FULVESTRANT-TEVA SOLUTION FOR INJECTION 250MG/5ML

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