Product image of Orserdu (Elacestrant) supplied by GNH India

Orserdu

Active Ingredient:
Elacestrant
Origin:
EU

Orserdu (Elacestrant)

Elacestrant, the active ingredient in Orserdu, is a selective estrogen receptor degrader (SERD) presented as an oral formulation for oral use. It treats estrogen receptor‑positive (ER+) HER2‑negative advanced or metastatic breast cancer in adult patients who have progressed after prior endocrine therapy.

GNH India supplies Orserdu as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres, hospitals and pharmacies worldwide with a focus on quality assurance and regulatory compliance for clinical trials and routine patient care.

Manufacturer / TM Owner

Stemline Therapeutics B.V.

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Indications & Clinical Uses

  • Orserdu, an oral selective estrogen receptor degrader, is used in the management of hormone‑responsive breast cancer.
  • Estrogen receptor‑positive (ER+) HER2‑negative advanced breast cancer: slows disease progression and may improve overall survival.
  • Metastatic ER+ HER2‑negative breast cancer after prior endocrine therapy: provides an oral SERD treatment option.
  • Advanced breast cancer with disease progression on prior SERD or CDK4/6 inhibitor therapy: offers a targeted hormonal control strategy.

How It Works

  • Elacestrant binds competitively to estrogen receptors in tumor cells, promoting receptor ubiquitination and proteasomal degradation. By removing functional estrogen receptors, it blocks estrogen‑mediated transcriptional activity and downstream proliferative signaling pathways, thereby inhibiting growth of ER‑positive breast cancer cells. The oral formulation enables systemic exposure sufficient to achieve receptor down‑regulation throughout the body.

Side Effects

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

Common Side Effects

  • Nausea
  • Fatigue
  • Diarrhea
  • Headache
  • Hot flashes
  • Decreased appetite

Serious or Rare Side Effects

  • Elevated liver enzymes (ALT/AST)
  • Thrombocytopenia
  • Interstitial lung disease or pneumonitis
  • Severe allergic reactions (anaphylaxis)
  • QT interval prolongation
  • Tumor progression despite therapy

Precautions & Warnings

  • When prescribing Elacestrant, clinicians should consider several precautionary measures to ensure patient safety.
  • Pregnancy: avoid use; discuss risks and benefits with a qualified healthcare professional.
  • Breastfeeding: not recommended; advise cessation of breastfeeding during treatment.
  • Liver impairment: use with caution; monitor hepatic function regularly.
  • Concomitant CYP3A4 inhibitors or inducers: adjust therapy as needed and monitor drug levels.
  • Monitoring: perform periodic complete blood counts and electrocardiograms.
  • Store at ambient temperature: keep below 25 °C in the original container, protect from moisture and light.

Avoid Interactions

Elacestrant can interact with other medicines, requiring attention to both major and moderate interaction potentials.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase Elacestrant exposure.
  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce therapeutic effect.
  • QT‑prolonging agents (e.g., certain antiarrhythmics): increase risk of cardiac arrhythmia.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may modestly raise drug levels.
  • Anticoagulants (e.g., warfarin): monitor INR for potential changes.
  • Hormonal therapies (e.g., aromatase inhibitors): assess combined endocrine effects.

Frequently Asked Questions

Orserdu contains the active ingredient elacestrant and is indicated for the treatment of estrogen receptor‑positive (ER+) HER2‑negative advanced or metastatic breast cancer. It is used when disease has progressed after prior endocrine therapies, providing an oral selective estrogen receptor degrader option.

Elacestrant binds to estrogen receptors on tumor cells, leading to receptor ubiquitination and proteasomal degradation. By removing functional receptors, it blocks estrogen‑driven transcription and downstream signaling pathways that promote cancer cell growth, thereby inhibiting tumor progression.

The specific dose and dosing schedule of Orserdu are determined by the prescribing physician based on the patient’s clinical condition, prior therapies, and overall health. Patients should follow the prescriber’s instructions and not alter the dose without medical advice.

Orserdu is not recommended for use during pregnancy or while breastfeeding. Women of childbearing potential should use effective contraception, and breastfeeding mothers should discuss alternative treatment options with their healthcare provider.

To order Orserdu, 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 and necessary import documentation.

Orserdu (elacestrant) is an oral SERD, offering the convenience of tablet administration compared with some injectable SERDs. Its mechanism of receptor degradation is similar, but clinical data suggest comparable efficacy with a distinct safety profile, especially regarding gastrointestinal tolerability.

Orserdu tablets should be stored at ambient temperature, preferably below 25 °C. Keep the medication in its original packaging, protect it from moisture and direct light, and store out of reach of children.

Orserdu is taken orally, usually as a whole tablet with water. The exact timing (e.g., with or without food) and frequency are prescribed by the treating physician based on individual treatment plans.

Serious risks include liver enzyme elevations, thrombocytopenia, interstitial lung disease, severe allergic reactions, and QT interval prolongation. Patients should be monitored regularly for hepatic function, blood counts, cardiac rhythm and respiratory symptoms.

Orserdu should not be used by patients with known hypersensitivity to elacestrant or any excipients, those with uncontrolled severe liver disease, or individuals taking strong CYP3A4 inducers that could markedly reduce its effectiveness. Pregnant or breastfeeding women should also avoid it.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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