Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Canakinumab
Drug ID BADD_D00345
Description Canakinumab is a recombinant, human anti-human-IL-1β monoclonal antibody that belongs to the IgG1/κ isotype subclass. It is expressed in a murine Sp2/0-Ag14 cell line and comprised of two 447- (or 448-) residue heavy chains and two 214-residue light chains, with a molecular mass of 145157 Daltons when deglycosylated. Both heavy chains of canakinumab contain oligosaccharide chains linked to the protein backbone at asparagine 298 (Asn 298). Canakinumab binds to human IL-1β and neutralizes its inflammatory activity by blocking its interaction with IL-1 receptors, but it does not bind IL-1alpha or IL-1 receptor antagonist (IL-1ra). Canakinumab is marketed under the brand name Ilaris and indicated for patients 4 years of age and older to treat Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), which are both part of the Cryopyrin-Associated Periodic Syndromes (CAPS) as well as for patients 2 years of age and older to treat systemic juvenile idiopathic arthritis (SJIA). Clinical trials have established the administration of canakinumab every 2 weeks to be safe and effective, offering a considerable advantage over the existing treatment with the human IL-1 receptor antagonist, anakinra, which must be injected daily and which is often poorly tolerated by patients.
Indications and Usage Used in patients 4 years of age and older to treat Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), which are both part of the Cryopyrin-Associated Periodic Syndromes (CAPS) as well as for patients 2 years of age and older to treat systemic juvenile idiopathic arthritis (SJIA).
Marketing Status approved; investigational
ATC Code L04AC08
DrugBank ID DB06168
KEGG ID D09315
MeSH ID C541220
PubChem ID Not Available
TTD Drug ID D0TD2G
NDC Product Code 0078-0734
UNII 37CQ2C7X93
Synonyms canakinumab | Ilaris | ACZ-885 | ACZ885 | immunoglobulin G1, anti-(human interleukin 1beta) (human clone ACZ885 heavy chain V region)
Chemical Information
Molecular Formula Not Available
CAS Registry Number 914613-48-2
SMILES Not Available
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
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ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Blood bilirubin increased13.03.04.018--
Bronchitis11.01.09.001; 22.07.01.001--
Diarrhoea07.02.01.001--
Gastroenteritis07.19.03.001; 11.01.07.004---
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Infection11.01.08.002---
Influenza11.05.03.001; 22.07.02.001---
Injection site reaction08.02.03.014; 12.07.03.015--
Musculoskeletal pain15.03.04.007--
Nasopharyngitis11.01.13.002; 22.07.03.002---
Nausea07.01.07.001--
Neutrophil count decreased13.01.06.010--
Pharyngitis07.05.07.004; 11.01.13.003; 22.07.03.004--
Platelet count decreased13.01.04.001--
Rhinitis11.01.13.004; 22.07.03.006--
Vertigo04.04.01.003; 17.02.12.002--
Weight increased13.15.01.006--
White blood cell count decreased13.01.06.012--
Transaminases increased13.03.04.036---
Abdominal abscess07.19.02.002; 11.01.07.006---
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