Ngenla Adverse Reactions

Summary of the safety profile: The most frequently occurring adverse reactions after treatment with NGENLA are injection site reactions (ISRs) (25.1%), headache (10.7%), and pyrexia (10.2%).
Tabulated list of adverse reactions: Safety data are derived from the phase 2, multi-center safety and dose-finding study, and the pivotal phase 3, multi-center non-inferiority study in pediatric GHD patients (see Pharmacology: Pharmacodynamics under Actions). The data reflect exposure of 265 patients to NGENLA administered once weekly (0.66 mg/kg/week).
Table 3 presents the adverse drug reactions (ADRs) for NGENLA within the system organ class (SOC). (See Table 3.)

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Long-term exposure: In an open-label extension (OLE) of a safety and dose-finding study (see Pharmacology: Pharmacodynamics under Actions), 37 patients received treatment with somatrogon for at least 5 years. No additional safety findings were reported.
Immunogenicity: In the pivotal safety and efficacy study, among 109 subjects treated with somatrogon, 84 (77.1%) tested positive for anti-drug antibodies (ADAs). There were no clinical or safety effects observed with the formation of antibodies (see Pharmacology: Pharmacokinetics under Actions).