Orladeyo

国: 欧州連合

言語: 英語

ソース: EMA (European Medicines Agency)

有効成分:

berotralstat dihydrochloride

から入手可能:

BioCryst Ireland Limited

ATCコード:

B06AC

INN（国際名）:

berotralstat

治療群:

Other hematological agents

治療領域:

Angioedemas, Hereditary

適応症:

Orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.

製品概要:

Revision: 5

認証ステータス:

Authorised

承認日:

2021-04-30

情報リーフレット

20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ORLADEYO 150 MG HARD CAPSULES
berotralstat
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Orladeyo is and what it is used for
2.
What you need to know before you take Orladeyo
3.
How to take Orladeyo
4.
Possible side effects
5.
How to store Orladeyo
6.
Contents of the pack and other information
1.
WHAT ORLADEYO IS AND WHAT IT IS USED FOR
Orladeyo is a medicine that contains the active substance
berotralstat. It is used to
PREVENT
ANGIOEDEMA ATTACKS
in adults, and adolescents aged from 12 years with hereditary
angioedema.
WHAT HEREDITARY ANGIOEDEMA IS
Hereditary angioedema is a condition that often runs in families. It
can limit your daily activity by
causing attacks of swelling and pain in different parts of your body
including:
•
hands and feet
•
face, eyelids, lips or tongue
•
voice-box (larynx), which may make breathing difficult
•
genitals
•
stomach and intestines
HOW ORLADEYO WORKS
In hereditary angioedema your blood does not have enough of a protein
called C1 inhibitor, or the
protein does not work properly. This leads to too much of the enzyme
plasma kallikrein, which in turn
increases the levels of bradykinin in your bloodstream. Too much
bradykinin leads to symptoms of
heredi

製品の特徴

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Orladeyo 150 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 150 mg berotralstat (as dihydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule)
Capsule (19.4 mm × 6.9 mm) with white opaque body imprinted with
“150” and light blue opaque cap
imprinted with “BCX”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Orladeyo is indicated for routine prevention of recurrent attacks of
hereditary angioedema (HAE) in
adult and adolescent patients aged 12 years and older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose for adults and adolescents aged 12 years and
older weighing ≥ 40 kg is
150 mg berotralstat once daily.
_Missed doses _
If a dose of berotralstat is missed, the patient should take the
forgotten dose as soon as possible
without exceeding one dose per day.
Orladeyo is not intended for treatment of acute HAE attacks (see
section 4.4)
_. _
_Special populations _
_Elderly population _
No dose adjustment is required for patients above 65 years of age (see
sections 4.4 and 5.2).
_Renal impairment _
No dose adjustment is required for patients with mild or moderate
renal impairment. In patients with
severe renal impairment, it is preferable to avoid the use of
berotralstat.
If treatment is required,
appropriate monitoring (e.g. ECGs) should be considered (see section
4.4).
3
There are no available clinical data for the use of berotralstat in
patients with end stage renal disease
(ESRD) requiring haemodialysis. As a precautionary measure, it is
preferable to avoid the use of
berotralstat in patients with ESRD (see section 5.2).
_Hepatic impairment _
No dose a