Reported ADRs in clinical trials in 135 PTPs with severe hemophilia A
|MedDRA Standard System Organ Class||Adverse reactions||Frequency*|
|Nervous system disorders||Paresthesia, Headache†||Uncommon|
|General disorders and administration site conditions||Injection site inflammation Injection site pain||Uncommon|
|Investigations||Non-neutralizing antibodies positive (without inhibitory activity as measured by the modified Bethesda assay)||Uncommon|
|Musculoskeletal and connective tissue disorders||Back pain†||Uncommon|
|Ear and labyrinth disorders||Vertigo||Uncommon|
|Gastrointestinal disorders||Dry mouth||Uncommon|
* Uncommon = frequency between 1/100 and 1/1000
† ADR in a pediatric patient.
ADR = Adverse drug reaction; MedDRA = Medical dictionary for regulatory activities
Adapted from Nuwiq Product Monograph
A non-neutralizing anti-FVIII antibody was detected in one adult patient at completion visit. The sample was tested by the central laboratory at eight dilutions. The result was positive only for undiluted sample and the antibody titre was very low. Inhibitory activity, as measured by the modified Bethesda assay, was not detected in this patient. Clinical efficacy and IVR of Nuwiq® were not affected in this patient.
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have rarely been observed with FVIII preparations and may in some cases progress to severe anaphylaxis (including shock).