EXEMESTANE tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Bryant Ranch Prepack

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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, exemestane tablets 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 cause

Tuoteyhteenveto:

Exemestane tablets are White colored, round, biconvex, film-coated tablets debossed with "X" on one side and "1" on other side. Each tablet contains 25 mg of exemestane. Exemestane tablets are packaged in HDPE bottles with a child-resistant screw cap, supplied in bottles of 30 tablets. 30-tablet HDPE bottle NDC 63629-2056-1. Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

EXEMESTANE- EXEMESTANE TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
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).
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 tablets 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
tablets and tamoxifen (6%
vs. 5%). Incidences of cardiac ischemic events (myocardial infarction,
angina, and myocardial ischemia)
were exemestane tablets 1.6%, tamoxifen 0.6%. Incidence of cardiac
f