Repatha Adverse Reactions

Summary of the safety profile: The most commonly reported adverse reactions at the recommended doses are nasopharyngitis (7.4%), upper respiratory tract infection (4.6%), back pain (4.4%), arthralgia (3.9%), influenza (3.2%), and injection site reactions (2.2%). The safety profile in the homozygous familial hypercholesterolaemia population was consistent with that demonstrated in the primary hypercholesterolaemia and mixed dyslipidaemia population.
Tabulated list of adverse reactions: Adverse reactions reported in pivotal, controlled clinical studies, and spontaneous reporting, are displayed by system organ class and frequency in Table 10 as follows using 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) and very rare (< 1/10,000). (See Table 10.)

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Description of selected adverse reactions: Injection site reactions: The most frequent injection site reactions were injection site bruising, erythema, haemorrhage, injection site pain and swelling.
Paediatric population: The safety and effectiveness of Evolocumab (Repatha) have been established in paediatric patients with heterozygous and homozygous familial hypercholesterolaemia. A clinical study to evaluate the effects of Evolocumab (Repatha) was conducted in 158 paediatric patients aged ≥ 10 to < 18 years old with heterozygous familial hypercholesterolaemia. No new safety concerns were identified and the safety data in this paediatric population was consistent with the known safety profile of the product in adults with heterozygous familial hypercholesterolaemia. Twenty-six paediatric patients with homozygous familial hypercholesterolaemia have been treated with Evolocumab (Repatha) in clinical studies conducted in patients aged ≥ 10 to < 18 years. No difference in safety was observed between paediatric and adult patients with homozygous familial hypercholesterolaemia.
Elderly population: Of the 18,546 patients treated with Evolocumab (Repatha) in double-blind clinical studies, 7,656 (41.3%) were ≥ 65 years old, while 1,500 (8.1%) were ≥ 75 years old. No overall differences in safety or efficacy were observed between these patients and younger patients.
Immunogenicity: In clinical studies, 0.3% of patients (48 out of 17,992 patients) treated with at least one dose of Evolocumab (Repatha) tested positive for binding antibody development. The patients whose sera tested positive for binding antibodies were further evaluated for neutralising antibodies and none of the patients tested positive for neutralising antibodies. The presence of anti-evolocumab binding antibodies did not impact the pharmacokinetic profile, clinical response, or safety of Evolocumab (Repatha).
The development of anti-evolocumab antibodies was not detected in clinical trials of paediatric patients treated with Evolocumab (Repatha).
Reporting of suspected adverse reactions: Seek medical attention immediately at the first sign of any adverse drug reaction.