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.
Faslodex 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 (LHRH) agonist.
One pre-filled syringe contains 250mg fulvestrant in 5ml solution. Each pack contains two pre-filled syringes. Safety needles (BD SafetyGlide) are also provided.
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.
Hypersensitivity to the active substance or to any of the excipients, pregnancy, in breast-feeding and in patients with severe hepatic impairment.
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.
Faslodex as Monotherapy
Consult Faslodex SmPC for a full list of side effects. Very common: Hypersensitivity reactions, hot flushes, nausea, asthenia, injection site reactions, elevated hepatic enzymes (ALT, AST, ALP), rash, joint and musculoskeletal pain.
Common: Reduced platelet count, vomiting, diarrhoea, anorexia, urinary tract infections, venous thromboembolism, headache, back pain, elevated bilirubin, vaginal haemorrhage, neuropathy peripheral, sciatica.
Uncommon: Hepatic failure, hepatitis, elevated gamma-GT, vaginal moniliasis, leukorrhoea, injection site haemorrhage, injection site haematoma and anaphylactic reactions.
Faslodex combined with palbociclib: Consult Faslodex SmPC and palbociclib SmPC.
All severity grades- Very common: Infections, neutropenia, leukopenia, anaemia, thrombocytopenia, decreased appetite, nausea, stomatitis, diarrhoea, vomiting, alopecia, rash, fatigue and pyrexia.
Common: Dysgeusia, lacrimation increased, vision blurred, dry eye, epistaxis, dry skin, asthenia, AST increased and ALT increased.
Uncommon: Febrile neutropenia. For further details of adverse reactions, particularly neutropenia, please consult Faslodex SmPC.
Legal category POM. Marketing Authorisation number EU/1/03/269/002 Presentation & Basic NHS cost 2 x 5 ml pre-filled syringes: £522.41 Marketing Authorisation Holder AstraZeneca AB, SE-151 85 Sodertalje, Sweden. SK10 2NA, UK. Further information is available from AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK.
FASLODEXTM is a trade mark of the AstraZeneca group of companies. SAFETYGLIDE is a trade mark of Becton Dickinson and Company. Date of preparation 09/2018. ONC 18 0024.
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AstraZeneca on 0800 783 0033.