GNH USA

Europe — EMA

Letrozole Hikma Farmacêutica (Portugal)

GNH USA supplies Letrozole Hikma Farmacêutica (Letrozole), a aromatase inhibitor for hormone receptor‑positive breast cancer in women.

Letrozole

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What is Letrozole?

Letrozole, the active ingredient in Letrozole Hikma Farmacêutica, is an aromatase inhibitor presented as an oral tablet for oral use. It treats hormone receptor‑positive breast cancer in postmenopausal women. The drug is formulated for systemic absorption and is indicated for endocrine therapy of breast cancer.

GNH USA supplies Letrozole Hikma Farmacêutica as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide. All batches are manufactured under EU Good Manufacturing Practice (GMP) standards and are distributed worldwide.

What is Letrozole used for?

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

- Hormone receptor‑positive breast cancer (postmenopausal): reduces estrogen production to inhibit tumor growth. - Adjuvant treatment of early‑stage breast cancer: lowers risk of disease recurrence after surgery. - Metastatic breast cancer (postmenopausal): provides systemic endocrine control of advanced disease.

What are the side effects of Letrozole?

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

Common Side Effects: - Hot flashes - Joint and muscle pain - Fatigue - Nausea - Headache - Dizziness

Serious or Rare Side Effects: - Osteoporosis or bone fractures - Elevated liver enzymes or hepatitis - Severe allergic reactions (anaphylaxis, skin rash) - Cardiovascular events (thromboembolism, QT prolongation)

What precautions apply to Letrozole?

When prescribing Letrozole, clinicians should consider several safety measures and monitoring requirements.

- Bone health monitoring: assess baseline bone mineral density and consider calcium/vitamin D supplementation. - Liver function: evaluate hepatic enzymes before initiation and periodically during therapy. - Cardiovascular risk: review patient history of thromboembolic disease or QT prolongation. - Pregnancy avoidance: contraindicated in pregnant women; ensure effective contraception in women of childbearing potential. - Drug interactions: review concomitant medications that affect CYP3A4 metabolism. - Store at ambient temperature: keep in original packaging, protect from moisture and direct sunlight.

What does Letrozole interact with?

Letrozole interacts with several medicines that can alter its plasma concentration or therapeutic effect.

Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may markedly reduce letrozole levels. - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase letrozole exposure and toxicity. - Estrogen‑containing hormone therapy: antagonizes letrozole’s estrogen‑lowering action.

Moderate Interactions (Monitor Closely): - Tamoxifen: combined use may affect endocrine balance; monitor clinical response. - Warfarin: letrozole may enhance anticoagulant effect; check INR regularly. - SSRIs (e.g., fluoxetine): potential for modest pharmacokinetic interaction; observe for side effects. - Cholesterol‑lowering agents (e.g., statins): monitor for hepatic effects.

Frequently asked questions

What is Letrozole Hikma Farmacêutica used for?+
Letrozole Hikma Farmacêutica is indicated as endocrine therapy for hormone receptor‑positive breast cancer in postmenopausal women. It is employed in the adjuvant setting after surgery, as well as in metastatic disease to control tumor growth by lowering estrogen levels.
How does Letrozole work?+
Letrozole works by selectively inhibiting the aromatase enzyme, which converts androgen precursors into estrogen. This inhibition reduces circulating estrogen, depriving estrogen‑dependent breast cancer cells of a key growth stimulus and thereby slowing tumor progression.
What is the usual dose of Letrozole?+
The dosage of Letrozole is determined by the prescribing clinician based on the patient’s clinical condition, renal and hepatic function, and other individual factors. Specific dosing regimens are not disclosed here and should follow the prescriber’s instructions.
Is Letrozole safe in pregnancy or breastfeeding?+
Letrozole is contraindicated during pregnancy because it can harm the fetus. Safety in breastfeeding has not been established; therefore, breastfeeding is generally not recommended while taking this medication. Effective contraception is required for women of childbearing potential.
How do I order Letrozole Hikma Farmacêutica from GNH USA?+
To order, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA supplies hospitals, pharmacies and procurement teams worldwide, and will request verification of trade or institutional credentials before providing pricing, availability, shipping details and import documentation.
How does Letrozole compare with the main alternative drug or class?+
Letrozole belongs to the aromatase inhibitor class, similar to anastrozole and exemestane. Compared with anastrozole, letrozole generally provides a slightly stronger suppression of estrogen levels, which may translate into marginally higher efficacy in some patients, though safety profiles are comparable.
What are the storage and handling requirements for Letrozole?+
Letrozole tablets should be stored at ambient temperature below 25 °C. Keep them in the original container, protect from moisture and direct sunlight, and keep out of reach of children.
How is Letrozole administered?+
Letrozole is taken orally as a tablet, usually once daily. It can be swallowed with or without food, and patients should follow the dosing schedule prescribed by their healthcare professional.
What are the most serious risks to watch for while taking Letrozole?+
Serious risks include osteoporosis or bone fractures due to reduced estrogen, severe liver injury indicated by elevated enzymes or hepatitis, allergic reactions such as anaphylaxis, and cardiovascular events like thromboembolism or QT‑interval prolongation. Patients should report any concerning symptoms promptly.
Who should not use Letrozole?+
Letrozole should not be used by pregnant women, women of childbearing potential who are not using reliable contraception, patients with severe hepatic impairment, or individuals with known hypersensitivity to letrozole or any of its excipients.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Letrozole
Route
Oral Use
Manufacturer
Hikma Farmacêutica (Portugal), S.A.
Origin
EU

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