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Thalidomide Oral capsule

It is used to treat multiple myeloma

Generic Name: thalidomide  |  Brand Name: Thalomid

Brand Names: Thalomid

There is an FDA Alert for this drug. Click here to view it.

    Teratogenic Effects
  • Known human teratogen; extremely high risk of severe, life-threatening birth defects if administered during pregnancy. Single dose (regardless of dosage strength) can cause teratogenic effects.
  • Major human fetal abnormalities include skeletal deformities (e.g., amelia [absence of legs and/or arms], absence of bones, phocomelia [short legs and/or arms], bone hypoplasia); external ear deformities (e.g., anotia, microtia or micro pinna, small or absent auditory canals); facial palsy; ocular abnormalities (e.g., anophthalmos and microphthalmos); congenital heart defects; renal and urinary tract malformations; genital malformations; and GI tract malformations.
  • Mortality rate at or shortly after birth in neonates with thalidomide-induced abnormalities about 40%.
    Teratogenicity Precautions
  • Contraindicated in pregnant women; use in females of childbearing potential only when alternative therapies considered inappropriate.
  • Pregnancy must be excluded by negative pregnancy test (sensitivity to detect human serum chorionic gonadotropin [HCG] concentrations of 50 million IU/mL) ≤24 hours before treatment initiation. Repeat pregnancy tests throughout therapy (i.e., once weekly during first month, then monthly or every 2 weeks in women with regular or irregular menstrual cycles, respectively).
  • Pregnancy must be prevented (even in females with a history of infertility) by simultaneous use of 2 forms of reliable contraception for ≥4 weeks prior to, throughout, and for 4 weeks after completion of therapy. (See Fetal/Neonatal Morbidity and Mortality under Cautions.) Mandatory contraception not required for females who have undergone hysterectomy, are postmenopausal and have had no menses for ≥24 consecutive months, or practice continuous abstinence from heterosexual contact.
  • Sexually mature males (including successfully vasectomized men) must completely avoid unprotected sexual contact with women of childbearing potential (i.e., use latex condom throughout and for ≥4 weeks after thalidomide therapy) because thalidomide distributes into semen.
  • Provide pregnancy tests and counseling if a patient misses her period or has abnormalities in menstrual bleeding.
  • If pregnancy occurs, immediately discontinue treatment. Refer patient to obstetrician-gynecologist experienced in reproductive toxicity for further evaluation and counseling. Report any suspected fetal exposure to FDA MedWatch Program at 1-800-FDA-1088 and to manufacturer at 1-888-423-5436.
    Restricted Distribution Program
  • Available only through restricted distribution program, the System for Thalidomide Education and Prescribing Safety (STEPS), designed to help ensure that fetal exposure does not occur. (See Restricted Distribution under Dosage and Administration.)
  • Limits access to thalidomide to prescribing clinicians, pharmacies, and patients who are registered in program and mandates compliance with registration, education, and safety requirements.
  • Registered prescribing clinicians must understand risks of teratogenicity if used during pregnancy and must not provide a prescription until a documented negative pregnancy test available.
  • Patient or parent/legal guardian (for minors 12–18 years of age) must be capable of understanding and complying with patient registration, education, patient survey, and safety requirements, including mandatory contraceptive measures and pregnancy testing.
  • Provide oral and written warnings of risk of possible contraceptive failure, hazards of using drug during pregnancy, exposing fetus to drug, and presence of drug in semen.
  • Patient or parent/legal guardian must provide written acknowledgment of understanding of these warnings and need for mandatory contraceptive measures.
    Venous Thromboembolism
  • Increased risk of venous thromboembolism (e.g., DVT, pulmonary embolism) in patients with multiple myeloma, especially when used in combination with chemotherapy, including dexamethasone.
  • Monitor for signs and symptoms of thromboembolism.
  • In selected patients, anticoagulation or aspirin may be beneficial.

REMS:

FDA approved a REMS for thalidomide to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of thalidomide and consists of the following: medication guide, elements to assure safe use, and implementation system. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

What is this medicine?

THALIDOMIDE (tha LI doe mide) 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.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • human immunodeficiency virus (HIV)
  • low blood pressure
  • low white blood cell count
  • seizure disorder
  • tingling or numbness in hands or feet or other nerve pain
  • an unusual or allergic reaction to thalidomide other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding or planning to breast-feed

How should I use this medicine?

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.

What if I miss a dose?

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.

What may interact with this medicine?

  • alcohol or any product that contains alcohol
  • barbiturates, like phenobarbital
  • certain antidepressants or tranquilizers
  • certain antihistamines used in cold medicines
  • medicines that may decrease the effectiveness of birth control pills
  • medicines which may cause tingling, numbness or nerve pain
  • muscle relaxants

What should I watch for while using this medicine?

This medicine is available only through a special program. Doctors, pharmacies, and patients must meet all of the conditions of the program. Your health care provider will help you get signed up with the program if you need this medicine. Through the program you will only receive up to a 28 day supply of the medicine at one time. You will need a new prescription for each refill.

This medicine causes severe birth defects or death to an unborn child. This can happen after just ONE capsule. Both men and women must agree to take steps to prevent exposure of this medicine to an unborn child. Females with child-bearing potential will need to have 2 negative pregnancy tests before starting this medicine. Pregnancy testing must be done every 2 to 4 weeks as directed while taking this medicine. Use 2 reliable forms of birth control together while you are taking this medicine and for 1 month after you stop taking this medicine. If you think that you might be pregnant talk to your doctor right away.

Men must use a latex condom during sexual contact with a woman while taking this medicine and for 28 days after you stop taking this medicine. A latex condom is needed even if you have had a vasectomy. Contact your doctor right away if your partner becomes pregnant. Do not donate sperm while taking this medicine and for 28 days after you stop taking this medicine.

Do not give blood while taking the medicine and for 1 month after completion of treatment to avoid exposing pregnant women to the medicine through the donated blood.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine.

You may need blood work done while you are taking this medicine.


Last Updated: February 19, 2013
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