thalidomide

thalidomide

Pronunciation: tha LID o mide

Brand: Thalomid

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

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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.

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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.

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Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.

What is thalidomide?

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 should I discuss with my healthcare provider before taking thalidomide?

If you have any of these conditions, you may not be able to take thalidomide, or you may need a dosage adjustment or special tests during treatment:

  • liver or kidney disease;
  • heart disease, history of stroke or blood clots;
  • HIV or AIDS;
  • epilepsy or seizures;
  • a weak immune system; or
  • nerve problems, such as numbness or tingling in your hands or feet.
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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.

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It is not known if thalidomide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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.

The birth control method you use must be proven highly effective: hormonal birth control (pills, implants, or injections), an intrauterine device (IUD), a tubal ligation, or a sexual partner's vasectomy. The extra form of birth control you use must be a barrier method such as a latex condom, a diaphragm, or a cervical cap.

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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 give this medicine to a child younger than 12 years old.

How should I take thalidomide?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

Swallow the capsule whole, without breaking it open.

Thalidomide is usually taken at bedtime. Take the medicine on an empty stomach, at least 1 hour after eating a meal.

While you are using thalidomide, you will be required to be listed on a patient registry and participate in occasional telephone surveys. You will be limited to a 28-day supply of thalidomide each time your prescription is refilled. You may continue getting refills only if you participate fully in the S.T.E.P.S. program and commit to all agreements.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

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

Never give thalidomide to another person, even if he or she has the same disorder for which you are being treated.

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Store thalidomide at room temperature away from moisture and heat. Keep each capsule in its blister pack until you are ready to take it.

Do not allow another person to handle your medicine without wearing disposable gloves. Caregivers should avoid handling broken capsules or inhaling the powder from a damaged capsule.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking thalidomide?

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Thalidomide may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

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Drinking alcohol can increase certain side effects of thalidomide.

What are the possible side effects of thalidomide?

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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.

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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 other drugs will affect thalidomide?

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Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by thalidomide. Tell your doctor if you regularly use any of these medicines.

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If you use hormonal birth control (pills, implants, injections) to prevent pregnancy: There are certain drugs that can make hormonal birth control less effective in your body. This list may not include all drugs that can affect hormonal birth control.

  • HIV medicines such as tipranavir (Aptivus), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), atazanavir (Reyataz), or nelfinavir (Viracept);
  • griseofulvin (Gris-PEG, Grifulvin V, Grisactin, or Fulvicin);
  • rifampin (Rimactane, Rifadin);
  • rifabutin (Mycobutin);
  • phenytoin (Dilantin); or
  • carbamazepine (Tegretol).

If you rely on hormonal birth control during your treatment with thalidomide, tell your doctor about all other medicines you use. You may need to replace your hormonal birth control method with another effective form of contraception. Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.

This list is not complete and other drugs may interact with thalidomide. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has more information about thalidomide written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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