Rhophylac Adverse Reactions

Summary of the safety profile: When anti-D immunoglobulins are administered by the intramuscular route, local pain and tenderness can 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 and <1/10), Uncommon (≥1/1,000 and <1/100), Rare (≥1/10,000 and <1/1,000), Very rare (<1/10,000). (See Table 2.)

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There have been spontaneous reports of severe intravascular haemolysis when anti-D has been administered intravenously to Rh(D)-positive ITP patients. Haemolysis resulting in death has been reported. The exact frequency of this adverse event is not known. For safety information with respect to transmissible agents, see Precautions.
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. Healthcare professionals are asked to report any suspected adverse reactions.