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thalidomide (Oral route)

Pronunciation

tha-LID-oh-mide

Oral route(Capsule)

Thalidomide can cause severe birth defects or embryofetal death, even with 1 dose, if taken during pregnancy. Thalidomide distribution is restricted through the THALOMID REMS(TM) program (formerly known as the S.T.E.P.S.(R) program). The use of thalidomide in multiple myeloma patients results in an increased risk of VTE , such as DVT and pulmonary embolism. Coadministration of dexamethasone increases this risk. Monitor for thromboembolism and consider thromboprophylaxis for individualized cases .

Commonly used brand name(s)

In the U.S.

  • Thalomid

Available Dosage Forms:

  • Capsule

Therapeutic Class: Leprostatic

Uses For thalidomide

Thalidomide is used to treat and prevent erythema nodosum leprosum (ENL), a painful skin disease associated with leprosy. It is also used together with dexamethasone (eg, Decadron®) to treat patients with multiple myeloma (a cancer of the blood). Thalidomide works on the immune system to reduce inflammation. It also interferes with the growth of multiple myeloma cells, which are eventually destroyed in the body. Thalidomide is an antineoplastic (cancer medicine) and leprostatic agent.

Slideshow: Flashback: FDA Drug Approvals 2013

thalidomide is available only with your doctor's prescription. The Thalomid® product is only available under a restricted distribution program. You will have to read and sign papers that explain how the medicine is used when you pick up your prescription.

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:

  • Esophagus ulcers in patients with human immunodeficiency virus (HIV) infection.
  • Multiple myeloma in newly diagnosed patients who are elderly or cannot have transplant surgery, in combination with oral melphalan and prednisone chemotherapy.

Before Using thalidomide

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 or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of thalidomide in children younger than 12 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of thalidomide in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with 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 healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using thalidomide with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Dexamethasone
  • Docetaxel

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of thalidomide. Make sure you tell your doctor if you have any other medical problems, especially:

  • Blood clots (eg, deep vein thrombosis, pulmonary embolism) or
  • Bradycardia (slow heartbeat) or
  • Heart attack, history of or
  • HIV infection or
  • Neutropenia (low white blood cells) or
  • Peripheral neuropathy (nerve problem) or
  • Seizures, history of or
  • Stroke, history of—Use with caution. May make these conditions worse.

Proper Use of thalidomide

Take thalidomide 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.

The Thalomid® product is only available under a restricted distribution program. You will have to read and sign papers that explain how the medicine is used when you pick up your prescription.

The medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Take thalidomide with water, preferably at bedtime, and at least 1 hour after the evening meal.

Do not open the blister pack with the capsule until you are ready to take it. If you touch a broken capsule or the medicine in the capsule, wash your skin with soap and water right away.

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.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For erythema nodosum leprosum:
      • Adults, teenagers, and children 12 years of age—100 to 300 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.
    • For multiple myeloma:
      • Adults, teenagers, and children 12 years of age—200 milligrams (mg) once a day together with dexamethasone. The dose is repeated every 28 days.
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of thalidomide, 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.

If you missed your dose and it has been more than 12 hours since your regular dosing schedule, skip the missed dose and take your next dose at the regular time.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Return unused capsules to your doctor or pharmacist.

Precautions While Using thalidomide

It is very important that your doctor check your progress closely while you are using thalidomide to see if it is working properly and to check for unwanted effects. Blood tests may be needed to check for unwanted effects.

Using thalidomide while you are pregnant can harm your unborn baby. If you are sexually active, use 2 forms of effective birth control together to avoid pregnancy. You should begin using birth control 4 weeks before you start therapy. Continue the birth control during therapy, even if the dose is stopped for a short time, and for at least 4 weeks after your last dose. Talk to your doctor about the most effective forms of birth control for you and your partner. Call your doctor right away if you think you are pregnant.

Women who can get pregnant must have a negative pregnancy test before starting therapy. Pregnancy tests may be done weekly for the first month during therapy, and then every 2 to 4 weeks.

Men who are sexually active must protect their female partner from getting pregnant. Thalidomide will appear in the semen of male patients. If you are sexually active, you must use a latex or synthetic condom every time you have sex with a woman who could get pregnant. If you have had a vasectomy, you still have to use a latex condom during sex. You must use a condom during therapy, even if the dose is stopped for a short time, and for at least 4 weeks after your last dose. Call your doctor right away if you think your sexual partner may be pregnant.

Do not donate blood or sperm while you are taking thalidomide and for at least 4 weeks after your last dose.

You must not share thalidomide with anyone, even someone who has similar symptoms.

thalidomide may cause blood clots, heart attack, or stroke. Check with your doctor right away if you have shortness of breath, chest pain, or leg pain or swelling. These could be symptoms of blood clots. Symptoms of stroke include confusion, difficulty with speaking, double vision, inability to move the arms, legs, or facial muscles, or slow speech.

thalidomide may cause you to feel dizzy, drowsy, or lightheaded. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. If you feel lightheaded, getting up slowing after sitting or lying down may help.

thalidomide may lower your white blood cells and you may get infections more easily. Avoid people who are sick and wash your hands often.

thalidomide may cause nerve damage. Check with your doctor right away if you have tingling, burning, numbness, or pain in your hands or feet. These could be symptoms of a nerve condition called peripheral neuropathy.

Serious skin reactions can occur with thalidomide. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills while you are using thalidomide.

Thalidomide may cause a serious type of reaction called tumor lysis syndrome in patients with multiple myeloma. Call your doctor right away if you have less urine than normal, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

thalidomide 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 medicines for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using thalidomide.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

thalidomide Side Effects

Along with its needed effects, a medicine may cause some 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
  • Anxiety
  • chest pain
  • cough
  • dizziness or lightheadedness
  • fainting
  • fast heartbeat
  • muscle weakness
  • pain, redness, or swelling in the arm or leg
  • sudden shortness of breath or troubled breathing
  • tingling, burning, numbness, or pain in the hands, arms, feet, or legs
Rare
  • Blood in the urine
  • decreased urination
  • fever, alone or with chills and sore throat
  • irregular heartbeat
  • low blood pressure
  • skin rash
Incidence not known
  • Blistering of the skin
  • confusion
  • convulsions
  • difficulty with speaking
  • double vision
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • itching skin
  • muscle jerking of the arms and legs
  • peeling and loosening of the skin
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • slow speech
  • sores, ulcers, or white spots in the mouth or on the lips
  • sudden loss of consciousness

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Constipation
  • diarrhea
  • drowsiness
  • nausea
  • stomach pain
Less common
  • Dry skin
  • dryness of the mouth
  • headache
  • increased appetite
  • mood changes

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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