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REVLIMID- lenalidomide capsule


  1. Patient Information
  2. Females Who Can Become Pregnant:
  3. There Is A Pregnancy Exposure Registry That Monitors The Outcomes Of Females Who Take Revlimid During Pregnancy, Or If Their Male Partner Takes Revlimid And They Are Exposed During Pregnancy. You Can Enroll In This Registry By Calling Celgene Corporation At The Phone Number Listed Above.revlimid Can Pass Into Human Semen:
  4. About All The Medicines You Take. Certain Other Medicines Can Also Increase Your Risk For Blood Clotscall 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:
  5. Signs Or Symptoms Of A Heart Attack May Include:
  6. Signs Or Symptoms Of Stroke May Include:
  7. What Is Revlimid?
  8. Who Should Not Take Revlimid?do Not Take Revlimid If You:
  9. What Should I Avoid While Taking Revlimid?
  10. What Are The Ingredients In Revlimid?active Ingredient:
  11. Inactive Ingredients:

Patient Information 

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

Embryo-Fetal Toxicity

Advise patients that REVLIMID is contraindicated in pregnancy[
Before you begin taking REVLIMID, you must read and agree to all of the instructions in the REVLIMID REMSprogram. Before prescribing REVLIMID, your healthcare provider will explain the REVLIMID REMS program to you and have you sign the Patient-Physician Agreement Form.
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.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

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 two acceptable forms of birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for at least 4 weeks after stopping REVLIMID.
  • Talk with your healthcare provider to find out about options for acceptable forms of birth control that you may use to prevent pregnancy before, during, and after treatment with REVLIMID.
  • If you had unprotected sex or if you think your birth control has failed, stop taking REVLIMID immediately and call your healthcare provider right away.
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 Celgene Customer Care Center at 1-888-423-5436. 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

There Is A Pregnancy Exposure Registry That Monitors The Outcomes Of Females Who Take Revlimid During Pregnancy, Or If Their Male Partner Takes Revlimid And They Are Exposed During Pregnancy. You Can Enroll In This Registry By Calling Celgene Corporation At The Phone Number Listed Above.revlimid Can Pass Into Human Semen: 

  • Males, including those who have had a vasectomy, must always use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while taking REVLIMID, during any breaks (interruptions) in your treatment with REVLIMID, and for up to 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, smoke, or if you have been told 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 Clotscall 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 adults with:
    • multiple myeloma (MM)
      • in combination with the medicine dexamethasone, or
      • as maintenance treatment after autologous hematopoietic stem cell transplantation (a type of stem cell transplant that uses your own stem cells)
    • 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.
    • mantle cell lymphoma (MCL) when the disease comes back or becomes worse after treatment with 2 prior medicines, one of which included bortezomib. MCL is a cancer of a type of white blood cell called lymphocytes that are in the lymph nodes.
    • follicular lymphoma (FL) or marginal zone lymphoma (MZL)
      • in combination with a rituximab product,and
      • who have previously been treated for their FL or MZL
      FL and MZL are types of cancer of white blood cells called B-cell lymphocytes that are found in the lymph nodes and spleen.
    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.

    Who Should Not Take Revlimid?do Not Take Revlimid If You: 

    • are pregnant, plan to become pregnant, or become pregnant during treatment with REVLIMID.
      • Take REVLIMID exactly as prescribed and follow all the instructions of the REVLIMID REMS program
      • Swallow REVLIMID capsules whole with water 1 time a day.Do not open, break, or chew your capsules.
      • REVLIMID may be taken with or without food.
      • Take REVLIMID at about the same time each day.
      • Do not open or break REVLIMID capsules or handle them any more than needed.
        • If powder from the REVLIMID capsule comes in contact with your skin, wash the skin right away with soap and water.
        • If powder from the REVLIMID capsule comes in contact with the inside of your eyes, nose, or mouth, flush well with 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 nottake 2 doses at the same time.
      • If you take too much REVLIMID, call your healthcare provider right away.

    What Should I Avoid While Taking 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 the safe and effective use of 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.

    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 shell contains 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.
    Manufactured for: Celgene Corporation, 86 Morris Avenue, Summit, NJ 07901
    REVLIMIDand REVLIMID REMSare registered trademarks of Celgene Corporation.
    Pat. http://www.celgene.com/therapies 2005-2019 Celgene Corporation All rights reserved. REVPlyMG.026 5/2019
    For more information, call 1-888-423-5436 or go to www.CelgeneRiskManagement.com.



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