VPRIV- velaglucerase alfa injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VELAGLUCERASE ALFA (UNII: 23HYE36B0I) (VELAGLUCERASE ALFA - UNII:23HYE36B0I)

Available from:

Takeda Pharmaceuticals America, Inc.

INN (International Name):

VELAGLUCERASE ALFA

Composition:

VELAGLUCERASE ALFA 2.5 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

VPRIV is indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease. None. Risk Summary Available data on use of velaglucerase alfa in pregnant women includes more than 300 pregnancies reported from the pharmacovigilance database and published observational cohort studies, including the international Gaucher Disease registry. While available data cannot definitively establish or exclude the absence of a velaglucerase alfa associated risk during pregnancy, these data have not identified an association with use of velaglucerase alfa during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies no fetal harm was observed in rats or rabbits when velaglucerase alfa was administered intravenously during organogenesis at doses with exposures up to 1.8 times and 4.3 times, respectively, the recommended human daily dose (see Data) . The estimated background risk of major birth defects and miscarriage for the indicate

Product summary:

How Supplied VPRIV (velaglucerase alfa) for injection is a sterile, preservative free, white to off-white lyophilized powder requiring reconstitution and further dilution prior to use. It is supplied in individually packaged single-dose glass vials, which are closed with a butyl rubber stopper with a fluoro-resin coating and are sealed with an aluminum overseal with a flip-off plastic cap. VPRIV is available as: 400 units/vial (NDC 54092-701-04). Storage Store VPRIV refrigerated at 2ºC to 8ºC (36ºF to 46ºF) in the original carton to protect from light. Do not freeze. Do not use VPRIV after the expiration date on the vial.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

VPRIV- VELAGLUCERASE ALFA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
TAKEDA PHARMACEUTICALS AMERICA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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
Dosage and Administration (2.4)
12/2020
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
Recommended Starting Dose in Adults and Pediatric Patients 4 Years of
Age or Older:
Patients Naïve to Enzyme Replacement Therapy: 60 Units/kg (2.1)
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)
Determine number of vials to be reconstituted based on patient's
actual weight and prescribed dose
(2.3)
Supplied VPRIV lyophilized powder must be reconstituted with Sterile
Water for Injection (2.3)
Reconstituted VPRIV solution must be diluted in 100 mL of 0.9% Sodium
Chloride Injection prior to
intravenous infusion (2.3)
Administer the diluted VPRIV solution through an in-line low
protein-binding 0.2 or 0.22 µm filter (2.4)
DOSAGE FORMS AND STRENGTHS
For injection: 400 units lyophilized powder single-dose vials (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions Including Anaphylaxis:
Hypersensitivity reactions including anaphylaxis have occurred (5.1)
Ensure that personnel administering product are adequately trained in
cardiopulmonary resuscitative
measures, and have ready access to emergency medical services (5.1)
Consider slowing infusion rate, treatment with antihistamines,
antipyretics and/or corticosteroids,
and/or stopping treatment if a hypersensitivity reaction occurs during
an infusion. Consider pre-
tr