ONDEXXYA for Intravenous Injection 200mg (オンデキサ静注用200mg)

Country: Japan

Language: English

Source: すりの適正使用協議会 RAD-AR Council, Japan

Active ingredient:

Andexanet alfa (genetical recombination)

Available from:

AstraZeneca K.K

INN (International Name):

Andexanet alfa (genetical recombination)

Pharmaceutical form:

injection

Patient Information leaflet

Drug Information Sheet("Kusuri-no-Shiori")
Injection
Published: 06/2022
The information on this sheet is based on approvals granted by the
Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse reactions (risks)
as well as efficacies (benefits). It is
important to minimize adverse reactions and maximize efficacy. To
obtain a better therapeutic response,
patients should understand their medication and cooperate with the
treatment.
BRAND NAME:
ONDEXXYA FOR INTRAVENOUS INJECTION 200MG
ACTIVE INGREDIENT:
Andexanet alfa (genetical recombination)
DOSAGE FORM:
injection
IMPRINT OR PRINT ON WRAPPING:
EFFECTS OF THIS MEDICINE
This medicine neutralizes the action of direct factor Xa inhibitors
(apixaban, rivaroxaban,
edoxaban tosylate hydrate).
It is usually used when life-threatening or uncontrolled bleeding
occurs in patients taking
direct factor Xa inhibitors.
THE FOLLOWING PATIENTS MAY NEED TO BE CAREFUL WHEN USING THIS
MEDICINE.BE SURE TO TELL YOUR DOCTOR
AND PHARMACIST.
・If you have previously experienced any allergic reactions (itch,
rash, etc.) to any medicines
or foods.
・If you are pregnant or breastfeeding.
・If you are taking any other medicinal products. (Some medicines may
interact to enhance or
diminish medicinal effects. Beware of over-the-counter medicines and
dietary supplements
as well as other prescription medicines.)
DOSING SCHEDULE (HOW TO TAKE THIS MEDICINE)
・
Your dosing schedule prescribed by your doctor is((         

to be written by a healthcare
professional
))
・In general, for adults, administer a fixed dose by rapid
intravenous injection, and then
administer a fixed dose over 2 hours by slow intravenous injection.
PRECAUTIONS WHILE TAKING THIS MEDICINE
POSSIBLE ADVERSE REACTIONS TO THIS MEDICINE
The most commonly reported adverse reactions include fever. If any of
these symptoms occur,
consult with your doctor or pharmacist.
THE SYMPTOMS DESCRIBED BELOW ARE RARELY SEEN AS INITIAL SYMPTOMS OF
THE ADVERSE REACTIONS IND