Understanding Side Effects

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.

Don't be afraind to talk to your doctor

Serious side effects

Risk to unborn babies
Low white blood cells (neutropenia)
Low platelets (thrombocytopenia)
Blood clots
Increased risk of death in people who have chronic lymphocytic leukemia (CLL)
Risk of new cancers
Severe liver problems, including liver failure and death
Serious skin reactions
Allergic reactions
Tumor lysis syndrome
Worsening of your tumor (tumor flare reaction)

Common side effects

Constipation
Diarrhea
Itching and rash
Tiredness (fatigue)
Muscle cramps

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 females. REVLIMID has harmed unborn animals in animal testing.

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

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 1-800-332-1088 , and
  • Celgene Corporation at 1-888-423-5436

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.
  • 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

Men, if your female partner becomes pregnant, you should call your healthcare provider right away.

Tell your doctor right away if:

Back to top

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:

If your white blood cell count becomes too low, your doctor may lower your dose of REVLIMID. 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.

Back to top

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.

FPO need callout image

If your platelet levels fall too low, your doctor may lower your dose of REVLIMID. 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.

Back to top

Blood clots

If you take REVLIMID and dexamethasone, you may have an increased risk for blood clots in your veins and lungs. A blood clot that usually occurs in the leg or lower body is called a deep vein thrombosis or DVT. These blood clots can cause swelling, tenderness, pain, and redness in the leg. But they can occur in other parts of the body as well.

The blood clots can break off and travel where they can block the flow of blood to the lungs. This is called a pulmonary embolism and can damage the lungs or cause death.

You should call your doctor or get emergency care right away if you have:

Back to top

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

Back to top

Risk of new cancers

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

Back to top

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

Back to top

Serious skin reactions

Serious skin reactions and swelling under the skin that require immediate medical attention 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.

Back to top

Allergic reactions

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

Back to top

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.

Back to top

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

Back to top

Common side effects

Constipation
Diarrhea
Itching and rash
Tiredness (fatigue)
Muscle cramps

Constipation

Treatment with REVLIMID with 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:

Back to top

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:

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 right away. He or she will want to know about any side effects you have.

You may want to ask your doctor:

Back to top

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:

Back to top

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:

Back to top

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:

Back to top

These are not all the side effects that may happen. Your doctor or nurse is there to help you throughout treatment. They are also there to answer any questions you may have about side effects that may happen with treatment.

Next: Learn how to take REVLIMID >

REVLIMID® (lenalidomide) is used with dexamethasone to treat patients with multiple myeloma (MM) who have already had another treatment

REVLIMID® (lenalidomide) is used to treat patients who have low- or intermediate-1–risk myelodysplastic syndromes (MDS) where part of chromosome 5 is missing (del 5q). These patients have low red blood cell counts (anemia) that require blood transfusions

REVLIMID should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial

It is not known if REVLIMID is safe and effective in children under 18 years of age

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) and lungs (pulmonary embolism).

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 deletion 5q MDS, your blood counts should be checked weekly during the first 8 weeks of treatment with REVLIMID and at least monthly thereafter
  • 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 in the veins (deep vein thrombosis) and in the lungs (pulmonary embolism)

  • REVLIMID causes a higher chance for blood clots in your veins and lungs
  • Call your healthcare provider or get medical help right away if you get any of these signs or symptoms: shortness of breath, chest pain, or arm or leg swelling

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, 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, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, and Medication Guide.

Close Close
You Are Now Leaving REVLIMID.com

Click "OK" to proceed or "CANCEL" to return to REVLIMID.com.

Ok Cancel
Close Close
You Are Now Leaving REVLIMID.com
The content of the linked site is the sole responsibility of the site provider.
Celgene Corporation does not control or endorse this third-party website.

Click "OK" to proceed or "CANCEL" to return to REVLIMID.com.

Ok Cancel
Close Time to Progression
Close Close
For Healthcare Professionals
The information contained in this section of REVLIMID.com is clinical in
nature and was specifically created for healthcare professionals. If you are
not a US healthcare professional, please click the "RETURN" button below
to return to the consumer section of the site.

Yes, I am a US Healthcare Professional and would like to continue.

Continue Return
Close Close
You Are Now Leaving REVLIMID.com
Click "OK" to proceed or "CANCEL" to return to REVLIMID.com.
Ok Cancel
Close Close

Full Prescribing Information: Contents*

WARNING: FETAL RISK, HEMATOLOGIC TOXICITY, and DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM

Highlights of Prescribing Information

Boxed Warning

1 Indication and Usage 1.1 Multiple Myeloma 1.2 Myelodysplastic Syndromes

2 Dosage and Administration 2.1 Multiple Myeloma 2.2 Myelodysplastic Syndromes

3 Dosage Forms and Strengths

4 Contraindications 4.1 Pregnancy 4.2 Allergic Reactions

5 Warnings and Precautions 5.1 Fetal Risk 5.2 Reproductive Risk and Special Prescribing Requirements (RevAssist Program) 5.3 Hematologic Toxicity
5.4 Deep Vein Thrombosis and Pulmonary Embolism
5.5 Allergic Reactions
5.6 Tumor Lysis Syndrome
5.7 Tumor Flare Reaction
5.8 Hepatotoxicity
5.9 Second Primary Malignancies

6 Adverse Reactions 6.1 Clinical Trials Experience in Multiple Myeloma 6.2 Clinical Trials Experience in Myelodysplastic Syndromes 6.3 Postmarketing Experience

7 Drug Interactions 7.1 Digoxin 7.2 Warfarin 7.3 Concomitant Therapies That May Increase the Risk of Thrombosis

8 Use in Specific Populations 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal Impairment 8.7 Hepatic Impairment

10 Overdosage

11 Description

12 Clinical Pharmacology 12.1 Mechanism of Action 12.3 Pharmacokinetics

13 Nonclinical Toxicology 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.3 Reproductive and Developmental Toxicity

14 Clinical Studies 14.1 Multiple Myeloma 14.2 Myelodysplastic Syndromes (MDS) with a Deletion 5q Cytogenetic Abnormality

15 References

16 How Supplied/Storage and Handling

17 Patient Counseling Information 17.1 Importance of Preventing Pregnancy 17.2 Hematologic Toxicity 17.3 Deep Vein Thrombosis and Pulmonary Embolism 17.4 Dosing Instructions

*Sections or subsections omitted from the Full Prescribing Information are not listed.

Close Close

MDS Educational Resources

Download the materials below to learn more about MDS

You must have the free Adobe® Reader® installed on your computer to view these PDF files.

If you do not have Adobe® Reader®, please click on the button below to download it.

Download Adobe Reader

REVLIMID® (lenalidomide) is used with dexamethasone to treat patients with multiple myeloma (MM) who have already had another treatment

REVLIMID® (lenalidomide) is used to treat patients who have low- or intermediate-1–risk myelodysplastic syndromes (MDS) where part of chromosome 5 is missing (del 5q). These patients have low red blood cell counts (anemia) that require blood transfusions

REVLIMID should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial

It is not known if REVLIMID is safe and effective in children under 18 years of age

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) and lungs (pulmonary embolism).

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 deletion 5q MDS, your blood counts should be checked weekly during the first 8 weeks of treatment with REVLIMID and at least monthly thereafter
  • 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 in the veins (deep vein thrombosis) and in the lungs (pulmonary embolism)

  • REVLIMID causes a higher chance for blood clots in your veins and lungs
  • Call your healthcare provider or get medical help right away if you get any of these signs or symptoms: shortness of breath, chest pain, or arm or leg swelling

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, 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, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, and Medication Guide.