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Drug Notebook

Generic Name: thalidomide

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A leprostatic - treats Leprosy and Multiple Myeloma

FDA Alerts

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 acknowledgement 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.

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(tha LID o mide)

What is the most important information I should know about thalidomide?

Thalidomide can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medication at the time of conception or during pregnancy. Even one dose of thalidomide can cause major birth defects of the baby's arms and legs, bones, ears, eyes, face, and heart. Never use thalidomide if you are pregnant.

For Women: You will be required to use two reliable forms of birth control beginning 4 weeks before you start taking thalidomide and ending 4 weeks after you stop taking it. Any woman who has not had a hysterectomy or has not been in menopause for at least 24 months in a row must agree in writing to use birth control before, during, and after taking thalidomide. Even women with fertility problems are required to use birth control while taking this medication. You must also have a negative pregnancy test within 24 hours before you start thalidomide treatment. While you are taking thalidomide, you will need to have a pregnancy test weekly during the first month of treatment, and then every 4 weeks thereafter.

Stop using thalidomide and call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.

For Men: You must not cause a woman to become pregnant while you are taking thalidomide because the medicine may affect your sperm and cause birth defects in the baby. You must agree in writing to always use latex condoms when having sex with a woman who is able to get pregnant, even if you have had a vasectomy. Avoid ejaculating without a condom because thalidomide can be passed in your sperm.

Thalidomide is available only under a special program called "System for Thalidomide Education and Prescribing Safety" (S.T.E.P.S.). You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control as required by the program. For patients between 12 and 18 years, a parent or legal guardian must read and sign all written requirements for the S.T.E.P.S. program.

Do not donate blood or sperm while you are using thalidomide. Avoid exposing another person to your blood or semen through casual or sexual contact.

What is thalidomide?

Thalidomide affects the immune system. It helps promote immune responses to prevent inflammation in the body.

Thalidomide is used to treat and prevent the debilitating and disfiguring skin sores caused by erythema nodosum leprosum (ENL), an inflammatory complication of leprosy. It is also used together with another medicine called dexamethasone to treat multiple myeloma (bone marrow cancer).

Thalidomide may also be used for purposes other than those listed in this medication guide.

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