ORLADEYO 150 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BEROTRALSTAT AS DIHYDROCHLORIDE

Available from:

NEOPHARM (ISRAEL) 1996 LTD

ATC code:

B06AC06

Pharmaceutical form:

CAPSULES

Composition:

BEROTRALSTAT AS DIHYDROCHLORIDE 150 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

BIOCRYST PHARMACEUTICALS, INC, USA

Therapeutic area:

BEROTRALSTAT

Therapeutic indications:

ORLADEYOTM is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older.

Authorization date:

2022-08-08

Patient Information leaflet

FILE NAME
Orladeyo_israel_PIL_ENG-D14-F
PRODUCT
orladeyo_
JOB NO.
SO22001095
LANGUAGE
English
ARTWORK
Patient Leaflet
DOCUMENT HISTORY
VER.
DATE
CHANGE DESCRIPTION
BY
29-Nov-22 16:09
Last save
_OUR EXPERTISE. YOUR SUCCESS._
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
ORLADEYO® 110 MG, hard gelatin capsules
ORLADEYO® 150 MG, hard gelatin capsules
THE ACTIVE SUBSTANCE AND ITS QUANTITY PER DOSAGE UNIT:
Each Orladeyo capsule contains berotralstat (as dihydrochloride) 110
mg or 150 mg.
For a list of inactive ingredients and allergens in the preparation:
see section 6 "Additional information"
in this leaflet.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains concise
information about this medicine. If you have any further questions,
consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it
seems to you that their medical condition is similar to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Orladeyo is intended to prevent attacks of Hereditary Angioedema (HAE)
in adults and children aged 12
and older
.
Restriction of use: Orladeyo is not intended for the treatment of an
acute attack of Hereditary
Angioedema.
THERAPEUTIC GROUP:
Orladeyo belongs to the group of haematological drugs used to treat
hereditary angioedema.
ATC code: B06AC06
Berotralstat, the active ingredient in Orladeyo, blocks the activity
of kallikrein enzymes in plasma,
resulting in low levels of bradykinin. This prevents the swelling and
pain that can be caused by attacks
of hereditary angioedema.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
YOU ARE SENSITIVE (ALLERGIC) TO THE ACTIVE INGREDIENT OR TO ANY OF THE
OTHER INGREDIENTS IN
THIS MEDICINE (SEE SECTION 6).
BEFORE TREATMENT WITH ORLADEYO, INFORM YOUR DOCTOR IF
:
•
You have liver problems or are undergoing kidney dialysis.
SPECIAL WARNINGS REGARDING THE USE OF

Summary of Product characteristics

1
FULL PRESCRIBING INFORMATION
NAME OF THE MEDICINAL PRODUCT
Orladeyo
®
110 mg
Orladeyo
®
150 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Orladeyo 110 mg
Each hard capsule contains 110 mg berotralstat (as dihydrochloride).
Orladeyo 150 mg
Each hard capsule contains 150 mg berotralstat (as dihydrochloride).
The inactive ingredients are listed in section 11.
PHARMACEUTICAL FORM
Hard gelatin capsule for oral use.
1
INDICATIONS AND USAGE
ORLADEYO
®
is indicated for prophylaxis to prevent attacks of hereditary
angioedema (HAE) in adults
and pediatric patients 12 years of age and older.
Limitations of Use:
The safety and effectiveness of ORLADEYO for the treatment of acute
HAE attacks have not been
established. ORLADEYO should not be used for treatment of acute HAE
attacks. Additional doses or
doses of ORLADEYO higher than 150 mg once daily are not recommended
due to the potential for
QT prolongation _[see Warnings and Precautions (5.1)]._
2
DOSAGE AND ADMINISTRATION
2.1 RECOMMENDED DOSAGE
The recommended dosage of ORLADEYO is one 150 mg capsule taken orally
once daily with food.
2.2 RECOMMENDED DOSAGE IN PATIENTS WITH HEPATIC IMPAIRMENT
No dosage adjustment of ORLADEYO is recommended for patients with mild
hepatic impairment
(Child-Pugh Class A) _[see Use in Specific Populations (8.7) and
Clinical Pharmacology (12.3)]_.
In patients with moderate or severe hepatic impairment (Child-Pugh B
or C), the recommended
dosage of ORLADEYO is one 110 mg capsule taken orally once daily with
food _[see Use in Specific _
_Populations (8.7) and Clinical Pharmacology (12.3)]_.
2.3 RECOMMENDED DOSAGE FOR CONCOMITANT USE WITH P-GP OR BCRP
INHIBITORS
In patients with chronic administration of P-gp or BCRP inhibitors
(e.g., cyclosporine), the
recommended dosage of ORLADEYO is one 110 mg capsule taken orally once
daily with food _[see _
_Drug Interactions (7.1) and Clinical Pharmacology (12.3)]_.
2
2.4 DOSAGE ADJUSTMENT IN PATIENTS WITH PERSISTENT GI REACTIONS
Gastrointestinal (GI) reactions may occur in patients receiving
ORLADEYO _[s