ANABREZ ANASTROZOLE FILM COATED TABLET USP 1MG

Prescription Only

Drug type: Therapeutic

ATC code: L02BG03

Dosage form: TABLET, FILM COATED

Route of administration: ORAL

Active ingredient: Anastrozole; ANASTROZOLE

INDICATIONS

ANABREZ is indicated for adjuvant treatment of postmenopausal women with hormone receptor positive early invasive breast cancer.

Treatment of advanced breast cancer in postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. Efficacy has not been demonstrated in oestrogen receptor negative patients unless they had a previous positive clinical response to tamoxifen.

CONTRAINDICATIONS

Anastrozole is contraindicated in:

premenopausal women
pregnant or lactating women
patients with severe renal impairment (creatinine clearance less than 20ml/min)
patients with moderate or severe hepatic disease
patients with known hypersensitivity to anastrozole or to any of the excipients

Oestrogen-containing therapies should not be co-administered with anastrozole as they would negate its pharmacological action.

Concurrent tamoxifen therapy (see DRUG INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

DOSE AND METHOD OF ADMINISTRATION

Adults including elderly: One 1mg tablet to be taken orally once a day

Special Populations

Children: Not recommended for use in children

Renal Impairment: No dose change is recommended in patients with mild or moderate renal impairment

Hepatic Impairment: No dose change is recommended in patients with mild hepatic disease.

For early disease, the recommended duration of treatment should be 5 years.

Method of Administration

For oral use

Registrant

RANBAXY (MALAYSIA) SDN. BHD.

Approval Date