Adverse reactions : תופעות לוואי

4.8 Undesirable effects
FEIBA can precipitate allergic-type hypersensitivity reactions that have included urticaria, angioedema, gastrointestinal manifestations, bronchospasm, and a drop in blood pressure; these reactions can be severe and can be systemic (e.g., anaphylaxis with urticaria and angioedema, bronchospasm, and circulatory shock). See also section 4.4 Hypersensitivity Reactions.

The adverse reactions presented in this section have been reported from post marketing surveillance as well as from 2 studies with FEIBA for the treatment of bleeding episodes in paediatric and adult patients with haemophilia A or B and inhibitors to factors VIII or IX. One study also enrolled acquired haemophilia patients with factor VIII inhibitors (2 of 49 patients). The adverse reactions from a third study comparing prophylaxis with on-demand treatment have been added.

Frequency categories are defined 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 unknown         cannot be estimated from the available data
                                                    Adverse Reactions
System organ class                          Preferred current MedDRA Term                             Frequency* (SOC)                                                                                           Category Blood and lymphatic             Disseminated intravascular coagulation (DIC)                           Unknown system disorders                Increase of inhibitor titre (anamnestic response)a                     Unknown Immune system disorders         Hypersensitivity c                                                     Common Urticaria                                                              Unknown Anaphylactic reaction                                                  Unknown Nervous system disorders        Paraesthesia                                                           Unknown Hypaesthesia                                                           Unknown Thrombotic stroke                                                      Unknown Embolic stroke                                                         Unknown Headachec                                                              Common Somnolence                                                             Unknown Dizzinessb                                                             Common Dysgeusia                                                              Unknown Cardiac disorders               Cardiac infarction                                                     Unknown Tachycardia                                                            Unknown Vascular disorders              Thrombosis                                                             Unknown Venous thrombosis                                                      Unknown Arterial thrombosis                                                    Unknown Embolism (thromboembolic complications)                                Unknown Hypotensionc                                                           Common Hypertension                                                           Unknown Flushing                                                               Unknown Respiratory, Thoracic,          Pulmonary embolism                                                     Unknown and Mediastinal disorders       Bronchospasm                                                           Unknown Wheezing                                                               Unknown Cough                                                                  Unknown Dyspnoea                                                               Unknown Gastrointestinal disorders      Vomiting                                                               Unknown Diarrhoea                                                              Unknown Abdominal discomfort                                                   Unknown Nausea                                                                 Unknown Skin and subcutaneous           Sensation of numbness in the face                                      Unknown tissue disorders                Angioedema                                                             Unknown Urticaria                                                              Unknown Pruritus                                                               Unknown Rashc                                                                  Common General disorders and           Pain at the injection site                                             Unknown administration site             Malaise                                                                Unknown conditions                      Feeling hot                                                            Unknown Chills                                                                 Unknown Pyrexia                                                                Unknown Chest pain                                                             Unknown Chest discomfort                                                       Unknown Investigations                  Drop in blood pressure                                                 Unknown Hepatitis B surface antibody positivec                                 Common Fibrin D-dimer increased                                               Unknown *A  precise estimate of the rate of these adverse reactions is not possible from the available data.
a Increase of inhibitor titre (anamnestic response) [not a MedDRA PT] is the rise of previously existing inhibitor titre occurring after the administration of FEIBA. See section 4.4.
b ADR reported in the original and prophylaxis studies. Frequency shown is from the prophylaxis study only.
c ADR reported in the prophylaxis study. Frequency shown is from the prophylaxis study.


Class Reactions
Other symptoms of hypersensitivity reactions to plasma-derived products include lethargy and restlessness.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of FEIBA is important. It allows continued monitoring of the benefit/risk balance of FEIBA. Healthcare professionals are asked to report any suspected adverse reactions to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/