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

Letrozol Sandoz

Active Ingredient:
Letrozole
Origin:
EU

Letrozol Sandoz (Letrozole)

Letrozole, the active ingredient in Letrozol Sandoz, is an aromatase inhibitor presented as an oral tablet for oral use. It is employed to treat hormone‑receptor‑positive breast cancer in postmenopausal women, including adjuvant and metastatic settings. The drug works by selectively blocking the aromatase enzyme, thereby lowering estrogen levels that can fuel tumor growth.

GNH India supplies Letrozol Sandoz as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and procurement teams worldwide, with capabilities for bulk manufacturing, regulatory support and reliable logistics.

Manufacturer / TM Owner

Sandoz N.V.

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Indications & Clinical Uses

  • Letrozole is used in hormone‑dependent breast cancer pathways to inhibit estrogen production.
  • Hormone‑receptor‑positive breast cancer in postmenopausal women: reduces tumor growth and disease progression.
  • Adjuvant treatment of early‑stage breast cancer: lowers risk of recurrence after surgery.
  • Metastatic breast cancer in postmenopausal patients: slows disease progression and may improve survival.

How It Works

  • Letrozole is a selective, non‑steroidal inhibitor of the aromatase enzyme (CYP19A1). By binding to the enzyme’s heme group, it blocks the conversion of adrenal and peripheral androgens (androstenedione and testosterone) into estrone and estradiol. The resulting profound reduction in circulating estrogen limits the hormonal stimulus for growth of estrogen‑dependent breast cancer cells. This inhibition is dose‑dependent and reversible, leading to sustained low estrogen levels during therapy.

Side Effects

Letrozole may cause a range of adverse reactions, which are classified by frequency and severity.

Common Side Effects

  • Hot flashes: sudden feeling of warmth, often with sweating.
  • Joint and muscle pain: arthralgia or myalgia affecting daily activities.
  • Fatigue: persistent tiredness not relieved by rest.
  • Nausea: mild to moderate upset stomach.
  • Headache: pressure or throbbing pain in the head.

Serious or Rare Side Effects

  • Severe liver injury: elevated transaminases or hepatitis.
  • Bone fracture: increased risk due to reduced estrogen.
  • Pulmonary embolism: blood clot in lung arteries.
  • Allergic reaction: rash, swelling, or anaphylaxis.

Precautions & Warnings

  • Before initiating Letrozole therapy, several precautions and monitoring measures should be considered.
  • Pregnancy contraindication: drug is classified Category X and must not be used in pregnant women.
  • Bone health monitoring: assess bone mineral density periodically due to risk of osteoporosis.
  • Liver function: evaluate hepatic enzymes before and during treatment.
  • Lipid profile: monitor cholesterol levels as estrogen reduction may affect lipids.
  • Drug interactions: review concomitant medications for potential CYP3A4 inducers or inhibitors.
  • Store at ambient temperature: keep below 25 °C in the original container, protect from moisture and light.

Avoid Interactions

Letrozole can interact with other medicines, altering its effectiveness or safety.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may markedly reduce Letrozole plasma levels.
  • Estrogen‑containing therapies (e.g., hormone replacement therapy): counteract aromatase inhibition.
  • Warfarin: increased anticoagulant effect leading to bleeding risk.

Moderate Interactions (Monitor Closely)

  • CYP2C19 inhibitors (e.g., fluconazole): may increase Letrozole exposure.
  • Selective serotonin reuptake inhibitors (e.g., paroxetine): potential modest increase in side effects.
  • Lipid‑lowering agents (e.g., statins): monitor lipid changes.

Frequently Asked Questions

Letrozol Sandoz contains letrozole, an aromatase inhibitor indicated for the treatment of hormone‑receptor‑positive breast cancer in postmenopausal women. It is used both as adjuvant therapy after surgery and for managing metastatic disease to reduce tumor growth driven by estrogen.

Letrozole selectively blocks the aromatase enzyme (CYP19A1), preventing the conversion of androgens into estrogens. By lowering circulating estrogen levels, it removes the hormonal stimulus that promotes the growth of estrogen‑dependent breast cancer cells.

The specific dose of Letrozol Sandoz is determined by the prescribing clinician based on the patient’s condition, renal and hepatic function, and treatment goals. In clinical practice, a common starting point is 2.5 mg taken orally once daily, but the exact regimen must be set by a qualified healthcare professional.

Letrozol Sandoz is classified as Pregnancy Category X, meaning it is contraindicated in pregnant women because it can cause fetal harm. It is also not recommended for breastfeeding mothers, as it may be excreted in milk and affect the infant. Effective contraception is required during treatment.

To place an order, submit an enquiry on the Letrozol Sandoz 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 required import documentation.

Letrozol Sandoz (letrozole) is a third‑generation aromatase inhibitor, similar in potency to anastrozole and exemestane. Compared with anastrozole, letrozole generally provides slightly greater estrogen suppression, which may translate into marginally higher efficacy in some settings, while sharing a comparable safety profile. Choice of agent depends on physician judgment and patient tolerance.

Letrozol Sandoz tablets should be stored at ambient temperature, preferably below 25 °C, in the original blister pack or container. Protect the product from moisture, direct sunlight and excessive heat to maintain potency throughout its shelf life.

Letrozol Sandoz is administered orally. The tablet is swallowed whole with a glass of water, typically once daily, and may be taken with or without food. Patients should follow the dosing schedule prescribed by their healthcare provider and not alter the regimen without medical advice.

Serious adverse events include severe liver injury, increased risk of bone fractures due to estrogen depletion, pulmonary embolism, and potentially life‑threatening allergic reactions such as anaphylaxis. Patients should be monitored regularly for liver function, bone health, and any signs of clotting or hypersensitivity.

Letrozol Sandoz should not be used by pregnant or breastfeeding women, premenopausal women, patients with known hypersensitivity to letrozole or any excipients, and those with severe hepatic impairment. Caution is also advised for individuals with a history of osteoporosis, thromboembolic disease, or uncontrolled cardiovascular conditions.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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