Thalomid

Generic Name: thalidomide (tha LID o mide)
Brand Names: Thalomid

What is Thalomid?

Thalomid affects the immune system. It promotes immune responses to help slow tumor growth.

Thalomid 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).

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

Important information

Thalomid 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 Thalomid can cause major birth defects of the baby's arms and legs, bones, ears, eyes, face, and heart. Never use Thalomid 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 Thalomid 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 Thalomid. 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 Thalomid treatment. While you are taking Thalomid, you will need to have a pregnancy test weekly during the first month of treatment, and then every 4 weeks thereafter.

Slideshow: Flashback: FDA Drug Approvals 2013

Stop using Thalomid 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 Thalomid 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.

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

Before taking this medicine

If you have any of these conditions, you may not be able to take Thalomid, 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.

Thalomid 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 Thalomid 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. 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 Thalomid 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 Thalomid. 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 Thalomid treatment. While you are taking Thalomid, 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.

Stop using Thalomid 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 Thalomid 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.

Thalomid 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 Thalomid?

Take Thalomid 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.

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

While you are using Thalomid, 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 Thalomid 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.

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

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

Store Thalomid 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?

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

What should I avoid?

Thalomid may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of Thalomid.

Thalidomide can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

Thalomid side effects

Stop using this medicine and get emergency medical help if you have any of these signs of an allergic reaction to Thalomid: 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 Thalomid 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.

See also: Side effects (in more detail)

What other drugs will affect Thalomid?

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 Thalomid. Tell your doctor if you regularly use any of these medicines. 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 Thalomid, 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 Thalomid. 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 Thalomid 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.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 7.03. Revision Date: 2013-07-15, 2:48:36 PM.

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