Special Warning : אזהרת שימוש

4.4       Special warnings and precautions for use
Faslodex should be used with caution in patients with mild to moderate, hepatic impairment (see sections 4.2, 4.3 and 5.2).
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 section 4.8). 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 sections 4.2 and 4.8).
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.


The falsely elevated estradiol levels could lead the clinician to incorrect medical decisions and unnecessary procedures. If this situation has occurred, reassessing the status of the patient by other means or using an alternate method for estradiol measurement should be considered.
The results should always be assessed in correlation with the clinical evaluation. The laboratory performing the Estradiol immunoassay should be informed that the patient is taking Faslodex.


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.

Paediatric population
Faslodex is not recommended for use in children and adolescents as safety and efficacy have not been established in this group of patients (see section 5.1).

Effects on Driving

4.7         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.