In the U.S.—

Thalidomide (tha-LI-doe-mide) is used to treat and prevent erythema nodosum leprosum (ENL), a painful skin disease associated with leprosy. This medicine may also be used for other problems 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, in the following dosage form:

Oral
• Capsules (U.S.)

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 thalidomide, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to thalidomide. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Thalidomide must not be used by pregnant women. If this medicine is taken early in pregnancy (within the first 8 weeks [2 months]), your baby may be born dead or with serious birth defects. Even a single dose (1 capsule) taken by a pregnant woman can cause severe birth defects. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant. Men who are taking thalidomide must always use condoms when having sexual contact with women who may become pregnant, even if they have undergone successful vasectomy.

Breast-feeding—It is not known if thalidomide passes into breast milk. Be sure you have discussed the risks and benefits of using this medicine with your doctor.

Children—A small number of children have been safely treated with thalidomide. Be sure to discuss with your child's doctor the use of this medicine in children.

Older adults— 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.

Other medicines—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 thalidomide, it is especially important that your health care professional know if you are taking any of the following:

• Alcohol or
• Barbiturates or
• Central nervous system (CNS) depressants (medicine that causes drowsiness) or
• Chlorpromazine (e.g., Thorazine) or
• Reserpine (e.g., Serpalan) or
• Tricyclic antidepressants (medicine for depression)—Use of these medicines with thalidomide may make you more drowsy

• Chloramphenicol (e.g., Chloromycetin) or
• Cisplatin (e.g., Platinol) or
• Dapsone (e.g., Avlosulfon) or
• Didanosine (e.g., Videx) or
• Ethambutol (e.g., Myambutol) or
• Ethionamide (e.g., Trecator-SC) or
• Hydralazine (e.g., Apresoline) or
• Isoniazid (e.g., Nydrazid) or
• Lithium (e.g., Eskalith, Lithobid) or
• Metronidazole (e.g., Flagyl) or
• Nitrofurantoin (e.g., Furadantin, Macrodantin) or
• Nitrous oxide or
• Phenytoin (e.g., Dilantin) or
• Stavudine (e.g., d4T, Zerit) or
• Vincristine (e.g., Oncovin) or
• Zalcitabine (e.g., HIVID)—Use of these medicines with thalidomide may increase the chance of peripheral neuropathy (tingling, burning, numbness, or pain in your hands or feet) or may make it worse

• Carbamazepine (e.g., Tegretol) or
• Griseofulvin (e.g., Grifulvin V) or
• Human immunodeficiency virus (HIV)–protease inhibitors (indinavir [e.g., Crixivan], nelfinavir [e.g., Viracept], ritonavir [e.g., Norvir], saquinavir [e.g., Fortovase, Invirase]) or
• Rifabutin (e.g., Mycobutin) or
• Rifampin (e.g., Rifadin)—Use of these medicines with certain birth control agents may keep the birth control agents from working properly; effective birth control is required for women taking thalidomide who are able to bear children

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

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 thalidomide 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 thalidomide. If your dose is different, do not change it unless your doctor tells you to do so:

• For oral dosage form (capsules):
  • For erythema nodosum leprosum (ENL):
    • Adults and teenagers—100 to 400 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.

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—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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 medicine 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.

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 must 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.

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.

Along with its needed effects, a medicine may cause other 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:

• More common
  • Muscle weakness;  tingling, burning, numbness, or pain in the hands, arms, feet, or legs 
  
  

• Rare
  • Blood in urine;  decreased urination ;  fever, alone or with chills and sore throat;  irregular heartbeat;  low blood pressure ;  skin rash 
  
  

• Incidence not known
  • Blistering of skin;  convulsions;  itching skin;  muscle jerking of arms and legs;  peeling and loosening of skin;  red, irritated eyes;  red skin lesions, often with a purple center;  sores, ulcers, or white spots in mouth or on lips;  sudden loss of consciousness  
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Constipation;  diarrhea;  dizziness;  drowsiness;  nausea;  stomach pain 
  
  

• Less common
  • Dryness of mouth;  dry skin;  headache;  increased appetite;  mood changes;  swelling in the legs 
  
  

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

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:

• Multiple myeloma (certain type of cancer of the blood)
• Esophagus ulcers in patients with human immunodeficiency virus (HIV) infection

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.