Revlimid

Before taking lenalidomide,

• tell your doctor and pharmacist if you are allergic to lenalidomide, any other medications, or any of the ingredients in lenalidomide capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and digoxin (Lanoxin). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you are lactose intolerant and if you have or have ever had kidney, thyroid, or liver disease. Also tell your doctor if you have ever taken thalidomide (Thalomid) and developed a rash during your treatment.
• tell your doctor if you are breastfeeding or are planning to breastfeed.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
• signs of a blood clot--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; pain, swelling, warmth, or redness in your arm or leg;
• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• signs of tumor cell breakdown--lower back pain, blood in your urine, little or no urinating; numbness or tingly feeling around your mouth; muscle weakness or tightness; fast or slow heart rate, weak pulse, feeling short of breath; confusion, fainting; or
• signs of a tumor getting worse--swollen glands, low fever, rash, or pain.

Common side effects may include:

• itching or rash;
• diarrhea; or
• tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Store Revlimid at room temperature, 59°F to 86°F (15°C to 30°C).
• Keep this and all medicines out of the reach of children.

Biologic response modifier; thalidomide analog with immunomodulatory, antineoplastic, and antiangiogenic activity.1 a b c d e 30

Contraindications

• Pregnancy.1 7 (See Boxed Warning and see Fetal/Neonatal Morbidity and Mortality under Cautions.)

• Females of childbearing potential, unless they comply with all special conditions required by manufacturer and RevAssist program.1 (See Boxed Warning and see Restricted Distribution Program under Dosage and Administration.)

• Known hypersensitivity to lenalidomide or any ingredient in the formulation.1 7

Warnings/Precautions

Warnings

May cause fetal harm.1 7 Teratogenic effects of lenalidomide not fully established, but considered a potential teratogen due to structural similarity to thalidomide, a known human teratogen associated with severe birth defects and fetal death.1 7 g (See Boxed Warning.)

Contraindicated in female patients who are or may become pregnant unless alternative therapies not available and adequate precautions taken to avoid pregnancy.1

Women of childbearing potential must use 2 forms of effective contraception ≥4 weeks prior to, throughout, and for 4 weeks following completion of therapy.1 7 Use a highly effective birth control method (e.g., intrauterine device [IUD]; oral, injectable, or implanted hormonal contraceptive; tubal ligation; vasectomized partner) and an effective barrier method (e.g., latex condom, diaphragm, cervical cap).1 If either IUD or hormonal contraceptive use contraindicated, may use another highly effective method or 2 simultaneous effective barrier methods.1

If clinician not available, information about emergency contraception (including information regarding clinicians who provide emergency contraceptive services) can be obtained by calling 1-888-668-2528.1

Not known whether lenalidomide is present in semen; sexually mature males (including those who have undergone successful vasectomy) receiving lenalidomide must use a latex condom each time they have sexual contact with a woman of childbearing potential during therapy and for 4 weeks following completion of therapy.1 7

Risk of severe (grade 3 or 4) neutropenia and/or thrombocytopenia.1 3 7 a 30

Grade 3/4 hematologic toxicities reported in about 80% of patients with MDS associated with deletion 5q abnormality.1 Generally occurs during initial weeks (approximately 6 weeks for neutropenia and 4 weeks for thrombocytopenia) of treatment and reverses with dosage reduction or discontinuance.1 3 5

Higher frequency of grade 3/4 hematologic toxicities reported in patients with multiple myeloma receiving combination therapy with dexamethasone compared with those receiving dexamethasone alone.1

Carefully monitor hematologic status during therapy.1 Obtain baseline CBCs.j In patients with MDS, perform weekly CBCs during first 8 weeks of therapy, and at least monthly thereafter.1 In patients with multiple myeloma, perform CBCs every 2 weeks for the first 12 weeks of therapy, and at least monthly thereafter.1

If hematologic toxicity occurs, interrupt therapy and/or reduce dosage according to degree of myelosuppression.1 (See Dosage Modification for Toxicity in Patients with MDS and also Dosage Modification for Toxicity in Patients with Multiple Myeloma under Dosage and Administration.) Initiate supportive therapy with blood product transfusions or growth factors (e.g., G-CSF) if indicated.1 5

Risk of venous thromboembolism (e.g., DVT, PE) in patients with multiple myeloma, especially when used in combination with dexamethasone.1 7 20 c h Venous thromboembolism also reported in patients with MDS or mantle cell lymphoma receiving lenalidomide monotherapy.40

Monitor for signs and symptoms of thromboembolism (e.g., shortness of breath, chest pain, arm or leg swelling).1

Carefully assess patients for risk factors for thromboembolism; base decisions regarding use of thromboprophylaxis and appropriate thromboprophylaxis regimens (e.g., aspirin, anticoagulant) on patient's risk.1 20 41 42 c d h

International Myeloma Working Group (IMWG) recommends aspirin for lenalidomide-treated multiple myeloma patients with ≤1 individual and/or myeloma-related risk factor and a low molecular weight heparin (LMWH) for those with ≥2 such risk factors.20 IMWG also recommends that thromboprophylaxis with an LMWH be considered in patients receiving lenalidomide with high-dose dexamethasone, doxorubicin, or multiple antineoplastic agents, independent of additional risk factors.20 IMWG states full-dose warfarin (INR 2–3) is an alternative to LMWHs, but clinical experience is limited.20

ASCO recommends pharmacologic thromboprophylaxis for multiple myeloma patients receiving lenalidomide with dexamethasone or antineoplastic agents.42 Those at lower risk for thromboembolism may receive aspirin or an LMWH; those at higher risk should receive an LMWH.42

Specific Populations

Category X.1 (See Contraindications and also Fetal/Neonatal Morbidity and Mortality under Cautions.)

Not known whether lenalidomide is distributed into milk.1 Discontinue nursing or the drug.1

Safety and efficacy not established in children <18 years of age.1 7

No substantial differences in efficacy relative to younger adults; however, increased incidence of serious adverse effects reported in patients >65 years of age compared with younger patients.1 8

Principally eliminated by kidneys.1 Assess renal function and select dosage carefully due to greater frequency of decreased renal function in geriatric patients.1 (See Geriatric Patients under Dosage and Administration.)

Substantially eliminated by kidneys; possible increased toxicity in patients with renal impairment.1

Monitor renal function; adjust dosage if necessary based on degree of renal impairment.1 (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

MDS: Thrombocytopenia,1 3 5 b 30 neutropenia,1 3 5 b c 30 diarrhea,1 3 7 30 pruritus,1 3 7 30 rash,1 7 30 fatigue,1 3 7 30 constipation,1 30 nausea,1 30 nasopharyngitis,1 arthralgia,1 back pain,1 fever,1 peripheral edema,1 30 cough,1 dizziness,1 headache,1 muscle cramps,1 dyspnea,1 pharyngitis,1 asthenia,1 epistaxis,1 upper respiratory tract infection,1 dry skin,1 abdominal pain,1 anemia,1 pneumonia,1 hypokalemia,1 limb pain,1 urinary tract infection,1 anorexia,1 edema,1 3 insomnia,1 vomiting.1

Multiple myeloma: Constipation,1 d fatigue,1 d insomnia,1 muscle cramps,1 diarrhea,1 neutropenia,1 anemia,1 asthenia,1 fever,1 nausea,1 headache,1 peripheral edema,1 dizziness,1 dyspnea,1 tremor,1 weight loss,1 thrombocytopenia,1 rash,1 d back pain,1 hyperglycemia,1 muscle weakness,1 blurred vision,1 cough,1 dyspepsia,1 anorexia,1 upper respiratory tract infection,1 dysgeusia,1 paresthesia,1 hypokalemia,1 pneumonia,1 arthralgia,1 vomiting.1

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Distribution of lenalidomide is restricted.1 (See Restricted Distribution Program under Dosage and Administration.)

It is very important that your doctor check your progress closely while you are using this medicine to see if it is working properly and to allow for a change in the dose. Blood tests may be needed to check for any unwanted effects.

Women should take the necessary precautions to avoid pregnancy while taking lenalidomide. Begin 2 forms of reliable contraception 4 weeks before starting lenalidomide, and continue contraceptive measures during therapy and for 4 weeks after the last dose. Routine pregnancy tests are necessary with this medicine. Call your doctor or 1-888-668-2528 for emergency contraception information if you think you are pregnant.

Men, even those who have had a vasectomy, must prevent pregnancy in their sexual partners during therapy and for 4 weeks after the last dose. Do not donate sperm while taking this medicine. Call your doctor or 1-888-668-2528 for emergency contraception information if you think your sexual partner may be pregnant.

Do not donate blood during therapy and for 1 month after the last dose.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may increase your risk of having blood clots. Check with your doctor right away if you have the following symptoms: anxiety, chest pain, fainting, a fast heartbeat, sudden shortness of breath or troubled breathing, or pain, redness, or swelling in the arm or leg.

This medicine may increase your risk of having a heart attack or stroke. This is more likely to occur if you already have a heart disease, high cholesterol, or if you smoke. Check with your doctor right away if you are having chest pain or discomfort, fast or irregular heartbeat, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, shortness of breath, or sweating.

Serious liver problems can occur with this medicine. Your doctor may order blood tests to monitor your liver. Check with your doctor right away if you have any symptoms of liver problems, such as dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellow skin or eyes.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

Lenalidomide may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

This medicine may increase your risk of getting certain cancers (eg, acute myelogenous leukemia, Hodgkin lymphoma). Talk to your doctor if you have concerns about this risk.

This medicine may cause a tumor flare reaction. Tell your doctor if you have swollen and painful lymph nodes, a mild fever, pain, or a rash.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

• This medicine may add to the chance of getting some types of cancer. Talk with the doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely. Tell your doctor if you get signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• Patients with cancer who take Revlimid may be at a greater risk of getting a bad health problem called tumor lysis syndrome (TLS). Sometimes, this has been deadly. Call your doctor right away if you have a fast heartbeat or a heartbeat that does not feel normal; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, loose stools, or not able to eat; or feel sluggish.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• Very bad and sometimes deadly liver problems have happened with this medicine. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• A very bad and sometimes deadly reaction has happened with Revlimid (lenalidomide). Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. Talk with the doctor.
• A mantle cell lymphoma study reported a higher rate of early deaths in patients treated with this medicine. For more information, talk with your doctor.
• If you are 65 or older, use Revlimid with care. You could have more side effects.
• If you are a man and have sex with a pregnant female or a female who can get pregnant, always use a latex or synthetic condom during sex. Do this even if you have had a vasectomy. Use a latex or synthetic condom during care, during any breaks in care, and for at least 4 weeks after care ends.
• If you are a man and have unprotected sex with a female who is or could get pregnant, or your female partner gets pregnant within 4 weeks of your last dose, call your doctor right away.
• If you have sex without using 2 kinds of birth control that you can trust, if you think you may be pregnant, or if you miss your period, call your doctor right away.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Back pain.
• Bone pain.
• Loose stools (diarrhea).
• Headache.
• Feeling tired or weak.
• Dizziness.
• Dry skin.
• Sweating a lot.
• Nose and throat irritation.
• Change in taste.
• Not able to sleep.
• Hard stools (constipation).
• Upset stomach or throwing up.
• Belly pain.
• Dry mouth.
• Shakiness.
• Not hungry.
• Weight loss.
• Joint pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Revlimid is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Revlimid (lenalidomide) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Revlimid. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Advise the patient to read the FDA-approved Patient labeling (Medication Guide)

Embryo-Fetal Toxicity
Advise patients that Revlimid is contraindicated in pregnancy [see Boxed Warning and Contraindications (4.1)]. Revlimid is a thalidomide analog and can cause serious birth defects or death to a developing baby [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].

• Advise females of reproductive potential that they must avoid pregnancy while taking Revlimid and for at least 4 weeks after completing therapy.
• Initiate Revlimid treatment in females of reproductive potential only following a negative pregnancy test.
• Advise females of reproductive potential of the importance of monthly pregnancy tests and the need to use 2 different forms of contraception including at least 1 highly effective form, simultaneously during Revlimid therapy, during dose interruption and for 4 weeks after she has completely finished taking Revlimid. Highly effective forms of contraception other than tubal ligation include IUD and hormonal (birth control pills, injections, patch or implants) and a partner’s vasectomy. Additional effective contraceptive methods include latex or synthetic condom, diaphragm and cervical cap.
• Instruct patient to immediately stop taking Revlimid and contact her healthcare provider if she becomes pregnant while taking this drug, if she misses her menstrual period, or experiences unusual menstrual bleeding, if she stops taking birth control, or if she thinks FOR ANY REASON that she may be pregnant.
• Advise patient that if her healthcare provider is not available, she should call Celgene Customer Care Center at 1-888-423-5436 [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3)].
• Advise males to always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking Revlimid and for up to 4 weeks after discontinuing Revlimid, even if they have undergone a successful vasectomy.
• Advise male patients taking Revlimid that they must not donate sperm [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3)].
• All patients must be instructed to not donate blood while taking Revlimid, during dose interruptions and for 4 weeks following discontinuation of Revlimid [see Warnings and Precautions (5.1)].

Revlimid REMS program
Because of the risk of embryo-fetal toxicity, Revlimid is only available through a restricted program called the Revlimid REMS program [see Warnings and Precautions (5.2)].

• Patients must sign a Patient-Physician agreement form and comply with the requirements to receive Revlimid. In particular, females of reproductive potential must comply with the pregnancy testing, contraception requirements and participate in monthly telephone surveys. Males must comply with the contraception requirements [see Use in Specific Populations (8.3)].
• Revlimid is available only from pharmacies that are certified in Revlimid REMS program. Provide patients with the telephone number and website for information on how to obtain the product.

Pregnancy Exposure Registry

Inform females there is a Pregnancy Exposure Registry that monitors pregnancy outcomes in females exposed to Revlimid during pregnancy and that they can contact the Pregnancy Exposure Registry by calling 1-888-423-5436 [see Use in Specific Populations (8.1)].

Hematologic Toxicity

Inform patients that Revlimid is associated with significant neutropenia and thrombocytopenia [see Boxed Warnings and Warnings and Precautions (5.3)].

Venous and Arterial Thromboembolism

Inform patients of the risk of thrombosis including DVT, PE, MI, and stroke and to report immediately any signs and symptoms suggestive of these events for evaluation [see Boxed Warnings and Warning and Precautions (5.4)].

Increased Mortality in Patients with CLL

Inform patients that Revlimid had increased mortality in patients with CLL and serious adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure [see Warning and Precautions (5.5)].

Second Primary Malignancies

Inform patients of the potential risk of developing second primary malignancies during treatment with Revlimid [see Warnings and Precautions (5.6)].

Hepatotoxicity

Inform patients of the risk of hepatotoxicity, including hepatic failure and death, and to report any signs and symptoms associated with this event to their healthcare provider for evaluation [see Warnings and Precautions (5.7)].

Allergic Reactions

Inform patients of the potential for allergic reactions including hypersensitivity, angioedema, Stevens-Johnson Syndrome, or toxic epidermal necrolysis if they had such a reaction to THALOMID and report symptoms associated with these events to their healthcare provider for evaluation [see Warnings and Precautions (5.8)].

Tumor Lysis Syndrome

Inform patients of the potential risk of tumor lysis syndrome and to report any signs and symptoms associated with this event to their healthcare provider for evaluation [see Warnings and Precautions (5.9)].

Tumor Flare Reaction

Inform patients of the potential risk of tumor flare reaction and to report any signs and symptoms associated with this event to their healthcare provider for evaluation [see Warnings and Precautions (5.10)].

Dosing Instructions

Inform patients how to take Revlimid [see Dosage and Administration (2)]

• Revlimid should be taken once daily at about the same time each day,
• Revlimid may be taken either with or without food.
• The capsules should not be opened, broken, or chewed. Revlimid should be swallowed whole with water.
• Instruct patients that if they miss a dose of Revlimid, they may still take it up to 12 hours after the time they would normally take it. If more than 12 hours have elapsed, they should be instructed to skip the dose for that day. The next day, they should take Revlimid at the usual time. Warn patients to not take 2 doses to make up for the one that they missed.

Manufactured for:    Celgene Corporation
                               Summit, NJ 07901

Revlimid®, Revlimid REMS® and THALOMID® are registered trademarks of Celgene Corporation.

Pat. www.celgene.com/therapies

©2005-2017 Celgene Corporation, All Rights Reserved.

                                                                                                                           RevPlyPI.021/MG.021  02/17

Revlimid (lenalidomide) Capsules, 2.5 mg - 28 Count Bottle

Revlimid (lenalidomide) Capsules, 5 mg - 28 Count Bottle

Revlimid (lenalidomide) Capsules, 10 mg - 28 Count Bottle

Revlimid (lenalidomide) Capsules, 15 mg - 21 Count Bottle

Revlimid (lenalidomide) Capsules, 20 mg - 21 Count Bottle

Revlimid (lenalidomide) Capsules, 25 mg - 21 Count Bottle

Revlimid (lenalidomide) affects the immune system. It promotes immune responses to help slow tumor growth.

Revlimid is used to treat multiple myeloma (bone marrow cancer), either in combination with another medicine or after stem cell transplant.

Revlimid is also used to treat anemia (a lack of red blood cells) in patients with myelodysplastic syndrome caused by an abnormal chromosome. This disorder is also called deletion 5q MDS, because part of chromosome 5 is missing. In people with this disorder, the bone marrow does not produce enough healthy blood cells.

Revlimid is also used to treat mantle cell lymphoma (a rare cancer of the lymph nodes), after other medications have been tried without success.

Revlimid should not be used for chronic lymphocytic leukemia (CLL) unless you are in a controlled medical study. Lenalidomide can increase the risk of death from serious heart problems in people with CLL.

This medicine is available only from a certified pharmacy under a special program called Revlimid REMS. Your doctor must be registered in the program in order to prescribe lenalidomide for you. You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control measures as required by the program.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Get emergency medical help if you have signs of an allergic reaction to Revlimid: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• signs of a stroke or blood clot - sudden numbness or weakness, severe headache, problems with speech or vision, shortness or breath, swelling or redness in your arm or leg;

• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, sweating;

• liver problems - upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• low blood cell counts - fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, easy bruising, unusual bleeding;

• signs of a tumor getting worse - swollen glands, low fever, rash, or pain;

• signs of tumor cell breakdown - lower back pain, blood in your urine, little or no urinating; numbness or tingly feeling around your mouth; muscle weakness or tightness; feeling short of breath; confusion, fainting; or

• severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Revlimid side effects may include:

• fever, cough, tiredness;

• itching, rash, swelling; or

• nausea, diarrhea, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Revlimid is used to treat certain types of cancer, such as multiple myeloma, myelodysplastic syndrome (MDS), and mantle cell lymphoma.

This drug comes in the form of a capsule you take by mouth.

Revlimid is a brand name for the drug lenalidomide. This drug is not available as a generic drug.

• FDA warning See Details

• Risk of new cancers See Details

• Liver failure See Details

• Allergic reactions See Details

What is Revlimid?

This drug is a prescription drug. It’s available as an oral capsule.

Revlimid is a brand name for the drug lenalidomide. This drug is not available as a generic drug.

This drug may be used as part of a combination therapy. This means you may need to take it with other medications.

Why it's used

This drug is used to treat certain types of cancer.

More Details

How it works

This drug belongs to a class of drugs called immunomodulary agents.

More Details

Revlimid can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well. 

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Medications that might interact with this drug

• Side effects from other drugs: Taking Revlimid with certain medications raises your risk of side effects from these drugs. Examples of these drugs include:
  • Digoxin. Your doctor may check the levels of digoxin in your body to make sure you’re not at a higher risk for side effects. Side effects can include irregular heart rate, dizziness, headache, and stomach pain.
  • Epoetin alfa, darbepoetin alfa, and estrogen-containing drugs. You may have a higher risk for a blood clot if you take these medications with Revlimid.
  • Warfarin. Your doctor can check your international normalized ratio (INR) to make sure you’re not at a higher risk for side effects such as bleeding and clots. You may need this monitoring if you have multiple myeloma and take Revlimid and dexamethasone. 

People with chronic lymphocytic leukemia (CLL)

People with CLL who take this drug have an increased risk of death compared to people with CLL who take the drug chlorambucil. This drug may cause serious heart problems that can be fatal (cause death). These problems include an irregular, fast heart rate, heart attack, or heart failure. You shouldn’t take this drug if you have CLL unless you’re participating in a controlled clinical trial.

People with a high tumor burden

If your doctor tells you that you have a high tumor burden, you have an increased risk for tumor lysis syndrome (TLS). TLS is caused by a fast breakdown of cancer cells. TLS can cause kidney failure, abnormal heart rhythm, seizures, and death. Your doctor can do blood tests to check for TLS. 

People with kidney problems

If you have kidney problems or a history of kidney disease, you may not be able to clear this drug from your body well. This may increase the levels of this drug in your body and cause more side effects. Your doctor will start you on a lowered dose or a different dosing schedule.

Pregnant women

This drug is a category X pregnancy drug. That means two things:

Category X drugs should never be used during pregnancy. 

Women shouldn’t get pregnant while taking this drug, during any breaks in treatment, and for at least 4 weeks after stopping this drug. During treatment, women must use two reliable forms of birth control to prevent pregnancy. 

Men must use a condom during any sexual contact with a pregnant woman or woman who can become pregnant while taking this drug and for 4 weeks after stopping the drug. This includes males who have had a vasectomy. Men who take this drug also shouldn’t donate sperm.

Women who are breast-feeding

This drug may pass into breast milk and may cause side effects in a child who is breastfed. 

Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

For seniors

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.

For children

This drug hasn’t been studied in children. It shouldn’t be used in people younger than 18 years.

Contact with drug

You cannot donate blood while taking this drug and for 4 weeks after stopping the drug. 

This drug can pass into semen. Men must use a condom during any sexual contact with a pregnant woman or woman who can become pregnant while taking this drug and for 4 weeks after stopping the drug. This includes males who have had a vasectomy. You shouldn’t donate sperm during this time either.

When to call the doctor

Call your doctor right away if you become pregnant while taking this drug. 

Allergies

This drug can cause a severe allergic reaction. Symptoms can include:

• swelling of your face, eyes, lips, tongue, or throat
• trouble swallowing
• trouble breathing
• skin rash, hives, or peeling of your skin
• blisters 

If you have an allergic reaction, call your doctor or local poison control center right away. If your symptoms are severe, call 9-1-1 or go to the nearest emergency room. 

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).