Fulvestrant Kabi Special Precautions

Fulvestrant should be used with caution in patients with mild to moderate hepatic impairment (see Dosage & Administration, Contraindications and Pharmacology: Pharmaokinetics under Actions).
Fulvestrant should be used with caution in patients with severe renal impairment (creatinine clearance less than 30 ml/min).
Due to the intramuscular route of administration, fulvestrant should be used with caution if treating patients with bleeding diatheses, thrombocytopenia or those taking anticoagulant treatment.
Thromboembolic events are commonly observed in women with advanced breast cancer and have been observed in clinical trials with fulvestrant (see Adverse Reactions). This should be taken into consideration when prescribing fulvestrant to patients at risk.
Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with fulvestrant injection. Caution should be taken while administering fulvestrant at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve (see Dosage & Administration and Adverse Reactions).
There are no long-term data on the effect of fulvestrant on bone. Due to the mechanism of action of fulvestrant, there is a potential risk of osteoporosis.
The efficacy and safety of fulvestrant (either as monotherapy or in combination with palbociclib) have not been studied in patients with critical visceral disease.
When fulvestrant is combined with palbociclib, also refer to the Summary of Product Characteristics of palbociclib.
Interference with estradiol antibody assays: Due to the structural similarity of fulvestrant and estradiol, fulvestrant may interfere with antibody based-estradiol assays and may result in falsely increased levels of estradiol.
Ethanol: This medicinal product contains 500 mg of alcohol (ethanol) in each injection which is equivalent to 100 mg/ml (10% w/v). The amount in each injection of this medicine is equivalent to 13 ml beer or 5 ml wine.
A dose of 500 mg of this medicine (two syringes) administered to an adult women weighing 70 kg would result in exposure to 14.3 mg/kg of ethanol which may cause a rise in blood alcohol concentration (BAC) of about 2.4 mg/100 ml (see Appendix I of report EMA/CHMP/43486/2018). For comparison, for an adult drinking a glass of wine or 500 ml of beer, the BAC is likely to be about 50 mg/100 ml.
Co-administration with medicines containing e.g. propylene glycol or ethanol may lead to accumulation of ethanol and induce adverse effects.
Benzyl alcohol: This medicinal product contains benzyl alcohol as an excipient which may cause allergic reactions.
Effects on ability to drive and use machines: Fulvestrant has no or negligible influence on the ability to drive or use machines. However, since asthenia has been reported very commonly with fulvestrant, caution should be observed by those patients who experience this adverse reaction when driving or operating machinery.
Use in Children: Fulvestrant is not recommended for use in children and adolescents as safety and efficacy have not been established in this group of patients (see Pharmacology: Pharmacodynamics under Actions).