Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Summary of Safety Profile
Replacement therapy may lead to the formation of circulating antibodies inhibiting one or more of the human prothrombin complex factors. If such inhibitors occur, the condition will manifest itself as a poor clinical response.
Allergic or anaphylactic-type reactions may rarely occur ( 1/10,000 to < 1/1,000) including severe anaphylactic reactions.
Increase in body temperature has been observed very rarely (<1/10,000).
There is a risk of thromboembolic episodes following the administration of human prothrombin complex (see section 4.4).

Tabulated list of adverse reactions of Octaplex
The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequencies have been based on clinical trial data, 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) or not known (cannot be estimated from the available data).
MedDRA Standard System Organ Class Adverse reactions                            Frequency Psychiatric Disorders                        Anxiety                            uncommon Vascular disorders                            Deep vein thrombosis                common Thrombosis                         uncommon
Hypertension                       uncommon
Respiratory, thoracic and                    Pulmonary embolism                 uncommon mediastinal disorders                        Bronchospasm                       uncommon Hemoptysis                         uncommon
Epistaxis                          uncommon
General disorders and administration site    Injection site burning             uncommon conditions
Investigations                               Fibrin D-dimer increased           uncommon Blood thrombin increased           uncommon
Hepatic Function Abnormal          uncommon
Injury, poisoning and procedural             Thrombosis in device               uncommon complications

The following adverse reactions have been reported during post-marketing use of Octaplex 500 IU. Because post-marketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not possible to reliably estimate the frequency of these reactions.

Immune system disorders
Anaphylactic shock, hypersensitivity
Nervous system disorders
Tremor
Cardiac disorders
Cardiac arrest, tachycardia
Vascular disorders
Circulatory collapse, hypotension
Respiratory, thoracic and mediastinal disorders
Dyspnoea, respiratory failure
Gastrointestinal disorders
Nausea
Skin and subcutaneous tissue disorders
Urticaria, rash
General disorders and administration site conditions
Chills

Octaplex 500 IU contains heparin. Therefore, a sudden, allergy induced reduction of the blood platelet count below 100.000/µl or 50 % of the starting count may be rarely observed (thrombocytopenia type II). In patients not previously hypersensitive to heparin, this decrease in thrombocytes may occur 6 - 14 days after the start of treatment. In patients with previous heparin hypersensitivity this reduction may happen within a few hours. The treatment with Octaplex 500 IU must be stopped immediately in patients showing this allergic reaction. These patients must not receive heparin containing medicinal products in the future.
For safety with respect to transmissible agents, see 4.4.

Paediatric population
No data is available regarding the use of Octaplex in paediatric population.

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/