Ondexxya 200 mg powder for solution for infusion

• 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.

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

• 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

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 andexanet alfa may pose an additional risk of developing thrombosis.

If you suffer side effects when you are being given Ondexxya by infusion (drip), your doctor may decide to slow down or pause your treatment. Your doctor may give you an antihistamine medicine to help with any side effects (see section 4).

If a surgery is planned for you which requires anticoagulation with heparin, Ondexxya should be avoided.

There is no information on the use of Ondexxya in children and adolescents.

Tell your doctor if you are taking, have recently taken, or might take, any other medicines.

This medicine has been designed to reverse the effects of factor Xa inhibitor medicines only. It is unlikely that Ondexxya will influence the effect of other medicines or that other medicines will influence Ondexxya.

Ondexxya-treatment should be avoided if anticoagulation with heparin might become necessary. Ondexxya causes unresponsiveness to heparin.

Tell your doctor if you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby.

Ondexxya is not recommended during pregnancy or if you have the potential to become pregnant and are not using birth control.

Do not breast-feed your child while you are taking this medicine. It is unknown if andexanet alfa is excreted in human milk.

This medicine is unlikely to affect your ability to drive and use machines.

Common (may affect up to 1 in 10 people)

• Stroke
• Heart-attack
• Blood clot in the leg, arm, lung or brain
• Fever

Uncommon (may affect up to 1 in 100 people)

• Mini stroke
• Cardiac arrest
• Signs/symptoms of infusion related reactions such as chills, high blood pressure, shortness of breath, confusion or agitation.

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system below: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is andexanet alfa.
• The other ingredients are Tris base, Tris hydrochloride, L-arginine hydrochloride, sucrose, mannitol, and polysorbate 80.

Ondexxya is supplied in glass vials as a white to off-white powder for solution for infusion, which is reconstituted (dissolved) before use. The reconstituted solution is a clear, colourless, or slightly yellow solution.

Each pack contains four or five vials.

Not all pack sizes may be marketed.