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Brand Name: Thalomid®
Active Ingredient:   thalidomide
Strength(s): 50 mg
Dosage Form(s):   Capsule
Company Name:    Celgene Corporation
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, 2022
*Approval by FDA does not mean that the drug is
available for consumers at this time.

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.


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

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
  • 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

What should I tell my doctor or health care provider? 

Certain drugs cause sleepiness. Thalomid (thalidomide) frequently increases this
effect for some other drugs, including barbiturates, chlorpromazine (a tranquilizer), and
reserpine (a high blood pressure medicine), as well as alcohol. Some medications cause
peripheral neuropathy (numbness, tingling, or pain and inflammation of the nerves), which
can be a side effect of Thalomid (thalidomide). Any of these drugs should be used with
caution while taking Thalomid (thalidomide). Review all the medications that you are
taking with your health care professional, including those you take without a

Women must not become pregnant while taking Thalomid (thalidomide). Men must
ensure they take adequate precautions to help prevent pregnancies. Even one dose of
Thalomid (thalidomide) can cause severe birth defects or death to an unborn baby as early
as the first month of pregnancy. (See Special Warnings section.) Because of potential side
effects on the infant, do not breast-feed a child if you’re taking Thalomid

What are some possible side effects of Thalomid (thalidomide)? (This
is NOT a complete list of side effects reported with Thalomid
Your health care provider can discuss with you a more complete list of 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.

For more detailed information about Thalomid (thalidomide), ask your
health care provider.

Link to    Thalomid’s
approved label 

Revised: 7/25/00


Back to Drug Side Effects

source: FDA

last update: December 2004

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