VPRIV 2.5 mg/mL
velaglucerase alfa · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Takeda Pharmaceuticals America, Inc.
VPRIV is a injection, powder, lyophilized, for solution containing velaglucerase alfa at 2.5 mg/mL, taken intravenous. Manufactured by Takeda Pharmaceuticals America, Inc..
Key Facts
- Brand Name
- VPRIV
- Generic Name
- velaglucerase alfa
- NDC Code (Product)
54092-701- Manufacturer
- Takeda Pharmaceuticals America, Inc.
- Strength
- 2.5 mg/mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA022575
- Drug Class
- Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC]
- Marketing Start
- 02/26/2010
Recall History
Shire Human Genetic Therapies, Inc.
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE VPRIV is indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease. 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 & Administration
2 DOSAGE AND ADMINISTRATION Administration of VPRIV should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis ( 2.1 ) Recommended Starting Dose in Adults and Pediatric Patients 4 Years of Age or Older: Patients Naïve to Enzyme Replacement Therapy: 60 Units/kg ( 2.2 ) Patients being treated with stable imiglucerase dosages for Gaucher disease: Can switch to VPRIV at previous imiglucerase dose two weeks after last imiglucerase dose ( 2.3 ) Determine number of vials to be reconstituted based on patient's actual weight and prescribed dose ( 2.4 ) Supplied VPRIV lyophilized powder must be reconstituted with Sterile Water for Injection ( 2.4 ) Reconstituted VPRIV solution must be diluted in 100 mL of 0.9% Sodium Chloride Injection prior to intravenous infusion ( 2.4 ) Administer the diluted VPRIV solution through an in-line low protein-binding 0.2 or 0.22 µm filter ( 2.5 ) 2.1 Recommendations Prior to VPRIV treatment Administration of VPRIV should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis [see Warnings and Precautions (5.1) ] . Initiate …
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (≥10%) are: hypersensitivity reactions, headache, dizziness, abdominal pain, nausea, back pain, joint pain, prolonged activated PTT, fatigue/asthenia, and pyrexia ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure of 94 patients with type 1 Gaucher disease who received VPRIV at doses ranging from 15 Units/kg to 60 Units/kg every other week in 5 clinical studies. Fifty-four (54) patients were naïve to enzyme replacement therapy (ERT) and received VPRIV for 9 months and 40 patients switched from imiglucerase to VPRIV treatment and received VPRIV for 12 months [see Clinical Studies (14) ] . Patients were between 4 and 71 years old at time of first treatment with VPRIV, and included 46 male and 48 female patient…
Frequently Asked Questions
What is VPRIV used for?
VPRIV contains velaglucerase alfa. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is VPRIV a controlled substance?
VPRIV is not classified as a controlled substance by the DEA.
What is the generic name for VPRIV?
The generic name for VPRIV is velaglucerase alfa. There are no other listed brand versions of velaglucerase alfa.
What is the NDC code for VPRIV 2.5 mg/mL?
The NDC (National Drug Code) for VPRIV 2.5 mg/mL is 54092-701, listed by Takeda Pharmaceuticals America, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)