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Thalomid Drug Description
THALOMID®
(thalidomide) Capsules 50 mg, 100 mg, 150 mg & 200 mg


WARNING
SEVERE, LIFE-THREATENING HUMAN BIRTH DEFECTS.
IF THALIDOMIDE IS TAKEN DURING PREGNANCY, IT CAN CAUSE SEVERE BIRTH DEFECTS
OR DEATH TO AN UNBORN BABY. THALIDOMIDE SHOULD NEVER BE USED BY WOMEN WHO ARE
PREGNANT OR WHO COULD BECOME PREGNANT WHILE TAKING THE DRUG. EVEN A SINGLE DOSE
[1 CAPSULE (REGARDLESS OF STRENGTH)] TAKEN BY A PREGNANT WOMAN DURING HER PREGNANCY
CAN CAUSE SEVERE BIRTH DEFECTS.
BECAUSE OF THIS TOXICITY AND IN AN EFFORT TO MAKE THE CHANCE OF FETAL EXPOSURE
TO THALOMID® (thalidomide) AS NEGLIGIBLE AS POSSIBLE, THALOMID® (thalidomide)
IS APPROVED FOR MARKETING ONLY UNDER A SPECIAL RESTRICTED DISTRIBUTION PROGRAM
APPROVED BY THE FOOD AND DRUG ADMINISTRATION. THIS PROGRAM IS CALLED THE "SYSTEM
FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY (S.T.E.P.S.® )".

UNDER THIS RESTRICTED DISTRIBUTION PROGRAM, ONLY PRESCRIBERS AND PHARMACISTS
REGISTERED WITH THE PROGRAM ARE ALLOWED TO PRESCRIBE AND DISPENSE THE PRODUCT.
IN ADDITION, PATIENTS MUST BE ADVISED OF, AGREE TO, AND COMPLY WITH THE REQUIREMENTS
OF THE S.T.E.P.S.® PROGRAM IN ORDER TO RECEIVE PRODUCT.
PLEASE SEE THE FOLLOWING BOXED WARNINGS CONTAINING SPECIAL INFORMATION FOR
PRESCRIBERS, FEMALE PATIENTS, AND MALE PATIENTS ABOUT THIS RESTRICTED DISTRIBUTION
PROGRAM.


PRESCRIBERS
THALOMID® (thalidomide) may be prescribed only by licensed prescribers
who are registered in the S.T.E.P.S.® program and understand the
risk of teratogenicity if thalidomide is used during pregnancy.
Major human fetal abnormalities related to thalidomide administration during
pregnancy have been documented: amelia (absence of limbs), phocomelia (short
limbs), hypoplasticity of the bones, absence of bones, external ear abnormalities
(including anotia, micro pinna, small or absent external auditory canals), facial
palsy, eye abnormalities (anophthalmos, microphthalmos), and congenital heart
defects. Alimentary tract, urinary tract, and genital malformations have also
been documented.1 Mortality at or shortly after birth has been reported
at about 40%.2
Effective contraception (see CONTRAINDICATIONS)
must be used for at least 4 weeks before beginning thalidomide therapy, during
thalidomide therapy, and for 4 weeks following discontinuation of thalidomide
therapy. Reliable contraception is indicated even where there has been a history
of infertility, unless due to hysterectomy or because the patient has been
postmenopausal for at least 24 months. Two reliable forms of contraception
must be used simultaneously unless continuous abstinence from heterosexual
sexual contact is the chosen method. Women of childbearing potential should
be referred to a qualified provider of contraceptive methods, if needed. Sexually
mature women who have not undergone a hysterectomy or who have not been postmenopausal
for at least 24 consecutive months (i.e., who have had menses at some time
in the preceding 24 consecutive months) are considered to be women of childbearing
potential.
Before starting treatment, women of childbearing potential should have
a pregnancy test (sensitivity of at least 50 mIU/mL). The test should be performed
within the 24 hours prior to beginning thalidomide therapy. A prescription for
thalidomide for a woman of childbearing potential must not be issued by the
prescriber until a written report of a negative pregnancy test has been obtained
by the prescriber.
Male Patients: Because thalidomide is present in the semen of patients
receiving the drug, males receiving thalidomide must always use a latex condom
during any sexual contact with women of childbearing potential even if he has
undergone a successful vasectomy.
Once treatment has started, pregnancy testing should occur weekly during
the first 4 weeks of use, then pregnancy testing should be repeated at 4 weeks
in women with regular menstrual cycles. If menstrual cycles are irregular, the
pregnancy testing should occur every 2 weeks. Pregnancy testing and counseling
should be performed if a patient misses her period or if there is any abnormality
in menstrual bleeding.
If pregnancy does occur during thalidomide treatment, thalidomide must be discontinued
immediately.
Any suspected fetal exposure to THALOMID® (thalidomide) must be reported
immediately to the FDA via the MedWatch number at 1-800-FDA-1088 and also to
Celgene Corporation at 1-888-423-5436. The patient should be referred to an
obstetrician/gynecologist experienced in reproductive toxicity for further evaluation
and counseling.


FEMALE PATIENTS
Thalidomide is contraindicated in WOMEN of childbearing potential unless alternative
therapies are considered inappropriate AND the patient MEETS ALL OF THE FOLLOWING
CONDITIONS (i.e., she is essentially unable to become pregnant while on thalidomide
therapy):

she understands and can reliably carry out instructions.
she is capable of complying with the mandatory contraceptive measures, pregnancy
testing, patient registration, and patient survey as described in the System
for Thalidomide Education and Prescribing Safety (S.T.E.P.S.® )
program.
she has received both oral and written warnings of the hazards of taking
thalidomide during pregnancy and of exposing a fetus to the drug.
she has received both oral and written warnings of the risk of possible
contraception failure and of the need to use two reliable forms of contraception
simultaneously (see CONTRAINDICATIONS),
unless continuous abstinence from heterosexual sexual contact is the chosen
method. Sexually mature women who have not undergone a hysterectomy or who
have not been postmenopausal for at least 24 consecutive months (i.e., who
have had menses at some time in the preceding 24 consecutive months) are
considered to be women of childbearing potential.
she acknowledges, in writing, her understanding of these warnings and of
the need for using two reliable methods of contraception for 4 weeks prior
to beginning thalidomide therapy, during thalidomide therapy, and for 4 weeks
after discontinuation of thalidomide therapy.
she has had a negative pregnancy test with a sensitivity of at least 50
mIU/mL, within the 24 hours prior to beginning therapy. (See PRECAUTIONS,
CONTRAINDICATIONS)
if the patient is between 12 and 18 years of age, her parent or legal guardian
must have read this material and agreed to ensure compliance with the above.



MALE PATIENTS
Thalidomide is contraindicated in sexually mature MALES unless the PATIENT
MEETS ALL OF THE FOLLOWING CONDITIONS:

he understands and can reliably carry out instructions.
he is capable of complying with the mandatory contraceptive measures that
are appropriate for men, patient registration, and patient survey as described
in the S.T.E.P.S.® program.
he has received both oral and written warnings of the hazards of taking
thalidomide and exposing a fetus to the drug.
he has received both oral and written warnings of the risk of possible contraception
failure and of the presence of thalidomide in semen. He has been instructed
that he must always use a latex condom during any sexual contact with women
of childbearing potential, even if he has undergone a successful vasectomy.
he acknowledges, in writing, his understanding of these warnings and of
the need to use a latex condom during any sexual contact with women of childbearing
potential, even if he has undergone a successful vasectomy. Sexually mature
women who have not undergone a hysterectomy or who have not been postmenopausal
for at least 24 consecutive months (i.e., who have had menses at any time
in the preceding 24 consecutive months) are considered to be women of childbearing
potential.
if the patient is between 12 and 18 years of age, his parent or legal guardian
must have read this material and agreed to ensure compliance with the above.



VENOUS THROMBOEMBOLIC EVENTS
The use of THALOMID® (thalidomide) in multiple myeloma results in an
increased risk of venous thromboembolic events, such as deep venous thrombosis
and pulmonary embolus. This risk increases significantly when thalidomide is
used in combination with standard chemotherapeutic agents including dexamethasone.
In one controlled trial, the rate of venous thromboembolic events was 22.5%
in patients receiving thalidomide in combination with dexamethasone compared
to 4.9% in patients receiving dexamethasone alone (p = 0.002). Patients and
physicians are advised to be observant for the signs and symptoms of thromboembolism.
Patients should be instructed to seek medical care if they develop symptoms
such as shortness of breath, chest pain, or arm or leg swelling. Preliminary
data suggest that patients who are appropriate candidates may benefit from concurrent
prophylactic anticoagulation or aspirin treatment.

DRUG DESCRIPTION



What are the possible side effects of thalidomide (Thalomid)?

Stop using this medicine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

chest pain, sudden shortness of breath, coughing up blood;
pain or swelling in your arm, thigh, or calf;
easy bruising, unusual bleeding or weakness;
slow heartbeats, shallow breathing;
...
Read All Potential Side Effects for Thalomid »




THALOMID® (thalidomide), α-(N-phthalimido) glutarimide, is an immunomodulatory
agent. The empirical formula for thalidomide is C13H10N2O4
and the gram molecular weight is 258.2. The CAS number of thalidomide is 50-35-1.
Chemical Structure of thalidomide









Note:• = asymmetric carbon atom
Thalidomide is an off-white to white, odorless, crystalline powder that is
soluble at 25°C in dimethyl sulfoxide and sparingly soluble in water and
ethanol. The glutarimide moiety contains a single asymmetric center and, therefore,
may exist in either of two optically active forms designated S-(-) or R-(+).
THALOMID® (thalidomide) is an equal mixture of the S-(-) and R-(+) forms
and, therefore, has a net optical rotation of zero.
THALOMID® (thalidomide) is available in 50 mg, 100 mg, 150 mg and 200 mg
capsules for oral administration. Active ingredient: thalidomide. Inactive ingredients:
pregelatinized starch and magnesium stearate. The 50 mg capsule shell contains
gelatin, titanium dioxide, and black ink. The 100 mg capsule shell contains
black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black ink.
The 150 mg capsule shell contains FD&C blue #2, black iron oxide, yellow
iron oxide, titanium dioxide, gelatin, and black and white ink. The 200 mg capsule
shell contains FD&C blue #2, titanium dioxide, gelatin, and white ink.
REFERENCES
1.Manson JM. 1986. Teratogenicity. Cassarett and Doull's Toxicology: The
Basic Science of Poisons. Third Edition. Pages 195-220. New York: MacMillan
Publishing Co.
2.Smithels RW and Newman CG. 1992. J. Med. Genet. 29(10):716-723.Last reviewed on RxList: 8/1/2007




Thalomid Drug Description
THALOMID®
(thalidomide) Capsules 50 mg, 100 mg, 150 mg & 200 mg


WARNING
SEVERE, LIFE-THREATENING HUMAN BIRTH DEFECTS.
IF THALIDOMIDE IS TAKEN DURING PREGNANCY, IT CAN CAUSE SEVERE BIRTH DEFECTS
OR DEATH TO AN UNBORN BABY. THALIDOMIDE SHOULD NEVER BE USED BY WOMEN WHO ARE
PREGNANT OR WHO COULD BECOME PREGNANT WHILE TAKING THE DRUG. EVEN A SINGLE DOSE
[1 CAPSULE (REGARDLESS OF STRENGTH)] TAKEN BY A PREGNANT WOMAN DURING HER PREGNANCY
CAN CAUSE SEVERE BIRTH DEFECTS.
BECAUSE OF THIS TOXICITY AND IN AN EFFORT TO MAKE THE CHANCE OF FETAL EXPOSURE
TO THALOMID® (thalidomide) AS NEGLIGIBLE AS POSSIBLE, THALOMID® (thalidomide)
IS APPROVED FOR MARKETING ONLY UNDER A SPECIAL RESTRICTED DISTRIBUTION PROGRAM
APPROVED BY THE FOOD AND DRUG ADMINISTRATION. THIS PROGRAM IS CALLED THE "SYSTEM
FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY (S.T.E.P.S.® )".

UNDER THIS RESTRICTED DISTRIBUTION PROGRAM, ONLY PRESCRIBERS AND PHARMACISTS
REGISTERED WITH THE PROGRAM ARE ALLOWED TO PRESCRIBE AND DISPENSE THE PRODUCT.
IN ADDITION, PATIENTS MUST BE ADVISED OF, AGREE TO, AND COMPLY WITH THE REQUIREMENTS
OF THE S.T.E.P.S.® PROGRAM IN ORDER TO RECEIVE PRODUCT.
PLEASE SEE THE FOLLOWING BOXED WARNINGS CONTAINING SPECIAL INFORMATION FOR
PRESCRIBERS, FEMALE PATIENTS, AND MALE PATIENTS ABOUT THIS RESTRICTED DISTRIBUTION
PROGRAM.


PRESCRIBERS
THALOMID® (thalidomide) may be prescribed only by licensed prescribers
who are registered in the S.T.E.P.S.® program and understand the
risk of teratogenicity if thalidomide is used during pregnancy.
Major human fetal abnormalities related to thalidomide administration during
pregnancy have been documented: amelia (absence of limbs), phocomelia (short
limbs), hypoplasticity of the bones, absence of bones, external ear abnormalities
(including anotia, micro pinna, small or absent external auditory canals), facial
palsy, eye abnormalities (anophthalmos, microphthalmos), and congenital heart
defects. Alimentary tract, urinary tract, and genital malformations have also
been documented.1 Mortality at or shortly after birth has been reported
at about 40%.2
Effective contraception (see CONTRAINDICATIONS)
must be used for at least 4 weeks before beginning thalidomide therapy, during
thalidomide therapy, and for 4 weeks following discontinuation of thalidomide
therapy. Reliable contraception is indicated even where there has been a history
of infertility, unless due to hysterectomy or because the patient has been
postmenopausal for at least 24 months. Two reliable forms of contraception
must be used simultaneously unless continuous abstinence from heterosexual
sexual contact is the chosen method. Women of childbearing potential should
be referred to a qualified provider of contraceptive methods, if needed. Sexually
mature women who have not undergone a hysterectomy or who have not been postmenopausal
for at least 24 consecutive months (i.e., who have had menses at some time
in the preceding 24 consecutive months) are considered to be women of childbearing
potential.
Before starting treatment, women of childbearing potential should have
a pregnancy test (sensitivity of at least 50 mIU/mL). The test should be performed
within the 24 hours prior to beginning thalidomide therapy. A prescription for
thalidomide for a woman of childbearing potential must not be issued by the
prescriber until a written report of a negative pregnancy test has been obtained
by the prescriber.
Male Patients: Because thalidomide is present in the semen of patients
receiving the drug, males receiving thalidomide must always use a latex condom
during any sexual contact with women of childbearing potential even if he has
undergone a successful vasectomy.
Once treatment has started, pregnancy testing should occur weekly during
the first 4 weeks of use, then pregnancy testing should be repeated at 4 weeks
in women with regular menstrual cycles. If menstrual cycles are irregular, the
pregnancy testing should occur every 2 weeks. Pregnancy testing and counseling
should be performed if a patient misses her period or if there is any abnormality
in menstrual bleeding.
If pregnancy does occur during thalidomide treatment, thalidomide must be discontinued
immediately.
Any suspected fetal exposure to THALOMID® (thalidomide) must be reported
immediately to the FDA via the MedWatch number at 1-800-FDA-1088 and also to
Celgene Corporation at 1-888-423-5436. The patient should be referred to an
obstetrician/gynecologist experienced in reproductive toxicity for further evaluation
and counseling.


FEMALE PATIENTS
Thalidomide is contraindicated in WOMEN of childbearing potential unless alternative
therapies are considered inappropriate AND the patient MEETS ALL OF THE FOLLOWING
CONDITIONS (i.e., she is essentially unable to become pregnant while on thalidomide
therapy):

she understands and can reliably carry out instructions.
she is capable of complying with the mandatory contraceptive measures, pregnancy
testing, patient registration, and patient survey as described in the System
for Thalidomide Education and Prescribing Safety (S.T.E.P.S.® )
program.
she has received both oral and written warnings of the hazards of taking
thalidomide during pregnancy and of exposing a fetus to the drug.
she has received both oral and written warnings of the risk of possible
contraception failure and of the need to use two reliable forms of contraception
simultaneously (see CONTRAINDICATIONS),
unless continuous abstinence from heterosexual sexual contact is the chosen
method. Sexually mature women who have not undergone a hysterectomy or who
have not been postmenopausal for at least 24 consecutive months (i.e., who
have had menses at some time in the preceding 24 consecutive months) are
considered to be women of childbearing potential.
she acknowledges, in writing, her understanding of these warnings and of
the need for using two reliable methods of contraception for 4 weeks prior
to beginning thalidomide therapy, during thalidomide therapy, and for 4 weeks
after discontinuation of thalidomide therapy.
she has had a negative pregnancy test with a sensitivity of at least 50
mIU/mL, within the 24 hours prior to beginning therapy. (See PRECAUTIONS,
CONTRAINDICATIONS)
if the patient is between 12 and 18 years of age, her parent or legal guardian
must have read this material and agreed to ensure compliance with the above.



MALE PATIENTS
Thalidomide is contraindicated in sexually mature MALES unless the PATIENT
MEETS ALL OF THE FOLLOWING CONDITIONS:

he understands and can reliably carry out instructions.
he is capable of complying with the mandatory contraceptive measures that
are appropriate for men, patient registration, and patient survey as described
in the S.T.E.P.S.® program.
he has received both oral and written warnings of the hazards of taking
thalidomide and exposing a fetus to the drug.
he has received both oral and written warnings of the risk of possible contraception
failure and of the presence of thalidomide in semen. He has been instructed
that he must always use a latex condom during any sexual contact with women
of childbearing potential, even if he has undergone a successful vasectomy.
he acknowledges, in writing, his understanding of these warnings and of
the need to use a latex condom during any sexual contact with women of childbearing
potential, even if he has undergone a successful vasectomy. Sexually mature
women who have not undergone a hysterectomy or who have not been postmenopausal
for at least 24 consecutive months (i.e., who have had menses at any time
in the preceding 24 consecutive months) are considered to be women of childbearing
potential.
if the patient is between 12 and 18 years of age, his parent or legal guardian
must have read this material and agreed to ensure compliance with the above.



VENOUS THROMBOEMBOLIC EVENTS
The use of THALOMID® (thalidomide) in multiple myeloma results in an
increased risk of venous thromboembolic events, such as deep venous thrombosis
and pulmonary embolus. This risk increases significantly when thalidomide is
used in combination with standard chemotherapeutic agents including dexamethasone.
In one controlled trial, the rate of venous thromboembolic events was 22.5%
in patients receiving thalidomide in combination with dexamethasone compared
to 4.9% in patients receiving dexamethasone alone (p = 0.002). Patients and
physicians are advised to be observant for the signs and symptoms of thromboembolism.
Patients should be instructed to seek medical care if they develop symptoms
such as shortness of breath, chest pain, or arm or leg swelling. Preliminary
data suggest that patients who are appropriate candidates may benefit from concurrent
prophylactic anticoagulation or aspirin treatment.

DRUG DESCRIPTION



What are the possible side effects of thalidomide (Thalomid)?

Stop using this medicine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

chest pain, sudden shortness of breath, coughing up blood;
pain or swelling in your arm, thigh, or calf;
easy bruising, unusual bleeding or weakness;
slow heartbeats, shallow breathing;
...
Read All Potential Side Effects for Thalomid »




THALOMID® (thalidomide), α-(N-phthalimido) glutarimide, is an immunomodulatory
agent. The empirical formula for thalidomide is C13H10N2O4
and the gram molecular weight is 258.2. The CAS number of thalidomide is 50-35-1.
Chemical Structure of thalidomide









Note:• = asymmetric carbon atom
Thalidomide is an off-white to white, odorless, crystalline powder that is
soluble at 25°C in dimethyl sulfoxide and sparingly soluble in water and
ethanol. The glutarimide moiety contains a single asymmetric center and, therefore,
may exist in either of two optically active forms designated S-(-) or R-(+).
THALOMID® (thalidomide) is an equal mixture of the S-(-) and R-(+) forms
and, therefore, has a net optical rotation of zero.
THALOMID® (thalidomide) is available in 50 mg, 100 mg, 150 mg and 200 mg
capsules for oral administration. Active ingredient: thalidomide. Inactive ingredients:
pregelatinized starch and magnesium stearate. The 50 mg capsule shell contains
gelatin, titanium dioxide, and black ink. The 100 mg capsule shell contains
black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black ink.
The 150 mg capsule shell contains FD&C blue #2, black iron oxide, yellow
iron oxide, titanium dioxide, gelatin, and black and white ink. The 200 mg capsule
shell contains FD&C blue #2, titanium dioxide, gelatin, and white ink.
REFERENCES
1.Manson JM. 1986. Teratogenicity. Cassarett and Doull's Toxicology: The
Basic Science of Poisons. Third Edition. Pages 195-220. New York: MacMillan
Publishing Co.
2.Smithels RW and Newman CG. 1992. J. Med. Genet. 29(10):716-723.Last reviewed on RxList: 8/1/2007




Thalomid Drug Description
THALOMID®
(thalidomide) Capsules 50 mg, 100 mg, 150 mg & 200 mg


WARNING
SEVERE, LIFE-THREATENING HUMAN BIRTH DEFECTS.
IF THALIDOMIDE IS TAKEN DURING PREGNANCY, IT CAN CAUSE SEVERE BIRTH DEFECTS
OR DEATH TO AN UNBORN BABY. THALIDOMIDE SHOULD NEVER BE USED BY WOMEN WHO ARE
PREGNANT OR WHO COULD BECOME PREGNANT WHILE TAKING THE DRUG. EVEN A SINGLE DOSE
[1 CAPSULE (REGARDLESS OF STRENGTH)] TAKEN BY A PREGNANT WOMAN DURING HER PREGNANCY
CAN CAUSE SEVERE BIRTH DEFECTS.
BECAUSE OF THIS TOXICITY AND IN AN EFFORT TO MAKE THE CHANCE OF FETAL EXPOSURE
TO THALOMID® (thalidomide) AS NEGLIGIBLE AS POSSIBLE, THALOMID® (thalidomide)
IS APPROVED FOR MARKETING ONLY UNDER A SPECIAL RESTRICTED DISTRIBUTION PROGRAM
APPROVED BY THE FOOD AND DRUG ADMINISTRATION. THIS PROGRAM IS CALLED THE "SYSTEM
FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY (S.T.E.P.S.® )".

UNDER THIS RESTRICTED DISTRIBUTION PROGRAM, ONLY PRESCRIBERS AND PHARMACISTS
REGISTERED WITH THE PROGRAM ARE ALLOWED TO PRESCRIBE AND DISPENSE THE PRODUCT.
IN ADDITION, PATIENTS MUST BE ADVISED OF, AGREE TO, AND COMPLY WITH THE REQUIREMENTS
OF THE S.T.E.P.S.® PROGRAM IN ORDER TO RECEIVE PRODUCT.
PLEASE SEE THE FOLLOWING BOXED WARNINGS CONTAINING SPECIAL INFORMATION FOR
PRESCRIBERS, FEMALE PATIENTS, AND MALE PATIENTS ABOUT THIS RESTRICTED DISTRIBUTION
PROGRAM.


PRESCRIBERS
THALOMID® (thalidomide) may be prescribed only by licensed prescribers
who are registered in the S.T.E.P.S.® program and understand the
risk of teratogenicity if thalidomide is used during pregnancy.
Major human fetal abnormalities related to thalidomide administration during
pregnancy have been documented: amelia (absence of limbs), phocomelia (short
limbs), hypoplasticity of the bones, absence of bones, external ear abnormalities
(including anotia, micro pinna, small or absent external auditory canals), facial
palsy, eye abnormalities (anophthalmos, microphthalmos), and congenital heart
defects. Alimentary tract, urinary tract, and genital malformations have also
been documented.1 Mortality at or shortly after birth has been reported
at about 40%.2
Effective contraception (see CONTRAINDICATIONS)
must be used for at least 4 weeks before beginning thalidomide therapy, during
thalidomide therapy, and for 4 weeks following discontinuation of thalidomide
therapy. Reliable contraception is indicated even where there has been a history
of infertility, unless due to hysterectomy or because the patient has been
postmenopausal for at least 24 months. Two reliable forms of contraception
must be used simultaneously unless continuous abstinence from heterosexual
sexual contact is the chosen method. Women of childbearing potential should
be referred to a qualified provider of contraceptive methods, if needed. Sexually
mature women who have not undergone a hysterectomy or who have not been postmenopausal
for at least 24 consecutive months (i.e., who have had menses at some time
in the preceding 24 consecutive months) are considered to be women of childbearing
potential.
Before starting treatment, women of childbearing potential should have
a pregnancy test (sensitivity of at least 50 mIU/mL). The test should be performed
within the 24 hours prior to beginning thalidomide therapy. A prescription for
thalidomide for a woman of childbearing potential must not be issued by the
prescriber until a written report of a negative pregnancy test has been obtained
by the prescriber.
Male Patients: Because thalidomide is present in the semen of patients
receiving the drug, males receiving thalidomide must always use a latex condom
during any sexual contact with women of childbearing potential even if he has
undergone a successful vasectomy.
Once treatment has started, pregnancy testing should occur weekly during
the first 4 weeks of use, then pregnancy testing should be repeated at 4 weeks
in women with regular menstrual cycles. If menstrual cycles are irregular, the
pregnancy testing should occur every 2 weeks. Pregnancy testing and counseling
should be performed if a patient misses her period or if there is any abnormality
in menstrual bleeding.
If pregnancy does occur during thalidomide treatment, thalidomide must be discontinued
immediately.
Any suspected fetal exposure to THALOMID® (thalidomide) must be reported
immediately to the FDA via the MedWatch number at 1-800-FDA-1088 and also to
Celgene Corporation at 1-888-423-5436. The patient should be referred to an
obstetrician/gynecologist experienced in reproductive toxicity for further evaluation
and counseling.


FEMALE PATIENTS
Thalidomide is contraindicated in WOMEN of childbearing potential unless alternative
therapies are considered inappropriate AND the patient MEETS ALL OF THE FOLLOWING
CONDITIONS (i.e., she is essentially unable to become pregnant while on thalidomide
therapy):

she understands and can reliably carry out instructions.
she is capable of complying with the mandatory contraceptive measures, pregnancy
testing, patient registration, and patient survey as described in the System
for Thalidomide Education and Prescribing Safety (S.T.E.P.S.® )
program.
she has received both oral and written warnings of the hazards of taking
thalidomide during pregnancy and of exposing a fetus to the drug.
she has received both oral and written warnings of the risk of possible
contraception failure and of the need to use two reliable forms of contraception
simultaneously (see CONTRAINDICATIONS),
unless continuous abstinence from heterosexual sexual contact is the chosen
method. Sexually mature women who have not undergone a hysterectomy or who
have not been postmenopausal for at least 24 consecutive months (i.e., who
have had menses at some time in the preceding 24 consecutive months) are
considered to be women of childbearing potential.
she acknowledges, in writing, her understanding of these warnings and of
the need for using two reliable methods of contraception for 4 weeks prior
to beginning thalidomide therapy, during thalidomide therapy, and for 4 weeks
after discontinuation of thalidomide therapy.
she has had a negative pregnancy test with a sensitivity of at least 50
mIU/mL, within the 24 hours prior to beginning therapy. (See PRECAUTIONS,
CONTRAINDICATIONS)
if the patient is between 12 and 18 years of age, her parent or legal guardian
must have read this material and agreed to ensure compliance with the above.



MALE PATIENTS
Thalidomide is contraindicated in sexually mature MALES unless the PATIENT
MEETS ALL OF THE FOLLOWING CONDITIONS:

he understands and can reliably carry out instructions.
he is capable of complying with the mandatory contraceptive measures that
are appropriate for men, patient registration, and patient survey as described
in the S.T.E.P.S.® program.
he has received both oral and written warnings of the hazards of taking
thalidomide and exposing a fetus to the drug.
he has received both oral and written warnings of the risk of possible contraception
failure and of the presence of thalidomide in semen. He has been instructed
that he must always use a latex condom during any sexual contact with women
of childbearing potential, even if he has undergone a successful vasectomy.
he acknowledges, in writing, his understanding of these warnings and of
the need to use a latex condom during any sexual contact with women of childbearing
potential, even if he has undergone a successful vasectomy. Sexually mature
women who have not undergone a hysterectomy or who have not been postmenopausal
for at least 24 consecutive months (i.e., who have had menses at any time
in the preceding 24 consecutive months) are considered to be women of childbearing
potential.
if the patient is between 12 and 18 years of age, his parent or legal guardian
must have read this material and agreed to ensure compliance with the above.



VENOUS THROMBOEMBOLIC EVENTS
The use of THALOMID® (thalidomide) in multiple myeloma results in an
increased risk of venous thromboembolic events, such as deep venous thrombosis
and pulmonary embolus. This risk increases significantly when thalidomide is
used in combination with standard chemotherapeutic agents including dexamethasone.
In one controlled trial, the rate of venous thromboembolic events was 22.5%
in patients receiving thalidomide in combination with dexamethasone compared
to 4.9% in patients receiving dexamethasone alone (p = 0.002). Patients and
physicians are advised to be observant for the signs and symptoms of thromboembolism.
Patients should be instructed to seek medical care if they develop symptoms
such as shortness of breath, chest pain, or arm or leg swelling. Preliminary
data suggest that patients who are appropriate candidates may benefit from concurrent
prophylactic anticoagulation or aspirin treatment.

DRUG DESCRIPTION



What are the possible side effects of thalidomide (Thalomid)?

Stop using this medicine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

chest pain, sudden shortness of breath, coughing up blood;
pain or swelling in your arm, thigh, or calf;
easy bruising, unusual bleeding or weakness;
slow heartbeats, shallow breathing;
...
Read All Potential Side Effects for Thalomid »




THALOMID® (thalidomide), α-(N-phthalimido) glutarimide, is an immunomodulatory
agent. The empirical formula for thalidomide is C13H10N2O4
and the gram molecular weight is 258.2. The CAS number of thalidomide is 50-35-1.
Chemical Structure of thalidomide









Note:• = asymmetric carbon atom
Thalidomide is an off-white to white, odorless, crystalline powder that is
soluble at 25°C in dimethyl sulfoxide and sparingly soluble in water and
ethanol. The glutarimide moiety contains a single asymmetric center and, therefore,
may exist in either of two optically active forms designated S-(-) or R-(+).
THALOMID® (thalidomide) is an equal mixture of the S-(-) and R-(+) forms
and, therefore, has a net optical rotation of zero.
THALOMID® (thalidomide) is available in 50 mg, 100 mg, 150 mg and 200 mg
capsules for oral administration. Active ingredient: thalidomide. Inactive ingredients:
pregelatinized starch and magnesium stearate. The 50 mg capsule shell contains
gelatin, titanium dioxide, and black ink. The 100 mg capsule shell contains
black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black ink.
The 150 mg capsule shell contains FD&C blue #2, black iron oxide, yellow
iron oxide, titanium dioxide, gelatin, and black and white ink. The 200 mg capsule
shell contains FD&C blue #2, titanium dioxide, gelatin, and white ink.
REFERENCES
1.Manson JM. 1986. Teratogenicity. Cassarett and Doull's Toxicology: The
Basic Science of Poisons. Third Edition. Pages 195-220. New York: MacMillan
Publishing Co.
2.Smithels RW and Newman CG. 1992. J. Med. Genet. 29(10):716-723.Last reviewed on RxList: 8/1/2007




Thalomid Drug Description
THALOMID®
(thalidomide) Capsules 50 mg, 100 mg, 150 mg & 200 mg


WARNING
SEVERE, LIFE-THREATENING HUMAN BIRTH DEFECTS.
IF THALIDOMIDE IS TAKEN DURING PREGNANCY, IT CAN CAUSE SEVERE BIRTH DEFECTS
OR DEATH TO AN UNBORN BABY. THALIDOMIDE SHOULD NEVER BE USED BY WOMEN WHO ARE
PREGNANT OR WHO COULD BECOME PREGNANT WHILE TAKING THE DRUG. EVEN A SINGLE DOSE
[1 CAPSULE (REGARDLESS OF STRENGTH)] TAKEN BY A PREGNANT WOMAN DURING HER PREGNANCY
CAN CAUSE SEVERE BIRTH DEFECTS.
BECAUSE OF THIS TOXICITY AND IN AN EFFORT TO MAKE THE CHANCE OF FETAL EXPOSURE
TO THALOMID® (thalidomide) AS NEGLIGIBLE AS POSSIBLE, THALOMID® (thalidomide)
IS APPROVED FOR MARKETING ONLY UNDER A SPECIAL RESTRICTED DISTRIBUTION PROGRAM
APPROVED BY THE FOOD AND DRUG ADMINISTRATION. THIS PROGRAM IS CALLED THE "SYSTEM
FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY (S.T.E.P.S.® )".

UNDER THIS RESTRICTED DISTRIBUTION PROGRAM, ONLY PRESCRIBERS AND PHARMACISTS
REGISTERED WITH THE PROGRAM ARE ALLOWED TO PRESCRIBE AND DISPENSE THE PRODUCT.
IN ADDITION, PATIENTS MUST BE ADVISED OF, AGREE TO, AND COMPLY WITH THE REQUIREMENTS
OF THE S.T.E.P.S.® PROGRAM IN ORDER TO RECEIVE PRODUCT.
PLEASE SEE THE FOLLOWING BOXED WARNINGS CONTAINING SPECIAL INFORMATION FOR
PRESCRIBERS, FEMALE PATIENTS, AND MALE PATIENTS ABOUT THIS RESTRICTED DISTRIBUTION
PROGRAM.


PRESCRIBERS
THALOMID® (thalidomide) may be prescribed only by licensed prescribers
who are registered in the S.T.E.P.S.® program and understand the
risk of teratogenicity if thalidomide is used during pregnancy.
Major human fetal abnormalities related to thalidomide administration during
pregnancy have been documented: amelia (absence of limbs), phocomelia (short
limbs), hypoplasticity of the bones, absence of bones, external ear abnormalities
(including anotia, micro pinna, small or absent external auditory canals), facial
palsy, eye abnormalities (anophthalmos, microphthalmos), and congenital heart
defects. Alimentary tract, urinary tract, and genital malformations have also
been documented.1 Mortality at or shortly after birth has been reported
at about 40%.2
Effective contraception (see CONTRAINDICATIONS)
must be used for at least 4 weeks before beginning thalidomide therapy, during
thalidomide therapy, and for 4 weeks following discontinuation of thalidomide
therapy. Reliable contraception is indicated even where there has been a history
of infertility, unless due to hysterectomy or because the patient has been
postmenopausal for at least 24 months. Two reliable forms of contraception
must be used simultaneously unless continuous abstinence from heterosexual
sexual contact is the chosen method. Women of childbearing potential should
be referred to a qualified provider of contraceptive methods, if needed. Sexually
mature women who have not undergone a hysterectomy or who have not been postmenopausal
for at least 24 consecutive months (i.e., who have had menses at some time
in the preceding 24 consecutive months) are considered to be women of childbearing
potential.
Before starting treatment, women of childbearing potential should have
a pregnancy test (sensitivity of at least 50 mIU/mL). The test should be performed
within the 24 hours prior to beginning thalidomide therapy. A prescription for
thalidomide for a woman of childbearing potential must not be issued by the
prescriber until a written report of a negative pregnancy test has been obtained
by the prescriber.
Male Patients: Because thalidomide is present in the semen of patients
receiving the drug, males receiving thalidomide must always use a latex condom
during any sexual contact with women of childbearing potential even if he has
undergone a successful vasectomy.
Once treatment has started, pregnancy testing should occur weekly during
the first 4 weeks of use, then pregnancy testing should be repeated at 4 weeks
in women with regular menstrual cycles. If menstrual cycles are irregular, the
pregnancy testing should occur every 2 weeks. Pregnancy testing and counseling
should be performed if a patient misses her period or if there is any abnormality
in menstrual bleeding.
If pregnancy does occur during thalidomide treatment, thalidomide must be discontinued
immediately.
Any suspected fetal exposure to THALOMID® (thalidomide) must be reported
immediately to the FDA via the MedWatch number at 1-800-FDA-1088 and also to
Celgene Corporation at 1-888-423-5436. The patient should be referred to an
obstetrician/gynecologist experienced in reproductive toxicity for further evaluation
and counseling.


FEMALE PATIENTS
Thalidomide is contraindicated in WOMEN of childbearing potential unless alternative
therapies are considered inappropriate AND the patient MEETS ALL OF THE FOLLOWING
CONDITIONS (i.e., she is essentially unable to become pregnant while on thalidomide
therapy):

she understands and can reliably carry out instructions.
she is capable of complying with the mandatory contraceptive measures, pregnancy
testing, patient registration, and patient survey as described in the System
for Thalidomide Education and Prescribing Safety (S.T.E.P.S.® )
program.
she has received both oral and written warnings of the hazards of taking
thalidomide during pregnancy and of exposing a fetus to the drug.
she has received both oral and written warnings of the risk of possible
contraception failure and of the need to use two reliable forms of contraception
simultaneously (see CONTRAINDICATIONS),
unless continuous abstinence from heterosexual sexual contact is the chosen
method. Sexually mature women who have not undergone a hysterectomy or who
have not been postmenopausal for at least 24 consecutive months (i.e., who
have had menses at some time in the preceding 24 consecutive months) are
considered to be women of childbearing potential.
she acknowledges, in writing, her understanding of these warnings and of
the need for using two reliable methods of contraception for 4 weeks prior
to beginning thalidomide therapy, during thalidomide therapy, and for 4 weeks
after discontinuation of thalidomide therapy.
she has had a negative pregnancy test with a sensitivity of at least 50
mIU/mL, within the 24 hours prior to beginning therapy. (See PRECAUTIONS,
CONTRAINDICATIONS)
if the patient is between 12 and 18 years of age, her parent or legal guardian
must have read this material and agreed to ensure compliance with the above.



MALE PATIENTS
Thalidomide is contraindicated in sexually mature MALES unless the PATIENT
MEETS ALL OF THE FOLLOWING CONDITIONS:

he understands and can reliably carry out instructions.
he is capable of complying with the mandatory contraceptive measures that
are appropriate for men, patient registration, and patient survey as described
in the S.T.E.P.S.® program.
he has received both oral and written warnings of the hazards of taking
thalidomide and exposing a fetus to the drug.
he has received both oral and written warnings of the risk of possible contraception
failure and of the presence of thalidomide in semen. He has been instructed
that he must always use a latex condom during any sexual contact with women
of childbearing potential, even if he has undergone a successful vasectomy.
he acknowledges, in writing, his understanding of these warnings and of
the need to use a latex condom during any sexual contact with women of childbearing
potential, even if he has undergone a successful vasectomy. Sexually mature
women who have not undergone a hysterectomy or who have not been postmenopausal
for at least 24 consecutive months (i.e., who have had menses at any time
in the preceding 24 consecutive months) are considered to be women of childbearing
potential.
if the patient is between 12 and 18 years of age, his parent or legal guardian
must have read this material and agreed to ensure compliance with the above.



VENOUS THROMBOEMBOLIC EVENTS
The use of THALOMID® (thalidomide) in multiple myeloma results in an
increased risk of venous thromboembolic events, such as deep venous thrombosis
and pulmonary embolus. This risk increases significantly when thalidomide is
used in combination with standard chemotherapeutic agents including dexamethasone.
In one controlled trial, the rate of venous thromboembolic events was 22.5%
in patients receiving thalidomide in combination with dexamethasone compared
to 4.9% in patients receiving dexamethasone alone (p = 0.002). Patients and
physicians are advised to be observant for the signs and symptoms of thromboembolism.
Patients should be instructed to seek medical care if they develop symptoms
such as shortness of breath, chest pain, or arm or leg swelling. Preliminary
data suggest that patients who are appropriate candidates may benefit from concurrent
prophylactic anticoagulation or aspirin treatment.

DRUG DESCRIPTION



What are the possible side effects of thalidomide (Thalomid)?

Stop using this medicine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

chest pain, sudden shortness of breath, coughing up blood;
pain or swelling in your arm, thigh, or calf;
easy bruising, unusual bleeding or weakness;
slow heartbeats, shallow breathing;
...
Read All Potential Side Effects for Thalomid »




THALOMID® (thalidomide), α-(N-phthalimido) glutarimide, is an immunomodulatory
agent. The empirical formula for thalidomide is C13H10N2O4
and the gram molecular weight is 258.2. The CAS number of thalidomide is 50-35-1.
Chemical Structure of thalidomide









Note:• = asymmetric carbon atom
Thalidomide is an off-white to white, odorless, crystalline powder that is
soluble at 25°C in dimethyl sulfoxide and sparingly soluble in water and
ethanol. The glutarimide moiety contains a single asymmetric center and, therefore,
may exist in either of two optically active forms designated S-(-) or R-(+).
THALOMID® (thalidomide) is an equal mixture of the S-(-) and R-(+) forms
and, therefore, has a net optical rotation of zero.
THALOMID® (thalidomide) is available in 50 mg, 100 mg, 150 mg and 200 mg
capsules for oral administration. Active ingredient: thalidomide. Inactive ingredients:
pregelatinized starch and magnesium stearate. The 50 mg capsule shell contains
gelatin, titanium dioxide, and black ink. The 100 mg capsule shell contains
black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black ink.
The 150 mg capsule shell contains FD&C blue #2, black iron oxide, yellow
iron oxide, titanium dioxide, gelatin, and black and white ink. The 200 mg capsule
shell contains FD&C blue #2, titanium dioxide, gelatin, and white ink.
REFERENCES
1.Manson JM. 1986. Teratogenicity. Cassarett and Doull's Toxicology: The
Basic Science of Poisons. Third Edition. Pages 195-220. New York: MacMillan
Publishing Co.
2.Smithels RW and Newman CG. 1992. J. Med. Genet. 29(10):716-723.Last reviewed on RxList: 8/1/2007




Thalomid Drug Description
THALOMID®
(thalidomide) Capsules 50 mg, 100 mg, 150 mg & 200 mg


WARNING
SEVERE, LIFE-THREATENING HUMAN BIRTH DEFECTS.
IF THALIDOMIDE IS TAKEN DURING PREGNANCY, IT CAN CAUSE SEVERE BIRTH DEFECTS
OR DEATH TO AN UNBORN BABY. THALIDOMIDE SHOULD NEVER BE USED BY WOMEN WHO ARE
PREGNANT OR WHO COULD BECOME PREGNANT WHILE TAKING THE DRUG. EVEN A SINGLE DOSE
[1 CAPSULE (REGARDLESS OF STRENGTH)] TAKEN BY A PREGNANT WOMAN DURING HER PREGNANCY
CAN CAUSE SEVERE BIRTH DEFECTS.
BECAUSE OF THIS TOXICITY AND IN AN EFFORT TO MAKE THE CHANCE OF FETAL EXPOSURE
TO THALOMID® (thalidomide) AS NEGLIGIBLE AS POSSIBLE, THALOMID® (thalidomide)
IS APPROVED FOR MARKETING ONLY UNDER A SPECIAL RESTRICTED DISTRIBUTION PROGRAM
APPROVED BY THE FOOD AND DRUG ADMINISTRATION. THIS PROGRAM IS CALLED THE "SYSTEM
FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY (S.T.E.P.S.® )".

UNDER THIS RESTRICTED DISTRIBUTION PROGRAM, ONLY PRESCRIBERS AND PHARMACISTS
REGISTERED WITH THE PROGRAM ARE ALLOWED TO PRESCRIBE AND DISPENSE THE PRODUCT.
IN ADDITION, PATIENTS MUST BE ADVISED OF, AGREE TO, AND COMPLY WITH THE REQUIREMENTS
OF THE S.T.E.P.S.® PROGRAM IN ORDER TO RECEIVE PRODUCT.
PLEASE SEE THE FOLLOWING BOXED WARNINGS CONTAINING SPECIAL INFORMATION FOR
PRESCRIBERS, FEMALE PATIENTS, AND MALE PATIENTS ABOUT THIS RESTRICTED DISTRIBUTION
PROGRAM.


PRESCRIBERS
THALOMID® (thalidomide) may be prescribed only by licensed prescribers
who are registered in the S.T.E.P.S.® program and understand the
risk of teratogenicity if thalidomide is used during pregnancy.
Major human fetal abnormalities related to thalidomide administration during
pregnancy have been documented: amelia (absence of limbs), phocomelia (short
limbs), hypoplasticity of the bones, absence of bones, external ear abnormalities
(including anotia, micro pinna, small or absent external auditory canals), facial
palsy, eye abnormalities (anophthalmos, microphthalmos), and congenital heart
defects. Alimentary tract, urinary tract, and genital malformations have also
been documented.1 Mortality at or shortly after birth has been reported
at about 40%.2
Effective contraception (see CONTRAINDICATIONS)
must be used for at least 4 weeks before beginning thalidomide therapy, during
thalidomide therapy, and for 4 weeks following discontinuation of thalidomide
therapy. Reliable contraception is indicated even where there has been a history
of infertility, unless due to hysterectomy or because the patient has been
postmenopausal for at least 24 months. Two reliable forms of contraception
must be used simultaneously unless continuous abstinence from heterosexual
sexual contact is the chosen method. Women of childbearing potential should
be referred to a qualified provider of contraceptive methods, if needed. Sexually
mature women who have not undergone a hysterectomy or who have not been postmenopausal
for at least 24 consecutive months (i.e., who have had menses at some time
in the preceding 24 consecutive months) are considered to be women of childbearing
potential.
Before starting treatment, women of childbearing potential should have
a pregnancy test (sensitivity of at least 50 mIU/mL). The test should be performed
within the 24 hours prior to beginning thalidomide therapy. A prescription for
thalidomide for a woman of childbearing potential must not be issued by the
prescriber until a written report of a negative pregnancy test has been obtained
by the prescriber.
Male Patients: Because thalidomide is present in the semen of patients
receiving the drug, males receiving thalidomide must always use a latex condom
during any sexual contact with women of childbearing potential even if he has
undergone a successful vasectomy.
Once treatment has started, pregnancy testing should occur weekly during
the first 4 weeks of use, then pregnancy testing should be repeated at 4 weeks
in women with regular menstrual cycles. If menstrual cycles are irregular, the
pregnancy testing should occur every 2 weeks. Pregnancy testing and counseling
should be performed if a patient misses her period or if there is any abnormality
in menstrual bleeding.
If pregnancy does occur during thalidomide treatment, thalidomide must be discontinued
immediately.
Any suspected fetal exposure to THALOMID® (thalidomide) must be reported
immediately to the FDA via the MedWatch number at 1-800-FDA-1088 and also to
Celgene Corporation at 1-888-423-5436. The patient should be referred to an
obstetrician/gynecologist experienced in reproductive toxicity for further evaluation
and counseling.


FEMALE PATIENTS
Thalidomide is contraindicated in WOMEN of childbearing potential unless alternative
therapies are considered inappropriate AND the patient MEETS ALL OF THE FOLLOWING
CONDITIONS (i.e., she is essentially unable to become pregnant while on thalidomide
therapy):

she understands and can reliably carry out instructions.
she is capable of complying with the mandatory contraceptive measures, pregnancy
testing, patient registration, and patient survey as described in the System
for Thalidomide Education and Prescribing Safety (S.T.E.P.S.® )
program.
she has received both oral and written warnings of the hazards of taking
thalidomide during pregnancy and of exposing a fetus to the drug.
she has received both oral and written warnings of the risk of possible
contraception failure and of the need to use two reliable forms of contraception
simultaneously (see CONTRAINDICATIONS),
unless continuous abstinence from heterosexual sexual contact is the chosen
method. Sexually mature women who have not undergone a hysterectomy or who
have not been postmenopausal for at least 24 consecutive months (i.e., who
have had menses at some time in the preceding 24 consecutive months) are
considered to be women of childbearing potential.
she acknowledges, in writing, her understanding of these warnings and of
the need for using two reliable methods of contraception for 4 weeks prior
to beginning thalidomide therapy, during thalidomide therapy, and for 4 weeks
after discontinuation of thalidomide therapy.
she has had a negative pregnancy test with a sensitivity of at least 50
mIU/mL, within the 24 hours prior to beginning therapy. (See PRECAUTIONS,
CONTRAINDICATIONS)
if the patient is between 12 and 18 years of age, her parent or legal guardian
must have read this material and agreed to ensure compliance with the above.



MALE PATIENTS
Thalidomide is contraindicated in sexually mature MALES unless the PATIENT
MEETS ALL OF THE FOLLOWING CONDITIONS:

he understands and can reliably carry out instructions.
he is capable of complying with the mandatory contraceptive measures that
are appropriate for men, patient registration, and patient survey as described
in the S.T.E.P.S.® program.
he has received both oral and written warnings of the hazards of taking
thalidomide and exposing a fetus to the drug.
he has received both oral and written warnings of the risk of possible contraception
failure and of the presence of thalidomide in semen. He has been instructed
that he must always use a latex condom during any sexual contact with women
of childbearing potential, even if he has undergone a successful vasectomy.
he acknowledges, in writing, his understanding of these warnings and of
the need to use a latex condom during any sexual contact with women of childbearing
potential, even if he has undergone a successful vasectomy. Sexually mature
women who have not undergone a hysterectomy or who have not been postmenopausal
for at least 24 consecutive months (i.e., who have had menses at any time
in the preceding 24 consecutive months) are considered to be women of childbearing
potential.
if the patient is between 12 and 18 years of age, his parent or legal guardian
must have read this material and agreed to ensure compliance with the above.



VENOUS THROMBOEMBOLIC EVENTS
The use of THALOMID® (thalidomide) in multiple myeloma results in an
increased risk of venous thromboembolic events, such as deep venous thrombosis
and pulmonary embolus. This risk increases significantly when thalidomide is
used in combination with standard chemotherapeutic agents including dexamethasone.
In one controlled trial, the rate of venous thromboembolic events was 22.5%
in patients receiving thalidomide in combination with dexamethasone compared
to 4.9% in patients receiving dexamethasone alone (p = 0.002). Patients and
physicians are advised to be observant for the signs and symptoms of thromboembolism.
Patients should be instructed to seek medical care if they develop symptoms
such as shortness of breath, chest pain, or arm or leg swelling. Preliminary
data suggest that patients who are appropriate candidates may benefit from concurrent
prophylactic anticoagulation or aspirin treatment.

DRUG DESCRIPTION



What are the possible side effects of thalidomide (Thalomid)?

Stop using this medicine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

chest pain, sudden shortness of breath, coughing up blood;
pain or swelling in your arm, thigh, or calf;
easy bruising, unusual bleeding or weakness;
slow heartbeats, shallow breathing;
...
Read All Potential Side Effects for Thalomid »




THALOMID® (thalidomide), α-(N-phthalimido) glutarimide, is an immunomodulatory
agent. The empirical formula for thalidomide is C13H10N2O4
and the gram molecular weight is 258.2. The CAS number of thalidomide is 50-35-1.
Chemical Structure of thalidomide









Note:• = asymmetric carbon atom
Thalidomide is an off-white to white, odorless, crystalline powder that is
soluble at 25°C in dimethyl sulfoxide and sparingly soluble in water and
ethanol. The glutarimide moiety contains a single asymmetric center and, therefore,
may exist in either of two optically active forms designated S-(-) or R-(+).
THALOMID® (thalidomide) is an equal mixture of the S-(-) and R-(+) forms
and, therefore, has a net optical rotation of zero.
THALOMID® (thalidomide) is available in 50 mg, 100 mg, 150 mg and 200 mg
capsules for oral administration. Active ingredient: thalidomide. Inactive ingredients:
pregelatinized starch and magnesium stearate. The 50 mg capsule shell contains
gelatin, titanium dioxide, and black ink. The 100 mg capsule shell contains
black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black ink.
The 150 mg capsule shell contains FD&C blue #2, black iron oxide, yellow
iron oxide, titanium dioxide, gelatin, and black and white ink. The 200 mg capsule
shell contains FD&C blue #2, titanium dioxide, gelatin, and white ink.
REFERENCES
1.Manson JM. 1986. Teratogenicity. Cassarett and Doull's Toxicology: The
Basic Science of Poisons. Third Edition. Pages 195-220. New York: MacMillan
Publishing Co.
2.Smithels RW and Newman CG. 1992. J. Med. Genet. 29(10):716-723.Last reviewed on RxList: 8/1/2007





Other reviews about Thalidomide on wordpress

Thalidomide Provides Hope to Women Diagnosed with Ovarian Cancer When Combined with Topotecan
  by Libby's H*O*P*E*
"We found that patients who received topotecan plus thalidomide showed an overall response rate of 47 percent compared to 21 percent response in patients who received only topotecan"' […]


Thalidomide
  by embryology
Thalilomide was the most celebrated limb reducing insult (teratogen) in humans which also produced a range of other deformities depending on developmental time and concentration of the drug […]


Thalidomide For Ovarian Treatment
  by patoconnor
Thalidomide For Ovarian Treatment Nov. 22, 2008 Washington: Thalidomide, a drug banned in the 1950s for causing birth defects, is showing promise as a safe and effective treatment for women […]


New data from two studies on adjuvant radiation and thalidomide post-surgery
  by Sitemaster
Biochemical recurrence after first-line treatment for localized prostate cancer affects some 30 to 40 percent of prostate cancer patients. Two articles to be published in the March 2009 issue of The Journal […]


Abnormal Development - Thalidomide
  by embryology
This PNAS paper looks into a basic mechanism for thalidomide's action on limb development and identified an effect on blood vessel growth within the limb.Thalidomide induces limb defects […]


Aging thalidomide victims require increased funding claims MP
  by ispystrangers
A Liberal Democrat MP has aked the government to consider a new compensation scheme for NHS thalidomide victims. The drug was prescribed worldwide from 1957 until 1961 when it […]


Brazil ordered to compensate thalidomide victims
  by Drug Recall Watch
A federal court has ordered the Brazilian government to compensate children of mothers who took thalidomide, a drug that caused birth defects in thousands of people across the […]


Medical Myths: Thalidomide
  by jdc325
Thalidomide, Animal Testing, And Investigative Journalism There are some apparently misreported 'facts' about thalidomide that seem to keep cropping up - for example, that the teratogenic effects were covered […]


Scientists may have found the mechanism by which Thalidomide causes defects
  by Timinator
From the Royal Society of Chemistry: Scientists in Japan believe they have revealed one of the key molecular targets that binds to the drug thalidomide to cause birth defects. […]


Thalidomide may fight blood vessel disorder: Nosebleeds eased with once-maligned drug
  by thassodotcom
April 05, 2010 - A very recent article by msnbc.com indicates that thalidomide, a drug that caused birth defects when it was launched as a morning sickness pill […]



Other reviews about Thalidomide on web:

This article is about the drug. For the musical about a person with Thalidomide disability, see Thalidomide!! A Musical. Thalidomide - Wikipedia, the free encyclopedia


thalidomide ( ) n. A sedative and hypnotic drug, C 13 H 10 N 2 O 4 , withdrawn from general use after it was found to cause severe birth defects when thalidomide: Definition from Answers.com


Official site from Celgene. Includes patient and prescribing information. THALOMID® (thalidomide): Homepage


Overview; History of birth defects; New therapeutic uses; Government regulation and safeguards; Current research; Links to useful information; Overview. In the 1960s the drug ... NTP-CERHR: Common Concerns - Thalidomide


All about Thalidomide. View complete and up to date Thalidomide information - part of the Drugs.com trusted medication database. Thalidomide Facts and Comparisons at Drugs.com


thalidomide , sleep-inducing drug found to produce skeletal defects in developing fetuses. The drug was marketed in Europe, especially in West... thalidomide Facts, information, pictures | Encyclopedia.com ...


Thalidomide — Comprehensive overview covers research, complications and uses, including treatment of multiple myeloma. Thalidomide: Research advances in cancer and other conditions ...


L'ACVT a besoin de votre générosité pour aider les victimes de la tragédie de la Thalidomide. TVAC Helps the Canadian victims of the Thalidomide www.thalidomide.ca - Thalidomide


Why It Is Prescribed. Thalidomide is used to treat and prevent skin conditions caused by erythema nodosum leprosum (ENL). This medication is sometimes prescribed for other uses; ask ... Thalidomide - Kosmix : Reference, Videos, Images, News, Shopping ...


This page contains brief information about thalidomide and a collection of links to more information about the use of this drug, related news and research results, and ongoing ... Thalidomide - National Cancer Institute





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59sec - the BEST lead management system around!
We tested 59sec - THE lead management system and we love it. 59sec helps small and medium companies to answer leads in maximum 59 seconds. Why...
MOVEorPAY - our favorite facebook app
We do love MOVEorPAY motivational facebook app, because it is very cool and useful. It makes you finish stuff that you know are good for you, but from various reasons, you never do...
ReviewsAZ is almost ready to be officially launched
yes, we have just a few loose ends to tie and we are ready to go :) meanwhile, I am putting some reviews on the site, so people will not get an empty site at the launch....