Cuvitru Adverse Reactions

Summary of the safety profile: Adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally.
Rarely, human normal immunoglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration.
Local reactions at infusion site: swelling, soreness, redness, induration, local heat, local pain, itching, bruising and rash, may frequently occur.
For safety information with respect to transmissible agents, see Precautions.
Tabulated list of adverse reactions: The safety of Cuvitru administered subcutaneously was evaluated in two prospective, open-label, non-controlled, multi-centre studies in 122 subjects with primary immune deficiency (PID).
The majority (98.8%) of local adverse reactions (ARs) were mild in intensity. One subject discontinued treatment due to a local AR (pain). 112 out of 122 subjects treated with Cuvitru completed a study.
The tables presented as follows is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. (See Tables 2 and 3.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

The following additional ADRs have been identified and reported during the post-marketing use of another subcutaneous immune globulin product: paraesthesia, tremor, tachycardia, dyspnoea, laryngospasm and chest discomfort.
Paediatric population: The safety profile in the paediatric population was similar to that in adult subjects.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.