Orserdu (elacestrant) -

This medication requires a valid prescription. Please refer to the ‘Prescription Guide’ for details.

Note: We can assist only if the medicine is unavailable in your country.”

Orserdu (elacestrant)

General Description:

Orserdu (elacestrant) is an oral therapy approved for the treatment of postmenopausal women or adult men with ER-positive, HER2-negative advanced or metastatic breast cancer who have an ESR1 mutation and have previously received endocrine therapy.

Getting Orserdu (elacestrant) in India

Orserdu has been approved in countries like the U.S. and Europe but is not yet available for commercial sale in India. However, it is accessible through the Named Patient Program (NPP) for eligible patients.

MitoGENE helps Indian patients access Orserdu legally and safely under their doctor’s supervision. We handle the documentation, regulatory approvals, and logistics to ensure compliance with Indian regulations.

If you or your loved one may benefit from Orserdu, MitoGENE is here to support your journey to access this treatment.

Disease Indications: ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

Manufacturer:Stemline Therapeutics

Usage:Oral

Medicine Approved by:

• Food and Drug Administration (FDA)
• European Medicines Agency (EMA)
• Health Canada (pending)
• Therapeutic Goods Administration (TGA) (pending)

Available Dosage Form & Package:

• 345 mg tablets – 28 tablets per pack

Shipping:Room Temperature Shipping. This medication is shipped using standard delivery methods, ensuring it remains within a controlled room temperature range of 15°C to 25°C throughout transit.

What is Orserdu (elacestrant)?

Orserdu is a prescription oral therapy used to treat patients with estrogen receptor-positive (ER+), HER2-negative advanced or metastatic breast cancer that harbors an ESR1 gene mutation, often associated with resistance to standard endocrine therapy. It is specifically intended for patients who have progressed after at least one prior endocrine treatment.

How does Orserdu work?

Orserdu contains elacestrant, a selective estrogen receptor degrader (SERD) that works by binding to the estrogen receptor and causing its degradation. This action prevents estrogen from stimulating the growth of cancer cells in ER-positive breast cancers.

Where is Orserdu approved?

                • U.S. FDA – Approved January 2023
                • EMA – Approved September 2023
                Note: May be under review or pending in other regions

What are the possible side effects?

                Common side effects include:
                • Nausea
                • Fatigue
                • Vomiting
                • Joint pain
                • Headache
                • Constipation
                • Increased cholesterol levels

Important: Use effective birth control during treatment and for 1 week after stopping. Avoid during pregnancy or breastfeeding.

Note:Orserdu is specifically intended for patients who test positive for an ESR1 mutation. Always consult your oncologist to assess if this medicine is appropriate based on your diagnostic results and treatment history.

References:

BreastCancer.org – SERDs and ESR1 Mutations in Breast Cancer.

U.S. Food and Drug Administration (FDA). Orserdu Prescribing Information.

European Medicines Agency (EMA). Orserdu Assessment Report.

Menarini Group/Stemline. Orserdu Product Information.

Journal of Clinical Oncology. EMERALD Study – Elacestrant in ER+/HER2- MBC with ESR1 Mutation.

How to Access Orserdu (elacestrant) in India in 4 Simple Steps with MitoGENE via the Named Patient Program (NPP)?

If Orserdu (elacestrant) is not yet approved or commercially available in India, MitoGENE can assist you in accessing it legally through the Named Patient Program (NPP). Here’s how the process works: