VPRIV Special Precautions

Traceability: In order to improve the traceability of biological medicinal products, the name and batch number of the administered medicinal product should be clearly recorded.
Hypersensitivity: Hypersensitivity reactions, including symptoms consistent with anaphylaxis, have been reported in patients in clinical studies and in post-marketing experience. The majority of hypersensitivity reactions usually occur up to 12 hours post infusion. The most frequently reported symptoms of hypersensitivity include nausea, rash, dyspnoea, back pain, chest discomfort (including chest tightness), urticaria, arthralgia, and headache.
Infusion-related reactions: An infusion-related reaction is defined as any adverse drug reaction occurring within 24 hours after the initiation of velaglucerase alfa infusion. Infusion-related reactions (IRR) were the most commonly observed adverse reactions in patients treated in clinical studies. An IRR often appears as a hypersensitivity reaction. The most frequently reported symptoms of hypersensitivity include nausea, rash, dyspnoea, back pain, chest discomfort (including chest tightness), urticaria, arthralgia, and headache. Symptoms consistent with anaphylaxis have been reported in patients in clinical studies and in post-marketing experience. Apart from symptoms associated with hypersensitivity reactions IRRs might show as fatigue, dizziness, pyrexia, blood pressure increase, pruritus, or vision blurred. In treatment-naïve patients, the majority of infusion-related reactions occurred during the first 6 months of treatment.
Prevention and management of infusion related reactions including hypersensitivity reactions: The management of infusion-related reactions should be based on the severity of the reaction, and include slowing the infusion rate, treatment with medicinal products such as antihistamines, antipyretics and/or corticosteroids, and/or stopping and resuming treatment with increased infusion time.
Due to the risk for hypersensitivity reactions including anaphylaxis, appropriate medical support, including adequately trained personnel in emergency measures, should be readily available when velaglucerase alfa is administered. If anaphylactic or other acute reactions occur, immediately discontinue the infusion and initiate appropriate medical treatment.
Treatment should be approached with caution in patients who have exhibited symptoms of hypersensitivity to velaglucerase alfa or other enzyme replacement therapy.
Pre-treatment with antihistamines and/or corticosteroids may prevent subsequent reactions in those cases where symptomatic treatment was required.
Immunogenicity: Antibodies may play a role in treatment-related reactions found with the use of velaglucerase alfa. To further evaluate the relationship, in cases of severe infusion-related reactions and in cases of lack or loss of effect, patients should be tested for the presence of antibodies and the results reported to the company.
In the clinical studies for Marketing Authorisation one of 94 (1%) patients developed IgG-class antibodies to velaglucerase alfa. In this one event, the antibodies were determined to be neutralising in an in vitro assay.
No patients developed IgE antibodies to velaglucerase alfa.
No infusion-related reactions were reported.
Post-marketing phase: During a post marketing extension study, one patient developed IgG antibodies to VPRIV. In addition, a few events of positive neutralising antibodies and lack of effect were reported post marketing.
Sodium: This medicinal product contains 12.15 mg sodium per vial. This is equivalent to 0.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Effects on ability to drive and use machines: VPRIV has no or negligible influence on the ability to drive or use machines.