REVLIMID- lenalidomide capsule 
Celgene Corporation

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MEDICATION GUIDE
REVLIMID® (rev-li-mid)
(lenalidomide)
capsules

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

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:

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:

REVLIMID can pass into human semen:

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


What is REVLIMID?

REVLIMID is a prescription medicine used to treat people:

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?

What should I tell my healthcare provider before taking REVLIMID?
Before you take REVLIMID, tell your healthcare provider if you:

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

Females who can become pregnant:

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?

What are the possible side effects of REVLIMID?

REVLIMID may cause serious side effects, including:

Your healthcare provider will do blood tests to check your liver function during your treatment with REVLIMID.

REVLIMID may cause serious side effects, including:

Common side effects of REVLIMID include:

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?

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.


Manufactured for:
Celgene Corporation
Summit, NJ 07901


Revised 11/2013

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

REVLIMID REMS™ is a trademark 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; 7,468,363; 7,855,217; 7,968,569


©2005-2013 Celgene Corporation, All Rights Reserved.

                                                                                                                                         RevPlyMG.018   11/13

Revised: 11/2013
 
Celgene Corporation