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Vimizim Generic Name & Formulations
Legal Class
Rx
General Description
Elosulfase alfa 1mg/mL; soln for IV infusion; preservative-free.
Pharmacological Class
Hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme.
How Supplied
Single-use vial (5mL)—1
Manufacturer
Vimizim Indications
Indications
Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome).
Vimizim Dosage and Administration
Adults and Children
<5yrs: not established. Give by IV infusion over 3.5–4.5 hours based on infusion volume. ≥5yrs: 2mg/kg once weekly. Pre-treat with antihistamines with or without antipyretics 30–60 mins prior to infusion.
Vimizim Contraindications
Not Applicable
Vimizim Boxed Warnings
Boxed Warning
Risk of anaphylaxis.
Vimizim Warnings/Precautions
Warnings/Precautions
Risk of serious anaphylactic reactions; observe patients during and after administration. Have epinephrine inj available. Discontinue immediately if severe hypersensitivity reactions occur. Acute febrile or respiratory illness; evaluate clinical status prior to therapy and consider delaying infusion. Risk of sleep apnea; consider evaluating airway patency prior to initiation. Have supplemental oxygen or continuous positive airway pressure available. Monitor for signs/symptoms of spinal or cervical cord compression. Pregnancy. Nursing mothers.
Vimizim Pharmacokinetics
See Literature
Vimizim Interactions
Vimizim Adverse Reactions
Adverse Reactions
Pyrexia, vomiting, headache, nausea, abdominal pain, chills, fatigue; sleep apnea, anaphylaxis, possible antibody formation.
Vimizim Clinical Trials
See Literature
Vimizim Note
Notes
To enroll in the Morquio A Registry for monitoring effects of Vimizim contact [email protected] or call (800) 983-4587.
Vimizim Patient Counseling
See Literature
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