Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Repatha

Repatha 140 mg solution for injection in pre-filled syringe Repatha 140 mg solution for injection in pre-filled pen Repatha 420 mg solution for injection in cartridge · Abschnitt 4.8 · PDF-Seite 6

HOS-131156 · Präparat HOS-097013

The safety and effectiveness of Repatha have been established in paediatric patients with heterozygous and homozygous familial hypercholesterolaemia. A clinical study to evaluate the effects of 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 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.

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