Included as part of the PRECAUTIONS section.
Severe hypersensitivity reactions may occur with HepaGam
B. HepaGam B should be administered in a setting with appropriate equipment,
medication and personnel trained in the management of hypersensitivity,
anaphylaxis and shock. In case of hypersensitivity, discontinue HepaGam B
infusion immediately and begin appropriate emergency treatment. Medications
such as epinephrine and antihistamines should be available for immediate
treatment of acute hypersensitivity reactions. HepaGam B contains trace amounts
of IgA (<40 micrograms per milliliter). Patients with known antibodies to
IgA may have a greater risk of severe hypersensitivity and anaphylactic
HepaGam B is contraindicated in IgA deficient patients
with antibodies against IgA and history of hypersensitivity reaction. (see CONTRAINDICATIONS)
Interference With Blood Glucose Testing
The maltose contained in HepaGam B can interfere with
some types of blood glucose monitoring systems, i.e., those based on the glucose
dehydrogenase pyrroloquinequinone (GDH-PQQ) method. This can result in falsely
elevated glucose readings and, consequently, in the inappropriate administration
of insulin, resulting in life-threatening hypoglycemia. Cases of true hypoglycemia
may go untreated if the hypoglycemic state is masked by falsely elevated results.
Monitoring: Serum Anti-HBs Antibody Levels
Liver transplant patients should be monitored regularly
for serum anti-HBs antibody levels using a quantitative assay to ensure that
adequate protective levels are maintained.
Certain adverse drug reactions may be related to the
rate of infusion. The recommended infusion rate given under Dosage and Administration
(2.1) must be closely followed. Patients must be closely monitored and
carefully observed for any symptoms throughout the infusion period and immediately
following an infusion.
Transmissible Infectious Agents
Because HepaGam B is made from human plasma, it may carry
a risk of transmitting infectious agents, e.g. viruses, and, theoretically, the
Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral
diseases or CJD have been associated with the use of HepaGam B. All infections
suspected by a physician possibly to have been transmitted by this product
should be reported by the physician or other healthcare provider to Aptevo
BioTherapeutics at 1- 844-859-6675.
For postexposure prophylaxis indications, HepaGam B must
be administered intramuscularly only. In patients who have severe
thrombocytopenia or any coagulation disorder that would contraindicate intramuscular
injections, HepaGam B should be given only if the expected benefits outweigh
the potential risks.
Thrombotic events may occur during or following treatment
with IGIV products4,5. Patients at risk 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/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 who are at risk of developing thrombotic events,
administer HepaGam B at the minimum rate of infusion practicable.
Use In Specific Populations
Pregnancy Category C. Animal reproduction studies have
not been conducted with HepaGam B. It is also not known whether HepaGam B can
cause fetal harm when administered to a pregnant woman or can affect
reproductive capacity. HepaGam B should be given to a pregnant woman only if
It is not known whether HepaGam B is excreted in human
milk. Because many drugs are excreted in human milk, caution should be
exercised when HepaGam B is administered to a nursing mother.
Safety and effectiveness have not been established in
pediatric patients. However, for postexposure prophylaxis, the safety and
effectiveness of similar hepatitis B immune globulins have been demonstrated in
infants and children8.
Clinical studies of HepaGam B did not include sufficient
numbers of subjects aged 65 and over to determine whether they respond
differently from younger subjects. Other reported clinical experience has not
identified differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually
starting at the low end of the dosing range, reflecting the greater frequency
of decreased hepatic, renal, or cardiac function, and of concomitant disease or
other drug therapy.
4. Dalakas MC. High-dose intravenous immunoglobulin and
serum viscosity: risk of precipitating thromboembolic events. Neurology 1994;
5. Woodruff RK, et al.: Fatal thrombotic events during
treatment of autoimmune thrombocytopenia with intravenous immunoglobulin in
elderly patients. Lancet 1986; 2:217-218.