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VPRIV is a brand name for Velaglucerase Alfa, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: VPRIV (velaglucerase alfa) is indicated for • long-term enzyme replacement therapy (ERT) for pediatric and adult patients with type 1 Gaucher disease.
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations VPRIV should be administered under the supervision of a healthcare professional. Home administration may be considered for patients who are tolerating their infusions well. • Patients currently being treated with other enzyme replacement therapy for type 1 Gaucher disease may be switched to VPRIV using the same dose and frequency.
2 Recommended Dose and Dosage Adjustment The recommended dose is 60 U/kg administered every other week as a 60-minute intravenous (IV) infusion. Dosage adjustments can be made on an individual basis based on achievement and maintenance of therapeutic goals.
Clinical studies have evaluated doses ranging from 15 to 60 U/kg every other week. 3 Administration VPRIV should be administered by IV infusion over a period of 60 minutes. 4 Reconstitution VPRIV should be prepared by and administered under the supervision of a healthcare professional.
Use aseptic technique. VPRIV is a lyophilized powder, which requires reconstitution and dilution, and is intended for intravenous infusion only. VPRIV contains no preservatives and vials are single-use only. Discard any unused solution.
VPRIV should be prepared as follows: 1. Determine the number of vials to be reconstituted based on the individual patient’s weight and the prescribed dose. Follow the instructions in Table 1 for reconstitution. 0 mL 100 U/mL 2. Upon reconstitution, mix vials gently.
DO NOT SHAKE. 3. Prior to further dilution, visually inspect the solution in the vials; the solution should be clear to slightly opalescent and colorless; do not use if the solution is discolored or if foreign particles are present. 4.
9% sodium chloride solution suitable for IV administration. Mix gently. DO NOT SHAKE. Slight flocculation (described as white irregularly shaped particles) may occasionally occur. 2 μm in-line filter over a period of 60 minutes. The infusion should be completed within 24 hours of reconstitution of vials.
VPRIV should not be infused with other products in the same infusion tubing as the compatibility in solution with other products has not been evaluated. 5 Missed Dose If a scheduled infusion is missed, administer the dose as soon as possible if it can be given at least 7 days before the next scheduled dose.
1 Adverse Reaction Overview The most common adverse drug reactions (incidence ≥ 10%) reported in the clinical trials were abdominal pain/abdominal pain upper, arthralgia, asthenia/fatigue, back pain, bone pain, dizziness, headache, infusion-related reactions, pyrexia/body temperature increased, and upper respiratory tract infections.
The only adverse reaction leading to discontinuation of VPRIV was an infusion-related reaction. The most serious adverse drug reactions in patients in clinical trials were arthralgia, hypersensitivity reactions, and urticaria. Serious adverse drug reactions observed post-market were anaphylactic reaction, chest discomfort, dyspnea, pruritis, and vomiting.
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. The data described below reflect exposure of 94 patients with type 1 Gaucher disease who received VPRIV at doses ranging from 15 to 60 U/kg every other week in 5 clinical studies.
Fifty- four (54) patients were naïve to ERT and 40 patients switched from imiglucerase to VPRIV. Patients were between 4 and 71 years old at the time of first treatment with VPRIV, and included 46 male and 48 female patients. The most serious adverse reactions in patients in clinical trials were hypersensitivity reactions.
See Warnings and Precautions, Immune and Adverse Reaction Overview, Table 4. Adverse drug reactions considered related to VPRIV are shown in Table 4. Information is presented by system organ class and frequency (very common ≥10%; common ≥1% and <10%;).
Carcinogenesis and Mutagenesis See NON-CLINICAL TOXICOLOGY. Driving and Operating Machinery No studies of VPRIV on the effects on the ability to drive and use machines have been performed. Due caution should be exercised when driving or operating a vehicle or potentially dangerous machinery.
Hepatic/Biliary/Pancreatic No studies have been performed in patients with hepatic impairment. Immune Hypersensitivity reactions including symptoms consistent with anaphylaxis have been reported in patients in clinical studies and in post-marketing experience.
As with any intravenous protein product, hypersensitivity reactions are possible, therefore appropriate medical support should be readily available when VPRIV is administered. If a severe reaction occurs, current medical standards for emergency treatment are to be followed.
Treatment with VPRIV should be approached with caution in patients who have exhibited symptoms of hypersensitivity to the active ingredient or excipients in the drug product or to other enzyme replacement therapy. Immunogenicity In clinical studies, 1 of 94 (1%) patients treated with VPRIV developed IgG-class antibodies to velaglucerase alfa.
In this one event the antibodies were determined to be neutralizing in an in vitro assay. No infusion-related reactions were reported for this patient. One additional patient developed IgG antibodies to velaglucerase alfa that were reported as having neutralizing activity Page 7 of 24 Unclassified / Non classifié during an extension study.
No adverse events considered related to velaglucerase alfa were reported for this patient. It is unknown if the presence of IgG antibodies to velaglucerase alfa is associated with a higher risk of infusion reactions. No patients developed IgE antibodies to velaglucerase alfa.
5%) of patients who switched from imiglucerase to VPRIV. Most of the infusion- related reactions were mild. The most commonly observed symptoms of infusion-related reactions were: headache, dizziness, hypotension, hypertension, nausea, fatigue/asthenia, and pyrexia/body temperature increased.
VPRIV is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITON AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5) * See Warnings and Precautions, Immune † Reactions occurring up to 24 hours after the start of the infusion § Includes dermatitis and anaphylactoid reaction In clinical studies, 1 of 94 patients treated with VPRIV developed IgG-class antibodies to velaglucerase alfa.
In this one event the antibodies were determined to be neutralizing in an in vitro assay. No infusion-related reactions were reported for this patient. One additional patient developed IgG antibodies to velaglucerase alfa that were reported as having neutralizing activity during an extension study.
No adverse events considered related to velaglucerase alfa were reported for this patient. It is unknown if the presence of IgG antibodies to velaglucerase alfa is associated with a higher risk of infusion reactions. No patients developed IgE antibodies to velaglucerase alfa.
6 Post-Market Adverse Reactions 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 * General Disorders and Administration Site Conditions: Chest discomfort Immune System Disorders: Anaphylactic reaction Respiratory, Thoracic and Mediastinal Disorder: Dyspnea Skin and Subcutaneous Tissue Disorders: Pruritis * In some cases vomiting can be serious.
In treatment-naïve patients, the majority of infusion-related reactions occurred during the first 6 months of treatment with VPRIV. Additional infusion-related reactions of chest discomfort, dyspnea, pruritis, and vomiting have been reported in post- marketing experience.
g. slowing the infusion rate, treatment with medications such as antihistamines, antipyretics and/or corticosteroids, and/or stopping and resuming treatment with increased infusion time. Pre-treatment with antihistamines and/or corticosteroids may prevent subsequent reactions in those cases where symptomatic treatment was required.
Patients were not routinely pre- medicated prior to infusion of VPRIV during clinical studies. Monitoring and Laboratory Tests No special laboratory tests are required for patients receiving VPRIV other than the usual tests that are required for monitoring patients with type 1 Gaucher disease.
Renal No studies have been conducted in patients with renal impairment. 1 Pregnant Women There are no data from studies in pregnant women and there are limited data from the use of VPRIV in pregnant women. It is not known whether VPRIV would cause fetal harm when administered to a pregnant woman or would affect reproductive capacity.
VPRIV should be administered during pregnancy only when clearly needed. In Segment I, II, and III animal reproductive and developmental toxicology studies (see NON- CLINICAL TOXICOLOGY) in rats and rabbits, the no observed effect level/no observed adverse effect level (NOEL/NOAEL) for velaglucerase alfa was the maximum dose evaluated: 17 mg/kg/dose for rats and 20 mg/kg/dose in rabbits, equal to 11-fold and 13-fold the maximum human dose of 60 U/kg on a milligrams-per-kilogram (mg/kg) basis.
Velaglucerase alfa showed no evidence of impaired fertility or maternal or developmental treatment-related effects. 2 Breast-feeding There is insufficient information on the excretion of VPRIV or its metabolites in human milk. Because many drugs are excreted in human milk, caution should be exercised when VPRIV is administered to a lactating woman.
3 Pediatrics Pediatrics (2 – 17 years of age): Twenty (20) of the 94 patients (21%) who received VPRIV during clinical studies were in the pediatric age range (2 to 17 years). The studies allowed inclusion of patients 2 years and older; however, no data are available from children under the age of 4 years.
The safety and efficacy profiles were similar between pediatric and adult patients. 4 Geriatrics Geriatrics (>65 years of age): In clinical studies, a total of 57 patients 65 years of age or older were treated with velaglucerase alfa.
Among 205 patients who participated in a clinical safety study and switched from imiglucerase to velaglucerase alfa, 52 patients were 65 years of age or older. The safety profile in elderly patients was consistent with that previously observed across pediatric and adult patients.