Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
Adverse reactions such as chills, headache, dizziness, pyrexia, vomiting, hypersensitivity, nausea, arthralgia, hypotension and moderate low back pain may occur occasionally.

Rarely human normal immunoglobulins may cause a sudden blood pressure decrease and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration.

Local reactions at infusion sites: swelling, pain, erythema, induration, warmth, itching, bruising and rash, may frequently occur.

For information on infectious disease risk see section 4.4. subheading “Transmissible agents”.

Tabulated list of adverse reactions

Adverse reactions have been collected from clinical studies and post-marketing experience.
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).

A frequency category has been applied to adverse reactions observed in clinical trials.
However for adverse reactions received from post-marketing experience, it is not always possible to reliably estimate frequency since reporting is voluntary and from a population of an uncertain size. For these reactions ‘not known’ has been assigned.

Frequency of Adverse Reactions (ADRs) with Beriglobin P



MedDRA System        Adverse Reaction            Frequency
Organ Class                                      s.c.             i.m.
(SOC)                                            administration   administration Immune system        Hypersensitivity            Common‡          Not known disorders            (including blood pressure decrease)
Anaphylactic                Not known        Not known shock/anaphylactic reactions (including dyspnoea, skin reaction)
Nervous system       Headache                    Common‡          Common‡ Syncope, dizziness          Common‡          Not known
Cardiac disorders    Cardiovascular disorder¶    Not known        Not known Vascular disorders   Thromboembolism             Not known        (---) (including myocardial infarction, ischaemic stroke, deep venous thrombosis and pulmonary embolism) ^
Respiratory,         Bronchospasm                Common‡          Not known thoracic and mediastinal disorders
Gastrointestinal     Nausea, vomiting            Not known        Not known disorders
Skin and             Rash                        Common‡          Not known subcutaneous tissue disorders
Musculoskeletal      Back pain§                  Common‡          Not known and connecitve tissue disorders
General disorders    Injections site pain§       Very common      Very common and administration   Injection site swelling,    Very common      Not known site conditions      erythema, induration,
warmth, pruritus,
bruising, rash§
Injection site urticaria†   (---)            Not known
Pyrexia                     Common‡          Common‡
Chills, malaise             Common‡          Not known
Arthralgia                  Not known        Not known



‡
Reported in single cases from clinical study.
¶
Cardiovascular disorder particularly if the product has been inadvertently injected intravascularly.
^
Thromboembolism (including myocardial infarction, ischaemic stroke, deep venous thrombosis and pulmonary embolism) has been observed in association with s.c. substitution therapy only.
§
In a clinical study with s.c. administration frequency of local reactions at the injection site (including pain, swelling, erythema, warmth, pruritus, bruising, rash) declined very rapidly with the first ten infusions, when patients became used to the s.c. form of treatment.
†
Injection site urticaria has been observed with i.m. administration only.



Description of selected adverse reactions

Injection site urticaria has been observed with i.m. administration only.
Thromboembolism (including myocardial infarction, ischaemic stroke, deep venous thrombosis and pulmonary embolism) has been observed in association with s.c. substitution therapy only.

Paediatric population

Frequency, type and severity of adverse reactions in children are expected to be 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 and emailed to the Registration Holder’s Patient Safety Unit at:
PV-IL@cslbehring.com