Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION, SOLUTION
**4.2 Posology and method of administration** **Posology** **Adult females (including the elderly)** The recommended dose is 500 mg at intervals of one month, with an additional 500 mg dose given two weeks after the initial dose. **Combination therapy with Palbociclib** When Fulvestrant-AFT is used in combination with palbociclib, refer to monotherapy recommended dose instruction for Fulvestrant-AFT. Refer to the prescribing information for palbociclib for Posology and method of administration. Prior to the start of treatment with the combination of Fulvestrant-AFT plus palbociclib, and throughout its duration, pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice. **Combination therapy with abemaciclib** When Fulvestrant-AFT is used in combination with abemaciclib, refer to monotherapy recommended dose instruction for Fulvestrant-AFT. Refer to the prescribing information for abemaciclib for Posology and method of administration. Prior to the start of treatment with the combination of Fulvestrant-AFT plus abemaciclib, and throughout its duration, pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice. **Combination therapy with ribociclib** When Fulvestrant-AFT is used in combination with ribociclib, refer to monotherapy recommended dose instruction for Fulvestrant-AFT. Refer to the prescribing information for ribociclib for Posology and method of administration. **Special population** **Paediatric patient** Fulvestrant-AFT is not recommended for use in children or adolescents, as safety and efficacy have not been established in this age group. **Renal impairment** No dose adjustments are recommended for patients with mild to moderate renal impairment (creatinine clearance ≥30 ml/min). Safety and efficacy have not been evaluated in patients with severe renal impairment (creatinine clearance < 30 ml/min) and, therefore, caution is recommended in these patients (see Special warnings and precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Hepatic impairment** No dose adjustments are recommended for patients with mild to moderate hepatic impairment. However, as fulvestrant exposure may be increased, Fulvestrant-AFT should be used with caution in these patients. There are no data in patients with severe hepatic impairment (see Contraindications, Special warnings and precautions for use and Pharmacokinetic properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Method of administration** Fulvestrant-AFT should be administered as two consecutive 5 ml injections by slow intramuscular injection (1–2 minutes/injection), one in each buttock (gluteal area). Caution should be taken if injecting Fulvestrant-AFT at the dorsogluteal site due to the proximity of the underlying sciatic nerve. For detailed instructions for administration, see Instructions for administration and Special precautions for disposal – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
INTRAMUSCULAR
Medical Information
**4.1 Therapeutic indications** Fulvestrant-AFT is indicated for the treatment of estrogen 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 antiestrogen therapy, or disease progression on antiestrogen therapy. **Combination therapy with Palbociclib** Fulvestrant-AFT is 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 with disease progression following endocrine therapy. **Combination therapy with abemaciclib** Fulvestrant-AFT is indicated in combination with abemaciclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women with disease progression after endocrine therapy. **Combination therapy with ribociclib** Fulvestrant-AFT is indicated in combination with ribociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in postmenopausal women as initial endocrine based therapy or following disease progression on endocrine therapy.
**4.3 Contraindications** Hypersensitivity to the active substance, or to any of the other excipients. Pregnancy and lactation (see Pregnancy and lactation – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Severe hepatic impairment (see Special warnings and precautions for use and Pharmacokinetic Properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Combination therapy with Palbociclib** See palbociclib local Prescribing Information for Contraindications. **Combination therapy with abemaciclib** See abemaciclib local Prescribing Information for Contraindications. **Combination therapy with ribociclib** See ribociclib local Prescribing Information for Contraindications.
L02BA03
fulvestrant
Manufacturer Information
APEX PHARMA MARKETING PTE. LTD.
Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
Active Ingredients
Documents
Package Inserts
Fulvestrant-AFT Solution For Injection PI.pdf
Approved: May 15, 2023