ONDEXXYA

Страна: Ізраїль

мова: англійська

Джерело: Ministry of Health

Активний інгредієнт:

ANDEXANET ALFA

Доступна з:

ALEXION PHARMA ISRAEL LTD

Код атс:

V03AB38

Фармацевтична форма:

POWDER FOR SOLUTION FOR INFUSION

Склад:

ANDEXANET ALFA 200 MG/VIAL

Адміністрація маршрут:

I.V

Тип рецепту:

Required

Виробник:

ALEXION PHARMA GMBH, SWITZERLAND

Терапевтична области:

ANDEXANET ALFA

Терапевтичні свідчення:

For adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

Дата Авторизація:

2022-12-26

Характеристики продукта

1
1.
NAME OF THE MEDICINAL PRODUCT
Ondexxya
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 200 mg of andexanet alfa*.
After reconstitution, each mL of solution contains 10 mg of andexanet
alfa.
* Andexanet alfa is produced by recombinant DNA technology in Chinese
Hamster Ovary
(CHO) cells.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion.
WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC
ARREST, AND SUDDEN DEATHS
TREATMENT WITH ONDEXXYA HAS BEEN ASSOCIATED WITH SERIOUS AND
LIFE-THREATENING
ADVERSE EVENTS, INCLUDING:

ARTERIAL AND VENOUS THROMBOEMBOLIC EVENTS

ISCHEMIC EVENTS, INCLUDING MYOCARDIAL INFARCTION AND ISCHEMIC STROKE

CARDIAC ARREST

SUDDEN DEATHS
MONITOR FOR THROMBOEMBOLIC EVENTS AND INITIATE ANTICOAGULATION WHEN
MEDICALLY
APPROPRIATE. MONITOR FOR SYMPTOMS AND SIGNS THAT PRECEDE CARDIAC
ARREST AND PROVIDE
TREATMENT AS NEEDED.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients treated with a direct factor Xa (FXa) inhibitor
(apixaban or rivaroxaban)
when
reversal of anticoagulation is needed due to life-threatening or
uncontrolled bleeding.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Restricted to hospital use only.
Posology
Andexanet alfa is administered as an intravenous bolus at a target
rate of approximately 30
mg/min over 15 minutes (low dose) or 30 minutes (high dose), followed
by administration
of a continuous infusion of 4 mg/min (low dose) or 8 mg/min (high
dose) for 120 minutes
(see table 1).
2
TABLE 1: DOSING REGIMENS
INITIAL
INTRAVENOUS
BOLUS
CONTINUOUS
INTRAVENOUS
INFUSION
TOTAL NUMBER
OF 200 MG
VIALS NEEDED
Low dose
400 mg at a target rate of
30 mg/min
4 mg/min for 120 minutes
(480 mg)
5
High dose
800 mg at a target rate of
30 mg/min
8 mg/min for 120 minutes
(960 mg)
9
Reversal of apixaban
The recommended dose regimen of Ondexxya is based on the dose of
apixaban the patient
is taking at the time of anticoagulation reversal, as well as on the
time since the patient’s
last dose of ap