Patient Information Sheet
Thalidomide (marketed as Thalomid)
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This is a summary of the most important information about Thalomid. For details, talk to your healthcare professional.
What is Thalomid (thalidomide) used for?
Thalomid (thalidomide) is used to treat:
- erythema nodosum leprosum (ENL), an inflammatory complication of leprosy. When there is inflammation of the nerves in
addition to skin sores, Thalomid (thalidomide) should not be used as the only drug treatment.
- newly diagnosed multiple myeloma in combination with a drug called dexamethasone.
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 she must take to avoid pregnancy. These actions include:
- Not having heterosexual sexual contact
starting 4 weeks before beginning to take Thalomid (thalidomide)
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 contact at all. One birth control method must
be highly effective, such as an Intrauterine Device (IUD), birth
control pills, or 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 contact.
For Men:
Because Thalomid (thalidomide) is present in semen, you must
agree in writing to use a latex condom when engaging in any sexual
contact 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 telephone survey 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.
The use of Thalomid (thalidomide) in multiple myeloma results in an increased
risk of blood-clotting events, such as deep venous thrombosis and pulmonary embolus. This risk increases significantly when Thalomid (thalidomide) is used in combination with standard chemotherapeutic
drugs including dexamethasone. Patients and doctors are advised to
watch for signs and symptoms of clotting events. Patients should
contact a doctor if they have symptoms like shortness of breath,
chest pain, or arm/leg swelling.
General Precautions with Thalomid:
- Thalomid (thalidomide) causes severe birth defects (see "Special Warnings" section).
- You must never share Thalomid (thalidomide) 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 healthcare
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 (thalidomide) can cause a decrease
in your white blood cell count. Your doctor should check your
blood regularly while you are taking Thalomid (thalidomide) if
there are any concerns about this.
What should I tell my doctor or healthcare 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 healthcare professional, including those you
take without a prescription.
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 (thalidomide).
What are some possible side effects of Thalomid (thalidomide)?
(This is NOT
a complete list of side effects reported with Thalomid
(thalidomide). Your healthcare 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.
Reports of patients’ experience after Thalomid (thalidomide)became available:
Seizures, including grand mal convulsions, have been reported since Thalomid
(thalidomide) has been approved for use. Most patients had
disorders that may have made them more likely to develop seizure
activity, and it is not currently known whether Thalomid(thalidomide)
has any seizure-causing influence. During therapy with Thalomid
(thalidomide), patients with a history of seizures or with other
risk factors for the development of seizures should be monitored
closely for clinical changes that could cause seizures to occur.
For more detailed information about Thalomid (thalidomide), ask
your healthcare provider.
Link to Thalidomid's Approved Labeling
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Updated: October 16, 2006 |