The incidence of adverse events associated with the administration of
IVIG is reported by the manufacturers to be in the range of
1 to 15 percent, usually less than 5 percent. Most of these
reactions are mild and self-limited. Severe reactions occur
very infrequently and usually do not contraindicate further
IVIG therapy. Neither HIV nor hepatitis B infection has been
transmitted to recipients of products currently licensed in
the U.S. The various IVIGs are manufactured from large
numbers of donors whose plasma has been tested and found to
be negative for hepatitis B surface antigen and HIV
antibody. A number of adverse events have been recognized.
These include the following:
- pyrogenic reactions marked by high fever and
- minor systemic reactions with headache, myalgia,
fever, chills, lightheadedness, nausea and/or vomiting;
- vasomotor and/or cardiovascular manifestations,
marked by changes in blood pressure and tachycardia.
These may be related to occasional reports of shortness
of breath and chest tightness; and
- hypersensitivity and anaphylactic reactions.
Patients with primary antibody deficiency syndromes may be at increased
risk for reactions. Anaphylactic reactions induced by anti-IgA
can occur in individuals who have a total absence of
circulating IgA and antibodies to IgA. These are extremely
rare in panhypogammaglobulinemic individuals and potentially
more frequent in patients with subclass deficiencies.
Frequency of reactions may be correlated with volume and/or
rate of infusion. Seriously ill patients with compromised
cardiac function may be at increased risk of vasomotor or
cardiac complications manifested by elevated blood pressure
and/or cardiac failure.
Adverse reactions often can be alleviated by reducing the rate or the
volume of infusion. For patients with repeated severe
reactions unresponsive to these measures, hydrocortisone,
1-2 mg/kg, intravenously, can be given 30 minutes before
IVIG infusion. In those rare instances when reactions
related to anti-IgA antibodies have occurred, use of
IgA-depleted preparations will reduce the likelihood of
further reactions. Avoidance of anaphylactic reactions may
require the use of material completely devoid of IgA.
Because the combination of the absence of IgA and the
presence of anti-IgA antibodies is infrequent and reactions
are rare, screening for IgA-deficiency is not routinely
recommended for potential recipients of IVIG.
As with any biologic or pharmacological product, the
potential for new or previously unrecognized adverse events
should be anticipated. With IVIG these include the
- transmission of blood-borne pathogens, such as the
newly identified hepatitis C virus.
- Immunosuppression--for example, administration of
IVIG has been associated with transient effects on
immune response that do not appear to have clinical
significance. However, with increased dosage of IVIG or
new products for the treatment of specific infections,
the possibility of adverse outcomes from
immunosuppression should be considered.
After nearly a decade of experience, the safety of IVIG
has been established. For any potential recipient, the small
risk of adverse reactions must be weighed against the
likelihood of significant benefit. For those patients who
require repeated courses of IVIG such as those with a
primary humoral immunodeficiency home infusion by the
patient or a family member after adequate training has been
effectively utilized and is cost-effective.
In a recent study of 600 patients following complications were seen 2
cases of myocardial infarction, one of acute coronary
syndrome, one of deep vein thrombosis (DVT) with pulmonary
embolism and one of isolated DVT.
The complications can be reduced to 1% by drinking more
fluids and using a aspirin daily.