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:

McKesson Corporation dba SKY Packaging

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. T

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 and are supplied in boxes of 10 x 10 UD 100's NDC 63739-143-10. 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). Distributed by: McKesson Corporation dba SKY Packaging Memphis, TN 38141 Manufactured by: Mayne Pharma Greenville, NC 27834 21831-2 July 2023

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

McKesson Corporation dba SKY Packaging
----------
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 tab

Summary of Product characteristics

TAMOXIFEN CITRATE- TAMOXIFEN CITRATE TABLET, FILM COATED
MCKESSON CORPORATION DBA SKY PACKAGING
----------
TAMOXIFEN CITRATE
WARNING
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)1. 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 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.
2 See TABLE 3 under CLINICAL PHARMACOLOGY, CLINICAL STUDIES.
DESCRIPTION
Tamoxifen citrate tablets USP, a nonsteroidal antiestrogen, are for
oral administration. Each tablet contains 10
mg tamoxifen (equivalent to 15.2 mg of tamoxifen citrate, USP).
Each tablet contains the following inactive ingredients:
croscarmellose sodium, hypromellose, lactose
(monohydrate), magnesium stearate,