Included as part of the "PRECAUTIONS" Section
Only administer BabyBIG as an intravenous infusion, since other routes of administration have not been
evaluated. Do not use BabyBIG if the reconstituted solution is turbid [see DOSAGE AND ADMINISTRATION].
Patient Monitoring For Administration
- Patients should be well hydrated prior to the initiation of the BabyBIG infusion.
- Assess renal function, including the measurement of blood urea nitrogen (BUN) or serum creatinine
prior to the initial infusion of BabyBIG [see DOSAGE AND ADMINISTRATION]. Periodic
monitoring of renal function tests and urine output is particularly important in patients judged to have
a potential risk for developing acute renal failure.[1-4] Increases in serum creatinine and BUN have
been observed as soon as one to two days following treatment with other IGIV products.
- During administration, monitor the patient's vital signs continuously and observe the patient carefully
for any associated symptoms.
- DO NOT EXCEED THE RECOMMENDED INFUSION RATE of 1 mL/kg/hour (50 mg/kg/h), and
follow the infusion schedule closely [see DOSAGE AND ADMINISTRATION]. If a patient
develops an infusion reaction, slow the rate of infusion immediately or temporarily interrupt the
Renal Adverse Reactions
Other IGIV products have been reported to be associated with renal dysfunction, acute renal failure,
osmotic nephrosis, and death.[5-6] While these reports of renal dysfunction and acute renal failure have
been associated with the use of many licensed IGIV products, those that contained sucrose as a
stabilizer and were administered at daily doses of 400 mg/kg or greater have accounted for a
disproportionate share of the total number. BabyBIG contains sucrose as a stabilizer. Patients
predisposed to acute renal failure include those patients with any degree of pre-existing renal
insufficiency, diabetes mellitus, volume depletion, sepsis, paraproteinemia, or who are receiving known
nephrotoxic drugs. Especially in such patients, BabyBIG should be administered at the minimum
concentration available and at the minimum rate of infusion practicable.
Transmission Of Blood-Borne Infectious Agents
BabyBIG is made from human plasma and, like other plasma products, carries the possibility for
transmission of blood-borne viral agents and, theoretically, the Creutzfeldt-Jakob disease agent. The
risk of transmission of recognized blood-borne viruses has been reduced by screening plasma donors
for prior exposure to certain viruses, for the presence of certain viral infections, and by the viral
inactivation and/or removal properties of the precipitation procedures used for the purification of
BabyBIG [see DESCRIPTION]. Despite these measures, some as yet unrecognized blood-borne
infectious agents may not be inactivated by the manufacturing process; therefore, BabyBIG, like any
other blood product, should be given only if a benefit is expected [see PATIENT INFORMATION].
- Severe reactions, such as angioedema and anaphylactic shock, although not observed during clinical
trials with BabyBIG, are a possibility.[8,9] Clinical anaphylaxis may occur even when the patient is
not known to be sensitive to immune globulin products. A reaction may be related to the rate of
infusion; therefore, carefully adhere to the infusion rates as outlined under "see DOSAGE AND ADMINISTRATION." If anaphylaxis or a drop in blood pressure occurs, discontinue the
infusion and administer epinephrine.[1-4]
- Although acute systemic allergic reactions were not seen in clinical trials with BabyBIG,
epinephrine should be available for treatment of acute allergic symptoms [see ADVERSE REACTIONS]. If hypotension or anaphylaxis occurs, discontinue the administration of BabyBIG
immediately and give supportive care as needed.
Aseptic Meningitis Syndrome
An aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IGIV
administration.[10-13] The syndrome usually begins within several hours to two days following IGIV
treatment. It is characterized by symptoms and signs that include the following: severe headache, nuchal
rigidity, drowsiness, fever, photophobia, painful eye movements, and nausea and vomiting.
Cerebrospinal fluid studies are frequently positive with pleocytosis up to several thousand cells per
cubic millimeter, predominately from the granulocytic series, and with elevated protein levels up to
several hundred mg/dL. Conduct a thorough neurolog10ical examination in patients exhibiting such
symptoms and signs to rule out other causes of meningitis.[10-13] AMS may occur more frequently in
association with high total doses (2 g/kg) of IGIV treatment. Discontinuation of IGIV treatment has
resulted in remission of AMS within several days without sequelae. AMS was not observed in
clinical trials of BabyBIG.
Hyperproteinemia, Hyponatremia, And Serum Viscosity
Hyperproteinemia, hyponatremia, and increased serum viscosity have been observed following
administration of IGIV products. It is clinically critical to distinguish true hyponatremia from
pseudohyponatremia caused by decreased calculated serum osmolality or elevated osmolar gap,
because treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead
to volume depletion, a further increase in serum viscosity and a higher risk of thromboembolic events.
These adverse events have not been observed with BabyBIG.
Thrombotic events may occur following IGIV treatment. Patients at risk may include those with a
history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output,
coagulation disorders, prolonged periods of immobilization, and/or known or suspected hyperviscosity.
Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those
with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or
monoclonal gammopathies. For patients judged to be at risk of developing thrombotic events, administer
BabyBIG at the minimum rate of infusion practicable.
IGIV products may contain blood group antibodies, which can act as hemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction and,
rarely, hemolysis. Hemolytic anemia may develop subsequent to IGIV therapy due to enhanced red
blood cell sequestration.
Monitor patients for clinical signs and symptoms of hemolysis. If these are present after BabyBIG
infusion, perform appropriate confirmatory laboratory testing.
Transfusion-Related Acute Lung Injury (TRALI)
Non-cardiogenic pulmonary edema may occur in patients following IGIV treatment. TRALI is
characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular
function, and fever. Symptoms typically occur within 1 to 6 hours following treatment [see PATIENT INFORMATION].
Monitor patients for pulmonary adverse reactions. If TRALI is suspected, perform appropriate tests for
the presence of anti-neutrophil antibodies in both the product and patient serum.
TRALI may be managed using oxygen therapy with adequate ventilatory support.
Use In Specific Populations
BabyBIG has been studied for safety and efficacy only in patients below one year of age [see ADVERSE REACTIONS and Clinical Studies]. It has not been tested in other populations.
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nephropathy in disguise? Am J Ther 1998; 5:399-403.
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major birch pollen allergen Bet v 1. Anti-allergen IgG can enhance the anaphylactic reaction. FEBS
Lett 2000; 465:39-46.
9. Burks AW, Sampson HA, Buckley RH. Anaphylactic reactions after gamma globulin administration
in patients with hypogammaglobulinemia. Detection of IgE antibodies to IgA. N Engl J Med 1986;
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immunoglobulin therapy: frequency and risk factors. Ann Intern Med 1994; 121:259-262.
11. Kato E, Shindo S, Eto Y, et al. Administration of immune globulin associated with aseptic meningitis.
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