MEDICATION GUIDE

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 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. 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 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. If you are being treated for deletion 5q myelodysplastic syndromes (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 multiple myeloma, your blood counts should be checked every 2 weeks for the first 12 weeks and then at least monthly thereafter.
• Blood clots. If you take REVLIMID and dexamethasone, you may have an increased risk 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 while taking REVLIMID:
  • shortness of breath
  • chest pain
  • arm or leg swelling

What is REVLIMID?

REVLIMID is a prescription medicine used:

• to treat people with multiple myeloma (MM) who have received at least one prior medicine, taken along with the medicine dexamethasone.
• to treat people 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.

It is not known if REVLIMID is safe and effective in people 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?"
• Do not take REVLIMID if you 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?
Before you take REVLIMID, tell your healthcare provider if you:

• 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 break, chew, or open 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?"
• Serious skin reactions. Serious skin reactions can happen with REVLIMID and may cause death. Call your healthcare provider right away if you have any skin reaction while taking REVLIMID.
• 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.
• Risk of new cancers (malignancies). People with multiple myeloma 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.

Common side effects of REVLIMID are:

• diarrhea
• itching
• rash
• tiredness

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 1-800-332-1088.

How should I store REVLIMID?

• Store REVLIMID at room temperature 68°F to 77°F (20°C to 25°C) with excursions permitted to 59°F to 86°F (15°C to 30°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.

This Medication Guide provides a summary of the most important information about REVLIMID. 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 visit
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.

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

February/2013

Manufactured for:
Celgene Corporation
Summit, NJ 07901

REVLIMID®, RevAssist®, and THALOMID® are registered trademarks of Celgene Corporation.

U.S. Pat. Nos. 5,635,517; 6,045,501; 6,281,230; 6,315,720; 6,555,554; 6,561,976; 6,561,977; 6,755,784; 6,908,432; 7,119,106; 7,189,740; 7,465,800; 7,855,217; 7,968,569

©2005-2013 Celgene Corporation, All Rights Reserved.

RevPlyMG.015L 02/13