Faslodex Special Precautions

Faslodex should be used with caution in patients with mild to moderate hepatic impairment (see Dosage & Administration, Contraindications and Pharmacology: Pharmacokinetics under Actions).
Faslodex 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, Faslodex 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 studies with Faslodex (see Adverse Reactions). This should be taken into consideration when prescribing Faslodex to patients at risk.
Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with Faslodex injection. Caution should be taken while administering Faslodex 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 Faslodex (either as monotherapy or in combination with palbociclib) have not been studied in patients with critical visceral disease.
When Faslodex is combined with palbociclib, please also refer to the package insert 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: Faslodex contains 10% w/v ethanol (alcohol) as an excipient, i.e. up to 500 mg per injection, equivalent to 10 ml beer or 4 ml wine. This may be harmful for those suffering from alcoholism and should be taken into account in high risk groups such as patients with liver disease and epilepsy.
Benzyl alcohol: Faslodex contains benzyl alcohol as an excipient which may cause allergic reactions.
Effects on ability to drive and use machines: Faslodex has no or negligible influence on the ability to drive or use machines. However, since asthenia has been reported very commonly with Faslodex, caution should be observed by those patients who experience this adverse reaction when driving or operating machinery.
Use in Children: Faslodex 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).