Reviews Thalomid


No reviews yet.

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 Thalomid on wordpress

Buy Thalomid Online Order Cheap Thalomid Generic Purchase Discount Without Prescription
  by worlddnews
FOLLOW THIS LINK FOR ENTER TO TRUSTED & REPUTABLE ONLINE DRUGSTORE WHERE YOU CAN GET ALL QUALIFIED INFORMATION ABOUT Thalomid ONLINE     In particular there is a energy or a […]


Birth Defects and Miscarriages and Infertility
  by freearticles4you
Messing around with a mother’s DNA or the DNA of her baby is one of the things that can lead to a miscarriage and birth defects. DNA tells […]


EntreMed Receives Deloitte Technology Fast 50 Award
  by julien42
ROCKVILLE, Md., Oct. 3 /PRNewswire-FirstCall/ -- EntreMed, Inc. , a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced […]


MM Update (Managing Neuropathy) 4/4/08
  by Eve
Managing Peripheral Neuropathy   Peripheral neuropathy is a disorder that occurs when nerves in your body's peripheral nervous system (outside the brain and spinal cord) are damaged. Peripheral nerves carry […]


Updated MM Info
  by Eve
Drug Test a Success for Amgen:  http://www.nytimes.com/2008/07/26/business/26amgen.html?_r=2&adxnnl=1&oref=slogin&pagewanted=print&adxnnlx=1217077587-G8/yNTAheWOwn2XfXdt3JQ&oref=slogin The Claim: Quinine Is Effective in Easing Leg Cramps:  http://www.nytimes.com/2008/08/05/health/05real.html?ex=1218600000&en=820377127aa89372&ei=5070&emc=eta1 How Molecules Out Of Balance Lead To Human Multiple Myeloma And Other Cancers: […]


Multiple Myeloma: Will Molecular and Genetic Studies Assist in Selection Treatment?
  by bmirtsching
Treatment of multiple myeloma has improved considerably in the past decade, with integration of high dose therapy (with autologous bone marrow transplant) and/or new drug therapies such as […]


Celgene earnings up 10%, positive clinical results for Revlimid for Multiple Myeloma
  by Shailesh
Celgene ($CELG) reported strong operating results. Some highlights: Revenue was $598 million Earnings of $143 million Revlimid net sales were $397 million, an increase of 22 percent Vidaza net sales reached $92 […]


The Price Of A Good Idea
  by drugsinus
In 1996, Beth Jacobson was watching her husband, a 35-year-old cardiologist, die from the blood cancer multiple myeloma. She spent her nights reading medical journals at […]


The Long Arm of Canada's Patented Medicine Prices Review Board (PMPRB)
  by Jeremy G
In Canada, the Patented Medicine Prices Review Board (PMPRB)'s mandate is to (1) "ensure that prices charged by patentees for patented medicines sold in Canada are not excessive," and […]


Celgene: The new 'Big Kid' on the block
  by Jeffrey Clark
[vodpod id=ExternalVideo.934236&w=425&h=350&fv=] Celgene announced that it expects its blood cancer medicines, long the core of its business (Revlimid, Thalomid & Vidaza), to bring in $6 billion […]



Other reviews about Thalomid on web:

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


Thalomid (thalidomide) is used to treat skin sores caused by erythema nodosum leprosum, a complication of leprosy. Includes Thalomid side effects, interactions and indications. Thalomid Information from Drugs.com


Accurate, FDA approved Thalomid information for healthcare professionals and patients - brought to you by Drugs.com. Thalomid Official FDA information, side effects and uses.


Learn about the prescription medication Thalomid (Thalidomide), drug uses, dosage, side effects, drug interactions, warnings, reviews and patient labeling. Thalomid (Thalidomide) Drug Information: Uses, Side Effects, Drug ...


Thalomid is the trade name for the generic chemotherapy drug Thalidomide. Thalomid is classified as an immunomodulatory agent and an antiangiogenic agent and has been approved by ... Thalomid, Thalidomide - Chemotherapy Drugs, Chemo Drug Side Effects


Thalomid is an immunotherapy indicated for multiple myeloma treatment, in combination with dexamethasone. Research information about Thalomid treatment and side effects at ... Thalomid Information: Description, Side Effects and Thalomid Treatment


Thalomid is an immunomodulatory agent used for treating and preventing skin inflammation in patients who have moderate to severe erythema nodosum leprosum (ENL, leprosy). Side ... Thalomid - drugstore.com. Low prices, side effects, interactions.


Consumer information and patient comments on perscription drugs ... We currently have info on 350 drugs Users have posted 4369 comments Thalomid - The Internet Drug Database


Learn about Thalomid from the publishers of the Physicians Desk Reference. Find prescription drug information resources including interactions, side effects, symptoms ... Thalomid | Prescription Drug Information, Side Effects | PDRHealth


Find patient medical information for Thalomid Oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Thalomid Oral : Uses, Side Effects, Interactions, Pictures ...





Featured Reviews

Reviews Exforge HCT

Exforge HCT Drug Description Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) Tablets WARNING: AVOID USE IN PREGNANCY When pregnancy is detected, discontinue Exforge HCT as soon as possible. Drugs that act directly on the...
Read More  |  Review This
Reviews Potassium Chloride

Slow-K Drug Description SLOW-K (potassium chloride) Tablet, Extended Release DRUG DESCRIPTION Slow-K, potassium chloride extended-release tablets USP, is a sugar-coated (not enteric-coated) tablet for oral administration, containing 600...
Read More  |  Review This
Reviews Diphenhydramine Injection

Benadryl Injection Drug Description Benadryl® (diphenhydramine hydrochloride) Injection, USP DRUG DESCRIPTION Benadryl (diphenhydramine hydrochloride) is an antihistamine drug having the chemical name 2-(Diphenylmethoxy)-N,N-dimethylethylamine...
Read More  |  Review This
Reviews Neomycin, Polymyxin and Bacitracin Zinc Ophthalmic Ointment

Neosporin Ophthalmic Ointment Drug Description NEOSPORIN® Ophthalmic Ointment Sterile (neomycin and polymyxin B sulfates and bacitracin zinc) Ophthalmic Ointment, USP) DRUG DESCRIPTION NEOSPORIN Ophthalmic Ointment (neomycin and polymyxin...
Read More  |  Review This
Reviews Skelid

Skelid Drug Description SKELID® (tiludronate disodium) DRUG DESCRIPTION What are the possible side effects of tiludronate (Skelid)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty...
Read More  |  Review This
Recent News
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....