Letrovitae

Letrovitae

letrozole

Manufacturer:

Pacific Healthcare

Distributor:

Pacific Healthcare
Concise Prescribing Info
Contents
Letrozole
Indications/Uses
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 endocrine state who have previously been treated w/ anti-estrogens. Adjuvant treatment of postmenopausal women w/ hormone receptor +ve invasive early breast cancer. Extended adjuvant treatment of hormone-dependent invasive breast cancer in postmenopausal women who have received 5 yr adjuvant tamoxifen therapy. Neo-adjuvant treatment of postmenopausal women w/ hormone receptor +ve, HER-2 -ve breast cancer where chemotherapy is not suitable & immediate surgery not indicated.
Dosage/Direction for Use
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Premenopausal endocrine status. Pregnancy & lactation.
Special Precautions
Allergic reactions eg, asthma (in patients allergic to ASA), angioedema, urticaria & anaphylactic shock. Tendonitis & tendon ruptures; closely monitor patient & initiate immobilisation for the affected tendon. Measure LH, FSH &/or estradiol level prior to initiating treatment in patients w/ unclear menopausal status. Assess bone mineral density in women w/ history of osteoporosis &/or fractures, or w/ increased risk of osteoporosis prior to & during extended adjuvant treatment, & monitor during & following treatment. Initiate treatment or prophylaxis of osteoporosis & monitor carefully as appropriate. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency, or glucose or galactose absorption problems. Avoid co-administration w/ tamoxifen, other anti-estrogens or estrogen-containing therapies. May produce +ve result in doping control tests. Minor influence on ability to drive & use machines. Renal impairment (CrCl <10 mL/min). Severe hepatic impairment (Child-Pugh C). Women of perimenopausal state or childbearing potential. Not recommended in childn & adolescents <18 yr.
Adverse Reactions
Hypercholesterolemia; hot flushes; hyperhidrosis; arthralgia; fatigue including asthenia, malaise. Decreased or increased appetite; depression; headache, dizziness; palpitations; HTN; nausea, dyspepsia, constipation, abdominal pain, diarrhoea, vomiting; alopecia, rash (including erythematous, maculopapular, psoriasiform & vesicular rash), dry skin; myalgia, bone pain & fractures, osteoporosis, arthritis; vag haemorrhage; peripheral oedema, chest pain; increased wt. TEN, erythema multiforme.
Drug Interactions
Diminished pharmacological action w/ tamoxifen, other antiestrogens or estrogen-containing therapies. Decreased plasma conc w/ tamoxifen. Concomitant use w/ medicinal products whose elimination is dependent on CYP450 isoenzymes 2A6 & 2C19 & w/ narrow therapeutic index eg, phenytoin, clopidogrel.
MIMS Class
Cancer Hormone Therapy
ATC Classification
L02BG04 - letrozole ; Belongs to the class of enzyme inhibitors. Used in treatment of neoplastic diseases.
Presentation/Packing
Form
Letrovitae FC tab 2.5 mg
Packing/Price
30's
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