Thalidomide, Oral

What are other names for this medicine?

Type of medicine: immunosuppressant

Generic and brand names: thalidomide, oral; Thalomid

What is this medicine used for?

This medicine is taken by mouth to treat and prevent new attacks of leprosy. This medicine is also taken to treat multiple myeloma. This medicine may also be used for other conditions as determined by your healthcare provider.

This medicine causes severe birth defects. Only a few healthcare providers are allowed to prescribe this medicine. Also, only a few pharmacies are allowed to sell it. For information on the distribution of this medicine, call 1-888-4CELGENE.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• a seizure disorder
• blood clots
• heart disease or heart failure
• high blood pressure
• kidney or liver disease
• nerve problems
• problems with constipation

DO NOT take this medicine if you are pregnant.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. The sores usually heal in about 2 weeks. Then your healthcare provider may lower your dosage gradually. Be sure you understand how much medicine to take and when to take it.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

An acute overdose of this medicine is not likely to cause life-threatening symptoms. If you think that you or anyone else may have taken too much of this medicine, call the poison control center at 800-222-1222.

What should I watch out for?

Females of childbearing age: DO NOT take this medicine if you are pregnant. The baby may die or be born with serious birth defects. You must start taking this medicine during a menstrual period to rule out pregnancy. You must use two reliable methods of birth control such as birth control pills and condoms or a diaphragm. Start using these birth control methods 1 month before you start taking this medicine. Use them while you are taking this medicine and for 1 month after you stop taking it. Discuss birth control with your healthcare provider.

Males: Use condoms during sexual intercourse with females of childbearing age while you are taking this medicine. Do not donate sperm while taking this medicine.

Do not donate blood while taking this medicine.

This medicine may increase your risk of developing blood clots. These can be either deep vein thrombosis, or a clot in the lung. While taking this medicine, you may also need to take medicine to thin your blood and help prevent blood clots.

You must sign a consent form after your healthcare provider explains the risks of taking this medicine. You will need a copy of the consent form and the prescription to give to the pharmacist at a pre-registered pharmacy. You cannot get more than one 28-day supply of this medicine. See your healthcare provider every 28 days for an exam and a new prescription, if needed.

This medicine may make you drowsy or dizzy. Do not drive or operate machinery until you are fully alert. You may also become dizzy and feel faint when you get up from sitting or lying down. Getting up slowly may help lessen this reaction.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report these to your healthcare provider right away): Severe leg pain or feeling of warmth in the calves; swelling of the legs, hands, or feet; shortness of breath; coughing up blood; severe drowsiness or dizziness; slow heartbeat; fever over 105.5°F.

Other: Numbness, pain, or swelling in your hands or feet; skin rash; new viral infections (in people with AIDS); decreased function of the thyroid gland, diarrhea, nausea, headache, tiredness, sweating, constipation.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• abatacept (Orencia)
• alcohol
• anakinra (Kineret)
• barbiturates such as phenobarbital, butabarbital (Butisol), and pentobarbital (Nembutal)
• dexamethasone
• natural remedies such as cat's claw, echinacea, and garlic
• other medicines that may cause numbness or pain in the hands or feet such as didanosine (Videx), zalcitabine (Hivid), leuprolide (Lupron), and nitrofurantoin (Macrobid, Macrodantin, Furadantin)

Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.

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