Leaflet ORSERDU 86mg film-coated tablets

Indicated for: breast cancer

Route of administration: oral

Substance: elacestrant (antineoplastic agent)

ATC: L02BA04 (Antineoplastic and immunomodulating agents | Hormone antagonists and related agents | Anti-estrogens)

Precautions:
Fertility warning
Fertility warning

This medicine may affect fertility.

Dose adjustment in hepatic impairment
Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Cytotoxic / special handling
Cytotoxic / special handling

Handle with special care.

Contraception required
Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding
Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Contraindicated during pregnancy
Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Myelosuppression / agranulocytosis
Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests
Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Severe skin reactions
Severe skin reactions

Stop taking the medicine and seek urgent medical help if a severe rash occurs.

Elacestrant is a medication used in the treatment of certain types of breast cancer, especially in postmenopausal women with hormone receptor-positive tumors. This medicine works by blocking estrogen receptors, thereby reducing the stimulation of hormone-dependent cancer cells. Elacestrant may be recommended when other hormonal therapies are no longer effective.

Elacestrant is usually administered as tablets, according to the oncologist’s instructions. The dose and duration of treatment are determined individually, based on the patient’s general condition and response to therapy. It is important to take the medication regularly and not to stop treatment without medical advice.

Side effects may include nausea, fatigue, headaches, hot flashes, or digestive disturbances. In some cases, changes in blood test results or allergic reactions may occur. If unusual or severe symptoms appear, it is recommended to contact your doctor immediately.

Elacestrant provides an additional option for patients with advanced breast cancer, helping to slow disease progression. Careful monitoring and constant communication with the medical team are essential for the safety and effectiveness of the treatment.

General data about ORSERDU 86mg

  • Substance: elacestrant
  • Date of latest medicines list: 01-06-2026
  • Product code: W71459001
  • Concentration: 86mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 28
  • Product type: Generic medicine
  • Price: 14474.80 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: STEMLINE THERAPEUTICS B.V. - TARILE DE JOS
  • Holder: CN UNIFARM S.A. - ROMANIA
  • Number: 1170/2026/01

Concentrations available for elacestrant

  • 345mg
  • 86mg