Trade name: Rhophylac®
Generic names: Rh0 (D) Immune Globulin Intravenous (Human). Also known as “Anti-D” in the United Kingdom.
Indication and Usage: This sterile Rh0 (D) Immune Globulin Intravenous (Human) solution is approved to be used in two main scenarios: Suppression of rhesus (Rh) isoimmunization and Immune thrombocytopenic purpura (ITP).
Ingredients: Rhophylac® contains a maximum of 30 mg/mL of human plasma proteins, 10 mg/mL of which is human albumin added as a stabilizer. Prior to the addition of the stabilizer, Rhophylac® has a purity greater than 95% IgG. Rhophylac® contains less than 5 mcg/mL of IgA, which is the limit of detection. Additional excipients are approximately 20 mg/mL of glycine and up to 0.25 M of sodium chloride. Rhophylac® contains no preservative. Human albumin is manufactured from pooled plasma of US donors by cold ethanol fractionation, followed by pasteurization.
Manufacturer-listed adverse reactions | RhoGAM can cause
in Suppression of Rh isoimmunization: Nausea/Vomiting, Dizziness/Headache, Injection-site pain, Malaise (discomfort), Vertigo/Chills, Hypotension (low blood pressure), Tachycardia (fast heartbeat), Dyspnea (shortness of breath), Rash, erythema, pruritus (hives), Backpain, Pyrexia/increased body temperature, Diarrhea.
in ITP: Chills, Pyrexia/increased body temperature, Headache, Mild extravascular hemolysis (increased bilirubin, decreased hemoglobin), Anemia, Acute renal insufficiency, Disseminated intravascular coagulation (DIC) and is difficult to detect, diagnosis is dependent mainly on laboratory testing, Death, Patients experiencing intravascular hemolysis may present with back pain, shaking chills, fever, and, most consistently, hemoglobinuria, as well as discolored urine, decreased urine output, sudden weight gain, edema, and/or shortness of breath.
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