What are the possible side effects?

Side effects of REVLIMID® (lenalidomide) with dexamethasone

You may experience side effects while taking REVLIMID with dexamethasone. Some of these side effects may be serious. Talk with your doctor or nurse about what may happen when you are taking REVLIMID with dexamethasone and when you should call your doctor. It is important for your doctor to know about any side effects you have while taking REVLIMID with dexamethasone. If you have certain side effects, your doctor may lower your dose. Your doctor may also delay or stop treatment.

Serious side effects of REVLIMID with dexamethasone include:

Common side effects of REVLIMID with dexamethasone include:

These are not all of the possible side effects of REVLIMID with dexamethasone. Tell your doctor about any side effect that bothers you or that does not go away.

In this section we will review these side effects and important information your healthcare team may need to know if you have any of them.

Serious side effects

Common side effects

Serious side effects of REVLIMID with dexamethasone

Risk to unborn babies

Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or who plan to become pregnant must not take REVLIMID.

REVLIMID is similar to the medicine thalidomide (THALOMID®). We know thalidomide can cause severe life-threatening birth defects. REVLIMID has not been tested in pregnant women. REVLIMID has harmed unborn animals in animal testing. If you are a woman who can become pregnant, you are required to have 2 pregnancy tests that show you are not pregnant before starting REVLIMID.

In females of childbearing potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment.

Females must not get pregnant:

  • for 4 weeks before starting REVLIMID
  • while taking REVLIMID
  • during any breaks (interruptions) in treatment with REVLIMID
  • for 4 weeks after stopping REVLIMID

Females who can become pregnant must agree to use 2 different forms of effective birth control at the same time for 4 weeks before starting, while taking, during any breaks (interruptions) in treatment with, and for 4 weeks after stopping REVLIMID.

REVLIMID can pass into semen. Males, including those who have had a vasectomy, must use a latex condom during any sexual contact with a pregnant female or a female that can become pregnant. Males must do this while taking REVLIMID, during any breaks (interruptions) in treatment with REVLIMID, and for 4 weeks after stopping REVLIMID. (If you or your partner are allergic to latex, please consult with your healthcare provider).

If you become pregnant while taking REVLIMID, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call 1-888-668-2528 for medical information. Healthcare providers and patients should report all cases of pregnancy to: FDA MedWatch at 1-800-FDA-1088 and Celgene Corporation at 1-888-423-5436.

Treatment with REVLIMID with dexamethasone lowers white blood cell and platelet counts in most patients. If your blood counts become too low, you may develop neutropenia or thrombocytopenia. You may need a blood transfusion or certain medicines if your blood counts drop too low. If you are being treated for multiple myeloma, your blood counts should be checked every 2 weeks for the first 12 weeks and then at least monthly thereafter.

Low white blood cells (neutropenia)

Neutropenia occurs when the level of a type of white blood cell, called a neutrophil, becomes too low. When the level of neutrophils becomes too low, it is difficult for the body to fight infections. Neutropenia is usually found when your doctor does a blood test to check the number of white blood cells in your blood. Your doctor may also think you have neutropenia if you get a lot of infections.

It is important to watch for signs of infection.

Tell your doctor right away if you have:

  • Body temperature 100.5°F or higher
  • Shaking chills or sweats
  • Sore throat
  • Cough or shortness of breath
  • Nasal congestion
  • Burning or pain when passing urine
  • Bloody or cloudy urine

If your white blood cell count becomes too low, your doctor may lower your dose. Your doctor may also delay or stop your treatment. Your doctor may check your counts with blood tests. He or she will make treatment decisions based on your test results.

Low platelets (thrombocytopenia)

Thrombocytopenia occurs when the level of platelets in the blood becomes too low. If you develop thrombocytopenia, you may notice bleeding under the skin. This will look like tiny red dots on the skin. You may also get small bruises from minor bumps. Your gums may bleed when you brush your teeth and you may see blood in your urine or stool.

If your platelet levels fall too low, your doctor may lower your dose. Your doctor may also delay or stop your treatment. Your doctor may check your counts with blood tests. He or she will make treatment decisions based on your test results.

Contact your doctor right away if you notice any unusual bleeding or bruising.

Blood clots

  • Blood clots in the arteries, veins, and lungs happen more often in people who take REVLIMID. This risk is even higher for people with multiple myeloma who take the medicine dexamethasone with REVLIMID. Heart attacks and strokes also happen more often in people who take REVLIMID with dexamethasone. To reduce this increased risk, most people who take REVLIMID will also take a blood thinner medicine.

Before taking REVLIMID, tell your healthcare provider:

    • if you have had a blood clot in the past
    • if you have high blood pressure
    • if you smoke
    • if you have been told that you have a high level of fat in your blood (hyperlipidemia)
    • about all the medicines you take. Certain other medicines can also increase your risk for blood clots.

Call your healthcare provider or get medical help right away if you get any of the following during treatment with REVLIMID:

    • signs or symptoms of a blood clot in the lung, arm, or leg may include: shortness of breath, chest pain, or arm or leg swelling
    • signs or symptoms of a heart attack may include: chest pain that may spread to the arms, neck, jaw, back, or stomach area (abdomen), feeling sweaty, shortness of breath, feeling sick, or vomiting
    • signs or symptoms of stroke may include: sudden numbness or weakness, especially on one side of the body, severe headache or confusion, or problems with vision, speech, or balance

Increased risk of death in people who have chronic lymphocytic leukemia (CLL)

People with CLL who take REVLIMID have an increased risk of death compared with people who take the medicine chlorambucil. REVLIMID may cause you to have serious heart problems that can lead to death, including atrial fibrillation, heart attack, or heart failure. You should not take REVLIMID if you have CLL unless you are a participant in a controlled clinical trial.

Risk of new cancers

People with MM who receive melphalan (a type of chemotherapy) or a blood stem cell transplant with the addition of REVLIMID have a higher risk of developing new cancers, including certain blood cancers (acute myelogenous leukemia, or AML) and a type of lymphoma called Hodgkin lymphoma. Talk with your healthcare provider about your risk of developing new cancers if you take REVLIMID. Your healthcare provider will check you for new cancers during your treatment with REVLIMID.

Severe liver problems, including liver failure and death

Tell your healthcare provider right away if you develop any of the following symptoms:

  • yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine
  • pain on the upper right side of your stomach area
  • bleeding or bruising more easily than normal
  • feeling very tired

Your healthcare provider will do blood tests to check your liver function during treatment with REVLIMID.

These changes can cause seizures, changes to kidney function and heartbeat, and sometimes death.

Your doctor will decide if you are at risk for developing tumor lysis syndrome. If you are, your doctor will watch you closely.

Serious skin reactions

Serious skin reactions can happen with REVLIMID. These skin reactions may cause death. Call your doctor right away if you have any skin reactions while taking REVLIMID. If you develop a skin reaction, your doctor may stop your treatment with REVLIMID.

Allergic reactions

Tell your healthcare provider if you are lactose intolerant as REVLIMID contains lactose.

Tumor lysis syndrome

Tumor lysis syndrome is a problem that can happen with treatment of cancer. It can sometimes happen even if the cancer isn’t treated. It is a metabolic complication that is caused when cancer cells die. The dying cancer cells release substances into the bloodstream and may cause changes to blood chemistry, such as:

  • higher levels of potassium, phosphorus, and uric acid
  • lower levels of calcium

These changes can cause seizures, changes to kidney function and heartbeat, and sometimes death. Your doctor will decide if you are at risk for developing tumor lysis syndrome. If you are, your doctor will watch you closely.

Worsening of your tumor (tumor flare reaction)

Tell your healthcare provider if you get any of these symptoms while taking REVLIMID

  • tender swollen lymph nodes
  • low-grade fever
  • pain
  • rash

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Some common side effects of
REVLIMID® (lenalidomide) with dexamethasone

Constipation

Treatment with REVLIMID and dexamethasone can cause constipation. When you have constipation, you do not have as many bowel movements as you normally do. You may also feel bloated and uncomfortable and have hard, painful bowel movements.

If you have constipation, tell your doctor or nurse. He or she will want to know about any side effects you have.

You may want to ask your doctor:

  • Are there foods I should eat when I have constipation?
  • Should I drink more water or liquids?
  • Would exercise help?
  • Should I keep track of my bowel movements?
  • Are there medicines that may help?

Diarrhea

Treatment with REVLIMID with dexamethasone can cause diarrhea. Diarrhea happens when your stools become watery and you go to the bathroom much more often than usual. Your doctor needs to know if you have diarrhea. Diarrhea can cause weight loss, fluid loss (dehydration), poor appetite, and weakness.

Diarrhea may cause complications, such as:

  • Dizziness
  • Fever
  • Sore or bleeding rectal area

If you have any of these complications or if you have diarrhea and cramps for more than a day, call your doctor or nurse right away.

If you have diarrhea, tell your doctor or nurse. He or she will want to know about any side effects you have.

You may want to ask your doctor:

  • Are there foods I should eat when I have diarrhea?
  • Are there foods I should not eat when I have diarrhea?
  • How much liquid should I drink each day?
  • Is there medicine I can take to help with the diarrhea?

Tiredness (fatigue)

Fatigue is a common side effect of treatment with REVLIMID with dexamethasone. Sometimes people describe fatigue as feeling tired, weak, exhausted, heavy, or slow. Fatigue can affect people physically, mentally, and emotionally.

If you feel tired, tell your doctor or nurse. He or she will want to know about any side effects you have.

You may want to ask your doctor:

  • Should I change my activity level?
  • Would exercise help me feel less tired?
  • Will sleeping more help my fatigue?
  • Should I eat certain foods or drink certain liquids when I am feeling tired?
  • Is there medicine that I can take to help the fatigue?
  • I am already taking a medicine that makes me feel tired. Will REVLIMID with dexamethasone make me more tired?

Muscle cramps

Treatment with REVLIMID with dexamethasone can cause muscle cramps. Muscle cramps are a painful, tightening, or sudden discomfort in the muscle.

If you have muscle cramps, tell your doctor or nurse. He or she will want to know about any side effects you have.

You may want to ask your doctor:

  • Will massaging the cramped muscle help?
  • Are there any exercises I can do to help relieve the cramps?
  • Are there any vitamins or supplements I can take to help relieve the cramps?
  • Are there any medicines I can take to help relieve the cramps?

Itching and rash

Treatment with REVLIMID with dexamethasone can cause pruritus. When you have pruritus, you feel itchy. Itching can be uncomfortable. If you scratch a lot, it can lead to breaks in the skin and infection.

Rash is another common side effect of REVLIMID. Rash may range in severity from mild irritation to obvious changes in skin color. Some patients have had serious skin reactions that required immediate medical attention or were fatal. If you get any kind of rash, tell your healthcare provider immediately.

If you feel itchy or you notice a rash on your body, tell your doctor or nurse. He or she will want to know about any skin changes you have.

You may want to ask your doctor:

  • Should I take hot or cold baths?
  • Is there anything I can put on my skin that may help the itching?
  • What type of clothes should I wear?
  • Should I avoid the sun?
  • Are there any medicines that I can take that may help the itching?

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NEXT: Taking REVLIMID: Important Information

Important Safety Information

WARNING: Risk to unborn babies, low blood counts, and blood clots

Before you begin taking REVLIMID, you must read and agree to all of the instructions in the REVLIMID REMS® program (formerly known as the RevAssist® program).

REVLIMID may cause serious side effects including:

Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or who plan to become pregnant must not take REVLIMID.

REVLIMID is similar to the medicine thalidomide (THALOMID®). We know thalidomide can cause severe life-threatening birth defects. REVLIMID has not been tested in pregnant females. REVLIMID has harmed unborn animals in animal testing.

In females of childbearing potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment.

Females must not get pregnant:

  • for 4 weeks before starting REVLIMID
  • while taking REVLIMID
  • during any breaks (interruptions) in your treatment with REVLIMID
  • for 4 weeks after stopping REVLIMID

If you become pregnant while taking REVLIMID, stop taking it right away and call your healthcare provider.

REVLIMID causes low white blood cells (neutropenia) and low platelets (thrombocytopenia) in most patients.

REVLIMID causes a higher chance for blood clots in your veins (deep vein thrombosis), lungs (pulmonary embolism), and arteries (heart attack or stroke).

Risk to Unborn Babies

REVLIMID may cause serious birth defects or death of an unborn baby. Do not get pregnant while taking REVLIMID.

Females who can become pregnant

  • Will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular
  • If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling
  • Must agree to use 2 different forms of effective birth control at the same time every time for 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping REVLIMID
  • If you become pregnant while taking REVLIMID, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call 1-888-668-2528 for medical information. Healthcare providers and patients should report all cases of pregnancy to: FDA MedWatch at 1-800-FDA-1088 and Celgene Corporation at 1-888-423-5436
  • Do not get pregnant and do not breastfeed while taking REVLIMID. REVLIMID must not be used by females who are pregnant or breastfeeding. It is not known if REVLIMID passes into your breast milk and harms your baby

Males

  • REVLIMID can pass into human semen. Males, including those who have had a vasectomy, must use a latex or synthetic condom during any sexual contact with a pregnant female or a female who can become pregnant. Males must do this while taking REVLIMID, during any breaks (interruptions) in your treatment with REVLIMID, and for 4 weeks after stopping REVLIMID. (If you or your partner are allergic to latex, please consult with your healthcare provider)
  • Do not have unprotected sexual contact with a female who is or could become pregnant. Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could become pregnant. Men, if your female partner becomes pregnant, you should call your healthcare provider right away
  • Do not donate sperm while taking REVLIMID, during any breaks (interruptions) in your treatment with REVLIMID, and for 4 weeks after stopping REVLIMID. If a female becomes pregnant with your sperm, the baby may be exposed to REVLIMID and may be born with birth defects

Females and Males

  • Do not share REVLIMID with other people. It may cause birth defects and other serious problems
  • Do not donate blood while you take REVLIMID, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping REVLIMID. If someone who is pregnant gets your donated blood, her baby may be exposed to REVLIMID and may be born with birth defects

Low white blood cells (neutropenia) and low platelets (thrombocytopenia)

  • REVLIMID causes low white blood cells and low platelets in most people. You may need a blood transfusion or certain medicines if your blood counts drop too low
  • If you are being treated for MM, your blood counts should be checked every 2 weeks for the first 12 weeks and then at least monthly thereafter

Blood clots

  • REVLIMID causes a higher chance for blood clots in your arteries, veins, and lungs
  • Risk is even higher for people with multiple myeloma taking REVLIMID with dexamethasone
  • Heart attacks and stroke also happen more often in people taking REVLIMID with dexamethasone
  • To reduce this increased risk, most people who take REVLIMID will also take a blood thinner medicine
  • Before taking REVLIMID tell your healthcare provider: if you have had a blood clot in the past, have high blood pressure, you smoke, you have been told you have high level of fat in your blood (hyperlipidemia), and all medicines you take. Certain other medicines can also increase your risk for blood clots
  • Call your healthcare provider or get medical help right away if you get any of these signs or symptoms: Blood clot in lung, arm or leg: shortness of breath, chest pain, or arm or leg swelling. Heart attack: chest pain that may spread to arms, neck, jaw, back or stomach area, feeling sweaty, shortness of breath, feeling sick or vomiting. Stroke: sudden numbness or weakness, especially on one side of the body, severe headache or confusion, or problems with vision, speech or balance

Other serious side effects

  • Increased risk of death in people who have chronic lymphocytic leukemia (CLL). People with CLL who take REVLIMID have an increased risk of death compared with people who take the medicine chlorambucil. REVLIMID may cause you to have serious heart problems that can lead to death, including atrial fibrillation, heart attack, or heart failure. You should not take REVLIMID if you have CLL unless you are participating in a controlled clinical trial
  • Risk of new cancers (malignancies). People with MM who receive melphalan (a type of chemotherapy) and a blood stem cell transplant with the addition of REVLIMID have a higher risk of developing new cancers, including certain blood cancers (acute myelogenous leukemia or AML) and a type of lymphoma called Hodgkin lymphoma. Talk with your healthcare provider about your risk of developing new cancers if you take REVLIMID. Your healthcare provider will check you for new cancers during your treatment with REVLIMID
  • Severe liver problems, including liver failure and death. Tell your healthcare provider right away if you develop any of the following symptoms: yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of your stomach area, bleeding or bruising more easily than normal and feeling very tired. Your healthcare provider will do blood tests to check your liver function during treatment with REVLIMID
  • Serious skin reactions and swelling under the skin that require immediate medical attention can happen with REVLIMID and may cause death. Call your healthcare provider right away if you have any skin reaction while taking REVLIMID
  • Allergic reactions. Tell your healthcare provider if you are lactose intolerant as REVLIMID contains lactose
  • Tumor lysis syndrome. Metabolic complications that can occur during treatment of cancer and sometimes even without treatment. These complications are caused by the breakdown products of dying cancer cells and may include the following: changes to blood chemistry, high potassium, phosphorus, uric acid, and low calcium. This may lead to changes in kidney function, heartbeat, seizures, and sometimes death
  • Worsening of your tumor (tumor flare reaction). Tell your healthcare provider if you get any of these symptoms while taking REVLIMID: tender swollen lymph nodes, low-grade fever, pain or rash

Common side effects

  • Common side effects of REVLIMID are diarrhea, itching, rash, and tiredness
  • These are not all the possible side effects of REVLIMID. Tell your healthcare provider about any side effect that bothers you or does not go away

Drug Interactions

  • REVLIMID with or without dexamethasone may affect how certain other medicines work. Especially tell your healthcare provider if you take or use warfarin (a blood thinner) or digoxin (a medicine used to treat heart problems including abnormal heart beats). Your healthcare provider may want to test your blood more often
  • Medicines that may cause blood clots, such as those that help make more red blood cells or those that contain estrogen, should be used cautiously in patients with MM who are taking REVLIMID with dexamethasone

Other important information about REVLIMID

  • Swallow REVLIMID capsules whole with water once a day. Do not break, chew, or open your capsules
  • Do not open the REVLIMID capsules or handle them any more than needed. If you touch a broken REVLIMID capsule or the medicine in the capsule, wash the area of your body with soap and water
  • If you miss a dose of REVLIMID, and it has been less than 12 hours since your regular time, take it as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time
  • If you have kidney problems or are on dialysis, be sure to talk with your doctor. He or she may need to adjust your dose of REVLIMID

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.