Adverse reactions : תופעות לוואי

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

Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with Octanate see section 5.1. 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.

For safety information with respect to transmissible agents, see section 4.4.

Tabulated list of adverse reactions
The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).

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).

MedDRA Standard System Adverse Reaction                                        Frequency Organ Class
Immune system disorders Hypersensitivity                                       Rare 
Anaphylactic shock                              Very rare
General     disorders      and Pyrexia                                         Rare administration site conditions
Blood and lymphatic system FVIII inhibition                                    Uncommon (PTPs)* disorders
Very common (PUPs)*
Investigations                        Anti factor        VIII     antibody Rare positive
* Frequency is based on studies with all FVIII products which included patients with severe haemophilia A.
PTPs = previously-treated patients, PUPs = previously-untreated patients Paediatric population
Frequency, type and severity of adverse reactions in children are the same as in adults.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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/