Generic name: VELAGLUCERASE ALFA 2.5mg in 1mL
Dosage form: injection, powder, lyophilized, for solution
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Recommended Starting Dosage in Patients Naïve to Enzyme Replacement Therapy
VPRIV should be administered under the supervision of a healthcare professional. The recommended starting VPRIV dosage in naïve adults and naïve pediatric patients 4 years of age and older is 60 Units/kg administered every other week as a 60-minute intravenous infusion. The dosage can be adjusted based on achievement and maintenance of each patient's therapeutic goals.
Switching from Imiglucerase to VPRIV
Adults and pediatric patients 4 years of age and older currently being treated on a stable dosage of imiglucerase for type 1 Gaucher disease may be switched to VPRIV by starting treatment with VPRIV at the previous imiglucerase dosage two weeks after the last imiglucerase dose. VPRIV should be administered under the supervision of a healthcare professional as a 60-minute intravenous infusion. The dosage can be adjusted based on achievement and maintenance of each patient's therapeutic goals.
Reconstitution of the VPRIV Lyophilized Powder
VPRIV is a lyophilized powder, which requires reconstitution and dilution, using sterile technique, prior to intravenous infusion. VPRIV should be prepared as follows:VPRIV is a lyophilized powder, which requires reconstitution and dilution, using sterile technique, prior to intravenous infusion. VPRIV should be prepared as follows:
- Determine the number of vials to be reconstituted based on the individual patient's weight and the prescribed dose.
- Inject 4.3 mL of Sterile Water for Injection, USP into a vial containing VPRIV lyophilized powder.
- Mix gently. DO NOT SHAKE. The reconstituted VPRIV solution will have a 100 Units/mL concentration (400 Units VPRIV in 4 mL of solution).
- If additional vials are needed, repeat steps (b) and (c)
- Visually inspect the reconstituted VPRIV solution in the vials. The solution should be clear to slightly opalescent and colorless. Do not use if the solution is discolored or if foreign particulate matter is present.
- With a single syringe, withdraw the calculated dose of drug from the appropriate number of vials. Using a separate syringe, withdraw air from a bag of 100 mL of 0.9% sodium chloride solution suitable for intravenous administration. Then dilute the calculated dose of VPRIV directly into the sodium chloride solution. Mix gently. DO NOT SHAKE. Slight flocculation (described as white irregular shaped particles) may occasionally occur. Diluted solution with slight flocculation is acceptable for administration.
- Because VPRIV contains no preservatives, use the reconstituted VPRIV solution and the diluted VPRIV solution immediately. If immediate use is not possible, the reconstituted VPRIV solution or the diluted VPRIV solution may be stored for up to 24 hours at 2 °C to 8°C (36 °F to 46°F). Do not freeze and protect from light. Complete the infusion within 24 hours of reconstitution of vials.
- Vials are for single use only. Discard any unused solution.Vials are for single use only. Discard any unused solution.
Important Administration Instructions
Administer the diluted VPRIV solution through an in-line low protein-binding 0.2μm filter over 60 minutes. Do not infuse VPRIV with other products in the same infusion tubing because the compatibility of a VPRIV solution with other products has not been evaluated.
Premedication to Reduce Risk of Subsequent Hypersensitivity Reactions
Consider pre-treatment with antihistamines and/or corticosteroids in patients who exhibited symptoms of hypersensitivity associated with prior VPRIV infusions. Appropriate medical support should be readily available when VPRIV is administered [see Warnings and Precautions (5.1)].