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Nolvadex Drug Description
NOLVADEX
(tamoxifen citrate) Tablets

WARNING
For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for
Breast Cancer: Serious and life-threatening events associated with NOLVADEX
in the risk reduction setting (women at high risk for cancer and women with
DCIS) include uterine malignancies, stroke and pulmonary embolism. Incidence
rates for these events were estimated from the NSABP P-1 trial (see CLINICAL
PHARMACOLOGY-Clinical Studies - Reduction in Breast
Cancer Incidence In High Risk Women). Uterine malignancies consist of
both endometrial adenocarcinoma (incidence rate per 1,000 women-years of 2.20
for NOLVADEX vs 0.71 for placebo) and uterine sarcoma (incidence rate per
1,000 women-years of 0.17 for NOLVADEX vs 0.4 for placebo)*. For stroke, the
incidence rate per 1,000 women-years was 1.43 for NOLVADEX vs 1.00 for placebo**.
For pulmonary embolism, the incidence rate per 1,000 women-years was 0.75
for NOLVADEX versus 0.25 for placebo**.
Some of the strokes, pulmonary emboli, and uterine malignancies were fatal.

Health care providers should discuss the potential benefits versus the potential
risks of these serious events with women at high risk of breast cancer and women
with DCIS considering NOLVADEX to reduce their risk of developing breast cancer.

The benefits of NOLVADEX outweigh its risks in women already diagnosed with
breast cancer.
REFERENCES
*Updated long-term follow-up data (median length of follow-up
is 6.9 years) from NSABP P-1 study. See WARNINGS:
Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma.
**See Table 3 under CLINICAL PHARMACOLOGY-Clinical
Studies.

DRUG DESCRIPTION
NOLVADEX® (tamoxifen citrate) Tablets, a nonsteroidal antiestrogen, are
for oral administration. NOLVADEX Tablets are available as:
10 mg Tablets
Each tablet contains 15.2 mg of tamoxifen citrate which is equivalent to 10
mg of tamoxifen.
20 mg Tablets
Each tablet contains 30.4 mg of tamoxifen citrate which is equivalent to 20
mg of tamoxifen.
Inactive Ingredients: carboxymethylcellulose calcium, magnesium stearate, mannitol
and starch.
Chemically, NOLVADEX is the trans-isomer of a triphenylethylene derivative.
The chemical name is (Z)2-[4-(1,2-diphenyl-1-butenyl) phenoxy]-N, N-dimethylethanamine
2 hydroxy-1,2,3- propanetricarboxylate (1:1). The structural and empirical formulas
are:








Tamoxifen citrate has a molecular weight of 563.62, the pKa' is 8.85, the equilibrium
solubility in water at 37°C is 0.5 mg/mL and in 0.02 N HCl at 37°C,
it is 0.2 mg/mL.Last reviewed on RxList: 4/10/2008




Nolvadex Drug Description
NOLVADEX
(tamoxifen citrate) Tablets

WARNING
For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for
Breast Cancer: Serious and life-threatening events associated with NOLVADEX
in the risk reduction setting (women at high risk for cancer and women with
DCIS) include uterine malignancies, stroke and pulmonary embolism. Incidence
rates for these events were estimated from the NSABP P-1 trial (see CLINICAL
PHARMACOLOGY-Clinical Studies - Reduction in Breast
Cancer Incidence In High Risk Women). Uterine malignancies consist of
both endometrial adenocarcinoma (incidence rate per 1,000 women-years of 2.20
for NOLVADEX vs 0.71 for placebo) and uterine sarcoma (incidence rate per
1,000 women-years of 0.17 for NOLVADEX vs 0.4 for placebo)*. For stroke, the
incidence rate per 1,000 women-years was 1.43 for NOLVADEX vs 1.00 for placebo**.
For pulmonary embolism, the incidence rate per 1,000 women-years was 0.75
for NOLVADEX versus 0.25 for placebo**.
Some of the strokes, pulmonary emboli, and uterine malignancies were fatal.

Health care providers should discuss the potential benefits versus the potential
risks of these serious events with women at high risk of breast cancer and women
with DCIS considering NOLVADEX to reduce their risk of developing breast cancer.

The benefits of NOLVADEX outweigh its risks in women already diagnosed with
breast cancer.
REFERENCES
*Updated long-term follow-up data (median length of follow-up
is 6.9 years) from NSABP P-1 study. See WARNINGS:
Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma.
**See Table 3 under CLINICAL PHARMACOLOGY-Clinical
Studies.

DRUG DESCRIPTION
NOLVADEX® (tamoxifen citrate) Tablets, a nonsteroidal antiestrogen, are
for oral administration. NOLVADEX Tablets are available as:
10 mg Tablets
Each tablet contains 15.2 mg of tamoxifen citrate which is equivalent to 10
mg of tamoxifen.
20 mg Tablets
Each tablet contains 30.4 mg of tamoxifen citrate which is equivalent to 20
mg of tamoxifen.
Inactive Ingredients: carboxymethylcellulose calcium, magnesium stearate, mannitol
and starch.
Chemically, NOLVADEX is the trans-isomer of a triphenylethylene derivative.
The chemical name is (Z)2-[4-(1,2-diphenyl-1-butenyl) phenoxy]-N, N-dimethylethanamine
2 hydroxy-1,2,3- propanetricarboxylate (1:1). The structural and empirical formulas
are:








Tamoxifen citrate has a molecular weight of 563.62, the pKa' is 8.85, the equilibrium
solubility in water at 37°C is 0.5 mg/mL and in 0.02 N HCl at 37°C,
it is 0.2 mg/mL.Last reviewed on RxList: 4/10/2008




Nolvadex Drug Description
NOLVADEX
(tamoxifen citrate) Tablets

WARNING
For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for
Breast Cancer: Serious and life-threatening events associated with NOLVADEX
in the risk reduction setting (women at high risk for cancer and women with
DCIS) include uterine malignancies, stroke and pulmonary embolism. Incidence
rates for these events were estimated from the NSABP P-1 trial (see CLINICAL
PHARMACOLOGY-Clinical Studies - Reduction in Breast
Cancer Incidence In High Risk Women). Uterine malignancies consist of
both endometrial adenocarcinoma (incidence rate per 1,000 women-years of 2.20
for NOLVADEX vs 0.71 for placebo) and uterine sarcoma (incidence rate per
1,000 women-years of 0.17 for NOLVADEX vs 0.4 for placebo)*. For stroke, the
incidence rate per 1,000 women-years was 1.43 for NOLVADEX vs 1.00 for placebo**.
For pulmonary embolism, the incidence rate per 1,000 women-years was 0.75
for NOLVADEX versus 0.25 for placebo**.
Some of the strokes, pulmonary emboli, and uterine malignancies were fatal.

Health care providers should discuss the potential benefits versus the potential
risks of these serious events with women at high risk of breast cancer and women
with DCIS considering NOLVADEX to reduce their risk of developing breast cancer.

The benefits of NOLVADEX outweigh its risks in women already diagnosed with
breast cancer.
REFERENCES
*Updated long-term follow-up data (median length of follow-up
is 6.9 years) from NSABP P-1 study. See WARNINGS:
Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma.
**See Table 3 under CLINICAL PHARMACOLOGY-Clinical
Studies.

DRUG DESCRIPTION
NOLVADEX® (tamoxifen citrate) Tablets, a nonsteroidal antiestrogen, are
for oral administration. NOLVADEX Tablets are available as:
10 mg Tablets
Each tablet contains 15.2 mg of tamoxifen citrate which is equivalent to 10
mg of tamoxifen.
20 mg Tablets
Each tablet contains 30.4 mg of tamoxifen citrate which is equivalent to 20
mg of tamoxifen.
Inactive Ingredients: carboxymethylcellulose calcium, magnesium stearate, mannitol
and starch.
Chemically, NOLVADEX is the trans-isomer of a triphenylethylene derivative.
The chemical name is (Z)2-[4-(1,2-diphenyl-1-butenyl) phenoxy]-N, N-dimethylethanamine
2 hydroxy-1,2,3- propanetricarboxylate (1:1). The structural and empirical formulas
are:








Tamoxifen citrate has a molecular weight of 563.62, the pKa' is 8.85, the equilibrium
solubility in water at 37°C is 0.5 mg/mL and in 0.02 N HCl at 37°C,
it is 0.2 mg/mL.Last reviewed on RxList: 4/10/2008




Nolvadex Drug Description
NOLVADEX
(tamoxifen citrate) Tablets

WARNING
For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for
Breast Cancer: Serious and life-threatening events associated with NOLVADEX
in the risk reduction setting (women at high risk for cancer and women with
DCIS) include uterine malignancies, stroke and pulmonary embolism. Incidence
rates for these events were estimated from the NSABP P-1 trial (see CLINICAL
PHARMACOLOGY-Clinical Studies - Reduction in Breast
Cancer Incidence In High Risk Women). Uterine malignancies consist of
both endometrial adenocarcinoma (incidence rate per 1,000 women-years of 2.20
for NOLVADEX vs 0.71 for placebo) and uterine sarcoma (incidence rate per
1,000 women-years of 0.17 for NOLVADEX vs 0.4 for placebo)*. For stroke, the
incidence rate per 1,000 women-years was 1.43 for NOLVADEX vs 1.00 for placebo**.
For pulmonary embolism, the incidence rate per 1,000 women-years was 0.75
for NOLVADEX versus 0.25 for placebo**.
Some of the strokes, pulmonary emboli, and uterine malignancies were fatal.

Health care providers should discuss the potential benefits versus the potential
risks of these serious events with women at high risk of breast cancer and women
with DCIS considering NOLVADEX to reduce their risk of developing breast cancer.

The benefits of NOLVADEX outweigh its risks in women already diagnosed with
breast cancer.
REFERENCES
*Updated long-term follow-up data (median length of follow-up
is 6.9 years) from NSABP P-1 study. See WARNINGS:
Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma.
**See Table 3 under CLINICAL PHARMACOLOGY-Clinical
Studies.

DRUG DESCRIPTION
NOLVADEX® (tamoxifen citrate) Tablets, a nonsteroidal antiestrogen, are
for oral administration. NOLVADEX Tablets are available as:
10 mg Tablets
Each tablet contains 15.2 mg of tamoxifen citrate which is equivalent to 10
mg of tamoxifen.
20 mg Tablets
Each tablet contains 30.4 mg of tamoxifen citrate which is equivalent to 20
mg of tamoxifen.
Inactive Ingredients: carboxymethylcellulose calcium, magnesium stearate, mannitol
and starch.
Chemically, NOLVADEX is the trans-isomer of a triphenylethylene derivative.
The chemical name is (Z)2-[4-(1,2-diphenyl-1-butenyl) phenoxy]-N, N-dimethylethanamine
2 hydroxy-1,2,3- propanetricarboxylate (1:1). The structural and empirical formulas
are:








Tamoxifen citrate has a molecular weight of 563.62, the pKa' is 8.85, the equilibrium
solubility in water at 37°C is 0.5 mg/mL and in 0.02 N HCl at 37°C,
it is 0.2 mg/mL.Last reviewed on RxList: 4/10/2008




Nolvadex Drug Description
NOLVADEX
(tamoxifen citrate) Tablets

WARNING
For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for
Breast Cancer: Serious and life-threatening events associated with NOLVADEX
in the risk reduction setting (women at high risk for cancer and women with
DCIS) include uterine malignancies, stroke and pulmonary embolism. Incidence
rates for these events were estimated from the NSABP P-1 trial (see CLINICAL
PHARMACOLOGY-Clinical Studies - Reduction in Breast
Cancer Incidence In High Risk Women). Uterine malignancies consist of
both endometrial adenocarcinoma (incidence rate per 1,000 women-years of 2.20
for NOLVADEX vs 0.71 for placebo) and uterine sarcoma (incidence rate per
1,000 women-years of 0.17 for NOLVADEX vs 0.4 for placebo)*. For stroke, the
incidence rate per 1,000 women-years was 1.43 for NOLVADEX vs 1.00 for placebo**.
For pulmonary embolism, the incidence rate per 1,000 women-years was 0.75
for NOLVADEX versus 0.25 for placebo**.
Some of the strokes, pulmonary emboli, and uterine malignancies were fatal.

Health care providers should discuss the potential benefits versus the potential
risks of these serious events with women at high risk of breast cancer and women
with DCIS considering NOLVADEX to reduce their risk of developing breast cancer.

The benefits of NOLVADEX outweigh its risks in women already diagnosed with
breast cancer.
REFERENCES
*Updated long-term follow-up data (median length of follow-up
is 6.9 years) from NSABP P-1 study. See WARNINGS:
Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma.
**See Table 3 under CLINICAL PHARMACOLOGY-Clinical
Studies.

DRUG DESCRIPTION
NOLVADEX® (tamoxifen citrate) Tablets, a nonsteroidal antiestrogen, are
for oral administration. NOLVADEX Tablets are available as:
10 mg Tablets
Each tablet contains 15.2 mg of tamoxifen citrate which is equivalent to 10
mg of tamoxifen.
20 mg Tablets
Each tablet contains 30.4 mg of tamoxifen citrate which is equivalent to 20
mg of tamoxifen.
Inactive Ingredients: carboxymethylcellulose calcium, magnesium stearate, mannitol
and starch.
Chemically, NOLVADEX is the trans-isomer of a triphenylethylene derivative.
The chemical name is (Z)2-[4-(1,2-diphenyl-1-butenyl) phenoxy]-N, N-dimethylethanamine
2 hydroxy-1,2,3- propanetricarboxylate (1:1). The structural and empirical formulas
are:








Tamoxifen citrate has a molecular weight of 563.62, the pKa' is 8.85, the equilibrium
solubility in water at 37°C is 0.5 mg/mL and in 0.02 N HCl at 37°C,
it is 0.2 mg/mL.Last reviewed on RxList: 4/10/2008





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