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VPRIV

"The U.S. Food and Drug Administration today approved Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type 1 form of Gaucher disease, a rare genetic disorder.

Gaucher disease occurs in people who do not produce e"...

VPRIV

VPRIV Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

VPRIV (velaglucerase alfa) is a 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 (velaglucerase alfa for injection) is indicated for long-term enzyme replacement therapy for pediatric and adult patients with the rare genetic disorder, type 1 Gaucher disease. It is not available as a generic drug. The most common adverse reactions to VPRIV are allergic reactions. Other observed adverse reactions with VPRIV are headache, dizziness, abdominal pain, back pain, joint pain, nausea, fatigue, weakness, fever, and prolonged blood clotting time.

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. No drug interactions with VPRIV have been studied. 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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

VPRIV in Detail - Patient Information: Side Effects

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

Some people receiving a velaglucerase alfa injection have had a reaction to the infusion (when the medicine is injected into the vein). Most infusion reactions have been mild. However, tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, itchy, short of breath, or have a fast heartbeat, chest tightness, or trouble breathing during the injection.

Less serious side effects may include:

  • headache;
  • low fever;
  • dizziness, tired feeling;
  • nausea, stomach pain;
  • knee pain, back pain; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

VPRIV Overview - Patient Information: Side Effects

SIDE EFFECTS: Fever, headache, nausea, dizziness, abdominal pain, back/joint pain, weakness, tiredness, or redness/pain/itching/swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for VPRIV (Velaglucerase Alfa for Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

VPRIV FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Studies Experience

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 na´ve to 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 2. The most common adverse reactions were infusion-related reactions.

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.

Table 2: Adverse Reactions Observed in ≥ 10% of Patients with Type 1 Gaucher Disease Treated with VPRIV

System Organ Class Preferred Term Na´ve to ERT
N = 54
Switched from imiglucerase to VPRIV
N = 40
Number of Patients (% )
Nervous system disorders
Headache 19 (35) 12 (30)
Dizziness 12 (22) 3 (8)
Gastrointestinal disorders
Abdominal pain 10 (19) 6 (15)
Nausea 3 (6) 4 (10)
Musculoskeletal and connective tissue disorders
Back pain 9 (17) 7 (18)
Joint pain (knee) 8 (15) 3 (8)
Infections and infestations
Upper respiratory tract infection 17 (31) 12 (30)
Investigations
Activated partial thromboplastin time prolonged 6 (11) 2 (5)
General disorders and administration site conditions
Infusion-related reaction* 28 (52) 9 (23)
Pyrexia 12 (22) 5 (13)
Asthenia/Fatigue 7 (13) 5 (13)
*Denotes any event considered related to and occurring within up to 24 hours of VPRIV infusion

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

Pediatric Patients

All adult adverse reactions to VPRIV are considered relevant to pediatric patients (ages 4 to 17 years). Adverse reactions more commonly seen in pediatric patients compared to adult patients include ( > 10% difference): upper respiratory tract infection, rash, aPTT prolonged, and pyrexia.

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. In clinical studies, 1 of 54 treatment-na´ve patients treated with VPRIV developed IgG class antibodies to VPRIV.

In this patient, the antibodies were determined to be neutralizing in an in vitro assay. No infusion-related reactions were reported for this patient. 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.

Immunogenicity assay results are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of 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 with the incidence of antibodies to other products may be misleading.

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

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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