VPRIV DOSING & ADMINISTRATION

DOSING CALCULATION

VPRIV Dosage

VPRIV should be administered under the supervision of a healthcare professional.1 HCPs should be referencing the Prescribing Information which contains complete dosing and administration information.

Treatment-Naïve
Patients
The recommended starting dosage in treatment-naïve patients (adults and children, aged 4 years and older) is 60 U/kg administered once every other week as a 60-minute IV infusion.1,2
Treatment-Experienced
Patients
Patients (adults and children, aged 4 years 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 2 weeks after the last imiglucerase dose.1,3
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  • Dosage adjustments may be made on an individual basis based on the achievement and maintenance of therapeutic goals.1

  • VPRIV is dosed according to body weight1

Dosing Calculator

Precise dosing requires patient’s exact weight and an individual calculation by the healthcare professional.

Please enter patient weight in:

Please enter patient weight in:
Patient's weight
Patient Weight =
=
kg

Syringe containing VPRIV
Dosage of VPRIV Required =
=
U
VPRIV vial
Number of Vials Needed =
=
vials

Calculation Steps:1

1

Obtain patient’s weight

2

Calculate the dosage of VPRIV required:* Patient weight (kg) x 60 U/kg

3

Calculate the number of vials needed: Required VPRIV dosage ÷ 400

Use the exact unit of the required VPRIV dosage.1 Dispose of unused product.

Example Calculation:

Patient weight
= 21 kg

21 kg x 60 U/kg of VPRIV
= 1,260 U

1,260 ÷ 400
= 3.15 vials needed

(4 vials are needed to extract 1,260 U of VPRIV)

*Recommended dose of VPRIV is 60 U/kg patient body weight administered once every other week as an intravenous (IV) infusion.1 This will change if lbs is used in the calculation instead.

1 vial of VPRIV = 400 Units (U).

PATIENT ASSESSMENT

As with any infusion or medical procedure, it is important to assess the patient’s current condition and review their medical history, including any prior enzyme replacement therapy (ERT) for type 1 Gaucher disease.1 Appropriate medical support should be readily available when VPRIV is administered.1

Patient's weight

Obtain the patient’s weight.1

Vital signs

Check perfusion vital signs and labs, if required per facility infusion protocol.

Infusion notes

Review previous infusion notes, if any, to determine if the patient has had infusion reactions to an ERT and to assess any changes since the last visit.1

Pre-treatment

Consider pre-treatment with antihistamines and/or corticosteroids in patients who exhibited symptoms of hypersensitivity associated with prior velaglucerase alfa product infusions.1

Exclamation mark in a speech bubble

Notify the patient’s treating physician if the infusion cannot be administered.1

Download the Dosing and Infusion Guide for more information.
VPRIV Dosing & Infusion Guide

VPRIV DOSING & ADMINISTRATION

ADMINISTERING VPRIV1

VPRIV should be administered under the supervision of a healthcare professional.

Diluted VPRIV should be administered through an in-line low protein-binding 0.2 or 0.22 µm filter. VPRIV should not be infused with other products in the same infusion tubing. The compatibility of VPRIV in a solution with other products has not been evaluated.

1

Attach IV tubing to the bag of VPRIV solution. IV tubing should have an in-line filter in place.

IV tubing being attached to the bag of VPRIV solution
2

Use normal saline to prime tubing and expel all air.

Saline being injected into IV tubing
3

Set the infusion to administer at the rate prescribed. A 60-minute infusion is recommended.

Set the infusion to administer at rate prescribed
4

Select the IV infusion site; this will vary by patient and may include: antecubital, wrist, or hand veins, or a central venous catheter.

IV tubing on a type 1 Gaucher patient's hand veins
Follow your facility’s policies for IV insertion, medication infusion, and disposal of biohazardous waste.
5

Begin VPRIV therapy infusion with the flow-regulating device or IV pump. Monitor the patient regularly. If anaphylactic or other acute reactions occur, discontinue VPRIV immediately and initiate appropriate medical treatment.

Please see Section 5.1 of the Warnings and Precautions section of the Prescribing Information for important information on hypersensitivity reactions

Download the Dosing and Infusion Guide for more information.
VPRIV Dosing & Infusion Guide

VPRIV DOSING & ADMINISTRATION

PREPARING VPRIV

RECONSTITUTION & DILUTION1

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

1
Patient's weight

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.

2
Sterile water being injected into a vial containing VPRIV powder

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.

3
Inspect VPRIV solution in the vial

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.*

4
Syringe withdrawing required dosage of VPRIV from a vial

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.

5
Gently mixed VPRIV and 0.9% Sodium Chloride

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

6
Diluted VPRIV solution can be stored for up to 24 hours

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 1-877-TAKEDA-7 (1-877-825-3327), or email medinfous@takeda.com for all U.S.A. inquiries if the solution is discolored or if foreign particulate matter is present.

HANDLING & STORING VPRIV1

VPRIV reconstitution and dilution prior use

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

VPRIV should be stored at 36℉ to 46℉ (2℃ to 8℃)

VPRIV does not contain preservatives and 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 VPRIV.

VPRIV vial

Remove the required number of vials from the fridge.

Expiration date

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

Download the Dosing and Infusion Guide for more information.
VPRIV Dosing & Infusion Guide