Fulevex Special Precautions

Fulevex should be used with caution in patients with mild to moderate hepatic impairment (see Dosage & Administration, Contraindications, and Pharmacology: Pharmacokinetics under Actions).
Fulevex should be used with caution in patients with severe renal impairment (creatinine clearance less than 30 ml/min) (see Pharmacology: Pharmacokinetics under Actions).
Due to the intramuscular route of administration, Fulevex should be used with caution if treating patients with bleeding diatheses, thrombocytopenia or those taking anticoagulant treatment.
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).
Thromboembolic events are commonly observed in women with advanced breast cancer and have been observed in clinical studies with fulvestrant (see Adverse Reactions). This should be taken into consideration when prescribing fulvestrant to patients at risk.
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.
Fulvestrant can interfere with oestradiol measurement by immunoassay, resulting in falsely elevated oestradiol levels.
Combination therapy with palbociclib: See palbociclib local Prescribing Information for Precautions.
Effects on ability to drive and use machines: Fulevex 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.