49
6.5 Special Considerations
6.6 Monitoring Patients During Infusions
6.51 Use in Pregnancy and Lactation
Animal reproduction studies have not been con-
ducted with Berinert
®
. Even though no adverse effects
on fertility, pre- and postnatal development are expected
in humans, only a limited amount of data on the use of
Berinert
®
during pregnancy is available and the benefits of
treatment should be weighed against the potential risks
(see chapter 9.2
Summary of Product Characteristics
).
A retrospective analysis of clinical data on 118 preg-
nancies in 41 patients has been performed.
72
Acute
attacks were treated with 500 IU Berinert
®
in 9 pati-
ents during 12 full-term pregnancies in 36 instances.
Additionally, 2 patients with severe recurrent attacks
received long-term prophylaxis with 500 IU Berinert
®
,
and short-term prophylaxis with 500 IU Berinert
®
was
administered in 15 cases. Treatment was invariably
effective in all cases and did not lead to any side effects or
complications.
72
An observational study on treatment with 500 or 1,000 IU
Berinert
®
in 22 women before, during, and after a total of
35 pregnancies reported no drug-related AEs and pointed
out the benefit of including C1-INH therapy in a manage-
ment plan for pregnant and nursing women with HAE.
73
Transfer of Berinert
®
in human milk seems unlikely due
to the drug’s high molecular weight (see chapter 9.2
Sum-
mary of Product Characteristics
). However, Berinert
®
has
not been clinically evaluated in nursing mothers and
should be given only if clearly needed.
Patients are to be monitored for early signs of allergic or
hypersensitivity reactions. If symptoms of allergic or early
signs of hypersensitivity reactions (including tachycardia,
hypertension or hypotension, flushing, hives, dyspnea,
headache, dizziness, or nausea) occur, administration has
6.52 Use in Pediatrics
The safety and efficacy of Berinert
®
was not systematically
evaluated in children. No apparent differences have been
reported in the safety and efficacy profiles in children as
compared to adult patients.
Data from the I.M.P.A.C.T. studies suggest that the
treatment response to Berinert
®
in pediatric patients
is generally comparable to that seen in adults. Treat-
ment of pediatric patients with 20 IU/kg Berinert
®
was
safe and well tolerated for HAE attacks at all body
locations. No serious AEs were reported and there were
no signs for any pediatric-specific safety concerns.
101
In a retrospective observational study in 20 pediatric pa-
tients assessing the efficacy and safety of home therapy
with 500 or 1,000 IU C1-INH, Berinert
®
was efficacious,
safe, and well tolerated during home therapy as well as
during physician-based therapy. No side effects including
virus transmission cases were reported.
90
6.53 Use in Geriatrics
The safety and efficacy of Berinert
®
in the geriatric
population have not been established. Clinical studies
with Berinert
®
included 4 patients older than 65 years.
There was an insufficient number of patients in this age
group to determine whether they respond differently from
younger patients.
Dosage
to be discontinued immediately and appropriate treat-
ment must be initiated. Refer to chapter 4.4 for
Warnings
and Precautions
and chapter 9.2
Summary of Product
Characteristics.
