Understanding the RevAssist® Program

REVLIMID is only available under a restricted distribution program called RevAssist®. Here's how it works:

Understanding the RevAssist Program

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® (lenalidomide).

  • If you are a woman who can become pregnant, you must have 2 pregnancy tests that show you are not pregnant before starting REVLIMID
  • Once treatment has started and during dose interruptions, pregnancy testing for women who can become pregnant should occur weekly during the first 4 weeks of use, then pregnancy testing should be repeated every 4 weeks in women with regular menstrual cycles. If menstrual cycles are irregular, the pregnancy testing should occur every 2 weeks
  • If pregnancy does occur during REVLIMID treatment, REVLIMID must be discontinued immediately
  • If you become pregnant while taking REVLIMID, stop taking it right away and call your healthcare provider
  • Lenalidomide is contraindicated in pregnant women and women capable of becoming pregnant. Females of childbearing potential may be treated with lenalidomide provided adequate precautions are taken to avoid pregnancy
  • REVLIMID can pass into human 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 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)

The documents listed below contain important information about REVLIMID® and describe the requirements of RevAssist®. Click a title to view.


Patient Medication Guide
Read the Patient Medication Guide before you start taking REVLIMID®, and each time you get a new prescription.

Important Information for Men and Women Taking REVLIMID® Spanish version Spanish version
There are special precautions for all patients taking REVLIMID®, and some of the requirements of the RevAssist® program are different for men and women.

RevAssist® Guide to Patient Surveys Spanish version Spanish version
Before your healthcare professional can write a prescription for REVLIMID®, you need to complete a brief, confidential telephone survey. This guide explains the process for you.

Emergency Contraception
This is the web version of a booklet developed by Planned Parenthood. Please consult with your healthcare professional for further information.

Documents in PDF format require the free Adobe® Reader®

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.

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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.

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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.

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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.