thalidomide

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Pronunciation: tha LID oh mide

Brand: Thalomid

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

Never use this medicine if you are pregnant. Even one dose of thalidomide can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medicine at the time of conception or during pregnancy.

Use birth control to prevent pregnancy, whether you are a man or a woman. For women: Use two forms of birth control beginning 4 weeks before you start taking thalidomide and ending 4 weeks after you stop taking it. For men: Use a condom to prevent pregnancy during your treatment, and for up to 4 weeks after your treatment ends.

Thalidomide may cause blood clots. Stop using this medicine and call your doctor at once if you have symptoms such as sudden numbness, severe headache, problems with vision or speech, chest pain, shortness of breath, or swelling in your arm or leg.

What is thalidomide?

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

Thalidomide is used together with dexamethasone to treat multiple myeloma (bone marrow cancer). Thalidomide is also used to treat and prevent moderate to severe skin lesions caused by leprosy.

Thalidomide is available only from a certified pharmacy under a special program called Thalomid REMS. You must be registered in the program and agree to use birth control as required. You will be limited to a 28-day supply of thalidomide each time your prescription is refilled.

Thalidomide may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking thalidomide?

You should not use thalidomide if you are allergic to it.

Thalidomide can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medicine 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. Tell your doctor right away if your period is late while taking thalidomide.

For Women: If you have not had a hysterectomy, 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. Even women with fertility problems are required to use birth control while taking this medicine. You must also have a negative pregnancy test at 10 to 14 days before treatment and again at 24 hours before. While you are taking thalidomide, you will have a pregnancy test every 2 to 4 weeks.

The birth control method you use must be proven highly effective, such as birth control pills, 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 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. Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.

For Men: If a man fathers a baby while using thalidomide, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment, and for up to 4 weeks after your treatment ends. 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. Contact your doctor if you have had unprotected sex, even once, or if you think your female sexual partner may be pregnant.

Treatment with thalidomide may increase your risk of a blood clot or stroke during treatment for multiple myeloma. Ask your doctor about your specific risk.

To make sure thalidomide is safe for you, tell your doctor if you have:

  • heart disease, or a history of stroke or blood clot;
  • a history of seizures; or
  • if you need surgery.

It is not known whether thalidomide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take thalidomide?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Never share this medicine with another person, even if they have the same disorder you have.

Take the medicine on an empty stomach, at least 1 hour after eating a meal. Swallow the capsule whole.

The medicine from an open capsule can be dangerous if it gets on your skin. If this occurs, wash your skin with soap and water. Ask your doctor or pharmacist how to safely handle and dispose of a broken capsule.

Your doctor will need to check your progress while you are using thalidomide.

Store 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.

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 while taking thalidomide?

You must not donate blood or sperm while you are using thalidomide, and for at least 4 weeks after your last dose. Avoid exposing another person to your blood or semen through casual or sexual contact.

Thalidomide may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase certain side effects of thalidomide.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's 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.

What are the possible side effects of thalidomide?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • numbness, tingling, or burning pain in your hands or feet;
  • slow heartbeats, shallow breathing, feeling like you might pass out;
  • a seizure (convulsions);
  • signs of bleeding --easy bruising, nosebleeds, bleeding gums, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • signs of a stroke or blood clot --sudden numbness or weakness, severe headache, slurred speech, problems with vision or balance, chest pain, shortness of breath, swelling or redness in your arm or leg;
  • heart attack symptoms --chest pain spreading to your jaw or shoulder, nausea, sweating;
  • low blood cell counts --fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores;
  • signs of tumor cell breakdown --lower back pain, blood in your urine, little or no urinating; numbness or tingly feeling around your mouth; muscle weakness or tightness; fast or slow heart rate, weak pulse; or
  • severe skin reaction --fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • headache, dizziness, drowsiness, weakness, tired feeling;
  • anxiety, agitation, confusion;
  • tremors, muscle weakness;
  • nausea, loss of appetite, constipation;
  • weight gain or loss;
  • swelling, trouble breathing;
  • rash, dry skin; or
  • low levels of calcium in your blood --numbness or tingly feeling around your mouth, muscle tightness or contraction, overactive reflexes.

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?

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking thalidomide with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

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. 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.

Other drugs can interact with thalidomide, and certain other medicines may further your increase your risk of blood clots. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with thalidomide. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

Your doctor or pharmacist can provide more information about thalidomide.

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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