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Tabulated list of adverse reactions: The following related adverse reactions from clinical investigations are listed as follows by system organ class and in order of decreasing frequency (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 the available data). (See Table 5.)
Click on icon to see table/diagram/imageDescription of selected adverse reactions: Hypoglycaemia: The following table describes the rate of documented symptomatic hypoglycaemia (≤3.9 mmol/L) and severe hypoglycaemia for both Soliqua and the comparator. (See Table 6.)
Click on icon to see table/diagram/imageGastrointestinal disorders: Gastrointestinal adverse reactions (nausea, vomiting and diarrhoea) were frequently reported adverse reactions during the treatment period. In patients treated with Soliqua, the incidence of related nausea, diarrhoea and vomiting was 8.4%, 2.2% and 2.2%, respectively. Gastrointestinal adverse reactions were mostly mild and transient in nature.
Immune system disorders: Allergic reactions (urticaria) possibly related with Soliqua have been reported in 0.3% of patients. Cases of generalised allergic reaction including anaphylactic reaction and angioedema have been reported during marketed use of insulin glargine and lixisenatide.
Immunogenicity: Administration of Soliqua may cause formation of antibodies against insulin glargine and/or lixisenatide.
Same with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing 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 SOLIQUA in the studies described as follows with the incidence of antibodies in other studies or to other products may be misleading.
The incidence of formation of anti-insulin glargine antibodies was 21.0% and 26.2%. In approximately 93% of the patients, anti-insulin glargine antibodies showed cross-reactivity to human insulin. The incidence of formation of anti-lixisenatide antibodies was approximately 43%. Neither status for anti-insulin glargine antibodies nor for anti-lixisenatide antibodies had a clinically relevant impact on safety or efficacy.
Skin and subcutaneous tissue disorders: Lipodystrophy and cutaneous amyloidosis may occur at the injection site of insulins and delay local insulin absorption. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions (see Precautions).
Lixisenatide: In the pool of 9 placebo-controlled studies, 70% of patients exposed to lixisenatide tested positive for anti-lixisenatide antibodies during the trials. In the subset of patients (2.4%) with the highest antibody concentrations (>100 nmol/L), an attenuated glycemic response was observed. A higher incidence of allergic reactions and injection-site reactions occurred in antibody positive patients [see Precautions].
Anti-lixisenatide antibody characterization studies have demonstrated the potential for development of antibodies cross-reactive with endogenous GLP-1 and glucagon, but their incidence has not been fully determined and the clinical significance of these antibodies is not currently known.
No information regarding the presence of neutralizing antibodies is currently available.
Injection site reactions: Some (1.7%) patients taking insulin containing therapy, including Soliqua have experienced erythema, local oedema, and pruritus at the site of injection.
Heart rate: Increase in heart rate has been reported with GLP-1 receptor agonist use and a transient increase was also observed in some studies with lixisenatide. No increase in mean heart rate was seen in all Phase 3 studies with Soliqua.
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.
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