EXEMESTANE tablet, film coated

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Amneal Pharmaceuticals LLC

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 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 toxicity, and prolonged gestation with abnormal or difficult labor [see Data] . Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In animal reproduction studies in rats and rabbits, exemestane caused embryo-fetal toxicity, and was abortifacient. Radioactivity related to 14 C-exemestane crossed the placenta of rats following oral administration of 1 mg/kg exemestane. The concentration of exemestane and its metabolites was approximately equivalent in maternal and fetal blood. When rats were administered exemestane from 14 days prior to mating until either days 15 or 20 of gestation, and resuming for the 21 days of lactation, an increase in placental weight was seen at 4 mg/kg/day (approximately 1.5 times the recommended human daily dose on a mg/m2 basis). Increased resorptions, reduced number of live fetuses, decreased fetal weight, retarded ossification, prolonged gestation and abnormal or difficult labor was observed at doses equal to or greater than 20 mg/kg/day (approximately 7.5 times the recommended human daily dose on a mg/m2 basis). Daily doses of exemestane, given to rabbits during organogenesis, caused a decrease in placental weight at 90 mg/kg/day (approximately 70 times the recommended human daily dose on a mg/m2 basis) and in the presence of maternal toxicity, abortions, an increase in resorptions, and a reduction in fetal body weight were seen at 270 mg/kg/day. No malformations were noted when exemestane was administered to pregnant rats or rabbits during the organogenesis period at doses up to 810 and 270 mg/kg/day, respectively (approximately 320 and 210 times the recommended human dose on a mg/m2 basis, respectively). Risk Summary There is no information on the presence of exemestane in human milk, or on its effects on the breastfed infant or milk production. Exemestane is present in rat milk at concentrations similar to maternal plasma [see Data] . Because of the potential for serious adverse reactions in breast-fed infants from exemestane, advise a woman not to breastfeed during treatment with exemestane and for 1 month after the final dose. Data Radioactivity related to exemestane appeared in rat milk within 15 minutes of oral administration of radiolabeled exemestane. Concentrations of exemestane and its metabolites were approximately equivalent in the milk and plasma of rats for 24 hours after a single oral dose of 1 mg/kg 14 C-exemestane. Pregnancy Testing Pregnancy testing is recommended for females of reproductive potential within seven days prior to initiating exemestane. Contraception Females Exemestane can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)] . Advise females of reproductive potential to use effective contraception during treatment with exemestane and for 1 month after the final dose. Infertility Based on findings in animals, male and female fertility may be impaired by treatment with exemestane [see Nonclinical Toxicology (13.1)] . Safety and effectiveness in pediatric patients have not been established. The AUC of exemestane was increased in subjects with moderate or severe hepatic impairment (Childs-Pugh B or C) [see Clinical Pharmacology (12.3)] . However, based on experience with exemestane at repeated doses up to 200 mg daily that demonstrated a moderate increase in non life-threatening adverse reactions, dosage adjustment does not appear to be necessary. The AUC of exemestane was increased in subjects with moderate or severe renal impairment (creatinine clearance <35 mL/min/1.73 m2 ) [see Clinical Pharmacology (12.3)] . However, based on experience with exemestane at repeated doses up to 200 mg daily that demonstrated a moderate increase in non life-threatening adverse reactions, dosage adjustment does not appear to be necessary.

Sommarju tal-prodott:

Exemestane tablets, USP are white, round, film-coated tablets and debossed with “A4” on one side and plain on the other side. Each tablet contains 25 mg of exemestane, USP. Exemestane tablets, USP are packaged in HDPE bottles with a child-resistant screw cap. They are available as follows: Bottles of 30: NDC 65162-240-03 Store at 20° to 25°C (68° to 77ºF); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

EXEMESTANE- EXEMESTANE TABLET, FILM COATED
AMNEAL PHARMACEUTICALS LLC
----------
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 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