Dupilumab: local formulary information
Safety
See the summary of product characteristics for dupilumab for contraindications, warnings, precautions for use and reported adverse effects.
Treatment-emergent adverse events
Treatment-emergent adverse events are safety events arising after starting treatment. In BOREAS and NOTUS combined, 938 people had dupilumab and 934 people had placebo. Table 2 shows all treatment-emergent adverse events experienced by 5% or more of participants in either group, or by at least 2% in the dupilumab group with an incidence of at least 1% higher than the placebo group, by preferred term.
| System organ class | preferred term | Dupilumab (n=938) | Placebo (n=934) |
|---|---|---|---|
|
All |
any |
676 (72.1) |
663 (71.0) |
|
Infections and infestations |
any |
402 (42.9) |
406 (43.5) |
|
Infections and infestations |
nasopharyngitis |
73 (7.8) |
69 (7.4) |
|
Infections and infestations |
COVID-19 |
65 (6.9) |
66 (7.1) |
|
Infections and infestation |
upper respiratory tract infection |
50 (5.3) |
57 (6.1) |
|
Infections and infestations |
urinary tract infection |
28 (3.0) |
18 (1.9) |
|
Nervous system disorders |
any |
108 (11.5) |
108 (11.6) |
|
Nervous system disorders |
headache |
73 (7.8) |
62 (6.6) |
|
Vascular disorders |
any |
54 (5.8) |
73 (7.8) |
|
Respiratory, thoracic and mediastinal disorders |
any |
123 (13.1) |
133 (14.2) |
|
Respiratory, thoracic and mediastinal disorders |
chronic obstructive pulmonary disease |
50 (5.3) |
64 (6.9) |
|
Gastrointestinal disorder |
any |
135 (14.4) |
130 (13.9) |
|
Gastrointestinal disorder |
gastritis |
19 (2.0) |
7 (0.7) |
|
Musculoskeletal and connective tissue disorders |
any |
126 (13.4) |
121 (13.0) |
|
Musculoskeletal and connective tissue disorders |
back pain |
42 (4.5) |
29 (3.1) |
|
Injury, poisoning and procedural complications |
any |
122 (13.0) |
139 (14.9) |
|
Injury, poisoning and procedural complications |
accidental overdose |
57 (6.1) |
62 (6.6) |
|
Cardiac disorders |
any |
56 (6.0) |
62 (6.6) |
The summary of product characteristics for dupilumab reports injection site reactions in people with COPD. Anaphylactic reaction, angioedema, serum sickness and serum sickness-like reactions have also been reported after administration of dupilumab.
Ocular reactions have been reported in people having dupilumab for conditions other than COPD, predominantly atopic dermatitis. These include conjunctivitis, allergic conjunctivitis, eye pruritus, blepharitis, dry eye, keratitis and ulcerative keratitis. See the MHRA drug safety update on dupilumab (Dupixent): risk of ocular adverse reactions and need for prompt management for further information.
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