VPRIV

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 11/16/2021
VPRIV Side Effects Center

What Is VPRIV?

VPRIV (velaglucerase alfa) is an enzyme produced in a fibroblast cell line that catalyzes the hydrolysis of the glycolipid glucocerebroside to glucose and ceramide in the lysosome of macrophage cell types. VPRIV is indicated for long-term enzyme replacement therapy for pediatric and adult patients with the rare genetic disorder, type 1 Gaucher disease.

What Are Side Effects of VPRIV?

The most common side effects of VPRIV are allergic reactions. Other side effects of VPRIV include:

Dosage for VPRIV

VPRIV is supplied as a sterile, preservative free, lyophilized powder in single-use vials in strengths of 200 or 400 units per vial. The recommended dose is 60 units per Kg, administered every other week as a 60-minute intravenous infusion, under the care of a professional caregiver trained in the administration of this drug.

What Drugs, Substances, or Supplements Interact with VPRIV?

No drug interactions with VPRIV have been studied.

VPRIV During Pregnancy and Breastfeeding

There are no adequate, well-controlled studies of VPRIV in pregnant women. VPRIV should be used during pregnancy only if clearly needed. There are no data from studies in breastfeeding women. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VPRIV is administered to a nursing woman. Pediatric patients have more severe side effects than adults such as fever, upper respiratory tract infections and prolonged PTT times.

Additional Information

Our VPRIV Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

VPRIV Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; fever; chest discomfort, difficult breathing; swelling of your face, lips, tongue, or throat.

An allergic reaction may occur during or shortly after infusion of this medicine. Tell your caregivers or get emergency medical help right away if you have any signs of a severe allergic reaction, such as headache, dizziness, fever, nausea, feeling weak or tired, and feeling like you might pass out.

Common side effects may include:

  • headache;
  • dizziness;
  • feeling weak or tired;
  • nausea, stomach pain;
  • joint pain, back pain; or
  • fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for VPRIV (Velaglucerase Alfa for Injection)

VPRIV Professional Information

SIDE EFFECTS

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 naive 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]. Patients were between 4 and 71 years old at time of first treatment with VPRIV, and included 46 male and 48 female patients.

The most serious adverse reactions in patients treated with VPRIV were hypersensitivity reactions [see WARNINGS AND PRECAUTIONS].

The most commonly reported adverse reactions (occurring in ≥10% of patients) that were considered related to VPRIV are shown in Table 1. The most common adverse reactions were hypersensitivity reactions.

Table 1: Adverse Reactions Observedin ≥ 10% of Adult and Pediatric Patients with Type 1 Gaucher Disease Treated with VPRIV in the Pooled 5 Clinical Studies

Adverse ReactionNaive to ERT
N = 54 Number of patients (%)
Switched from imiglucerase to VPRIV
N = 40 Number of patients (% )
Hypersensitivity reaction*28 (52)9 (23)
Headache19 (35)12 (30)
Dizziness12 (22)3 (8)
Pyrexia12 (22)5 (13)
Abdominal pain10 (19)6 (15)
Back pain9 (17)7 (18)
Joint pain (knee)8 (15)3 (8)
Asthenia/Fatigue8 (15)5 (13)
Activated partial thromboplastin time prolonged6 (11)2 (5)
Nausea3 (6)4 (10)
*Denotes any event considered related to and occurring within up to 24 hours of VPRIV infusion, including one case of anaphylaxis.

Less common adverse reactions affecting more than one patient (>2% in the treatment-naive group and > 3% in patients switched from imiglucerase to VPRIV treatment) were bone pain, tachycardia, rash, urticaria, flushing, hypertension, and hypotension.

Adverse Reactions In Pediatric Patients

The safety profile of VPRIV was similar between pediatric patients (ages 4 to 17 years) and adult patients. Adverse reactions more commonly seen in pediatric patients compared to adult patients include (>10% difference): rash, aPTT prolonged, and pyrexia.

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to VPRIV in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

In clinical studies, 1 of 54 (2%) enzyme treatment-naive patients treated with VPRIV developed IgG antibodies to VPRIV. One additional patient developed IgG antibodies to VPRIV during an extension study. In both patients, the IgG antibodies to VPRIV were determined to be neutralizing in an in vitro assay. The presence of IgG antibodies to VPRIV was not associated with hypersensitivity reactions. 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 enzyme replacement therapies who are switching to VPRIV should continue to be monitored for antibodies to VPRIV.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of VPRIV. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal disorders: vomiting (in some cases vomiting can be serious, requiring hospitalization and/or drug discontinuation)

Read the entire FDA prescribing information for VPRIV (Velaglucerase Alfa for Injection)

© VPRIV Patient Information is supplied by Cerner Multum, Inc. and VPRIV Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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