- Approval Id
- 8681d378349d6127
- Drug Name
- FULEVEX FULVESTRANT SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 250 MG/5 ML
- Product Name
- FULEVEX FULVESTRANT SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 250 MG/5 ML
- Approval Number
- SIN16466P
- Approval Date
- 2022-04-04
- Registrant
- DKSH SINGAPORE PTE. LTD.
- Licence Holder
- DKSH SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- - **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 Fulevex is used in combination with palbociclib, refer to monotherapy recommended dose instruction for Fulevex. Refer to the prescribing information for palbociclib for Posology and method of administration.
Prior to the start of treatment with the combination of fulvestrant plus palbociclib, and throughout its duration, pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice.
Special population
_Paediatric patient:_
Fulevex 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, Fulevex 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**
Fulevex 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 Fulevex 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_.
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- - **Therapeutic indications**
Fulevex 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
Fulevex 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.
- Contraindications
- - **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_.
- Atc Code
- L02BA03
- Atc Item Name
- fulvestrant
- Pharma Manufacturer Name
- DKSH SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/cbda6ad0d0b82155/dksh-singapore-pte-ltd
