FEMCORD SOLUTION FOR INJECTION 250 MG/5 ML

INJECTION, SOLUTION

• **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 Femcord is used in combination with palbociclib, refer to monotherapy recommended dose instruction for Femcord. Refer to the prescribing information for palbociclib for Posology and method of administration. Prior to the start of treatment with the combination of Femcord 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 Femcord is used in combination with abemaciclib, refer to monotherapy recommended dose instruction for Femcord. Refer to the prescribing information for abemaciclib for Posology and method of administration. Prior to the start of treatment with the combination of Femcord 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 Femcord is used in combination with ribociclib, refer to monotherapy recommended dose instruction for Femcord. Refer to the prescribing information for ribociclib for Posology and method of administration. Special population _Paediatric patient:_ Femcord 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, Femcord 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** Femcord 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 Femcord 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_.