Emend IV Special Precautions

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 I.V. should be used with caution in these patients (see Pharmacology: Pharmacokinetics under Actions).
CYP3A4 interactions: EMEND I.V. 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 Interactions). 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 Interactions).
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 Interactions).
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: Infusion site reactions (ISRs) have been reported with the use of EMEND I.V. (see Adverse Reactions). The majority of severe ISRs, including thrombophlebitis and vasculitis, were reported with concomitant vesicant (e.g., anthracycline-based) chemotherapy administration, particularly when associated with extravasation. Necrosis was also reported in some patients with concomitant vesicant chemotherapy. Mild injection site thrombosis has been observed at higher doses without concomitant vesicant chemotherapy.
EMEND I.V. should not be given as a bolus injection, but should always be diluted and given as a slow intravenous infusion (see Dosage & Administration). EMEND I.V. should not be administered intramuscularly or subcutaneously (see Pharmacology: Toxicology: Pre-clinical safety data under Actions). If signs or symptoms of local irritation occur, the injection or infusion should be terminated and restarted in another vein.
Effects on ability to drive and use machines: EMEND I.V. may have minor influence on the ability to drive and use machines. Dizziness and fatigue may occur following administration of EMEND I.V. (see Adverse Reactions).