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 Optivate. If such inhibitors occur, the condition may 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). The table lists adverse reactions reported from 96 patients in clinical studies.
Approximately 10% of patients can be expected to experience adverse reactions on long-term treatment.
MedDRA Standard                 Adverse reactions                 Frequency System Organ Class
Blood and lymphatic             Factor VIII inhibition            Uncommon (PTPs)* system disorders                                                  Very common (PUPs)*
Nervous system disorders        Headache                          Common Somnolence                        Common
Ear and labyrinth               Vertigo (dizziness)               Common disorders
Skin and subcutaneous           Rash                              Common tissue disorders
Pruritus                          Common
Musculoskeletal and         Muscle and joint stiffness            Common connective tissue disorders
General disorders and           Infusion site erythema, rash,     Common administration site             or pain conditions
Oedema peripheral                 Common
Shivering (rigors)                Common
Fever (pyrexia)                   Common
* Frequency is based on studies with all factor VIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients.
In post marketing experience the following additional undesirable effects have been reported: sneezing, cough, throat irritation, abdominal pain and malaise.

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
Additionally, you should also report to Kamada LTD to email address: pharmacovigilance@kamada.com