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Altrol (anastrozole) tablets for oral administration contain 1
mg of anastrozole, a non-steroidal aromatase inhibitor. Each
tablet contains as inactive ingredients: lactose, magnesium
stearate, hydroxypropylmethylcellulose, polyethylene glycol,
povidone, sodium starch glycolate, and titanium dioxide.
INDICATIONS
Adjuvant Treatment
Altrol is indicated for adjuvant treatment of postmenopausal women
with hormone receptor-positive early breast cancer.
First-Line Treatment
Altrol is indicated for the first-line treatment of postmenopausal
women with hormone receptor-positive or hormone receptor unknown
locally advanced or metastatic breast cancer.
Second-Line Treatment
Altrol is indicated for the treatment of advanced breast cancer in
postmenopausal women with disease progression following tamoxifen
therapy. Patients with ER-negative disease and patients who did
not respond to previous tamoxifen therapy rarely responded to
Altrol.
DOSAGE AND ADMINISTRATION
Recommended Dose
The dose of Altrol is one 1 mg tablet taken once a day. For
patients with advanced breast cancer, Altrol should be continued
until tumor progression. Altrol can be taken with or without food.
For adjuvant treatment of early breast cancer in postmenopausal
women, the optimal duration of therapy is unknown. In the ATAC
trial Altrol was administered for five years.
No dosage adjustment is necessary for patients with renal
impairment or for elderly patients.
Patients with Hepatic Impairment
No changes in dose are recommended for patients with
mild-to-moderate hepatic impairment. Altrol has not been studied
in patients with severe hepatic impairment.
Storage
Store at controlled room temperature, 20-25°C (68-77°F)
PRECAUTIONS
Ischemic Cardiovascular Events
In women with pre-existing ischemic heart disease, an increased
incidence of ischemic cardiovascular events was observed with
Altrol in the ATAC trial (17% of patients on Altrol and 10% of
patients on tamoxifen). Consider risk and benefits of Altrol
therapy in patients with pre-existing ischemic heart disease.
Bone Effects
Results from the ATAC trial bone substudy at 12 and 24 months
demonstrated that patients receiving Altrol had a mean decrease in
both lumbar spine and total hip bone mineral density (BMD)
compared to baseline. Patients receiving tamoxifen had a mean
increase in both lumbar spine and total hip BMD compared to
baseline
holesterol
During the ATAC trial, more patients receiving Altrol were
reported to have elevated serum cholesterol compared to patients
receiving tamoxifen (9% versus 3.5%, respectively)
CONTRAINDICATIONS
Pregnancy and Premenopausal Women
Altrol may cause fetal harm when administered to a pregnant woman
and offers no clinical benefit to premenopausal women with breast
cancer. Altrol is contraindicated in women who are or may become
pregnant. There are no adequate and well- controlled studies in
pregnant women using Altrol. If Altrol is used during pregnancy,
or if the patient becomes pregnant while taking this drug, the
patient should be apprised of the potential hazard to a fetus or
potential risk for loss of the pregnancy.
Hypersensitivity
Altrol is contraindicated in any patient who has shown a
hypersensitivity reaction to the drug or to any of the excipients.
Observed reactions include anaphylaxis, angioedema, and urticaria.
Presentation
Altrol
Tablets
Blister of 10 Tablets
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