Fulevex Dosage/Direction for Use

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: Safety and efficacy of fulvestrant not established in patients with renal impairment. However, the drug is not extensively eliminated in the urine. Data from clinical studies indicate that plasma fulvestrant concentrations in women with creatinine clearances as low as 30 mL/minute were similar to those in women with normal renal function.
Hepatic impairment: No dosage adjustment necessary in patients with mild hepatic impairment. Safety and efficacy of fulvestrant not established in patients with moderate to severe hepatic impairment.
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 under Cautions for Usage".