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 pediatric and adult patients with hemophilia A or B and inhibitors to factors VIII or IX. One study also enrolled acquired hemophilia 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 titer (anamnestic response)a                    Unknown Immune system disorders          Hypersensitivity c                                                    Common Urticaria                                                             Unknown Anaphylactic reaction                                                 Unknown Nervous system disorders         Paresthesia                                                           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 Dyspnea                                                               Unknown Gastrointestinal disorders       Vomiting                                                              Unknown Diarrhea                                                              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 *A  precise estimate of the rate of these adverse reactions is not possible from the available data.
a Increase of inhibitor titer (anamnestic response) [not a MedDRA PT] is the rise of previously existing inhibitor titers 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/