33
4.3 Contraindication
Berinert
®
is contraindicated in individuals with known
hypersensitivity to any of the components of the product.
4.41 Hypersensitivity Reactions
As with other pharmaceutical agents, allergic reactions may
occur. If symptoms of allergic or early signs of hypersensitivity
reactions (eg, tachycardia, hyper- or hypotension, flushing,
hives, dyspnea, headache, dizziness, nausea) occur,
administration has to be discontinued immediately. As
hypersensitivity reactions may have symptoms similar to
HAE attacks, treatment methods should be considered
carefully. In very rare cases (less than 1 in 10,000 patients
or in single cases), a hypersensitivity reactionmight progress
to shock. The treatment required depends on the nature
and severity of the reaction.
4.42 Considerations Regarding Transmissible
Infectious Agents
Berinert
®
is made from human plasma. The risk that
Berinert
®
will transmit an infectious agent has been reduced
or eliminated by screening plasma donors for prior exposure
to certain viruses, by testing for the presence of specific
known viruses, and by a process demonstrated to inactivate
and/or remove certain viruses duringmanufacturing through
pasteurization (heat treatment in aqueous solution at 60°C
for 10 hours), hydrophobic interaction chromatography
(HIC), and virus filtration (nanofiltration).
Inmore than half a million treatments worldwide, no proven
case of infection due to HIV-1/2, HBV, HCV, HAV, or B19V
has been reported with the use of Berinert
®
.
1
For more on reducing the risk of transmissible
infectious agents, see chapter 8.
4.43 Development of Thrombosis
Continuing cases of thrombotic events associated with the
treatment of HAE with a C1-INH concentrate other than
Berinert
®
were found in a retrospective data mining analysis
of the United States Food and Drug Administration Adverse
Events Reporting System, but no causal relationship could
be established.
77
Rare cases of thrombotic events have been reported at the
recommended dose of 20 IU/kg body weight Berinert
®
following treatment of HAE.
77
The development of thrombosis has also been reported
after excessively high doses (greater than 90 IU/kg body
weight) of Berinert
®
, in newborns and young children with
congenital heart anomalies during or after cardiac surgery
under extracorporeal circulation (see section 9.2
Summary
of Product Characteristics
).
4.4 Warnings and Precautions
Product Description
