thalidomide

tha-LID-oh-mide

Oral route(Capsule)

Thalidomide can cause severe birth defects or death to an unborn baby if taken during pregnancy. Women of childbearing potential should have a pregnancy test before starting therapy, then weekly for first month, and monthly thereafter. Effective contraception must be used for at least 4 weeks before beginning thalidomide therapy, during thalidomide therapy, and for 4 weeks following discontinuation of thalidomide therapy. Males must always use a latex condom during any sexual contact with women of childbearing potential. Only prescribers and pharmacists registered with the S.T.E.P.S.(R) distribution program can prescribe and dispense thalidomide. The use of thalidomide in multiple myeloma results in an increased risk of venous thromboembolic events, such as deep vein thrombosis and pulmonary embolus .

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 (e.g., Decadron®) to treat patients who have just been diagnosed with multiple myeloma (a certain type of cancer of the blood) . thalidomide may also be used for other diseases as determined by your doctor.

Thalidomide is available only from your doctor. It has not been widely available since the early 1960s because it was found to cause birth defects. However, under special conditions, your doctor may decide that thalidomide will be useful for your treatment.

thalidomide is available only with your doctor's 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 up to 12 years of age. Safety and efficacy have not been established .

Geriatric

thalidomide has been tested in a limited number of patients up to 90 years of age and has not been shown to cause different side effects or problems in older people than it does in younger adults.

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.

• Darbepoetin Alfa


• 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:

• Decreased white blood cell counts or


• Epilepsy or risk of seizures or


• Peripheral neuropathy—Thalidomide may make these conditions worse.

Proper Use of thalidomide

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

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. Also, do not stop taking thalidomide without checking with your doctor first.

Only take medicine that your doctor has prescribed specifically for you. Do not share your medicine with others.

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 (ENL):
    
    • Adults and teenagers—100 to 400 milligrams (mg) once a day until the condition improves. Then, the dose may be decreased as determined by your doctor.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For multiple myeloma:
    
    • Adults and teenagers—200 milligrams (mg) once a day in combination with dexamethasone in 28-day treatment cycles as instructed by your doctor. The dose of dexamethasone that you need to take will be determined by your doctor .
    
    
    • Children—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.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using thalidomide

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

Your doctor will inform you of a safety program called S.T.E.P.S.® that you must agree to and comply with in order to receive your thalidomide prescription. Be sure to ask your doctor or pharmacist if you have any questions about this program .

For women of childbearing age: If you are able to bear children, you must have a pregnancy test within 24 hours before starting thalidomide treatment, once a week during the first month of treatment, and every 2 to 4 weeks after that. Also, you must not have heterosexual sexual contact unless you use two effective birth control methods at the same time for at least 1 month before starting thalidomide treatment, during treatment, and for at least 1 month after you stop taking thalidomide.

For men taking thalidomide: If you have heterosexual sexual contact with women of childbearing potential, you must always use a condom during sexual contact while taking thalidomide and for 4 weeks after you stop taking it, even if you have had a vasectomy.

Your doctor may prescribe an anticoagulant (prevents the clotting of blood) or aspirin treatment while you are taking thalidomide to prevent blood clots. You should take thalidomide as instructed by your doctor .

You should contact your doctor right away if you develop shortness of breath, chest pain, or arm or leg swelling. These could be symptoms of blood clots that require immediate attention.

It is very important that your doctor check you at regular visits for any nerve problems that may be caused by thalidomide. If you notice any symptoms of peripheral neuropathy (tingling, burning, numbness, or pain in the hands or feet), stop taking thalidomide and call your doctor right away.

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 urine


• decreased urination


• fever, alone or with chills and sore throat


• irregular heartbeat


• low blood pressure


• skin rash

Incidence not known

• Blistering of skin


• convulsions


• itching skin


• muscle jerking of arms and legs


• peeling and loosening of skin


• red skin lesions, often with a purple center


• red, irritated eyes


• 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 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: thalidomide side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More thalidomide resources

• Thalidomide Side Effects (in more detail)
• Thalidomide Dosage
• Thalidomide Use in Pregnancy & Breastfeeding
• Thalidomide Drug Interactions
• Thalidomide Support Group
• 0 Reviews for Thalidomide - Add your own review/rating

• Thalidomide Professional Patient Advice (Wolters Kluwer)


• Thalidomide Monograph (AHFS DI)


• Thalidomide MedFacts Consumer Leaflet (Wolters Kluwer)


• Thalomid Prescribing Information (FDA)


• Thalomid Consumer Overview

Compare thalidomide with other medications

• Leprosy, Erythema Nodosum Leprosum
• Multiple Myeloma