AROMASIN- exemestane tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Pharmacia & Upjohn Company LLC

INN (International ime):

EXEMESTANE

Sastav:

EXEMESTANE 25 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

AROMASIN is 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 AROMASIN for completion of a total of five consecutive years of adjuvant hormonal therapy [see Clinical Studies (14.1)]. AROMASIN is indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see Clinical Studies (14.2)]. AROMASIN is 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, AROMASIN 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 increased incidence of abortions, embryo-fetal toxicit

Proizvod sažetak:

AROMASIN Tablets are round, biconvex, and off-white to slightly gray. Each tablet contains 25 mg of exemestane. The tablets are printed on one side with the number "7663" in black. AROMASIN is packaged in HDPE bottles with a child-resistant screw cap, supplied in packs of 30 tablets. 30-tablet HDPE bottle NDC 0009-7663-04 Store at 25°C (77ºF); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].

Status autorizacije:

New Drug Application

Svojstava lijeka

AROMASIN- EXEMESTANE TABLET
PHARMACIA & UPJOHN COMPANY LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AROMASIN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AROMASIN.
AROMASIN® (EXEMESTANE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
AROMASIN is an aromatase inhibitor indicated for:
•
•
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
•
•
•
ADVERSE REACTIONS
•
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PFIZER INC AT
1-800-438-1985 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Strong CYP 3A4 inducers: Concomitant use of strong CYP 3A4 inducers
decreases exemestane exposure.
Increase the AROMASIN dose to 50 mg (2.2, 7).
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed (8.2).
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 11/2021
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
AROMASIN 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).
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).
Early breast cancer: Adverse reactions occurring in ≥10% of patients
in any treatment group
(AROMASIN vs.