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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
Not Applicable
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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