Patients naive to immunoglobulin may experience a higher frequency of adverse events, including those of a minor nature. Reactions to IV immunoglobulin tend to be related to the infusion rate and are most likely to occur during the 1st hour of the infusion. It is recommended that the patient's vital signs and general status be monitored regularly throughout the infusion.
Reactions Associated with Intragam P in Clinical Trials: Primary Immune Deficiency:
The following adverse reactions occurred in 35 patients receiving Intragam P during the clinical trial (expressed as the number of patients experiencing the adverse reaction): Headache (8), migraine (2), anaemia (2), nausea (2), vertigo (1), neutropenia (1), thrombocytopenia (1) and fatigue (1). The dose of Intragam P ranged from 0.2-0.67 g/kg body weight/month.
Idiopathic Thrombocytopenic Purpura (ITP):
The following adverse reactions occurred in 17 patients receiving Intragam P during the clinical trial (expressed as the number of patients experiencing the adverse reaction): Headache (10), positive direct Coombs test (5), haemolysis (4), nausea (3), rigors (3), fever (2), myalgia (1), somnolence (1), abdominal pain (1), vomiting (1), hypertension (1), flushing (1), haemolytic anemia (1), leucopenia (1), reticulocytosis (1), lymphopenia (1), allergic reaction (1), hot flushes (1) and injection site inflammation (1). The dose of Intragam P ranged from 0.66-2 g/kg body weight received via infusion once daily over 1-3 consecutive days.
Reactions Associated with Intragam P Use Post-Marketing:
Haemolytic anaemia associated with the presence of anti-A and/or anti-B antibodies has been reported following high cumulative doses over the course of several days with Intragam P in patients of blood group A, B or AB particularly in recipients with reduced bone marrow reserve or post haemopoietic stem cell transplantation.
Reactions Associated with IV Immunoglobulins:
The types of reaction that may occur include: Malaise, abdominal pain, headache, chest-tightness, facial flushing or pallor, erythema, hot sensations, dyspnoea or respiratory difficulty, non-urticarial skin rash, cutaneous vasculitis, pompholyx on hands/palms, itching, tissue swelling, change in blood pressure, nausea or vomiting. Should any of these reactions develop during infusion of Intragam P, the infusion should be temporarily stopped until the patient improves clinically (5-10 min) and then cautiously recommenced at a slower rate.
Some patients may develop delayed adverse reactions to IV immunoglobulins (IVIG) eg, nausea, vomiting, chest pain, rigors, dizziness, aching legs or arthralgia. These adverse reactions occur after the infusion has stopped but usually within 24 hrs.
True hypersensitivity reactions to IVIG eg, urticaria, angioedema, bronchospasm or hypotension occur very rarely. Should an anaphylactic reaction to Intragam P develop, the infusion should be stopped and treatment instituted with adrenaline, oxygen, antihistamine and steroids.
Haemolytic anaemia and neutropenia have been reported in rare instances in association with IVIG treatment.
Mild and moderate elevations of serum transaminases (AST, ALT, gamma GT) have been observed in a small number of patients given IVIG. Such changes were transient and not associated with the transmission of hepatitis. Elevated liver function tests have been reported in some untreated patients with Guillain-Barre Syndrome (GBS).
An aseptic meningitis syndrome (AMS) and thrombophlebitis have occurred in patients receiving IVIG (see Precautions).
Thrombotic events have been reported in association with IVIG therapy. Rarely, renal dysfunction and acute renal failure have been reported (see Precautions).