FERMA 2.5/MG TAB 30/TAB

Indications

Approved Uses

Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer, Extended adjuvant treatment of early breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy, First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer, Treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

Dosage & Administration

Dosing by Condition

Approved breast cancer indications (adjuvant, extended adjuvant, advanced/metastatic): 2.5 mg orally once daily, continued as directed (e.g., until disease progression in advanced disease).

Initial Dose

2.5 mg once daily.

Maintenance Dose

2.5 mg once daily.

Maximum Dose

2.5 mg once daily.

Children's Dosage

Not approved for children.

Dose Adjustment Notes

Renal impairment: no dose adjustment generally required (including severe renal impairment if CrCl ≥10 mL/min). Hepatic impairment: no adjustment for mild-moderate; for severe hepatic impairment/cirrhosis (Child-Pugh C), reduce to 2.5 mg every other day and monitor closely.

How to Take

Swallow 1 tablet (2.5 mg) whole with water; may be taken with or without food; take once daily at the same time each day.

Side Effects

Common Side Effects

Hot flushes/flushing, arthralgia (joint pain), fatigue/asthenia, headache, dizziness, nausea, increased sweating, peripheral edema, bone pain, hypercholesterolemia; longer-term risk: decreased bone mineral density/osteoporosis and fractures.

Safety & Warnings

Contraindications

Hypersensitivity to letrozole or any excipients; pregnancy. (Premenopausal endocrine status is a 'not indicated/avoid use' warning rather than a strict contraindication; breastfeeding is generally advised against during therapy but is not consistently listed as a formal contraindication across labels.)

Warnings & Precautions

Monitor/manage bone mineral density loss (baseline and periodic BMD; consider calcium/vitamin D and antiresorptive therapy when indicated); monitor lipids/cholesterol; caution regarding dizziness/fatigue affecting driving; confirm postmenopausal status/avoid use in premenopausal women; use caution in severe hepatic impairment.

Age Restriction

Indicated for postmenopausal women; not indicated for premenopausal women and not established/approved in pediatric patients (<18 years).

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Avoid concomitant estrogen-containing therapies (including HRT) as they counteract efficacy; avoid/ do not coadminister with tamoxifen as it reduces letrozole exposure and may reduce efficacy. No clinically meaningful CYP-mediated interactions generally require routine dose adjustment; warfarin interaction is not a standard clinically significant interaction but monitor if clinically indicated.

Interaction Severity

MAJOR: Estrogen-containing therapies (antagonize effect-avoid); Tamoxifen (reduces letrozole exposure-avoid coadministration). Other interactions are generally not clinically significant; routine warfarin interaction is not expected but monitor if clinically indicated.

Food Interaction

No clinically significant food effect; may be taken with or without food.

Special Populations

Pregnancy

Contraindicated

Children

Not approved for children.

Elderly

Standard adult dosing - no dose adjustment required based on age alone

Kidney Impairment

CrCl ≥10 mL/min: no dose adjustment. CrCl <10 mL/min: use with caution (insufficient data).

Liver Impairment

Child-Pugh A/B: no dose adjustment. Child-Pugh C (severe): reduce to 2.5 mg every other day (use with caution).

Storage & Patient Advice

Overdose

No specific antidote; manage with symptomatic/supportive care and consider decontamination (e.g., activated charcoal) if recent ingestion; seek urgent medical attention.

Patient Counseling

Take 2.5 mg once daily at the same time, with or without food; avoid estrogen-containing products and do not combine with tamoxifen unless specifically directed; may cause hot flushes, fatigue/dizziness-use caution driving; report severe bone/joint pain or fracture symptoms; bone density and cholesterol may be monitored; contraindicated in pregnancy-use effective contraception if pregnancy is possible during treatment and for at least 3 weeks after stopping.

Monitoring Requirements

Monitor bone health (baseline and periodic bone mineral density) and manage osteoporosis risk; monitor lipids/cholesterol periodically; consider liver function tests if hepatic disease; clinical monitoring for musculoskeletal symptoms and fracture risk.

Pharmacology

Mechanism of Action

Non-steroidal, selective aromatase inhibitor that reversibly binds to the heme of cytochrome P450 aromatase, inhibiting conversion of androgens to estrogens and lowering circulating estrogen in postmenopausal women.

Onset of Action

Estrogen suppression begins within ~24 hours with near-maximal suppression within a few days; steady-state plasma concentrations are reached in ~2-6 weeks.

Duration of Effect

Terminal elimination half-life is ~2 days; pharmacodynamic estrogen suppression is maintained with once-daily continuous dosing.

Half-Life

Approximately 2 days (48 hours)

Bioavailability

Oral bioavailability is high (approximately ~99%); absorption is rapid and essentially complete.

Metabolism

Hepatic metabolism mainly via CYP3A4 and CYP2A6 to an inactive carbinol metabolite (with subsequent conjugation, e.g., glucuronidation).

Excretion

Primarily renal: ~90% of a dose is recovered in urine, mostly as metabolites (notably the glucuronide conjugate of the inactive carbinol metabolite); only a small fraction (~5-10%) is excreted unchanged. Minor fecal excretion occurs.

Product Information

Available Dosage Forms

Tablet, film-coated (oral).

Composition per Dose

Each film-coated tablet: Letrozole 2.5 mg

OTC Alternatives

No OTC alternative

Primary Use

Treatment of hormone receptor-positive breast cancer in postmenopausal women by reducing estrogen production

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