FASLODEXTM is indicated as monotherapy for the treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:
- Not previously treated with endocrine therapy, or
- With disease relapse on or after adjuvant antioestrogen therapy, or disease progression on antioestrogen therapy
Faslodex is also indicated in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.
- In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinising hormone releasing hormone agonist.
FASLODEXTM 250mg solution for injection (fulvestrant)
Consult Summary of Product Characteristics before prescribing.
Dosage and administration
Adult females (including the elderly): 500mg at monthly intervals, with an additional 500mg dose given two weeks after initial dose. When Faslodex is used in combination with palbociclib, consult palbociclib SmPC. Prior to the start of combination treatment, and throughout its duration, pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice. Administered intramuscularly as two consecutive injections, one in each buttock (gluteal area). Exercise caution if injecting at the dorsogluteal site due to the proximity of the sciatic nerve. Faslodex is not recommended for use in children or adolescents, as safety and efficacy have not been established in this age group. No dose adjustments are needed for patients with mild to moderate hepatic or renal impairment (creatinine clearance ≥ 30 ml/min). However, safety and efficacy have not been evaluated in patients with severe hepatic or renal impairment. Dosage adjustment is not necessary for patients co-prescribed Faslodex and CYP3A4 inhibitors or inducers.