Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Summary of the safety profile
The most serious adverse reactions observed during the treatment are hypersensitivity or allergic reactions which may in rare cases progress to a sudden fall in blood pressure and anaphylactic shock even when the patient has shown no hypersensitivity to previous administration. When anti-D immunoglobulins are administered by the intramuscular route, local pain and tenderness may be observed at the injection site.

Tabulated list of adverse reactions
The following adverse reactions have been reported from 592 patients in clinical studies and from post-marketing experience. The summary table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Frequency has been evaluated using the following criteria: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000).

System Organ Class             Adverse Reaction               Frequency of ADR (SOC, MedDRA)                  (MedDRA Preferred Term
(PT))
Immune system disorders        Hypersensitivity,              rare anaphylactic shock
Nervous system disorders       Headache                       uncommon Cardiac disorders              Tachycardia                    rare Vascular disorders             Hypotension                    rare Respiratory, thoracic and      Dyspnoea                       rare mediastinal disorders
Gastrointestinal disorders     Nausea, vomiting               rare Skin and subcutaneous          Skin reaction, erythema,       uncommon tissue disorders               pruritus
Musculoskeletal and            Arthralgia                     rare connective tissue disorders
General disorders and           Pyrexia, malaise, chills        uncommon administration site             At injection site:              rare conditions                      swelling, pain, erythema,
induration, warmth, pruritus,
rash

There have been spontaneous reports of severe intravascular haemolysis when anti-D has been administered intravenously to Rh(D) positive patients with primary immune thrombocytopenia (ITP). Haemolysis resulting in death has been reported. The exact frequency of this adverse event is not known.
For safety with respect to transmissible agents, see section 4.4.

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