TAMOXIFEN CITRATE tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

A-S Medication Solutions

INN (Международно Name):

TAMOXIFEN CITRATE

Композиция:

TAMOXIFEN 20 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Tamoxifen citrate tablets, USP 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, USP 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, USP 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 one 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 1-888-838-2872. 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 citrate 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 citrate 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.

Каталог на резюме:

Product: 50090-0942 NDC: 50090-0942-0 90 TABLET in a BOTTLE, PLASTIC

Статус Оторизация:

Abbreviated New Drug Application

Листовка

A-S Medication Solutions
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MEDICATION GUIDE
Dispense with Medication Guide available at: www.tevausa.com/medguides
Tamoxifen Citrate (ta mox′ i fen si′ trate) Tablets, USP
Written for women who use tamoxifen 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 to lower the
chance of getting breast cancer in
high-risk women and in women treated for DCIS.
People taking tamoxifen 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 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 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
to lower your chance of getting
breast cancer.
You and your doctor should talk about whether the possible benefit of
tamoxifen 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 to decrease your chance
of getting invasive (spreading) breast cancer.
Read this guide carefully before you start tamoxifen. 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 and does not take the place of talking with your doctor.
Only you and your doctor can determine if tamoxifen is right for you.
What is the most important information I should know about using
tamoxifen to reduce the chance of
getting breast cancer?
Tamoxifen is a prescription medicine that is like estrogen (female
hormone)

Данни за продукта

TAMOXIFEN CITRATE- TAMOXIFEN CITRATE TABLET
A-S MEDICATION SOLUTIONS
----------
TAMOXIFEN CITRATE TABLETS, USP
RX ONLY
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 citrate outweigh its risks in women already
diagnosed
with breast cancer.
*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.
DESCRIPTION
Tamoxifen citrate tablets, USP, a nonsteroidal antiestrogen, are for
oral administration.
Chemically, tamoxifen 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