Ovupic

Adjuvant treatment of postmenopausal women w/ hormone receptor +ve invasive early breast cancer. Extended adjuvant treatment of hormone-dependent early invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 yr. 1st-line treatment in postmenopausal women w/ hormone-dependent advanced breast cancer. Advanced breast cancer after relapse or disease-progression in women w/ natural or artificially induced postmenopausal status, previously treated w/ anti-estrogens. Neoadjuvant treatment of postmenopausal women w/ hormone receptor +ve, HER-2 -ve breast cancer where chemotherapy is not suitable & immediate surgery not indicated.

Adult & elderly 2.5 mg once daily. Duration: Patients w/ advanced or metastatic breast cancer: Continue until tumour progression is evident. Adjuvant & extended adjuvant setting: Continue for 5 yr or until tumour relapse occurs, whichever is 1st. Neo-adjuvant setting: Continue for 4-8 mth.

May be taken with or without food.

Hypersensitivity. Premenopausal endocrine status. Pregnancy & breast-feeding.

Efficacy has not been demonstrated in hormone receptor -ve breast cancer. Only women of postmenopausal endocrine status should receive Ovupic. Measure LH, FSH &/or estradiol levels before initiating treatment in patients whose menopausal status is unclear. Formally assess bone mineral density in women w/ a history of osteoporosis &/or fractures or are at increased risk of osteoporosis prior to commencement of adjuvant & extended adjuvant treatment, & monitor during & following treatment. Tendonitis & tendon ruptures may rarely occur. Avoid co-administration w/ tamoxifen, other anti-estrogens or estrogen-containing therapies. Carefully consider potential risk/benefit to patients w/ CrCl <10 mL/min before administration. Closely supervise patients w/ severe hepatic impairment (Child-Pugh C). Discuss adequate contraception when necessary since there are reports of women regaining ovarian function during treatment despite a clear postmenopausal status at start of therapy. Increased FSH levels due to inhibition of estrogen synthesis can induce ovulation in premenopausal women. Not recommended in childn & adolescents.

Hypercholesterolemia; hot flushes; hyperhidrosis, increased sweating; arthralgia; fatigue (including asthenia, malaise). Anorexia, increased appetite; depression; headache, dizziness; palpitations; HTN; nausea, dyspepsia, constipation, abdominal pain, diarrhea, vomiting; alopecia, rash (including erythematous, maculopapular, psoriasiform, & vesicular rash), dry skin; myalgia, bone pain, osteoporosis, bone fractures, arthritis; vag hemorrhage; peripheral edema, chest pain; increased wt.

Pharmacological action may be diminished w/ tamoxifen, other anti-estrogens or estrogen-containing therapies. Decreased plasma conc w/ tamoxifen. Caution w/ medicinal products whose elimination is mainly dependent on CYP2A6 & CYP2C19, & whose therapeutic index is narrow (eg, phenytoin, clopidogrel).

Cancer Hormone Therapy

L02BG04 - letrozole ; Belongs to the class of enzyme inhibitors. Used in treatment of neoplastic diseases.

Rx