Dosing Calculator | VPRIV® (velaglucerase alfa) for injection

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VPRIV DOSING CALCULATOR

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.

DOSING CALCULATION

VPRIV dosing

VPRIV is administered as a 60-minute intravenous (IV) infusion once every other week under the supervision of a healthcare professional¹
Always refer to VPRIV’s Prescribing Information, which contains complete dosing and administration information, before administering VPRIV

TREATMENT-NAÏVE PATIENTS

TREATMENT-EXPERIENCED 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.^1,2

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

Dosage adjustments may be made on an individual basis based on the achievement and maintenance of therapeutic goals¹
VPRIV is dosed according to body weight¹

VPRIV dosing calculator

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

Obtain patient’s weight¹

Please enter patient weight in:

kg lbs

Patient Weight

Dosage of VPRIV Required

Number of Vials Needed

vials

CALCULATION STEPS

Obtain patient’s weight¹

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

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

Use the exact unit of the required VPRIV dosage—do not round up to the nearest full vial.¹

Dispose of unused product.

EXAMPLE CALCULATION

Patient’s weight = 21 kg

21 kg × 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 IV infusion.¹ This will change if pounds are used in the calculation instead.

^†1 vial of VPRIV = 400 Units (U)¹

PATIENT ASSESSMENT

As with any infusion or medical procedure, it is important to assess your patient’s current condition and review their medical history, including any ERT for type 1 Gaucher disease.¹ Initiate VPRIV treatment in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment.¹ Administration of VPRIV should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis.¹

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

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 visit¹

Consider pre-treatment with antihistamines and/or corticosteroids in patients who exhibited symptoms of hypersensitivity associated with prior velaglucerase alfa product infusions¹

Notify the patient’s treating physician if the infusion cannot be administered¹

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