MEPSEVII
vestronidase alfa
Product profile Marketed injection containing VESTRONIDASE ALFA.
Dose form and route INJECTION · INTRAVENOUS
Structured Monograph
Clinical summary
Product profile Marketed injection containing VESTRONIDASE ALFA. Dose form and route INJECTION · INTRAVENOUS
Boxed Warning
WARNING: ANAPHYLAXIS Anaphylaxis has occurred with MEPSEVII administration, as early as the first dose [see Warnings and Precautions ( 5.1 )] , therefore appropriate medical support should be readily available when MEPSEVII is administered. Closely observe patients during and for 60 minutes after MEPSEVII infusion [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 )]. Immediately discontinue the MEPSEVII infusion if the patient experiences anaphylaxis [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 )]. WARNING: ANAPHYLAXIS See full prescribing information for complete boxed warning. Anaphylaxis has occurred with MEPSEVII administration, as early as the first dose ( 5.1 ), therefore appropriate medical support should be readily available when MEPSEVII is administered. Closely observe patients during and for 60 minutes after MEPSEVII infusion ( 2.2 , 5.1 ). Immediately discontinue the MEPSEVII infusion if the patient experiences anaphylaxis ( 2.2 , 5.1 ).
Monitoring
- • These reactions occurred during MEPSEVII infusion and were observed as early as the first dose of MEPSEVII for one patient.
- • Manifestations included respiratory distress, cyanosis, decreased oxygen saturation, and hypotension.
- • The two patients with anaphylaxis to MEPSEVII during the clinical trials had one occurrence each and tolerated subsequent infusions of MEPSEVII, without recurrence.
- • Review the product-specific label before prescribing.
Interaction Notes
- • Interaction data should be confirmed against the corresponding label.