination with Rituxan (rituximab), for up to 12 cycles.
Myelodysplastic syndromes: The typical dose is 10 mg by mouth once daily.
Your dose might be different if you experience certain side effects, have kidney or liver problems, or you’re taking medications that might interact with lenalidomide (Revlimid).
Interactions between Lenalidomide (Revlimid) and other drugs
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Lenalidomide (Revlimid) contraindications
Pregnancy
What are alternatives to Lenalidomide (Revlimid)?
Blood cancers:
Multiple myeloma, with dexamethasone or after stem cell transplant
Myelodysplastic syndromes (deletion 5q)
Mantle cell lymphoma, relapsed or refractory after 2 prior therapies, including Velcade (bortezomib)
Follicular lymphoma, previously treated
Marginal zone lymphoma, previously treated
Multiple myeloma, previously treated with at least 2 prior therapies
Kaposi sarcoma
Newly diagnosed multiple myeloma, given together with dexamethasone
Prevention and treatment of a skin reaction in leprosy (erythema nodosum leprosum)
What is the latest news about Lenalidomide (Revlimid)?
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References
Best studies we foundAmerican Cancer Society. (2018). What are myelodysplastic syndromes?
American Cancer Society. (2018). What is multiple myeloma?
American Cancer Society. (2020). Managing fatigue or weakness.
American Cancer Society. (2022). Physical activity and the person with cancer.
Bristol-Myers Squibb Company. (n.d.). Welcome to Lenalidomide REMS.
Celgene Corporation. (2023). Revlimid- lenalidomide capsule [package insert]. DailyMed.
Gupta, A., et al. (2018). Tumor lysis syndrome. Journal of the American Medical Association Oncology.
Kaseb, H., et al. (2022). Follicular lymphoma. StatPearls.
Kurtin, S. E. (2013). Relapsed or relapsed/refractory multiple myeloma. Journal of the Advanced Practitioner in Oncology.
Leukaemia Foundation. (2020). Deletion 5q.
Leukemia and Lymphoma Society. (n.d.). Marginal zone lymphoma (MZL).
Lymphoma Research Foundation. (n.d.). What is lymphoma?
McDaniel, J. M., et al. (2022). Molecular action of lenalidomide in lymphocytes and hematologic malignancies. Advances in Hematology.
National Cancer Institute. (n.d.). Autologous stem cell transplant.
National Cancer Institute. (n.d.). Refractory cancer.
National Cancer Institute. (n.d.). Relapse.
National Cancer Institute. (2021). Diarrhea: Cancer treatment side effect.
National Comprehensive Cancer Network. (2023). Multiple myeloma.
Raedler, L. A. (2016). Revlimid (lenalidomide) now FDA approved as first-line therapy for patients with multiple myeloma. American Health & Drug Benefits.
Taleb, B. A. (2019). Tumour flare reaction in cancer treatments: A comprehensive literature review. Anti-cancer Drugs.
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