Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

  1. Thalomid

Descriptions


Thalidomide is used to treat and prevent erythema nodosum leprosum, 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.

This medicine is available only under a restricted distribution program called the Thalomid® REMS (Risk Evaluation and Mitigation Strategy) program.

This product is available in the following dosage forms:

  • Capsule

Before Using

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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. However, elderly patients are more likely to have unwanted effects (eg, blood clotting problems, heart rhythm problem), which may require caution and an adjustment in the dose for patients receiving this medicine.

Breastfeeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Drug Interactions

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 this medicine, 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 this medicine 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

Other Interactions

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Blood clots or
  • Bradycardia (slow heartbeat) or
  • HIV infection or
  • Neutropenia (low white blood cells) or
  • Peripheral neuropathy (nerve problem) or
  • Seizures, history of or
  • Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.
  • Deep vein thrombosis (blood clot in leg), history of or
  • Heart attack, history of or
  • Pulmonary embolism (blood clot in lung), history of or
  • Stroke, history of—Use with caution. May cause side effects to become worse.

Proper Use

Take this medicine 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.

It is very important that you understand the rules of the Thalomid® REMS program. Read the patient Medication Guide. Ask your doctor or pharmacist if you have any questions. You might be asked to sign a form to show that you understand the information.

Take this medicine with water at least 1 hour after the evening meal, preferably at bedtime.

Do not open the blister pack with the capsule until you are ready to take it. Do not break, chew, or open it. If you accidentally open the capsule and have contact with the powder, wash your skin with soap and water. If the medicine gets into your eyes, nose, or mouth, rinse them with water.

Dosing

The dose of this medicine 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 this medicine. 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 and children 12 years of age and older—At first, 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 and children 12 years of age and older—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 this medicine, 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 miss a dose of this medicine and it is less than 12 hours since your regular time, take it as soon as you can, then take your next dose at the normal time.

If you miss a dose and it has been more than 12 hours since your scheduled dose, 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

It is very important that your doctor check your progress closely at regular visits to see if the medicine is working properly and to allow for a change in the dose. Blood tests may be needed to check for unwanted effects.

Women should take the necessary precautions to avoid pregnancy while taking thalidomide. Begin 2 forms of effective birth control together 4 weeks before starting treatment, during treatment, 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 treatment with this medicine. Pregnancy tests may be done weekly for the first month during treatment, 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 treatment, 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 this medicine and for at least 4 weeks after your last dose.

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

This medicine may increase your risk of having blood clots, a 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.

Do not receive pembrolizumab together with thalidomide and dexamethasone if you have multiple myeloma.

This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If you feel lightheaded, getting up slowing after sitting or lying down may help.

Thalidomide can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

This medicine 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.

Check with your doctor right away if you have a fever, chills, cough, sore throat, swollen, painful, or tender lymph glands in the neck, armpit, or groin, or yellow skin or eyes while using this medicine. These could be symptoms of a serious condition called drug reaction with eosinophilia and systemic symptoms (DRESS).

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

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.

This medicine 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.

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

  1. Anxiety
  2. black, tarry stools
  3. chest pain
  4. chills
  5. confusion
  6. cough
  7. dizziness or lightheadedness
  8. dry mouth
  9. fainting
  10. fast heartbeat
  11. fever
  12. irregular heartbeat
  13. irritability
  14. loss of taste
  15. lower back or side pain
  16. mood or mental changes
  17. muscle cramps in the hands, arms, feet, legs, or face
  18. muscle weakness
  19. nervousness
  20. numbness and tingling around the mouth, fingertips, or feet
  21. pain in the chest, groin, or legs, especially the calves
  22. pain, redness, or swelling in the arm or leg
  23. painful or difficult urination
  24. pale skin
  25. peeling and loosening of the skin
  26. restlessness
  27. seizures
  28. severe, sudden headache
  29. skin rash
  30. shakiness in the legs, arms, hands, or feet
  31. slurred speech
  32. sore throat
  33. sores, ulcers, or white spots in the mouth or on the lips
  34. stomach cramps
  35. sudden, unexplained shortness of breath
  36. sudden loss of coordination
  37. sudden, severe weakness or numbness in the arm or leg
  38. swollen glands
  39. tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
  40. tingling, burning, numbness, or pain in the hands, arms, feet, or legs
  41. trembling or shaking of hands or feet
  42. trouble sleeping
  43. troubled breathing
  44. unusual bleeding or bruising
  45. unusual tiredness or weakness
  46. vision changes

Rare

  1. Blood in the urine
  2. decreased urination

Incidence not known

  1. Bleeding gums
  2. blistering of the skin
  3. blood in the stools
  4. difficulty with speaking
  5. inability to move the arms, legs, or facial muscles
  6. inability to speak
  7. itching skin
  8. muscle jerking of the arms and legs
  9. pinpoint red spots on the skin
  10. red skin lesions, often with a purple center
  11. red, irritated eyes
  12. slow speech
  13. 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

  1. Constipation
  2. dry skin
  3. diarrhea
  4. dizziness
  5. drowsiness
  6. loss of appetite
  7. nausea
  8. stomach pain
  9. weight changes

Less common

  1. Headache
  2. increased appetite

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.