Product image of Letrozol Edigen (Letrozole) supplied by GNH India

Letrozol Edigen

Active Ingredient:
Letrozole
Origin:
EU

Letrozol Edigen (Letrozole)

Letrozole, the active ingredient in Letrozol Edigen, is an aromatase inhibitor presented as an oral tablet for systemic use. It works by lowering estrogen production and is indicated for the treatment of hormone receptor‑positive breast cancer in postmenopausal women, helping to slow tumor growth and reduce recurrence risk.

GNH India supplies Letrozol Edigen as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres, hospitals and pharmacies worldwide. All batches meet EU GMP requirements and are shipped with full documentation, ensuring traceability and regulatory compliance.

Manufacturer / TM Owner

Aristo Pharma Iberia, S.L.

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Indications & Clinical Uses

Letrozole is an aromatase inhibitor used in the management of hormone‑dependent breast cancer.

  • Metastatic breast cancer: reduces tumor progression in postmenopausal women with hormone‑receptor‑positive disease.
  • Early‑stage adjuvant therapy: lowers risk of recurrence after surgery in hormone‑receptor‑positive breast cancer.
  • Extended adjuvant therapy: provides continued estrogen suppression following 5 years of tamoxifen in postmenopausal patients.

How It Works

  • Letrozole reversibly binds to the aromatase enzyme (CYP19A1) in peripheral tissues, inhibiting the conversion of androstenedione and testosterone to estrone and estradiol. This reduction in circulating estrogen deprives estrogen‑dependent tumor cells of growth stimulation, thereby slowing or halting the progression of hormone‑receptor‑positive breast cancer.

Side Effects

Letrozole may cause a range of adverse reactions, most of which are mild to moderate.

Common Side Effects

  • Hot flashes: sudden feeling of warmth, often with sweating.
  • Joint and muscle pain: aching in knees, hips, or shoulders.
  • Fatigue: persistent tiredness not relieved by rest.
  • Nausea: mild stomach upset or queasiness.
  • Headache: pressure or throbbing pain in the head.
  • Increased sweating: excessive perspiration unrelated to activity.

Serious or Rare Side Effects

  • Severe liver injury: jaundice, dark urine, or abdominal pain.
  • Bone fracture: increased risk of osteoporosis‑related breaks.
  • Pulmonary embolism: sudden shortness of breath, chest pain.
  • Deep vein thrombosis: swelling, pain, or redness in a limb.
  • Allergic reactions: rash, itching, swelling of face or throat.
  • Elevated cholesterol: significant rise in blood lipid levels.

Precautions & Warnings

Before initiating Letrozol Edigen, clinicians should consider several safety measures.

  • Bone health monitoring: assess baseline bone mineral density and consider calcium/vitamin D supplementation.
  • Liver function assessment: obtain baseline hepatic enzymes and repeat periodically.
  • Cardiovascular risk evaluation: review history of thromboembolic events or hyperlipidaemia.
  • Pregnancy and lactation avoidance: ensure effective contraception in women of child‑bearing potential.
  • Pre‑menopausal status: avoid use in women who have not reached menopause.
  • Store at ambient temperature: keep below 25 °C in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Letrozole can interact with several medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • Concomitant estrogen therapy: may counteract aromatase inhibition and reduce anticancer effect.
  • Tamoxifen: antagonistic action can diminish therapeutic benefit.
  • Strong CYP2A6 inhibitors (e.g., methoxsalen): can increase letrozole plasma concentrations.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin, carbamazepine): may lower letrozole levels, reducing effectiveness.
  • Warfarin: letrozole may enhance anticoagulant effect, requiring INR monitoring.
  • Statins metabolised by CYP3A4: increased risk of myopathy; monitor muscle symptoms.

Frequently Asked Questions

Letrozol Edigen contains letrozole, an aromatase inhibitor prescribed for hormone‑receptor‑positive breast cancer in postmenopausal women. It is used in metastatic, adjuvant, and extended adjuvant settings to lower estrogen levels and help control tumor growth.

Letrozole blocks the aromatase enzyme, which converts androgens into estrogen in peripheral tissues. By inhibiting this conversion, circulating estrogen concentrations fall, depriving estrogen‑dependent cancer cells of a key growth signal and thereby slowing disease progression.

The specific dose and dosing schedule are determined by the treating physician based on the patient’s clinical condition, renal and hepatic function, and treatment goals. Only a qualified prescriber can set the appropriate regimen.

Letrozole is contraindicated in pregnancy because it can harm the developing fetus. Women of child‑bearing potential should use effective contraception during treatment and for a period after the last dose. Safety during breastfeeding has not been established, and nursing is generally discouraged.

To request Letrozol Edigen, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain needs), and import documentation.

Letrozole belongs to the aromatase‑inhibitor class, which generally offers more complete estrogen suppression than selective estrogen‑receptor modulators such as tamoxifen. In postmenopausal patients, aromatase inhibitors have shown superior disease‑free survival in several trials, though individual choice depends on patient tolerance, comorbidities, and physician judgment.

Letrozol Edigen tablets should be stored at ambient temperature, preferably below 25 °C. Keep them in the original blister pack or container, protect from moisture, heat, and direct sunlight to maintain potency throughout the shelf life.

Letrozol Edigen is taken orally, usually once daily, with or without food, as directed by the prescribing clinician. Swallow the tablet whole with a glass of water; do not crush or split unless instructed by a healthcare professional.

Serious risks include severe liver injury, osteoporosis‑related fractures, and rare thromboembolic events such as pulmonary embolism or deep‑vein thrombosis. Patients should be monitored regularly for liver function, bone health, and any signs of clotting disorders.

Letrozol Edigen is not recommended for premenopausal women, pregnant or nursing individuals, and patients with known hypersensitivity to letrozole or any tablet excipients. Caution is also advised in patients with severe hepatic impairment or uncontrolled cardiovascular disease.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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