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Praluent · 4.8 · General allergic reactions General allergic reactions were reported more frequently in the alirocumab group (8
Eintrag öffnenPraluent · 4.8 · General disorders and Injection site Flu-like illness administration site conditions reactions**
Eintrag öffnenPraluent · 4.8 · Immune system disorders Hypersensitivity, hypersensitivity vasculitis Respiratory, thoracic and Upper respirat
Eintrag öffnenPraluent · 4.8 · Immunogenicity/ Anti-drug-antibodies (ADA)
Eintrag öffnenPraluent · 4.8 · In a pool of controlled studies using a 75 mg every 2 week (Q2W) starting dose and in which the dose was incre
Eintrag öffnenPraluent · 4.8 · In all clinical studies background lipid lowering therapies could not be adjusted by trial design. The percent
Eintrag öffnenPraluent · 4.8 · In the ODYSSEY OUTCOMES trial, 5.5% of patients treated with alirocumab 75 mg and/or 150 mg every 2 weeks (Q2W
Eintrag öffnenPraluent · 4.8 · LDL-C values <0.65 mmol/L (<25 mg/dL)
Eintrag öffnenPraluent · 4.8 · Local injection site reactions Local injection site reactions, including erythema/redness, itching, swelling,
Eintrag öffnenPraluent · 4.8 · No difference in the safety profile was observed between the two doses (75 mg and 150 mg) used in the Phase 3
Eintrag öffnenPraluent · 4.8 · Paediatric population The safety and efficacy of Praluent have been established in children and adolescents wi
Eintrag öffnenPraluent · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenPraluent · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenPraluent · 4.8 · Special populations
Eintrag öffnenPraluent · 4.8 · Summary of the safety profile
Eintrag öffnenPraluent · 4.8 · Table 1 – Adverse reactions System organ class Common Rare Not known
Eintrag öffnenPraluent · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenPraluent · 4.8 · The experience of alirocumab in paediatric patients with homozygous familial hypercholesterolaemia (HoFH) is l
Eintrag öffnenPraluent · 4.8 · The following adverse reactions were reported in patients treated with alirocumab in pooled controlled studies
Eintrag öffnenPraluent · 4.8 · The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived
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