TAMOXIFEN CITRATE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TAMOXIFEN CITRATE (UNII: 7FRV7310N6) (TAMOXIFEN - UNII:094ZI81Y45)

Available from:

Golden State Medical Supply, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy. Tamoxifen citrate tablets are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some tamoxifen adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. Tamoxifen citrate tablets are indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. The estrogen and progesterone receptor values may help to predict whether adjuvant tamoxifen therapy is likely to be beneficial. Tamoxifen reduces the occurrence of contralateral breast cancer in patients receiving adjuvant tamoxifen therapy for breast cancer. In women with DCIS, following breast surgery and radiation, tamoxifen citrate tablets are indicated to reduce the risk of invasive breast cancer (see BOXED WARNING at the beginning of the label). The decision regarding therapy with tamoxifen for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen therapy. Current data from clinical trials support 5 years of adjuvant tamoxifen therapy for patients with breast cancer. Tamoxifen citrate tablets are indicated to reduce the incidence of breast cancer in women at high risk for breast cancer. This effect was shown in a study of 5 years planned duration with a median follow-up of 4.2 years. Twenty-five percent of the participants received drug for 5 years. The longer-term effects are not known. In this study, there was no impact of tamoxifen on overall or breast cancer-related mortality (see BOXED WARNING at the beginning of the label). Tamoxifen citrate tablets are indicated only for high-risk women. "High risk" is defined as women at least 35 years of age with a 5 year predicted risk of breast cancer ≥ 1.67%, as calculated by the Gail Model. Examples of combinations of factors predicting a 5 year risk ≥ 1.67% are: Age 35 or older and any of the following combination of factors: - One first degree relative with a history of breast cancer, 2 or more benign biopsies, and a history of a breast biopsy showing atypical hyperplasia; or - At least 2 first degree relatives with a history of breast cancer, and a personal history of at least 1 breast biopsy; or - LCIS Age 40 or older and any of the following combination of factors: - One first degree relative with a history of breast cancer, 2 or more benign biopsies, age at first live birth 25 or older, and age at menarche 11 or younger; or - At least 2 first degree relatives with a history of breast cancer, and age at first live birth 19 or younger; or - One first degree relative with a history of breast cancer, and a personal history of a breast biopsy showing atypical hyperplasia. Age 45 or older and any of the following combination of factors: - At least 2 first degree relatives with a history of breast cancer and age at first live birth 24 or younger; or - One first degree relative with a history of breast cancer with a personal history of a benign breast biopsy, age at menarche 11 or less and age at first live birth 20 or more. Age 50 or older and any of the following combination of factors: - At least 2 first degree relatives with a history of breast cancer; or - History of 1 breast biopsy showing atypical hyperplasia, and age at first live birth 30 or older and age at menarche 11 or less; or - History of at least 2 breast biopsies with a history of atypical hyperplasia, and age at first live birth 30 or more. Age 55 or older and any of the following combination of factors: - One first degree relative with a history of breast cancer with a personal history of a benign breast biopsy, and age at menarche 11 or less; or - History of at least 2 breast biopsies with a history of atypical hyperplasia, and age at first live birth 20 or older. Age 60 or older and: - Five-year predicted risk of breast cancer ≥ 1.67%, as calculated by the Gail Model. For women whose risk factors are not described in the above examples, the Gail Model is necessary to estimate absolute breast cancer risk. Health Care Professionals can obtain a Gail Model Risk Assessment Tool by dialing 1-844-825-8500. There are insufficient data available regarding the effect of tamoxifen on breast cancer incidence in women with inherited mutations (BRCA1, BRCA2) to be able to make specific recommendations on the effectiveness of tamoxifen in these patients. After an assessment of the risk of developing breast cancer, the decision regarding therapy with tamoxifen for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen therapy. In the NSABP P-1 trial, tamoxifen treatment lowered the risk of developing breast cancer during the follow-up period of the trial, but did not eliminate breast cancer risk (see Table 3 in CLINICAL PHARMACOLOGY ). Tamoxifen citrate tablets are contraindicated in patients with known hypersensitivity to the drug or any of its ingredients. Tamoxifen citrate tablets are contraindicated in women who require concomitant coumarin-type anticoagulant therapy or in women with a history of deep-vein thrombosis or pulmonary embolus.

Product summary:

Tamoxifen citrate tablets USP, 10 mg (base) are white to off-white, round biconvex beveled edges film coated tablets debossed with "MYX" and "642" on one face of the tablet and plain on the other. Supplied in bottles of 60. (NDC 51407-439-60) Tamoxifen citrate tablets USP, 20 mg (base) are white to off-white, round biconvex beveled edges film coated tablets debossed with "MYX" and "643" on one face of the tablet and plain on the other. Supplied in bottles of 30. (NDC 51407-440-30) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required). Medication Guides available at products.maynepharma.com or call 1-844-825-8500.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Golden State Medical Supply, Inc.
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MEDICATION GUIDE
Tamoxifen (TA mox i fen) Citrate Tablets USP
Rx only
Written for women who use tamoxifen citrate tablets to lower their
high chance of getting breast cancer or
who have ductal carcinoma in situ (DCIS)
This Medication Guide discusses only the use of tamoxifen citrate
tablets to lower the chance of getting
breast cancer in high-risk women and in women treated for DCIS.
People taking tamoxifen citrate tablets to treat breast cancer have
different benefits and different
decisions to make than high-risk women or women with ductal carcinoma
in situ (DCIS) taking
tamoxifen citrate tablets to reduce the chance of getting breast
cancer. If you already have breast cancer,
talk with your doctor about how the benefits of treating breast cancer
with tamoxifen citrate tablets
compare to the risks that are described in this document.
Why should I read this Medication Guide?
This guide has information to help you decide whether to use tamoxifen
citrate tablets to lower your
chance of getting breast cancer.
You and your doctor should talk about whether the possible benefit of
tamoxifen citrate tablets in
lowering your high chance of getting breast cancer is greater than its
possible risks. Your doctor has a
special computer program or hand-held calculator to tell if you are in
the high-risk group. If you have
DCIS and have been treated with surgery and radiation therapy, your
doctor may prescribe tamoxifen
citrate tablets to decrease your chance of getting invasive
(spreading) breast cancer.
Read this guide carefully before you start tamoxifen citrate tablets.
It is important to read the information
you get each time you get more medicine. There may be something new.
This guide does not tell you
everything about tamoxifen citrate tablets and does not take the place
of talking with your doctor.
Only you and your doctor can determine if tamoxifen citrate tablets
are right for you.
What is the most important information I should know about using
tamoxifen citrate tablets

Summary of Product characteristics

TAMOXIFEN CITRATE- TAMOXIFEN CITRATE TABLET, FILM COATED
GOLDEN STATE MEDICAL SUPPLY, INC.
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TAMOXIFEN CITRATE
WARNING
FOR WOMEN WITH DUCTAL CARCINOMA IN SITU (DCIS) AND WOMEN AT HIGH
RISK FOR BREAST CANCER
Serious and life-threatening events associated with tamoxifen 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 tamoxifen vs. 0.71
for placebo)
and uterine sarcoma (incidence rate per 1,000 women-years of 0.17 for
tamoxifen
vs. 0.4 for placebo)
. For stroke, the incidence rate per 1,000 women-years was
1.43 for tamoxifen vs. 1.00 for placebo
. For pulmonary embolism, the incidence
rate per 1,000 women-years was 0.75 for tamoxifen 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 tamoxifen to reduce their risk of developing
breast cancer.
The benefits of tamoxifen outweigh its risks in women already
diagnosed with
breast cancer.
1
2
DESCRIPTION
Tamoxifen citrate tablets USP, a nonsteroidal antiestrogen, are for
oral administration.
Each tablet contains 10 mg or 20 mg tamoxifen (equivalent to 15.2 mg
or 30.4 mg,
respectively, of tamoxifen citrate, USP).
Each tablet contains the following inactive ingredients:
croscarmellose sodium,
hypromellose, lactose (monohydrate), magnesium stearate, polyethylene
glycol 400,
povidone, corn starch, and titanium dioxide.
Chemically, tamoxifen is the trans-isomer of a triphenylethylene
derivative. The chemical
name is (Z)2-[4-(1,2-diphenyl-1-butenyl)phenoxy]- _