Pronunciation: tha LID oh mide

Brand: Thalomid

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

Thalidomide in just a single dose can cause severe birth defects or death of a baby. Never use thalidomide if you are pregnant or may become pregnant.

You must have a negative pregnancy test before taking thalidomide. You will also be required to use two forms of birth control to prevent pregnancy while taking this medicine. Stop using thalidomide and call your doctor at once if you think you might 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.

Thalidomide is available only under a special program called THALOMID REMS. You must be registered in the program and understand the risks and benefits of taking this medicine.

What is thalidomide?

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

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. Never use thalidomide if you are pregnant.

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

  • heart disease, or a history of stroke or blood clot;
  • low white blood cell (WBC) counts, or a weak immune system;
  • a history of seizures; or
  • if you need surgery.

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.

Thalidomide can cause severe birth defects or death of a baby if the mother or the father takes 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.

You must have a negative pregnancy test before taking thalidomide. While you are taking thalidomide, you will need to have a pregnancy test every 1 to 4 weeks. You will also be required to use two forms of birth control to prevent pregnancy before and during treatment with thalidomide, and for at least 4 weeks after your treatment ends.

Any woman who has not had a hysterectomy or been in menopause for at least 24 months in a row must use birth control before, during, and after taking thalidomide. Even women with fertility problems are required to use birth control while taking thalidomide.

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: Do not get a woman pregnant while you are taking thalidomide. This medicine may affect your sperm and cause birth defects in the baby. Even if you have had a vasectomy, always use a condom when having sex with a woman who is pregnant or could become pregnant. Avoid ejaculating without a condom because thalidomide can be passed in your sperm.

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.

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

Thalidomide should not be given to a child younger than 12 years old.

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.

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

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.

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.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

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?

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 (including urine, feces, vomit, semen, vaginal fluid). 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.

What are the possible side effects of thalidomide?

Get emergency medical help if you have any of these 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;
  • seizure (convulsions);
  • signs of a stroke --sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot in the lung --chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
  • signs of a blood clot in your leg --pain, swelling, warmth, or redness in one or both legs;
  • heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • low levels of calcium in your blood --numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes;
  • low white blood cell counts --fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;
  • 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, feeling short of breath; confusion, fainting; 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, tremors, confusion;
  • nausea, loss of appetite, constipation;
  • weight gain or loss;
  • swelling, trouble breathing; or
  • rash, dry skin.

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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