Brand Name: Thalomid®
(s): 50 mg
Company Name: Celgene Corporation
only, and only with participation by prescriber
, and patient in S.T.E.P.S.
Date Approved by FDA
: July 16, 1998
What is Thalomid used for?
Thalomid (thalidomide) is used to treat the debilitating
skin ]inflammation] that is sometimes a reaction to erythema nodosum leprosum
), 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).
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
), 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 period
s 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
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.
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
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
, or pain
or a burning sensation
in your hands
, 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
, 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