EXEMESTANE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

EXEMESTANE (UNII: NY22HMQ4BX) (EXEMESTANE - UNII:NY22HMQ4BX)

Disponible desde:

Zydus Pharmaceuticals USA Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Exemestane tablets are indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane tablets for completion of a total of five consecutive years of adjuvant hormonal therapy [see Clinical Studies (14.1)] . Exemestane tablets are indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see Clinical Studies (14.2) ]. Exemestane tablets are contraindicated in patients with a known hypersensitivity to the drug or to any of the excipients. Risk Summary Based on findings in animal studies and its mechanism of action, exemetane can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . Limited human data from case reports are insufficient to inform a drug-associated risk. In animal reproduction studies, administration of exemestane to pregnant rats and rabbits caused increase

Resumen del producto:

Exemestane Tablets USP, 25 mg are white to off-white, round-shaped, film-coated tablets debossed with '383' on one side and plain on other side and are supplied as follows: NDC 68382-383-06 in bottle of 30 tablets with child-resistant closure Storage Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

EXEMESTANE - EXEMESTANE TABLET
Zydus Pharmaceuticals USA Inc.
----------
FDA- Approved Patient Labeling
Patient Information
Exemestane (EX-e-MES-tane) Tablets, USP
What are exemestane tablets?
Exemestane tablets are used in women who are past menopause for the
treatment of:
•
Early breast cancer (cancer that has not spread outside the breast) in
women who:
•
have cancer that needs the female hormone estrogen to grow and
•
have had other treatments for breast cancer and
•
have taken tamoxifen for 2 to 3 years and
•
are switching to exemestane to complete 5 years in a row of hormonal
therapy.
•
Advanced breast cancer (cancer that has spread), after treatment with
tamoxifen and it did not work
or is no longer working.
It is not known if exemestane tablets are safe and effective in
children.
Do not take exemestane tablets if you are allergic to exemestane or
any of the ingredients in exemestane
tablets. See the end of this leaflet for a complete list of
ingredients in exemestane tablets.
Before you take exemestane tablets, tell your doctor about all your
medical conditions, including if you:
•
are still having menstrual periods (are not past menopause).
Exemestane is only for women who are
past menopause.
•
have weak or brittle bones (osteoporosis)
•
are pregnant or plan to become pregnant. Taking exemestane during
pregnancy or within 1 month of
becoming pregnant can harm your unborn baby.
•
Females who are able to become pregnant should have a pregnancy test
within 7 days before
starting treatment with exemestane.
•
Females who are able to become pregnant should use effective birth
control (contraceptive)
during treatment with exemestane and for 1 month after your last dose
of exemestane. Tell
your doctor right away if you become pregnant or think you may be
pregnant.
•
are breastfeeding or plan to breastfeed. It is not known if exemestane
passes into your breast milk. Do
not breast-feed during treatment with exemestane and for 1 month after
your last dose of exemestane.
•
Have liver or kid

Ficha técnica

EXEMESTANE - EXEMESTANE TABLET
ZYDUS PHARMACEUTICALS USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EXEMESTANE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
EXEMESTANE TABLETS.
EXEMESTANE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Exemestane tablets are an aromatase inhibitor indicated for:
adjuvant treatment of postmenopausal women with estrogen-receptor
positive early breast cancer who
have received two to three years of tamoxifen and are switched to
exemestane tablets for completion
of a total of five consecutive years of adjuvant hormonal therapy
(14.1).
the treatment of advanced breast cancer in postmenopausal women whose
disease has progressed
following tamoxifen therapy (14.2).
DOSAGE AND ADMINISTRATION
Recommended Dose: One 25 mg tablet once daily after a meal (2.1).
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg (3)
CONTRAINDICATIONS
Patients with a known hypersensitivity to the drug or to any of the
excipients (4)
WARNINGS AND PRECAUTIONS
Reductions in bone mineral density (BMD) over time are seen with
exemestane use (5.1).
Routine assessment of 25-hydroxy vitamin D levels prior to the start
of aromatase inhibitor treatment
should be performed (5.2).
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of
reproductive potential of the potential
risk to a fetus and to use effective contraception (5.6, 8.1, 8.3).
ADVERSE REACTIONS
Early breast cancer: Adverse reactions occurring in ≥ 10% of
patients in any treatment group
(exemestane vs. tamoxifen) were hot flushes (21% vs. 20%), fatigue
(16% vs. 15%), arthralgia (15% vs.
9%), headache (13% vs. 11%), insomnia (12% vs. 9%), and increased
sweating (12% vs. 10%).
Discontinuation rates due to AEs were similar between exemestane and
tamoxifen (6% vs. 5%).
Incidences of cardiac ischemic events (myocardial infarction, angina,
and myocardial ischemia) were
exemestane 1.6%, tamoxifen 0.6%. Incidence of cardiac failure:
exemestane 0.4