Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).

Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with ELOCTA. If such inhibitors occur, the condition will manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre be contacted.

Tabulated list of adverse reactions
The Table 2 presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequencies of adverse reactions are based on clinical studies with a total of 379 patients with severe haemophilia A, of which 276 were previously treated patients (PTPs) and 103 were previously untreated patients (PUPs). See section 5.1 for additional details on the clinical studies.

Frequencies have been evaluated according to 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 seriousness.


Table 2: Adverse reactions reported for ELOCTA in clinical trials1
MedDRA System Organ Class                 Adverse reactions                         Frequency category1 Blood and lymphatic system disorders      FVIII inhibition                          Uncommon (PTPs)2 Very common (PUPs)2
Nervous system disorders                          Headache                          Uncommon Dizziness                         Uncommon
Dysgeusia                         Uncommon
Cardiac disorders                                 Bradycardia                       Uncommon Vascular disorders                                Hypertension                      Uncommon Hot flush                         Uncommon
Angiopathy4                       Uncommon
Respiratory, thoracic, and mediastinal            Cough                             Uncommon disorders
Gastrointestinal disorders                        Abdominal pain, lower             Uncommon Skin and subcutaneous tissue disorders            Papular rash                      Common (PUPs)3 Rash                              Uncommon
Musculoskeletal and connective tissue             Arthralgia                        Uncommon disorders                                         Myalgia                           Uncommon Back pain                         Uncommon
Joint swelling                    Uncommon
General disorders and administration site         Device related thrombosis         Common (PUPs)3 conditions                                        Malaise                           Uncommon Chest pain                        Uncommon
Feeling cold                      Uncommon
Feeling hot                       Uncommon
Injury, poisoning, and procedural                 Procedural hypotension            Uncommon complications
PTPs = previously treated patients, PUPs = previously untreated patients.
1
ADRs and frequency are based on occurrence in PTPs only, unless otherwise noted.
2
Frequency is based on studies with all FVIII products which included patients with severe haemophilia A.
3
ADRs and frequency are based on occurrence in PUPs only.
4
Investigator term: vascular pain after injection of ELOCTA.

Paediatric population
No age-specific differences in adverse reactions were observed between paediatric and adult subjects.
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il