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Mepsevii Generic Name & Formulations
Legal Class
Rx
General Description
Vestronidase alfa-vjbk 2mg/mL; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Recombinant human lysosomal beta glucuronidase.
How Supplied
Single-dose vial (5mL)—1
Manufacturer
Generic Availability
NO
Mepsevii Indications
Indications
Treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome).
Limitations of Use
Effect on the CNS manifestations of MPS VII has not been determined.
Mepsevii Dosage and Administration
Adults and Children
Premedicate with a non-sedating antihistamine with or without an antipyretic 30–60mins prior to infusion. Give as IV infusion over 4hrs (infuse first 2.5% of total volume over 1hr, then increase rate as tolerated over next 3hrs); see full labeling. 4mg/kg every 2 weeks.
Mepsevii Contraindications
Not Applicable
Mepsevii Boxed Warnings
Boxed Warning
Anaphylaxis.
Mepsevii Warnings/Precautions
Warnings/Precautions
Have appropriate medical support readily available. Should be administered under supervision of healthcare professional. Monitor during and for ≥60mins post-infusion for anaphylaxis; discontinue immediately if a severe systemic reaction occurs. Elderly. Pregnancy. Nursing mothers.
Mepsevii Pharmacokinetics
See Literature
Mepsevii Interactions
Not Applicable
Mepsevii Adverse Reactions
Adverse Reactions
Infusion site extravasation, diarrhea, rash, anaphylaxis, infusion site swelling, peripheral swelling, pruritus.
Mepsevii Clinical Trials
See Literature
Mepsevii Note
Not Applicable
Mepsevii Patient Counseling
See Literature
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