Brand Name: Thalomid®
Active Ingredient:
thalidomide
Strength(s): 50
mg
Dosage Form(s): Capsule
Company Name:
Celgene Corporation
Availability:
Prescription only, and only with participation by
prescriber,
pharmacist, and patient in
S.T.E.P.S. restricted
distribution program.
Date Approved by
FDA: July 16, 1998
What is Thalomid used for?
Thalomid (thalidomide) is used to treat the
debilitating and
disfiguring skin ]inflammation] that is sometimes a reaction to
erythema nodosum leprosum (
ENL), an inflammatory complication of
leprosy and to prevent and control its return. When there is inflammation of the
nerves in addition to
skin sores, Thalomid (thalidomide) should not be used as the only drug treatment. Efficacy in
HIV disease has not been proven.
SPECIAL WARNINGS CONCERNING THALOMID:
Thalomid (thalidomide) causes severe
birth defects. If even one dose of Thalomid (thalidomide) is taken, it can cause severe birth defects or death to an unborn baby. Major birth defects include babies with no arms and legs, short arms and legs, and
missing bones. The greatest risk of severe birth defects is in the first 1-2 months of pregnancy, before a woman may know she is
pregnant. You should NEVER use Thalomid (thalidomide) if you could become pregnant, are already pregnant, or could make someone pregnant. Both men and women must agree in writing to their understanding of the risks of Thalomid (thalidomide) and the actions they must take while being treated with Thalomid (thalidomide).
For Women:
When no other treatment is appropriate for a woman of
child-bearing age, she must agree in writing to many important actions you must take to avoid pregnancy. These actions include:
Not having
heterosexual sexual intercourse starting 4 weeks before beginning to take Thalomid and continuing until 4 weeks after the last dose of Thalomid (thalidomide). Or, using TWO methods of
birth control. No method of birth control is completely reliable except for not having heterosexual sexual intercourse at all. One birth control method must be highly effective, such as an
Intrauterine Device (
IUD),
birth control pills, tying of the
fallopian tubes, and one additional effective method of birth control, such as a
diaphragm or partner's
condom, must be used. Begin using both birth control methods 4 weeks before beginning to take Thalomid (thalidomide) and continue until 4 weeks after the last dose of Thalomid (thalidomide). These steps must be taken even if you have a history of
infertility, unless your
uterus has been surgically removed or you have had no
periods for at least 24 months.
You must have a
pregnancy test within 24 hours before beginning treatment. Your doctor must see a written report of a negative pregnancy test before Thalomid (thalidomide) can be prescribed. Another pregnancy test must be taken every week during the first month of taking Thalomid (thalidomide) and during every month for the rest of the treatment, if your
cycles are regular. For women with
irregular cycles, pregnancy tests must be taken every 2 weeks.
If you miss your period or have abnormal
menstrual bleeding while taking Thalomid (thalidomide), contact your health professional right away.
Some medications can reduce the effectiveness of birth control pills. These include some HIV medications,
griseofulvin (an
anti-fungus medication),
phenytoin (an
anti-seizure medication),
rifampin (an
anti-tuberculosis medication), and
carbamazepine (a medication used for
epilepsy). If you are being treated with any of these drugs, you should use two methods of birth control other than birth control pills or not have heterosexual sexual intercourse.
For Men:
It is not known whether Thalomid (thalidomide) is present in the
semen of men taking the drug. Because Thalomid (thalidomide) may be present in semen, you must agree in writing to use a
latex condom when engaging in
sexual activity with a woman of child-bearing age even if you have had a successful
vasectomy.
For All
Patients:
You will be told about these risks and receive the information in writing and be given the opportunity to view a
video. Then you will be asked to sign a form saying that you understand the risks and the actions you must take to avoid them.
You will be required to submit your name and address to a national
registry of patients taking Thalomid (thalidomide) so that health professionals can track any side effects. You will be asked to complete a
questionnaire for this registry.
If you are under 18 years old, a
parent or
guardian must read the information and agree to comply with the instructions.
General Precautions with Thalomid:
Thalomid causes severe birth defects (see "Special Warnings" section).
You must never share Thalomid with anyone. You must take it only as prescribed.
Thalomid (thalidomide) can cause significant
nerve damage (called
peripheral neuropathy) that can be permanent. Your doctor will examine you regularly for signs of this condition. If you have
numbness,
tingling, or
pain or a
burning sensation in your
hands or
feet, tell your doctor right away.
Thalomid (thalidomide) causes
sleepiness. Avoid situations where sleepiness may be a problem. For example, it may be difficult for you to drive a car or use other complex machinery. Do not take other medications that can cause additional sleepiness unless you have consulted with your health care professional.
Thalomid (thalidomide) can cause rapid changes in
blood pressure when you stand up resulting in
dizziness, weakness or feeling
faint. If you have been lying down or sitting, take a few moments to sit on the edge of the bed or chair before standing up.
Some people have had an
allergic reaction to Thalomid (thalidomide). If you have a
rash,
fever,
rapid heartbeat, or very
low blood pressure (e.g., feeling faint, weak or dizzy), contact your doctor right away.
Thalomid can cause a decrease in your
white blood cell count. Your doctor should check your blood regularly while you are taking Thalomid if there are any concerns about this.
Possible side effects:
The most serious side effect of Thalomid (thalidomide) is its ability to cause birth defects. (See "Special Warnings" section.)
There is also a concern that Thalomid (thalidomide) may cause an increase in
viral load for HIV-positive patients.
More information can be found at www.fda.gov/cder/ or with you physician or on
package insert.