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.
Warnings and precautions
Use with caution in patients with mild to moderate hepatic impairment or severe renal impairment. Use with caution if treating patients with bleeding diatheses, thrombocytopenia or those taking anticoagulant treatment. Thromboembolic events are commonly observed in women with advanced breast cancer in clinical studies and should be taken into consideration when prescribing Faslodex to patients at risk. Injection site related events including sciatica, neuralgia, neuropathic pain and peripheral neuropathy have been reported. There are no long-term data on the effect of fulvestrant on bone. There is a potential risk of osteoporosis with Faslodex. Efficacy and safety of Faslodex (either as monotherapy or in combination with palbociclib) have not been studied in patients with critical visceral disease. When Faslodex is combined with palbociclib,also consult palbociclib SmPC. Fulvestrant may interfere with antibody based-estradiol assays and may result in falsely increased levels of estradiol.
Pregnancy and breast-feeding: Patients of childbearing potential should be advised to use eff ective contraception during treatment. Patients must be informed of the potential hazard to the foetus and potential risk for loss of pregnancy if they become pregnant whilst taking Faslodex.Breast-feeding must be stopped during treatment.
Ability to drive and use machines: Asthenia (a loss of strength) has been reported during treatment with Faslodex, therefore caution should be observed if experiencing this symptom when driving or operating machinery.