Safety profile

Safety profile

Waylivra safety profile1

Two of the most common adverse reactions reported in the APPROACH trial were injection-site reactions and decreased platelet count1

System organ class Very common reactions Common reactions
Blood and lymphatic system disorders Thrombocytopenia Leukopenia, eosinophilia, immune thrombocytopenic purpura, spontaneous haematoma
Immune system disorders   Immunisation reaction, hypersensitivity, serum sickness-like reaction
Metabolism and nutrition disorders   Diabetes mellitus
Psychiatric disorders   Insomnia
Nervous system disorders   Headache, hypoaesthesia, presyncope, retinal migraine, syncope, dizziness, tremor
Eye disorders   Conjunctival haemorrhage, vision blurred
Vascular disorders   Haematoma, hypertension, haemorrhage, hot flush
Respiratory, thoracic, and mediastinal disorders   Epistaxis, cough, dyspnoea, nasal congestion, pharyngeal oedema, wheezing
Gastrointestinal disorders   Nausea, diarrhoea, dry mouth, gingival bleeding, mouth haemorrhage, parotid gland enlargement, vomiting, abdominal pain, abdominal distension, dyspepsia, gingival swelling
Skin and subcutaneous tissue disorders   Erythema, pruritus, urticaria, hyperhidrosis, rash, petechiae, ecchymosis, night sweats, papule, skin hypertrophy, swelling face
Musculoskeletal and connective tissue disorders   Myalgia, arthralgia, pain in extremity, arthritis, back pain, musculoskeletal pain, neck pain, muscle spasms, joint stiffness, myositis, pain in jaw, polymyalgia rheumatica
Renal and urinary disorders   Haematuria, proteinuria
General disorders and administration site conditions Injection-site erythema, injection-site pain, injection-site pallor, injection-site swelling, injection-site pruritus, injectionsite discolouration, injection-site induration, injection-site bruising, injection-site oedema Asthenia, fatigue, injection-site haematoma, injection-site reaction, injection-site urticaria, injection-site warmth, chills, pyrexia, injection-site dryness, injection-site haemorrhage, injection-site hypoaesthesia, injection-site vesicles, malaise, feeling hot, influenza-like illness, injection-site discomfort, injectionsite inflammation, injection-site mass, pain, injection-site paraesthesia, injection-site scab, injection-site papule, oedema, non-cardiac chest pain, vessel puncture site haemorrhage
Investigations Platelet count decreased Blood creatinine increased, blood urea increased, creatinine renal clearance decreased, transaminases increased, white blood cell count decreased, haemoglobin decreased, hepatic enzyme increased, international normalised ratio increased
Injury, poisoning, and procedural complications   Contusion


  1. Waylivra® SmPC