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Thalidomide (Oral Route)

US Brand Names

Description

Thalidomide is used to treat and prevent erythema nodosum leprosum (ENL), a painful skin disease associated with leprosy. It is also used together with dexamethasone (e.g., Decadron®) to treat patients who have just been diagnosed with multiple myeloma (a certain type of cancer of the blood) . This medicine may also be used for other diseases as determined by your doctor.

Thalidomide is available only from your doctor. It has not been widely available since the early 1960s because it was found to cause birth defects. However, under special conditions, your doctor may decide that this medicine will be useful for your treatment.

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, thalidomide is used in certain patients with the following medical conditions:

• Esophagus ulcers in patients with human immunodeficiency virus (HIV) infection
• Multiple myeloma in newly diagnosed patients who are elderly or cannot have transplant surgery, in combination with oral melphalan and prednisone chemotherapy .

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of thalidomide in children up to 12 years of age. Safety and efficacy have not been established .

Geriatric

This medicine has been tested in a limited number of patients up to 90 years of age and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Darbepoetin Alfa
• Dexamethasone
• Docetaxel

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Decreased white blood cell counts or
• Epilepsy or risk of seizures or
• Peripheral neuropathy—Thalidomide may make these conditions worse.

Proper Use

You should take this medicine with water, preferably at bedtime and at least 1 hour after the evening meal .

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking with your doctor first.

Only take medicine that your doctor has prescribed specifically for you. Do not share your medicine with others.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For erythema nodosum leprosum (ENL):
    • Adults and teenagers—100 to 400 milligrams (mg) once a day until the condition improves. Then, the dose may be decreased as determined by your doctor.
    • Children—Use and dose must be determined by your doctor.
  • For multiple myeloma:
    • Adults and teenagers—200 milligrams (mg) once a day in combination with dexamethasone in 28-day treatment cycles as instructed by your doctor. The dose of dexamethasone that you need to take will be determined by your doctor .
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

This medicine will add to the effects of alcohol and other CNS depressants (medicines that may make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these while you are using thalidomide.

Your doctor will inform you of a safety program called S.T.E.P.S.® that you must agree to and comply with in order to receive your thalidomide prescription. Be sure to ask your doctor or pharmacist if you have any questions about this program .

For women of childbearing age: If you are able to bear children, you must have a pregnancy test within 24 hours before starting thalidomide treatment, once a week during the first month of treatment, and every 2 to 4 weeks after that. Also, you must not have heterosexual sexual contact unless you use two effective birth control methods at the same time for at least 1 month before starting thalidomide treatment, during treatment, and for at least 1 month after you stop taking thalidomide.

For men taking thalidomide: If you have heterosexual sexual contact with women of childbearing potential, you must always use a condom during sexual contact while taking thalidomide and for 4 weeks after you stop taking it, even if you have had a vasectomy.

Your doctor may prescribe an anticoagulant (prevents the clotting of blood) or aspirin treatment while you are taking thalidomide to prevent blood clots. You should take this medicine as instructed by your doctor .

You should contact your doctor right away if you develop shortness of breath, chest pain, or arm or leg swelling. These could be symptoms of blood clots that require immediate attention.

It is very important that your doctor check you at regular visits for any nerve problems that may be caused by this medicine. If you notice any symptoms of peripheral neuropathy (tingling, burning, numbness, or pain in the hands or feet), stop taking this medicine and call your doctor right away.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Anxiety
• Chest pain
• Cough
• Dizziness or lightheadedness
• Fainting
• Fast heartbeat
• Muscle weakness
• Pain, redness, or swelling in the arm or leg
• Sudden shortness of breath or troubled breathing
• Tingling, burning, numbness, or pain in the hands, arms, feet, or legs

• Blood in urine
• Decreased urination
• Fever, alone or with chills and sore throat
• Irregular heartbeat
• Low blood pressure
• Skin rash

• Blistering of skin
• Convulsions
• Itching skin
• Muscle jerking of arms and legs
• Peeling and loosening of skin
• Red skin lesions, often with a purple center
• Red, irritated eyes
• Sores, ulcers, or white spots in the mouth or on the lips
• Sudden loss of consciousness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Constipation
• Diarrhea
• Drowsiness
• Nausea
• Stomach pain

• Dry skin
• Dryness of mouth
• Headache
• Increased appetite
• Mood changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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