Fulvestrant Fresenius Kabi 250mg/5ml solution for injection in pre-filled syringe

Manufacturer
Laboratorios Farmalan S.A.(SPAIN)

Registraction Number
MAL24106020ACRZ


Content:
Fulvestrant Fresenius Kabi 250mg/5ml solution for injection in pre-filled syringe contains Fulvestrant, equivalent to 250 mg in 5 ml. The solution is clear, colorless to yellow, and viscous.
Indications:
Fulvestrant is indicated for:

• Monotherapy: Treatment of estrogen receptor-positive, locally advanced or metastatic breast cancer in postmenopausal women who are human epidermal growth factor receptor 2 (HER2)-negative and not previously treated with endocrine therapy, or with disease relapse on or after adjuvant endocrine therapy, or disease progression on endocrine therapy.
• Combination Therapy: Used in combination with ribociclib, abemaciclib, or palbociclib for the treatment of hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women, as initial endocrine-based therapy or following disease progression on endocrine therapy.

• Monotherapy: 500 mg at intervals of one month, with an additional 500 mg dose given two weeks after the initial dose.
• Combination Therapy: Follow the specific dosing instructions for the combination regimen as per the Summary of Product Characteristics for the prescribed product.