)‫בטיחות‬
)‫מידע בטיחות‬
‫החמרה (( מידע‬
‫על החמרה‬
‫הודעה על‬
‫הודעה‬
_22.12.10____ ‫תאריך‬
_________Tysabri_______‫שם תכשיר באנגלית‬
_________136453150500 _______‫מספר רישום‬
Medison Pharma Ltd___‫שם בעל הרישום‬
‫השינויים בעלון מסומנים על רקע צהוב‬
‫לרופא‬
‫בעלון לרופא‬
‫בעלון‬
‫ים‬/‫ים המבוקש‬/‫פרטים על השינוי‬
‫טקסט חדש‬
‫טקסט נוכחי‬
TYSABRI therapy is to be
initiated and continuously
supervised by specialised
physicians experienced in the
diagnosis and treatment of
neurological conditions, in
centres with timely access to
MRI.
TYSABRI therapy is to be
initiated and continuously
supervised by specialised
physicians experienced in the
diagnosis and treatment of
neurological conditions, in
centres with timely access to
MRI.
Patients treated with TYSABRI
must be given the patient alert
card and be informed about the
risks of Tysabri (see also
patient information leaflet).
After 2 years of treatment,
patients should be re-informed
about the risks of Tysabri,
especially the increased risk of
PML, and should be instructed
together with their caregivers
on early signs and symptoms
of PML.
Patients treated with TYSABRI
must be given the patient alert
card and be informed about
the risks of Tysabri (see also
patient information leaflet).
After 2 years of treatment,
patients should be re-informed
about the risks of Tysabri,
especially the increased risk of
PML, and should be instructed
together with their caregivers
on early signs and symptoms
of PML.
Resources for the management
of hypersensitivity reactions
and access to MRI should be
available.
Resources for the
management of
hypersensitivity reactions and
access to MRI should be
available.
Patients can switch directly
After dilution (see section 6.6),
from beta interferon or
the infusion is to be
glatiramer acetate to
administered over
natalizumab providing there are approximately 1 hour and
no signs of relevant
patients are to be observed
treatment-related abnormalities during the infusion and for
e.g. neutropenia. If there are
1 hour after the completion of
signs of treatment-related
the infusion for signs and
abnormalities these must return symptoms of hypersensitivity
to normal before treatment with reactions.
natalizumab is started.
TYSABRI must not be
‫פרק בעלון‬
Posology and
method of
administration
Some patients may have been
exposed to
immunosuppressive
medications (e.g. mitoxantrone,
cyclophosphamide,
azathioprine). These drugs
have the potential to cause
prolonged immunosuppression,
even after dosing is
discontinued. Therefore the
physician must confirm that
such patients are not
immunocompromised before
starting treatment with
TYSABRI (see also section
4.4).
Posology
Adults
TYSABRI 300 mg is
administered by intravenous
infusion once every 4 weeks.
administered as a bolus
injection
Patients can switch directly
from beta interferon or
glatiramer acetate to
natalizumab providing there
are no signs of relevant
treatment-related
abnormalities e.g. neutropenia.
If there are signs of
treatment-related
abnormalities these must
return to normal before
treatment with natalizumab is
started.
Some patients may have been
exposed to
immunosuppressive
medications (e.g.
mitoxantrone,
cyclophosphamide,
azathioprine). These drugs
have the potential to cause
prolonged
immunosuppression, even
after dosing is discontinued.
Therefore the physician must
confirm that such patients are
not immunocompromised
before starting treatment with
TYSABRI.
Elderly
TYSABRI is not recommended
for use in patients aged over 65
due to a lack of data in this
population.
Children and adolescents
Paediatric Population
TYSABRI is contraindicated in
children below the age of 18
years (see section 4.3).
Method of Administration
For instructions on dilution of
the medicinal product before
administration, see section 6.6.
Adults
TYSABRI 300 mg is
administered by intravenous
infusion once every 4 weeks.
After dilution (see section 6.6),
the infusion is to be
administered over
approximately 1 hour and
patients are to be observed
during the infusion and for
1 hour after the completion of
the infusion for signs and
symptoms of hypersensitivity
reactions.
TYSABRI must not be
administered as a bolus
injection.
Children below the age of 18
years.
Elderly
TYSABRI is not recommended
for use in patients aged over
65 due to a lack of data in this
population.
Children and adolescents
TYSABRI is contraindicated in
children and adolescents (see
section 4.3).
Contraindications
Children and adolescents.
Use of TYSABRI has been
associated with an increased
risk of PML which may be fatal
or result in severe disability.
The risk of PML increases with
treatment duration, especially
beyond 2 years. There is
limited experience in patients
who received more than 3
years of Tysabri treatment
therefore the risk of PML in
these patients cannot currently
be estimated. The risk of PML
is also increased in patients
who have been treated with an
immunosuppressant prior to
receiving TYSABRI. This
increased risk appears to be
independent of TYSABRI
treatment duration.
Patients with a treatment
history of immunosuppressant
medications are at increased
risk for PML.
Fertility, pregnancy and
lactation
Women of childbearing
potential
There are no adequate data
from the use of natalizumab in
pregnant women. Studies in
animals have shown
reproductive toxicity (see
section 5.3). The potential risk
for humans is unknown.
Natalizumab should not be
used during pregnancy unless
clearly necessary.
Use of TYSABRI has been
associated with an increased
risk of PML which may be fatal
or result in severe disability.
The risk of PML appears to
increase with treatment
duration, especially beyond 2
years. There is limited
experience in patients who
received more than 3 years of
Tysabri treatment therefore the
risk of PML in these patients
cannot currently be estimated.
Patients with a treatment
history of immunosuppressant
medications including
cyclophosphamide and
mitoxantrone, may experience
prolonged immunosuppression
and therefore may be are at
increased risk for PML.
There are no adequate data
from the use of natalizumab in
pregnant women. Studies in
animals have shown
reproductive toxicity (see
section 5.3). The potential risk
for humans is unknown.
Natalizumab should not be
used during pregnancy unless
clearly necessary.
Special warnings
and
precautions
for use
Concurrent or prior
treatment
with immuno
suppressants
Pregnancy and
lactation
If a woman becomes pregnant
while taking TYSABRI,
discontinuation of TYSABRI
should be considered.
If a woman becomes pregnant
while taking TYSABRI,
discontinuation of TYSABRI
should be considered.
Pregnancy
There are no adequate data
from the use of natalizumab in
pregnant women. Studies in
animals have shown
reproductive toxicity (see
section 5.3). The potential risk
for humans is unknown.
Natalizumab should not be
used during pregnancy unless
the clinical condition of the
women requires treatment with
TYSABRI.
Breastfeeding
It is not known whether
TYSABRI is excreted in human
milk, but it has been observed
in animal studies (see section
5.3). Patients receiving
TYSABRI should not
breastfeed their infants.
Fertility
Reductions in female guinea
pig fertility were observed in
one study at doses in excess of
the human dose; natalizumab
did not affect male fertility. It is
considered unlikely that
natalizumab will affect fertility
performance in humans
following the maximum
recommended dose.
No studies on the effects on
the ability to drive and use
machines have been
performed
Based on the pharmacological
mechanism of action of
natalizumab, the use of
TYSABRI has no or negligible
influence on the is not
expected to affect patient's
It is not known whether
TYSABRI is excreted in human
milk, but it has been observed
in animal studies (see section
5.3). Patients receiving
TYSABRI should not
breastfeed their infants.
. Based on the
pharmacological mechanism of
action of natalizumab, the use
of TYSABRI is not expected to
affect patient's ability to drive
and use machines.
Effects on ability to
drive and use
machines
ability to drive and use
machines.