ONDEXXYA

Generic Name/API: andexanet alfa

Manufacturer: SK Life Science

Dosage Forms & Strength & Pack Size:
• Tablets: 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg. 14’s, 28’s, 30’s.

Storage:
Store XCOPRI tablets at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C
(59°F to 86°F).

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATION
What is Ondexxya and what is it used for?
Ondexxya is a medicine used for stopping life-threatening or uncontrolled bleeding in adults taking the
anticoagulant medicines apixaban or rivaroxaban.
Ondexxya contains the active substance andexanet alfa.

IMPORTANT SAFETY INFORMATION
Do not use ONDEXXYA if:
• You are allergic to andexanet alfa or to any ingredients in ONDEXXYA. If you are not sure, talk to
your healthcare professional before you are given ONDEXXYA.
• You are receiving heparin.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you
take ONDEXXYA. Talk about any health conditions or problems you may have, including if you:
• Are planning to have surgery which requires blood thinning with heparin.
• Are pregnant, think you may be pregnant or are planning to have a baby.
• Are breast-feeding. It is not known if ONDEXXYA is excreted in human milk.
Other warnings you should know about:
• ONDEXXYA has not been shown to be effective for, and is not indicated for, the treatment of bleeding
related to any FXa inhibitors other than apixaban and rivaroxaban.
• 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 you should start taking blood thinners
again.
• If you experience side effects during the infusion of ONDEXXYA, your doctor may decide to slow
down or pause the treatment. Your doctor may give other medicines to help with the side effects.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins,
minerals, natural supplements or alternative medicines.
The following may interact with ONDEXXYA:
• ONDEXXYA treatment should be avoided if anticoagulation with heparin might become necessary.
ONDEXXYA causes unresponsiveness to heparin.

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