Fulvestrant Sandoz 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.
[Fulvestrant in indication "combination with palbociclib"]: When fulvestrant is used in combination with palbociclib, please also refer to the Summary of Product Characteristics of palbociclib.
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.
[Fulvestrant in all indications]: Special population: 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 Precautions).
Hepatic impairment: No dose adjustments are recommended for patients with mild to moderate hepatic impairment. However, as fulvestrant exposure may be increased, fulvestrant should be used with caution in these patients. There are no data in patients with severe hepatic impairment (see Contraindications, Precautions and Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of fulvestrant in children from birth to 18 years of age have not been established.
Fulvestrant is not indicated for use in children. The European Medicines Agency has waived the obligation to submit the results of studies with fulvestrant in all subsets of the paediatric population in breast cancer.
Method of administration: Fulvestrant should be administered as two consecutive 5 ml injections by slow intramuscular injection (1-2 minutes/injection), one in each buttock.
Caution should be taken if injecting fulvestrant at the dorsogluteal site due to the proximity of the underlying sciatic nerve.
For detailed instructions for administration see Special precautions for disposal and other handling under Cautions for Usage.
For instructions of the medicinal product before administration see Special precautions for disposal and other handling under Cautions for Usage.