POMALYST- pomalidomide capsule 
Celgene Corporation

----------

MEDICATION GUIDE
POMALYST® (POM-uh-list)
(pomalidomide)
capsules

Read the Medication Guide that comes with POMALYST before you start taking it and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.

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

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

What is POMALYST?

POMALYST is a prescription medicine used to treat people with multiple myeloma who:

It is not known if POMALYST is safe and effective in people under 18 years of age.

Who should not take POMALYST?

Do not take POMALYST if you are pregnant, plan to become pregnant, or become pregnant during treatment with POMALYST. See “What is the most important information I should know about POMALYST?

What should I tell my healthcare provider before taking POMALYST?

Before you take POMALYST, 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. POMALYST 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 POMALYST?

Take POMALYST exactly as prescribed and follow all the instructions of the POMALYST REMS program.

Before prescribing POMALYST, your healthcare provider will:

  • explain the POMALYST REMS program to you
  • have you sign the Patient-Physician Agreement Form

Females who can become pregnant:

Males who take POMALYST, 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 POMALYST?

What are the possible side effects of POMALYST?
POMALYST may cause serious side effects, including:

The most common side effects of POMALYST include:

These are not all the possible side effects of POMALYST.

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

How should I store POMALYST?

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

General information about POMALYST

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take POMALYST for conditions for which it was not prescribed. Do not give POMALYST 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 POMALYST. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about POMALYST that is written for healthcare providers.

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

What are the ingredients in POMALYST?

Active ingredient: pomalidomide
Inactive ingredients: mannitol, pregelatinized starch, and sodium stearyl fumarate.

The 1-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, white ink, and black ink.
The 2-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, FD&C red 3, and white ink.
The 3-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, and white ink.
The 4-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 1, FD&C blue 2, and white ink.

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

Issued 05/2014

Manufactured for:
Celgene Corporation
Summit, NJ 07901

POMALYST®, REVLIMID®, and THALOMID® are registered trademarks of Celgene Corporation.
POMALYST REMS is a trademark of Celgene Corporation.
Pat. http://www.celgene.com/therapies

© 2005-2014 Celgene Corporation   All rights reserved.

                                                                                                                    POMMG.003 05/2014

Revised: 05/2014
 
Celgene Corporation