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New medicines Composition: Fosaprepitant. Ivemend (and oral aprepitant) should be used with caution in patients receiving medicines that are metabolised primarily through CYP3A4. Concomitant administration with irinotecan should be approached with extra caution as the combination might result in increased toxicity. Concomitant use of fosaprepitant with ergot alkaloid derivatives, which are CYP3A4 substrates, may result in elevated plasma concentrations of these medicinal products; caution is advised due to the potential risk of ergot-related toxicity. In patients on chronic warfarin therapy, international normalised ratio should be monitored closely for two weeks after a three-day regimen of fosaprepitant followed by oral aprepitant (and throughout ongoing treatment with oral aprepitant). Non-hormonal contraception should be used if required during treatment with fosaprepitant or aprepitant and for two months following the last dose of aprepitant. Concomitant administration of fosaprepitant with medicinal products that strongly induce CYP3A4 activity, including St John’s Wort, should be avoided. Concomitant administration of fosaprepitant with medicinal products that inhibit CYP3A4 activity should be approached cautiously as the combination results in increased plasma concentrations of aprepitant. Corticosteroid doses need to be adjusted when administered with fosaprepitant/aprepitant (as per standard anti-emetic regimens that include aprepitant). Ivemend should not be given as a bolus injection, but should always be diluted and given as a slow intravenous infusion. Ivemend should not
be administered intramuscularly or subcutaneously. 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. |
SPC changes
Lyrica Nexavar Reminyl The SPC for Reminyl XL now says about switching to Reminyl XL from Reminyl tablets or oral solution: “It is recommended that the same total daily dose of galantamine is administered to patients. Patients switching to the once-daily regimen should take their last dose of Reminyl tablets or oral solution in the evening and start Reminyl XL prolonged release capsules once daily the following morning.” Viread Zevalin New details have been added to the special warnings section, including:
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