Summary of the safety profile The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]). Back pain, arthralgia and pain in extremity were reported commonly (≥ 1/100 to < 1/10). Musculoskeletal pain was generally of mild to moderate severity, transient and could be controlled in most patients with standard analgesics.
Serious angioedema occurred on subsequent treatment with efbemalenograstim alfa (uncommon [ ≥ 1/1 000 to < 1/100]). Splenomegaly, generally asymptomatic, is uncommon. 4) 7 Uncommon pulmonary adverse reactions such as pulmonary oedema occurred on treatment with efbemalenograstim alfa.
Other pulmonary adverse reactions including interstitial pneumonia, pulmonary infiltrates and pulmonary fibrosis have been reported following administration of G-CSF. 4). 4). 4 and section “Description of selected adverse reactions” below.
Tabulated list of adverse reactions The safety of efbemalenograstim alfa has been evaluated based on the results from clinical trials.. Adverse reactions are divided into groups according to the MedDRA system organ class (SOC) and into frequency groups 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), very rare (< 1/10 000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriouness. 8 Table 1. List of adverse reactions MedDRA system organ class Adverse reactions Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1 000 to < 1/100) Infections and infestations Herpes infection2 Blood and lymphatic system disorders Leukopenia, Neutropenia, Thrombocytopenia, Anaemia, Splenomegaly Metabolism and nutrition disorders Hyperglycaemia, Decreased appetite Nervous system disorders Headache1 Dizziness, Taste disorder2, Muscle spasticity, Peripheral neuropathy2, Somnolence Eye disorders Lacrimation increased Ear and labyrinth disorders Vertigo1 Cardiac disorders Tachycardia, Palpitations Vascular disorders Vasculitis, Hot flush Respiratory, thoracic and mediastinal disorders Pulmonary oedema, Epistaxis, Oropharyngeal pain, Cough, Dyspnoea, Nasal dryness Gastrointestinal disorders Nausea1, Diarrhoea1, Vomiting1 Stomatitis, Dry mouth, Dyspepsia, Abdominal pain, Dysphagia Skin and subcutaneous tissue disorders Alopecia, Urticaria1, Dermatitis allergic, Rash, Dermatitis, Erythema, Toxic skin eruption, Rash maculo- papular, Pruritus, Eczema, Dry skin, Skin disorder, Angioedema, Cold sweat, Night sweats, Onychalgia Musculoskeletal and connective tissue disorders Bone pain Back pain, Arthralgia, Pain in extremity Myalgia, Osteoarthropathy, Musculoskeletal discomfort, Neck pain General disorders and administration site conditions Asthenia1, Fatigue1, Pyrexia1 Injection site reactions2 , Peripheral swelling, Chills, Thirst Investigations White blood cell count increased1, Alanine aminotransferase increased1, Aspartate aminotransferase increased1 Neutrophil count increased, Blood creatinine increased, Gamma-glutamyltransferase increased, Weight increased The frequency category was estimated from a statistical calculation based upon 488 patients receiving Ryzneuta in four clinical trials.
1 See section “Description of selected adverse reactions” below. 2 Includes multiple adverse reaction terms. Description of selected adverse reactions Nausea, vomiting, diarrhoea, asthenia, fatigue, pyrexia, vertigo and headaches were commonly observed in patients receiving chemotherapy.
9 One case of serious urticaria was reported after efbemalenograstim alfa treatment. White blood cell count increased was commonly reported after efbemalenograstim alfa treatment. 4). Increases in alanine aminotransferase (ALT), aspartate aminotransferase (AST) have been commonly observed in patients after receiving efbemalenograstim alfa following cytotoxic chemotherapy.
These elevations are transient and return to baseline. 4). 4). Cases of capillary leak syndrome have been reported after G-CSF administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration. 4). 4). 4).
4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows […]