Thalomid

Thalidomides

THALIDOMIDE is used to treat multiple myeloma. It is also used to treat moderate to severe new lesions of leprosy and to prevent and keep the skin lesions of leprosy from coming back.

Oral route (Capsule)

Thalidomide can cause severe birth defects or embryo-fetal death if taken during pregnancy. Thalidomide should never be used by women who are pregnant or who could become pregnant while taking the drug. 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 results in an increased risk of venous thromboembolism, such as DVT and pulmonary embolism .


Commonly Used Brand Name(s): Thalomid

Therapeutic Classification: Leprostatic

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.

This medicine 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:

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.

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 this medicine 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 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, 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 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 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.

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.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersXStudies 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.

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.

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.

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:

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

Using this medicine 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 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 cause blood clots that require immediate medical attention. 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.

This medicine 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.

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

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.

Serious skin reactions can occur with this medicine. 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 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 or vitamin supplements.

They need to know if you have any of these conditions:

Take this medicine by mouth with a glass of water. Follow the directions on your prescription label. Do not cut, crush or chew this medicine. If you are only taking this medicine once a day, take your dose at bedtime at least 1 hour after your evening meal to decrease the drowsiness effects. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 12 hours, then do not take

the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

Keep out of reach of children. Return any unused portion of this medicine to the pharmacy where your prescription was filled. Your pharmacy will accept all unused medicine as part of the controlled distribution program.

Store at room temperature between 59 and 86 degrees F (15 and 30 degrees C). Protect from light. Do not use any expired medicine.

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