THALOMID- thalidomide capsule 
Celgene Corporation

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MEDICATION GUIDE
THALOMID® (tha-lo-mid)
(thalidomide)
capsules

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


Females must not become pregnant:
 

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

Talk to your healthcare provider right away if you have unprotected sex or if you think your birth control has failed.  If your healthcare provider is not available, you can call 1-888-668-2528 for emergency contraception information.


If you become pregnant while taking THALOMID, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call 1-800-332-1088 for medical information. Healthcare providers and patients should report all pregnancies to:

  • FDA MedWatch at 1-800-332-1088, and
  • Celgene Corporation at 1-888-423-5436

THALOMID 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 that can become pregnant, while taking THALOMID, during any breaks (interruptions) in your treatment with THALOMID, and for 4 weeks after stopping THALOMID.
  • 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 THALOMID, during breaks (interruptions) in your treatment, and for 4 weeks after stopping THALOMID. If a female becomes pregnant with your sperm, the baby may be exposed to THALOMID and may be born with birth defects.

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

 

  • Blood clots. If you take THALOMID 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 THALOMID:
    • shortness of breath
    • chest pain
    • arm or leg swelling

What is THALOMID?

THALOMID is a prescription medicine used:

It is not known if THALOMID is safe and effective in children under 12 years of age.

Who should not take THALOMID?

What should I tell my healthcare provider before taking THALOMID?

Before you take THALOMID, 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.  THALOMID and other medicines may affect each other causing serious side effects.

Certain medicines can affect the way that birth control pills, injections, patches, or implants work. You could become pregnant.

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

How should I take THALOMID?

Take THALOMID exactly as prescribed and follow all the instructions of the THALOMID REMS™ program (formerly known as the S.T.E.P.S.® program).


Before prescribing THALOMID, your healthcare provider will:
 
  • explain the THALOMID REMS™ program to you
  • have you sign the Patient-Physician Agreement Form

Females who can become pregnant:

Males who take THALOMID, 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 THALOMID?

What are the possible side effects of THALOMID?

THALOMID may cause serious side effects, including:

The most common side effects of THALOMID for treatment of multiple myeloma include:

  • tiredness
  • decreased calcium levels
  • swelling of the hands and feet
  • constipation
  • numbness or tingling
  • low blood counts
  • skin rash or peeling
  • confusion
  • decreased appetite
  • nausea
  • anxiety
  • decreased energy or strength
  • tremor
  • fever
  • weight loss
  • muscle twitching and cramping
  • weight gain
  • dizziness
  • dry skin

The most common side effects THALOMID for treatment of leprosy include:

  • sleepiness
  • rash
  • headache
  • dizziness
  • impotence
  • decreased energy or strength
  • not feeling well
  • pain

These are not all the possible side effects of THALOMID.

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 THALOMID?

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

General information about THALOMID

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

Active ingredient: thalidomide

Inactive ingredients: pregelatinized starch and magnesium stearate.

The 50 mg capsule shell contains gelatin, titanium dioxide and black ink.
The 100 mg capsule shell contains black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black ink.
The 150 mg capsule shell contains FD&C blue #2, black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black and white ink.
The 200 mg capsule shell contains FD&C blue #2, titanium dioxide, gelatin, and white ink.

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

Revised February/2013

Manufactured for:

Celgene Corporation

Summit, NJ 07901

THALOMID® and S.T.E.P.S.® are registered trademarks of Celgene Corporation.

U.S. Pat. Nos. 5,629,327; 6,045,501; 6,315,720; 6,235,756; 6,561,976; 6,561,977; 6,755,784; 6,869,399; 6,908,432; 7,141,018; 7,230,012; 7,435,745, 7,723,361, 7,874,984 and 7,959,566

©1998-2013 Celgene Corporation. All Rights Reserved.

THALPLYMG. 018 02/13 CG

Revised: 11/2013
 
Celgene Corporation