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Basic Drug Info
Drug Name:Aromasin
Manufacturer:Pharmacia and Upjohn Company
Other Info:Rx onlyLAB-0098-11.0October 2008



Clinical Trials:


Indications and Usage
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.AROMASIN is indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.
Breast Carcinoma -- (brest KAN-ser) Cancer that forms in tissues of the breast, usually the ducts (tubes that carry milk to the nipple) and lobules (glands that make milk). It occurs in both men and women, although male breast cancer is rare.

Malignant neoplasm of breast -- A primary or metastatic malignant neoplasm involving the breast. The vast majority of cases are carcinomas arising from the breast parenchyma or the nipple. Malignant breast neoplasms occur more frequently in females than in males. -- 2003

Advanced Malignant Neoplasm --

Disease -- A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown.

Contraindications
AROMASIN Tablets are contraindicated in patients with a known hypersensitivity to the drug or to any of the excipients.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

AROMASIN Tablets may cause fetal harm when administered to a pregnant woman.

Radioactivity related to 14C-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).

Prolonged gestation and abnormal or difficult labor was observed at doses equal to or greater than 20 mg/kg/day.

Increased resorption, reduced number of live fetuses, decreased fetal weight, and retarded ossification were also observed at these doses.

No malformations were noted when exemestane was administered to pregnant rats during the organogenesis period at doses up to 810 mg/kg/day (approximately 320 times the recommended human 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).

Abortions, an increase in resorptions, and a reduction in fetal body weight were seen at 270 mg/kg/day.

There was no increase in the incidence of malformations in rabbits at doses up to 270 mg/kg/day (approximately 210 times the recommended human dose on a mg/m2 basis).There are no studies in pregnant women using AROMASIN.

AROMASIN is indicated for postmenopausal women.

If there is exposure to AROMASIN during pregnancy, the patient should be apprised of the potential hazard to the fetus and potential risk for loss of the pregnancy.

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