Guidelines for Use
Our guideline named ELACESTRANT (Orserdu) requires the following rule(s) be met for approval:
- You have advanced or metastatic breast cancer (breast cancer that has spread to other parts of the body)
- Your breast cancer is estrogen receptor (ER: type of protein)-positive, human epidermal growth factor receptor 2 (HER2: type of protein)-negative with ESR1 (type of gene) mutation
- You have disease progression following endocrine therapy (disease has worsened after using a type of hormone therapy)
Rationale
Ensure appropriate diagnostic, utilization and safety criteria are used for the management of requests for Orserdu.
Indications for Use
Orserdu is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
Dosage and Administration
The recommended dosage of Orserdu is 345 mg taken orally with food once daily until disease progression or unacceptable toxicity occurs.
References
Orserdu [Prescribing Information]. New York, NY: Stemline Therapeutics, Inc.; January 2023.