Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
Patients with moderate to severe hepatic impairment
There are limited data in patients with moderate hepatic impairment and no data in patients with severe hepatic impairment. EMEND IV should be used with caution in these patients (see section 5.2).

CYP3A4 interactions
EMEND IV should be used with caution in patients receiving concomitant active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, ergot alkaloid derivatives, fentanyl, and quinidine (see section 4.5). Additionally, concomitant administration with irinotecan should be approached with particular caution as the combination might result in increased toxicity.

Co-administration with warfarin (a CYP2C9 substrate)
In patients on chronic warfarin therapy, the International Normalised Ratio (INR) should be monitored closely for 14 days following the use of fosaprepitant (see section 4.5).

Co-administration with hormonal contraceptives
The efficacy of hormonal contraceptives may be reduced during and for 28 days after administration of fosaprepitant. Alternative non-hormonal back-up methods of contraception should be used during treatment with fosaprepitant and for 2 months following the use of fosaprepitant (see section 4.5).

Hypersensitivity reactions
Immediate hypersensitivity reactions including flushing, erythema, dyspnoea and anaphylaxis/anaphylactic shock have occurred during or soon after infusion of fosaprepitant.
These hypersensitivity reactions have generally responded to discontinuation of the infusion and administration of appropriate therapy. It is not recommended to reinitiate the infusion in patients who experience hypersensitivity reactions.

Administration and infusion site reactions
EMEND IV should not be given as a bolus injection, but should always be diluted and given as a slow intravenous infusion (see section 4.2). EMEND IV should not be administered intramuscularly or subcutaneously (see section 5.3). Mild injection site thrombosis has been observed at higher doses. If signs or symptoms of local irritation occur, the injection or infusion should be terminated and restarted in another vein.

Effects on Driving

4.7   Effects on ability to drive and use machines

EMEND IV may have minor influence on the ability to drive and use machines. Dizziness and fatigue may occur following administration of EMEND IV (see section 4.8).