VPRIV Adverse Reactions

Summary of the safety profile: The most serious adverse reactions in patients in clinical studies were hypersensitivity reactions (2.1%).
The most common adverse reactions were infusion-related reactions (39.4%). The most commonly observed symptoms of infusion-related reactions were: headache, dizziness, hypotension, hypertension, nausea, fatigue/asthenia, and pyrexia/body temperature increased (see Precautions for further information). The only adverse reaction leading to discontinuation of treatment was an infusion-related reaction.
Tabulated list of adverse reactions: Adverse reactions reported in patients with type 1 Gaucher disease are listed in Table 2. Information is presented by system organ class and frequency according to MedDRA convention. Frequency is defined as very common (≥1/10), common (≥1/100 to <1/10), and uncommon (≥1/1,000 to <1/100). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 2.)

Click on icon to see table/diagram/image

Description of selected adverse reactions: Vomiting: In some cases vomiting can be serious and severe. Vomiting most often occurs during the infusion and up to 24 hours after the infusion.
Other special populations: Elderly population (≥65 years): The safety profile of VPRIV in clinical studies involving patients aged 65 years and above was similar to that observed in other adult patients.
Paediatric population: The safety profile of VPRIV in clinical studies involving children and adolescents aged 4 to 17 years was similar to that observed in adult patients.