These highlights do not include all the information needed to use VPRIV safely and effectively. See full prescribing information for VPRIV.
VPRIV® (velaglucerase alfa for injection), for intravenous use
Initial U.S. Approval: 2010
RECENT MAJOR CHANGES
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Dosage and Administration (2.3)
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Warnings and Precautions (5.1)
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4/2015
4/2015 |
INDICATIONS AND USAGE
VPRIV is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease (1)
DOSAGE AND ADMINISTRATION
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Recommended Starting Dose in Adults and Pediatric Patients 4 Years of Age or Older:
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Patients Naïve to Enzyme Replacement Therapy: 60 Units/kg (2.1)
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Patients being treated with stable imiglucerase dosages for Gaucher disease: Can switch to VPRIV at previous imiglucerase dose two weeks after last imiglucerase dose (2.2).
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Determine number of vials to be reconstituted based on patient's actual weight and prescribed dose (2.3)
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Supplied VPRIV lyophilized powder must be reconstituted with Sterile Water for Injection (2.3)
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Reconstituted VPRIV solution must be diluted in 100 mL of 0.9% sodium chloride solution prior to intravenous infusion (2.3)
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Administer the diluted VPRIV solution through an in-line low protein-binding 0.2μm filter (2.4)
DOSAGE FORMS AND STRENGTHS
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Lyophilized powder to be reconstituted and diluted for infusion (3).
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Available in 400 Units single-use vials (3).
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions Including Anaphylaxis: