Preparation & Handling | VPRIV® (velaglucerase alfa) for injection

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VPRIV PREPARATION

You understand your patients and the various stages they’ll experience in their individual journeys. We understand your needs in supporting your patients on their journey. Our goal is to help make sure you’re not just ready, you’re VPRIV Ready.

VPRIV preparation

Supplies Needed
VPRIV is a lyophilized powder that requires reconstitution and dilution, using sterile technique, prior to intravenous (IV) infusion.¹ The following supplies will help with the preparation and administration of VPRIV:

IV Apparatus

IV infusion pump

IV infusion tubing

IV start kit

In-line low protein-binding 0.2
or 0.22 μm filter

Equipment

Syringes and ≤20 gauge needles

Angiocatheter

If initiating treatment, appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment should be available

Anaphylaxis kit

Antihistamines and/or corticosteroids as pre-treatment as needed or per facility infusion protocol

Solutions

Sterile Water for Injection, USP

100 mL of 0.9% Sodium Chloride Injection, USP

Storage & Handling

VPRIV is a sterile, white to off-white, lyophilized powder supplied in
individually packaged single-dose glass vials, requiring reconstitution
and dilution prior to use¹

VPRIV should be stored refrigerated at 36°F to 46°F (2°C to 8°C) in the
original carton away from light. Do not freeze VPRIV¹

Check the expiration date on the vial and DO NOT use VPRIV after
the expiration date¹

Reconstitution & Dilution

VPRIV is a lyophilized powder that requires reconstitution and dilution, using sterile technique, prior to intravenous infusion.¹ VPRIV should be prepared as follows¹:

Determine the number of vials to be reconstituted based on the individual patient’s weight
and the prescribed dose. See Dosing Calculation for VPRIV dosing guidelines.

Inject 4.3 mL of Sterile Water for Injection, USP, into a vial containing VPRIV powder. Mix
gently, do not shake. The reconstituted VPRIV solution will have a 100 U/mL concentration
(400 U of VPRIV in 4 mL of solution). If more vials are needed, repeat the above steps.

Visually inspect the solution in the vials. It should be clear to slightly opalescent and colorless.
Do not use if the solution is discolored or if foreign particulate matter is present.*

Use a single syringe to withdraw the calculated dosage of drug from the appropriate number of
prepared vials. See Dosing Calculation for VPRIV dosing guidelines. Using a separate syringe, withdraw
air from a bag of 100 mL of 0.9% Sodium Chloride Injection suitable for IV administration. Inject the
calculated dosage of prepared VPRIV directly into the 0.9% Sodium Chloride Injection to dilute.

Mix gently, do not shake. Slight flocculation (white irregularly shaped particles) may occasionally
occur. A diluted solution with slight flocculation is acceptable for administration.

Place medication label on the IV bag according to site/organization policy. Use immediately. If immediate
use is not possible, the diluted VPRIV solution may be stored for up to 24 hours at 36°F to 46°F (2°C to 8°C).
Do not freeze, and protect from light. Complete the infusion within 24 hours of reconstitution.

*Contact Medical Information at 1-866-888-0660, option 2 or email medinfous@takeda.com for all US inquiries if the solution is discolored or if foreign particulate matter is present.

IMPORTANT SAFETY INFORMATION

WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS

Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy.

Initiate VPRIV in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment.

INDICATION

VPRIV® (velaglucerase alfa) for injection is indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease.

IMPORTANT SAFETY INFORMATION

WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS

Initiate VPRIV in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment.

If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue VPRIV and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur.

Life-threatening hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with enzyme replacement therapies, including VPRIV. VPRIV-treated patients have had these reactions occur in clinical studies and postmarketing experience.

Hypersensitivity reactions were the most commonly observed adverse reactions in patients treated with VPRIV in clinical studies. Patients were not routinely pre-medicated prior to infusion of VPRIV. The most commonly observed symptoms of hypersensitivity reactions were: headache, dizziness, hypotension, hypertension, nausea, fatigue/asthenia, and pyrexia. Hypersensitivity reactions in the clinical trials include any event considered related to and occurring within up to 24 hours of VPRIV infusion, including one case of anaphylaxis. Generally the reactions were mild and, in treatment-naïve patients, onset occurred mostly during the first 6 months of treatment and tended to occur less frequently with time. Additional hypersensitivity reactions of chest discomfort, dyspnea, pruritus and vomiting have been reported in post-marketing experience. In some cases vomiting can be serious, requiring hospitalization and/or drug discontinuation.

Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Administration of VPRIV should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis. Initiate VPRIV in a healthcare setting with appropriate medical monitoring and support measures including access to cardiopulmonary resuscitation equipment.

Management of hypersensitivity reactions should be based on severity of the reaction, such as slowing the infusion rate, treatment with medications such as antihistamines, antipyretics and/or corticosteroids, and/or stopping and resuming treatment with increased infusion time. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue VPRIV and immediately initiate appropriate medical treatment, including use of epinephrine. In cases where patients have exhibited symptoms of hypersensitivity to velaglucerase alfa or excipients in the drug product or to other enzyme replacement therapy, pre-treatment with antihistamines and/or corticosteroids may prevent subsequent reactions. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur.

The most common adverse reactions during clinical studies (in ≥10% of patients) were hypersensitivity reactions, headache, dizziness, abdominal pain, nausea, back pain, joint pain, prolonged activated partial thromboplastin time (aPTT), fatigue/asthenia, and pyrexia. In clinical studies, the overall frequency of adverse events was generally higher in the population naïve to enzyme replacement therapy (ERT) than in the population switched from imiglucerase to VPRIV.

The safety and efficacy profiles were similar in pediatric (ages 4 to 17) and adult patients. The safety of VPRIV has not been established in patients under 4 years of age. Adverse reactions more commonly seen in pediatric patients compared to adult patients include (>10% difference): rash, prolonged aPTT, and pyrexia. The adverse reaction profile in elderly patients was consistent with that previously observed across pediatric and adult patients. In general, dose selection for an elderly patient should be approached cautiously, considering comorbid conditions.

As with all therapeutic proteins, there is a potential for immunogenicity. In clinical studies, 1 of 54 (2%) enzyme treatment-naïve patients treated with VPRIV developed IgG class antibodies (neutralizing in an in vitro assay). One additional patient developed IgG antibodies to VPRIV during an extension study. It is unknown if the presence of IgG antibodies to VPRIV is associated with a higher risk of infusion reactions. Patients with an immune response to other ERTs who are switching to VPRIV should continue to be monitored for antibodies to VPRIV.

To report SUSPECTED ADVERSE REACTIONS, contact Medical Information at 1-866-888-0660, option 2 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for Full Prescribing Information, including Boxed WARNING for Risk of Anaphylaxis.

For more information, contact Takeda at 1-877-TAKEDA-7 (1-877-825-3327), or by email at medinfous@takeda.com