Faslodex

Faslodex Special Precautions

fulvestrant

Manufacturer:

AstraZeneca

Marketer:

AstraZeneca
Full Prescribing Info
Special Precautions
Faslodex should be used with caution in patients with mild to moderate hepatic impairment (see Pharmacology: Pharmacokinetics under Actions, Dosage & Administration and Contraindications).
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 trials 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.
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.
Effects on ability to drive and to 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).
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