Adverse experience (AE) complaints related to RhoGAM® Ultra-Filtered and MICRhoGAM® Ultra-Filtered are received at a rate of approximately one complaint per 60,000 doses distributed for use. 20 These AE complaints are split between reports of anti-D formation despite RhoGAM or MICRhoGAM administration and reports of local reactions at the site of administration.
Local AE reactions include swelling, induration, redness and mild pain at the site of injection, and a small number of patients have noted a slight elevation in temperature. Rarely, these reactions have been treated with antihistamines or corticosteroids. Systemic reactions to RhoGAM or MICRhoGAM are extremely rare. There have been no reported fatalities due to anaphylaxis or any other cause related to RhoGAM or MICRhoGAM administration.
As with any Rho(D) Immune Globulin (Human), administration to patients who have received Rh-positive red blood cells may result in signs and symptoms of a hemolytic reaction, including fever, back pain, nausea and vomiting, hypo- or hypertension, hemoglobinuria/emia, elevated bilirubin and creatinine and decreased haptoglobin.