thalidomide (Oral route)
- WARNING: SEVERE, LIFE-THREATENING HUMAN BIRTH DEFECTS
- If thalidomide is taken during pregnancy, it can cause severe birth defects or death to an unborn baby. Thalidomide should never be used by women who are pregnant or who could become pregnant while taking the drug. Even a single dose [1 capsule (50 mg, 100 mg or 200 mg)] taken by a pregnant woman during her pregnancy can cause severe birth defects.
- Because of this toxicity and in an effort to make the chance of fetal exposure to thalidomide as negligible as possible, thalidomide is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called the "System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.(R))."
- Under this restricted distribution program, only prescribers and pharmacists registered with the program are allowed to prescribe and dispense the product. In addition, patients must be advised of, agree to, and comply with the requirements of the S.T.E.P.S.(R) program in order to receive product.
- Please see the following containing special information for prescribers, female patients, and male patients about this restricted distribution program.
- Thalidomide may be prescribed only by licensed prescribers who are registered in the S.T.E.P.S.(R) program and understand the risk of teratogenicity if thalidomide is used during pregnancy. Major human fetal abnormalities related to thalidomide administration during pregnancy have been documented: amelia (absence of limbs), phocomelia (short limbs), hypoplasticity of the bones, absence of bones, external ear abnormalities (including anotia, micro pinna, small or absent external auditory canals), facial palsy, eye abnormalities (anophthalmos, microphthalmos), and congenital heart defects. Alimentary tract, urinary tract, and genital malformations have also been documented. Mortality at or shortly after birth has been reported at about 40%.
- 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. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or because the patient has been postmenopausal for at least 24 months. Two reliable forms of contraception must be used simultaneously unless continuous abstinence from heterosexual sexual contact is the chosen method. Women of childbearing potential should be referred to a qualified provider of contraceptive methods, if needed. Sexually mature women who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months (i.e., who have had menses at some time in the preceding 24 consecutive months) are considered to be women of childbearing potential.
- Before starting treatment, women of childbearing potential should have a pregnancy test (sensitivity of at least 50 mIU/mL). The test should be performed within the 24 hours prior to beginning thalidomide therapy. A prescription for thalidomide for a woman of childbearing potential must not be issued by the prescriber until a written report of a negative pregnancy test has been obtained by the prescriber.
- Male Patients: Because thalidomide is present in the semen of patients receiving the drug, males receiving thalidomide must always use a latex condom during any sexual contact with women of childbearing potential even if he has undergone a successful vasectomy.
- Once treatment has started, pregnancy testing should occur weekly during the first 4 weeks of use, then pregnancy testing should be repeated at 4 weeks in women with regular menstrual cycles. If menstrual cycles are irregular, the pregnancy testing should occur every 2 weeks. Pregnancy testing and counseling should be performed if a patient misses her period or if there is any abnormality in menstrual bleeding.
- If pregnancy does occur during thalidomide treatment, thalidomide must be discontinued immediately. Any suspected fetal exposure to thalidomide must be reported immediately to the FDA via the MedWatch number at 1-800-FDA-1088 and also to Celgene Corporation. The patient should be referred to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling.
- FEMALE PATIENTS
- Thalidomide is contraindicated in women of childbearing potential unless alternative therapies are considered inappropriate and the patient meets all of the following conditions (i.e., she is essentially unable to become pregnant while on thalidomide therapy): 1) she understands and can reliably carry out instructions, 2) she is capable of complying with the mandatory contraceptive measures, pregnancy testing, patient registration, and patient survey as described in the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.(R)) program, 3) she has received both oral and written warnings of the hazards of taking thalidomide during pregnancy and of exposing a fetus to the drug, 4) she has received both oral and written warnings of the risk of possible contraception failure and of the need to use two reliable forms of contraception simultaneously, unless continuous abstinence from heterosexual sexual contact is the chosen method. Sexually mature women who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months (i.e., who have had menses at some time in the preceding 24 consecutive months) are considered to be women of childbearing potential, 5) she acknowledges, in writing, her understanding of these warnings and of the need for using two reliable methods of contraception for 4 weeks prior to beginning thalidomide therapy, during thalidomide therapy, and for 4 weeks after discontinuation of thalidomide therapy, 6) she has had a negative pregnancy test with a sensitivity of at least 50 mIU/mL, within the 24 hours prior to beginning therapy, and 7) if the patient is between 12 and 18 years of age, her parent or legal guardian must have read this material and agreed to ensure compliance with the above.
- MALE PATIENTS
- Thalidomide is contraindicated in sexually mature males unless the patient meets all of the following conditions: 1) he understands and can reliably carry out instructions, 2) he is capable of complying with the mandatory contraceptive measures that are appropriate for men, patient registration, and patient survey as described in the S.T.E.P.S.(R) program, 3) he has received both oral and written warnings of the hazards of taking thalidomide and exposing a fetus to the drug, 4) he has received both oral and written warnings of the risk of possible contraception failure and of the presence of thalidomide in semen. He has been instructed that he must always use a latex condom during any sexual contact with women of childbearing potential, even if he has undergone a successful vasectomy, 5) he acknowledges, in writing, his understanding of these warnings and of the need to use a latex condom during any sexual contact with women of childbearing potential, even if he has undergone a successful vasectomy. Sexually mature women who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months (i.e., who have had menses at any time in the preceding 24 consecutive months) are considered to be women of childbearing potential, and 6) if the patient is between 12 and 18 years of age, his parent or legal guardian must have read this material and agreed to ensure compliance with the above .
- VENOUS THROMBOEMBOLIC EVENTS
- The use of thalidomide in multiple myeloma results in an increased risk of venous thromboembolic events, such as deep venous thrombosis and pulmonary embolus. The risk increases significantly when thalidomide is used in combination with standard chemotherapeutic agents including dexamethasone. In one controlled trial, the rate of venous thromboembolic events was 22.5% in patients receiving thalidomide in combination with dexamethasone compared to 4.9% in patients receiving dexamethasone alone (p=0.002). Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism. Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Preliminary data suggest that patients who are appropriate candidates may benefit from concurrent prophylactic anticoagulation or aspirin treatment .
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.
Available Dosage Forms:
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:
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.
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 .
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.
|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.|
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
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
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.
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.
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.
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
- chest pain
- dizziness or lightheadedness
- 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
Incidence not known
- Blood in urine
- decreased urination
- fever, alone or with chills and sore throat
- irregular heartbeat
- low blood pressure
- skin rash
- Blistering of skin
- 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
- stomach pain
- Dry skin
- dryness of mouth
- 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.
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- Thalidomide Professional Patient Advice (Wolters Kluwer)
- Thalidomide MedFacts Consumer Leaflet (Wolters Kluwer)
- Thalomid Prescribing Information (FDA)
- Thalomid Consumer Overview