Anti-D (rh) immunoglobulin interacts in the following cases:
Active immunisation with live virus vaccines (e.g. measles, mumps, rubella or varicella) should be postponed until 3 months after the last administration of anti-D immunoglobulin, as the efficacy of the live virus vaccine may be impaired.
If anti-D immunoglobulin needs to be administered within 2 to 4 weeks of a live virus vaccination, then the efficacy of such a vaccination may be impaired.
Human anti-D immunoglobulin is intended for use in pregnancy. No study drug-related adverse events were reported in children delivered of 432 women who received antepartum administration of 300 micrograms human anti-D immunoglobulin.
Human anti-D immunoglobulin can be used during breastfeeding. Immunoglobulins are excreted in human milk. No study drug-related adverse events were reported in children delivered of 256 women who received postpartum administration of 300 micrograms human anti-D immunoglobulin, nor in children delivered of 139 women who received postpartum administration of 200 micrograms human anti-D immunoglobulin.
No animal fertility studies have been conducted with human anti-D immunoglobulin. Nevertheless, clinical experience with human anti-D immunoglobulin suggests that no harmful effects on fertility are to be expected.
Human anti-D immunoglobulin has no influence on the ability to drive and use machines.
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.
The following adverse reactions have been reported from 592 patients in clinical studies and from post-marketing experience. The summary listed 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 (SOC, MedDRA) | Adverse Reaction (MedDRA Preferred Term (PT) | Frequency of ADR |
|---|---|---|
| Immune system disorders | Hypersensitivity, anaphylactic shock | rare |
| Nervous system disorders | Headache | uncommon |
| Cardiac disorders | Tachycardia | rare |
| Vascular disorders | Hypotension | rare |
| Respiratory, thoracic and mediastinal disorders | Dyspnoea | rare |
| Gastrointestinal disorders | Nausea, vomiting | rare |
| Skin and subcutaneous tissue disorders | Skin reaction, erythema, pruritus | uncommon |
| Musculoskeletal and connective tissue disorders | Arthralgia | rare |
| General disorders and administration site conditions | Pyrexia, malaise, chills | uncommon |
| At injection site: swelling, pain, erythema, induration, warmth, pruritus, rash | rare |
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.
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