August 30, 2015

Revlimid




PATIENT INFORMATION

REVLIMID®
(rev-li-mid)
(lenalidomide) Capsules

What is the most important information I should know about REVLIMID?

  • 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.

Females must not get pregnant:

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

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 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.
  • Do not donate sperm while taking REVLIMID, during any breaks (interruptions) in your treatment, 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.

  • 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. Your healthcare provider should check your blood counts often especially during the first several months of treatment with REVLIMID, and then at least monthly. Tell your healthcare provider if you develop any bleeding or bruising,during treatment with REVLIMID.
  • 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.

What is REVLIMID?

REVLIMID is a prescription medicine used to treat people:

  • with multiple myeloma (MM), in combination with the medicine dexamethasone.
  • who have a condition called myelodysplastic syndromes (MDS). REVLIMID is for the type of MDS with a chromosome problem where part of chromosome 5 is missing. This type of MDS is known as deletion 5q MDS. People with this type of MDS may have low red blood cell counts that require treatment with blood transfusions.
  • with mantle cell lymphoma (MCL) when the disease comes back or becomes worse after treatment with two prior medicines, one of which included bortezomib. Mantle cell lymphoma is a cancer of a type of white blood cell called lymphocytes that are in the lymph nodes.

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.

Who should not take REVLIMID?

Do not take REVLIMID if you:

  • are pregnant, plan to become pregnant, or become pregnant during REVLIMID treatment. See “What is the most important information I should know about REVLIMID?”
  • are allergic to lenalidomide or any of the ingredients in REVLIMID. See the end of this Medication Guide for a complete list of ingredients in REVLIMID.

What should I tell my healthcare provider before taking REVLIMID?

See “What is the most important information I should know about REVLIMID?”

Before you take REVLIMID, tell your healthcare provider if you:

  • have liver problems
  • have kidney problems or receive kidney dialysis treatment
  • are lactose intolerant. REVLIMID contains lactose.
  • have any other medical condition
  • are breastfeeding. REVLIMID must not be used by females who are breastfeeding. It is not known if REVLIMID passes into your breast milk and can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. REVLIMID and other medicines may affect each other causing serious side effects.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.

How should I take REVLIMID?

Take REVLIMID exactly as prescribed and follow all the instructions of the REVLIMID REMS™ program (formerly known as the RevAssist® program).

Before prescribing REVLIMID, your healthcare provider will:

    • explain the REVLIMID REMS™ program to you
    • have you sign the Patient-Physician Agreement Form
  • Swallow REVLIMID capsules whole with water 1 time a day. Do not open, break, or chew your capsules.
  • Take REVLIMID at about the same time each day.
  • 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 take too much REVLIMID or overdose, call your healthcare provider right away.

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.

Males who take REVLIMID, even those who have had a vasectomy, must agree to use a latex or synthetic condom during sexual contact with a pregnant female or a female who can become pregnant.

What should I avoid while taking REVLIMID?

  • See “What is the most important information I should know about REVLIMID?”
  • Females: Do not get pregnant and do not breastfeed while taking REVLIMID.
  • Males: Do not donate sperm.
  • 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.

What are the possible side effects of REVLIMID?

REVLIMID may cause serious side effects, including:

  • See “What is the most important information I should know about REVLIMID?”
  • 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 multiple myeloma who receive Revlimid and melphalan, and a blood stem cell transplant have a higher risk of developing new cancers, including certain blood cancers (acute myelogenous leukemia or AML, and myelodysplastic syndrome or MDS) 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 of liver problems:
    • 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 (abdomen)
    • bleeding or bruising more easily than normal
    • feeling very tired
      Your healthcare provider will do blood tests to check your liver function during your treatment with REVLIMID.
  • Serious allergic reactions and serious skin reactions can happen with REVLIMID and may cause death. Call your healthcare provider right away if you develop any of these signs or symptoms of a serious allergic reaction or serious skin reaction during treatment with REVLIMID:
    • swelling of your face, eyes, lips, tongue, throat
    • trouble swallowing
    • trouble breathing
    • skin rash, hives, or peeling of your skin
    • blisters
  • Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure and sometimes death. Your healthcare provider may do blood tests to check you for TLS.
  • Worsening of your tumor (tumor flare reaction). Tell your healthcare provider if you get any of these symptoms of tumor flare reaction while taking REVLIMID: tender swollen lymph nodes, low-grade fever, pain, or rash.

Common side effects of REVLIMID include:

  • diarrhea
  • constipation
  • itching
  • rash
  • tiredness
  • swelling of the limbs and skin
  • nausea
  • fever
  • cough

These are not all the possible side effects of REVLIMID.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store REVLIMID?

  • Store REVLIMID at room temperature between 68°F to 77°F (20°C to 25°C).
  • Return any unused REVLIMID to Celgene or your healthcare provider.

Keep REVLIMID and all medicines out of the reach of children.

General information about REVLIMID

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take REVLIMID for conditions for which it was not prescribed. Do not give REVLIMID to other people, even if they have the same symptoms you have. It may harm them and may cause birth defects.

If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about REVLIMID that is written for health professionals.

For more information, call 1-888-423-5436 or go to www.celgeneriskmanagement.com.

What are the ingredients in REVLIMID?

Active ingredient: lenalidomide

Inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate.

The 5 mg and 25 mg capsule shells contain gelatin, titanium dioxide and black ink. The 2.5 and 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink. The 15 mg capsule shell contains gelatin, FD&C blue #2, titanium dioxide and black ink. The 20 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

RISK EVALUATION AND MITIGATION STRATEGY (REMS)

GOALS

The goals of the REVLIMID risk evaluation and mitigation strategy are as follows:

To prevent the risk of embryo-fetal exposure to REVLIMID.

To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for REVLIMID.

REMS ELEMENTS

Elements To Assure Safe Use

Healthcare providers Who Prescribe REVLIMID are specially certified.

Celgene will ensure that healthcare providers who prescribe REVLIMID are specially certified in the REVLIMID REMSprogram.

To become certified, each prescriber must complete the Prescriber Enrollment Form and agree to do the following:

  1. Provide patient counseling on the benefits and risks of REVLIMID therapy, including risks described in the BOXED WARNINGS.
  2. Enroll each patient by completing and submitting to the Celgene Customer Care Center via mail (86 Morris Avenue, Summit, NJ 07901), email (customercare@celgene.com), fax (1-888-432-9325), or online (www.celgeneriskmanagement.com), a signed Patient-Physician Agreement Form (PPAF) identifying the patient's risk category (see PPAFs for all six risk categories) for each new patient. In signing the PPAF, each prescriber acknowledges that they understand that REVLIMID is available only through the REVLIMID REMS™ program, and that they must comply with program requirements.
  3. Provide contraception and emergency contraception counseling with each new prescription prior to and during REVLIMID treatment.
  4. Provide scheduled pregnancy testing for females of reproductive potential and verify negative pregnancy test results prior to writing a new prescription or subsequent prescriptions.
  5. Report any pregnancies in female patients or female partners of male patients prescribed REVLIMID immediately to Celgene Drug Safety (or Celgene Customer Care Center, 1-888-4235436).
  6. Complete a prescriber survey (phone or online) for every patient (new and follow-up), obtain a unique prescription authorization number for each prescription written, and include this authorization number on the prescription. The authorization number can be obtained by contacting the Celgene Customer Care Center, using the automated IVR system, or via the www.CelgeneRiskMangement.com website.
    For females of reproductive potential, authorization numbers are valid only for 7 days from date of last pregnancy test and 30 days from the date it is issued for all other patients.
  7. Facilitate compliance with the mandatory REVLIMID REMS™ program patient survey by instructing patients to complete the mandatory surveys (phone or online) at program specified frequencies.
  8. Prescribe no more than a 4-week (28-day) supply, with no automatic refills or telephone prescriptions.
  9. Contact a REVLIMID REMS™ program pharmacy certified by the REVLIMID REMS™ program to fill the REVLIMID prescription.
  10. Return all unused REVLIMID brought in by patients to Celgene Customer Care.
  11. Re-enroll patients in the REVLIMID REMS™ program if REVLIMID is required and previous therapy with REVLIMID has been discontinued for 12 consecutive months.

Celgene will:

  1. Ensure that the REVLIMID REMS™ program materials including prescriber enrollment are available on the CelgeneRiskManagement.com website or can be obtained by contacting Celgene Customer Care Center at 1-888-423-5436
  2. Maintain a secure database of all REVLIMID REMSprogram certified prescribers.
  3. Monitor to ensure that only REVLIMID REMSprogram certified prescribers are prescribing REVLIMID.
  4. Monitor and ensure that patients have been assigned correctly to one of the following patient risk categories. Confirm risk category when completing the PPAFs during the patient enrollment process:
    1. Adult female of reproductive potential: all females who are menstruating, amenorrheic from previous medical treatments, under 50 years, and/or perimenopausal.
    2. Female child of reproductive potential: all females under 18 years who are menstruating.
    3. Adult female NOT of reproductive potential: females who have had a natural menopause for at least 24 consecutive months, a hysterectomy, and/or bilateral oophorectomy.
    4. Female child NOT of reproductive potential: all females under 18 years who are not menstruating.
    5. Adult males 18 years or older
    6. Male child under 18 years
  5. Monitor certified prescriber compliance with the REVLIMID REMSprogram, including patient risk categorization and the appropriate corresponding counseling requirements, contraception requirements, pregnancy testing, and survey completion for all patients treated with REVLIMID.
  6. Institute corrective action and prevent the certified prescriber from prescribing REVLIMID if the prescriber is found to be non-compliant with the REVLIMID REMSprogram.
  7. Train REVLIMID REMSprogram certified prescribers in adverse experience reporting procedures, including the requirement to immediately report to Celgene any suspected embryo-fetal exposure to REVLIMID if a pregnancy occurs.
  8. Ensure that once the prescriber submits the completed PPAF, the prescriber will receive a confirmation letter via fax or online to confirm the patient's enrollment and signify that the prescriber and patient surveys can be taken to receive an authorization number for the REVLIMID prescription (for all males, the PPAF is considered the initial survey). The authorization number is written on the REVLIMID prescription.
  9. Ensure that, for subsequent prescriptions, the prescriber completes a telephone or online survey designed to look for signals of at-risk behavior (e.g., pending or outdated pregnancy test), report the patient's pregnancy test results, correct assignment of risk category, and confirm or re-enforce patient understanding of contraceptive requirements. The completion of the survey will allow the prescriber to obtain a new authorization number every time a prescription for REVLIMID is written.

The following materials are part of the REMS, and are appended:

  • Prescriber Enrollment Form
  • Patient Prescription Form
  • Patient Prescription Form (Veterans Administration)
  • Prescriber Guide to REVLIMID REMS™ Program
  • REVLIMID REMS™ At-A-Glance
  • Welcome Letter
  • Celgene Risk Management.com website

REVLIMID will only be dispensed by pharmacies that are specially certified.

Celgene will ensure that REVLIMID is only dispensed from REVLIMID REMS™ program certified pharmacies. To become a certified pharmacy, the pharmacy must agree to do the following before filling a REVLIMID prescription:

  1. Only accept prescriptions with a prescription authorization number. Authorization numbers are valid for 7 days from date of last pregnancy test for females of reproductive potential and 30 days from the date it is issued for all other patients.
  2. Dispense no more than a 4-week (28-day) supply, and require a new prescription from the patient prior to dispensing additional REVLIMID.
  3. Dispense subsequent prescriptions only if there are 7 days or less remaining on an existing REVLIMID prescription.
  4. Obtain a REVLIMID REMS™ confirmation number from the Celgene Customer Care Center (phone or online) and write this confirmation number on the prescription. The REVLIMID REMS™ confirmation number may be obtained using the following procedure:
    1. Enter the pharmacy identification number (NABP or DEA);
    2. Enter the prescription authorization number written on the prescription;
    3. Enter the number of capsules and milligram (mg) strength being dispensed;
    4. Dispense or ship the prescribed REVLIMID within 24 hours of obtaining and recording the REVLIMID REMS™ confirmation number and confirmation date.
  5. Dispense REVLIMID only after a REVLIMID REMS™ program confirmation number is obtained. If no confirmation is obtained, then no REVLIMID is dispensed. Contact the patient's physician and Celgene for further instruction.
  6. Accept unused REVLIMID (previously dispensed) from a patient or patient caregiver and return to Celgene Corporation for proper disposal.
  7. For each patient receiving treatment, retain a record of each REVLIMID prescription dispensed and the corresponding completed REVLIMID REMS™ Education and Counseling Checklist.
  8. Complete the checklist that applies to the REVLIMID REMS™ program patient risk category written on the front of the Education and Counseling Checklist for Pharmacies.
  9. Provide counseling to patients and/or guardians of patients under 18 years of age receiving REVLIMID treatment.
    1. Counsel all patients and guardians of patients under 18 years of age on the following:
      • The benefits and risks of REVLIMID therapy.
      • Not sharing REVLIMID medication
      • Not donating blood while taking REVLIMID, during dose interruptions, and for 4 weeks after stopping REVLIMID.
      • Not to break, chew, or open REVLIMID capsules.
      • Instructions on REVLIMID dose and administration.
      • To read the REVLIMID REMS™ program education materials and encourage compliance with the requirements.
    2. In addition to above, counsel Females of Reproductive Potential on the following:
      • The potential for embryo-fetal toxicity with exposure to REVLIMID.
      • Using 2 forms of effective birth control at the same time or abstaining from heterosexual sexual intercourse.
      • Continuing to use 2 forms of birth control if REVLIMID therapy is interrupted and for at least 4 weeks after therapy is discontinued.
      • Obtaining a pregnancy test weekly during the first 4 weeks of REVLIMID use, then a repeat pregnancy test every 4 weeks in females with regular menstrual cycles, and every 2 weeks in females with irregular menstrual cycles.
      • The need to stop taking REVLIMID and notify their REVLIMID prescriber immediately if they become pregnant or suspect they may be pregnant.
    3. In addition to items listed for all patients above, counsel Males receiving REVLIMID treatment about the potential for embryo-fetal toxicity with exposure to REVLIMID and the importance of using barrier contraception by wearing a latex or synthetic condom when engaging in sexual intercourse with a female of reproductive potential even if the male receiving REVLIMID has had a successful vasectomy.
      • The need to not donate sperm while taking REVLIMID, during dose interruptions, and for 4 weeks after stopping REVLIMID.
    • d. Counsel the Parent or legal guardian of Female Child NOT of reproductive potential who is receiving REVLIMID treatment about the need to inform their REVLIMID prescriber when the child begins menses.

Before a certified pharmacy dispenses REVLIMID, Celgene will train the appropriate pharmacy staff:

  1. About the REVLIMID REMS™ program
  2. About the procedures for reporting adverse experiences to Celgene, including the requirement to immediately report to Celgene any suspected embryo-fetal exposure to REVLIMID if a pregnancy occurs.

The following materials are part of the REMS, and are appended:

  • Pharmacy Guide to REVLIMID REMS™ Program
  • Education and Counseling Checklist for Pharmacies
  • Celgene REMS Programs Pharmacy Training: REVLIMID REMS™
  • Pharmacy Certification Quiz (the REVLIMID REMS™ Program)

Celgene will ensure that REVLIMID® will only be dispensed to patients enrolled in the REVLIMID REMS™ program with evidence or other documentation of safe-use conditions.

Celgene will ensure that all patients treated with REVLIMID are enrolled by a certified prescriber. The prescriber will enroll the patient by completing Patient-Physician Agreement Form and submitting the form via mail (86 Morris Avenue, Summit, NJ 07901), fax (1-888-432-9325), email (customercare@celgene.com) or online (www.celgeneriskmanagement.com) for each patient who receives REVLIMID. Each patient and/or guardian of patients under 18 years of age consents to participate in the program by:

  1. acknowledging that he or she understands that:
    1. severe birth defects or death to an unborn baby may occur if a female becomes pregnant while she is receiving REVLIMID;
    2. REVLIMID must not be shared with anyone, even someone with similar symptoms;
    3. REVLIMID must be kept out of the reach of children and should NEVER be shared with females who are able to have children;
    4. they cannot donate blood while receiving REVLIMID including during dose interruptions, and for 4 weeks after stopping REVLIMID;
    5. they might be asked to participate in the REVLIMID Pregnancy Exposure Registry; and
    6. they may be contacted by Celgene about following the rules of the REMS.
  2. In addition, each patient and/or guardian of patients under 18 years of age consents to participate in the program by:
    1. agreeing to return unused REVLIMID to Celgene or their REVLIMID prescriber, or to the pharmacy that dispensed the REVLIMID to them ;
    2. agreeing to participate in a monthly (telephone or online) survey while on REVLIMID (with the exception of Adult Females Not of Reproductive Potential who are required to take a survey once every six months); and
    3. reviewing the REVLIMID REMS™ program educational materials and asking their prescriber any questions that have not been answered.

In addition, Females and guardians of female children must attest to their understanding of their/their child's reproductive potential, as categorized by the prescribing physician.

Females of Reproductive Potential and guardians of Female Children of Reproductive Potential will attest that they/their child:

  1. is not currently pregnant, and will try to refrain from becoming pregnant while receiving REVLIMID therapy and for at least 4 weeks after completely stopping REVLIMID therapy;
  2. must not take REVLIMID if pregnant, breastfeeding a baby, or not using birth control as defined in the REMS;
  3. will, unless abstinent, use contraception as defined within the REMS: for at least 4 weeks before starting REVLIMID, while receiving REVLIMID, during dose interruptions, and for at least 4 weeks after stopping REVLIMID;
  4. will have pregnancy testing done as ordered by the certified prescriber within 10 to 14 days and 24 hours prior to starting REVLIMID, every week for at least the first 4 weeks of REVLIMID therapy, and then every 4 weeks if the Female of Reproductive Potential has regular menstrual cycles, or every 2 weeks if the Female of Reproductive Potential has irregular menstrual cycles, while receiving REVLIMID;
  5. will immediately stop taking REVLIMID and inform the certified prescriber if the patient becomes pregnant, misses a menstrual period, experiences unusual menstrual bleeding, stops using contraception, or thinks for any reason that she might be pregnant; if the prescriber is not available, the Female of Reproductive Potential or guardian of a Female Child of Reproductive Potential can call the Celgene Customer Care Center at 1-888-423-5436 or the Emergency Contraception Hotline at 1-888-668-2528 for information on emergency contraception.

Males or Guardians of males will attest that they/their child will:

  1. never have unprotected sexual contact with a female who can become pregnant;
  2. wear a latex or synthetic condom every time the male patient has sexual contact with a female who is or who can become pregnant; continue condom use with sexual contact while the male patient is receiving REVLIMID treatment, during dose interruptions, and for 4 weeks after the male patient stops taking REVLIMID, even if the patient has had a successful vasectomy; and
  3. inform their certified prescriber if the male patient has unprotected sexual contact with a female who can become pregnant, or if they think for any reason that the male patient's sexual partner might be pregnant; the male patient or guardian of an underage male patient can call the Celgene Customer Care Center at 1-888-423-5436 or the Emergency Contraception Hotline at 1-888-668-2528 for information on emergency contraception;
  4. not donate sperm while taking (including dose interruptions) and for 4 weeks after stopping REVLIMID

The following appended materials are part of the REMS:

  • Patient-Physician Agreement Form for Adult Male
  • Patient-Physician Agreement Form for Male Child
  • Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant
  • Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant
  • Patient-Physician Agreement Form for Female Child Who Can Not Get Pregnant
  • Patient-Physician Agreement Form for Female Child Who Can Get Pregnant
  • Patient Guide to REVLIMID REMS™ Program
  • Emergency Contraception Brochure
  • Patient Survey Reminder Card
  • REVLIMID Risk Evaluation and Mitgation Strategy (REMS)™ Program Education and Safety Kit
  • REVLIMID REMS™ Patient Resource Pack Envelope

Female patients or female partners of male patients receiving REVLIMID who report a pregnancy that occurred during REVLIMID therapy will be enrolled in the REVLIMID Pregnancy Exposure Registry.

Upon receiving a report of pregnancy from the REVLIMID REMS™ program, Celgene Pregnancy Prevention Plan programs in the rest of the world, clinical trials, or directly from a prescriber, a pharmacy, or a patient, Celgene will enroll the female patient or female partner of the male patient taking REVLIMID into the REVLIMID Pregnancy Exposure Registry. The objectives of the registry are to monitor pregnancy outcomes in female patients of reproductive potential and male patients' female partners who are exposed to REVLIMID and to understand why the REVLIMID REMS™ program was unsuccessful.

Implementation System

The implementation system will include the following:

  1. Celgene will maintain a secure database of all certified entities, including enrolled patients and certified prescribers and pharmacies to monitor and evaluate implementation of the elements provided for in Sections 2.1.1, 2.1.2, and 2.1.3.
  2. Celgene will monitor pharmacy certification compliance and address deviations by monitoring real time dispensing activity and conducting pharmacy audits.
    1. The Celgene Customer Care Center will monitor the certified pharmacies in the manner described in the REMS supporting document to ensure only enrolled and authorized patients are receiving REVLIMID. If a certified pharmacy is found to be non-compliant with the REVLIMID REMS™ program, Celgene will institute corrective action and may de-activate pharmacies for which retraining has proven ineffective, removing them from the REVLIMID REMS™ program.
    2. Celgene will perform regular audits of contract pharmacies participating in the REVLIMID REMS™ program. For pharmacies that have been in the program for more than two years, Celgene will perform a risk-based assessment to select which pharmacies will be audited. The REVLIMID REMS™ program compliance audits will be performed by internal auditors of Celgene and/or outside auditors contracted and trained by Celgene.
  3. Celgene will monitor and ensure that the prescriptions are filled within the allowed timeframes.
  4. Celgene Customer Care Center will address customer complaints received that are related to the REVLIMID REMS™ program and distribution and dispensing of REVLIMID.
  5. Celgene will maintain a reporting and collection system for safety information that includes a process to monitor pregnancy testing results and pregnancy outcomes (should one occur) through the REVLIMID Pregnancy Exposure Registry and to understand why the REVLIMID REMS™ program was unsuccessful for the pregnancy case in question.
  6. Based on monitoring and evaluation of these elements to assure safe use, Celgene will take reasonable steps to work to improve implementation of these elements as applicable.
  7. Celgene will develop and follow written procedures related to the implementation of the REMS.

Timetable for Submission of Assessment Reports

Celgene will submit REMS assessments at six months and then annually following the initial approval date of the REMS (August 3, 2010). To facilitate inclusion for as much information as possible while allowing reasonable time to prepare the submission, the reporting interval covered by each assessment should conclude no earlier than 60 days before the submission date for that assessment. Celgene will submit each assessment so it will be received by the FDA on or before the due date.

Last reviewed on RxList: 3/6/2015
This monograph has been modified to include the generic and brand name in many instances.

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