Ondexxya

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

andexanet alfa

Available from:

AstraZeneca AB

ATC code:

V03AB

INN (International Name):

andexanet alfa

Therapeutic group:

All other therapeutic products

Therapeutic area:

Drug-Related Side Effects and Adverse Reactions

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.

Product summary:

Revision: 16

Authorization status:

Authorised

Authorization date:

2019-04-26

Patient Information leaflet

24
B.
PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AND
USER
ONDEXXYA 200 MG POWDER FOR SOLUTION FOR INFUSION
andexanet alfa
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, BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU. PLEASE NOTE
THIS MEDICINE IS MAINLY USED IN EMERGENCY SITUATIONS, AND THE DOCTOR
WILL HAVE DECIDED THAT YOU
NEEDED IT.

Keep this leaflet.
You may need to read it again.

If you have any further questions, ask your doctor or nurse.

If you get any side effects, talk to your doctor or nurse.
This includes any possible side
effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ondexxya is and what it is used for
2.
What you need to know before you receive Ondexxya
3.
How Ondexxya is used
4.
Possible side effects
5.
How Ondexxya is stored
6.
Contents of the pack and other information
1.
WHAT ONDEXXYA IS AND WHAT IT IS USED FOR
Ondexxya contains the active ingredient andexanet alfa. It reverses
the effects of certain
anticoagulants called factor Xa inhibitors (apixaban or rivaroxaban).
Factor Xa inhibitors are given
to prevent clots in your blood vessels.
Your doctor may decide to give you Ondexxya to rapidly
reverse
the effects of the anticoagulant in case of a life-threatening or
uncontrolled bleeding
situation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE ONDEXXYA DO NOT USE ONDEXXYA:

if you are allergic to andexanet alfa or any of the other ingredients
of this medicine (listed
in section 6).

if you are allergic to hamster proteins

if you are receiving heparin
WARNINGS AND PRECAUTIONS
Reversing the effect of a factor Xa inhibitor with Ondexxya may
increase the risk of blood clots.
After treatment with Ondexxya, your doctor will decide when to restart
anticoagulant therapy.
An independent pro-coagulant effect of andex

Summary of Product characteristics

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
Ondexxya 200 mg powder for solution for infusion
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
White to off-white lyophilized powder
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). Posology of
andexanet alfa is based upon PK/PD-modelling and simulation exercises
(see sections 5.1 and 5.2).
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
3
at
the time of anticoagulation reversal, as well as on the time since the
patient’s last dose of
apixaban (see table 2). If the strength