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Brand Names: Thalomid

Generic Name: thalidomide (Pronunciation: tha LID o mide)

• What is thalidomide (Thalomid)?
• What are the possible side effects of thalidomide (Thalomid)?
• What is the most important information I should know about thalidomide (Thalomid)?
• What should I discuss with my healthcare provider before taking thalidomide (Thalomid)?
• How should I take thalidomide (Thalomid)?
• What happens if I miss a dose (Thalomid)?
• What happens if I overdose (Thalomid)?
• What should I avoid while taking thalidomide (Thalomid)?
• What other drugs will affect thalidomide (Thalomid)?
• Where can I get more information?

What is thalidomide (Thalomid)?

Thalidomide affects the immune system. It helps promote immune responses to prevent inflammation in the body.

Thalidomide is used to treat and prevent the debilitating and disfiguring skin sores caused by erythema nodosum leprosum (ENL), an inflammatory complication of leprosy. It is also used together with another medicine called dexamethasone to treat multiple myeloma (bone marrow cancer).

Thalidomide may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of thalidomide (Thalomid)?

Stop using this medicine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• chest pain, sudden shortness of breath, coughing up blood;
• pain or swelling in your arm, thigh, or calf;
• fever, chills, body aches, flu symptoms, easy bruising or bleeding;
• slow heartbeats, shallow breathing;
• feeling like you might pass out;
• a red, blistering, peeling skin rash;
• a red, raised skin rash (especially if you also have fever, fast heart rate, and dizziness or fainting);
• numbness, burning, pain, or tingly feeling; or
• seizure (convulsions).

Less serious side effects may include:

• feeling drowsy or sleepy;
• anxiety, confusion, tremors or shaking;
• bone pain, muscle weakness;
• sleep problems (insomnia); or
• nausea, constipation, loss of appetite.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about thalidomide (Thalomid)?

Thalidomide can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medication at the time of conception or during pregnancy. Even one dose of thalidomide can cause major birth defects of the baby's arms and legs, bones, ears, eyes, face, and heart. Never use thalidomide if you are pregnant.

For Women: You will be required to use two reliable forms of birth control beginning 4 weeks before you start taking thalidomide and ending 4 weeks after you stop taking it. Any woman who has not had a hysterectomy or has not been in menopause for at least 24 months in a row must agree in writing to use birth control before, during, and after taking thalidomide. Even women with fertility problems are required to use birth control while taking this medication. You must also have a negative pregnancy test within 24 hours before you start thalidomide treatment. While you are taking thalidomide, you will need to have a pregnancy test weekly during the first month of treatment, and then every 4 weeks thereafter.

Stop using thalidomide and call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.

For Men: You must not cause a woman to become pregnant while you are taking thalidomide because the medicine may affect your sperm and cause birth defects in the baby. You must agree in writing to always use latex condoms when having sex with a woman who is able to get pregnant, even if you have had a vasectomy. Avoid ejaculating without a condom because thalidomide can be passed in your sperm.

Thalidomide is available only under a special program called "System for Thalidomide Education and Prescribing Safety" (S.T.E.P.S.). You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control as required by the program. For patients between 12 and 18 years, a parent or legal guardian must read and sign all written requirements for the S.T.E.P.S. program.

Do not donate blood or sperm while you are using thalidomide. Avoid exposing another person to your blood or semen through casual or sexual contact.