200 mg powder for solution for infusion andexane
alfa
What Ondexxya is and what it is used for
Ondexxya contains the active substance andexane alfa. It eliminates the effects of certain blood-thinning ( anticoagulant ) medicines called factor Xa inhibitors (apixaban or rivaroxaban). Factor Xa inhibitors are given to prevent blood clots in the blood vessels. Your doctor may decide to give you Ondexxya to quickly eliminate the effects of the blood-thinning medicine in a life-threatening or uncontrolled bleeding situation.
What you need to know before you get Ondexxya
Do not use Ondexxya
- if you are allergic to andexane 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 cautions
Undoing 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 start treatment with blood thinners again.
An independent procoagulant effect of andexane alfa may pose an additional risk of developing blood clots.
If you get any side effects while taking Ondexxya as an infusion (drip), your doctor may decide to slow down or pause the treatment. Your doctor may prescribe you medicine with antihistamines to help with side effects (see section 4).
If surgery requiring heparin as a blood thinner is planned, Ondexxya should be avoided.
Children and young people
There is no information on the use of Ondexxya in children and adolescents.
Other medicines and Ondexxya
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
This medicine is only intended to abolish the effects of factor Xa inhibitors. It is unlikely that Ondexxya will affect the effectiveness of other medicines or that other medicines will affect Ondexxya.
Treatment with Ondexxya should be avoided if treatment with heparin as a blood thinner may become necessary. Ondexxya leads to treatment with heparin not working.
Pregnancy and breastfeeding
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 may become pregnant and do not use contraception.
You should not breast-feed your baby while taking this medicine. It is unknown whether andexane alfa passes into breast milk.
Driving and using machines
This medicine is unlikely to affect your ability to drive or use machines.
How to use Ondexxya
This medicine is for hospital use only.
Your doctor or nurse will give you this medicine as an injection or infusion into a vein.
Your doctor and nurse will calculate the dose you need for this medicine. Dose one is based on the blood-thinning medicine you are taking and its dose and the time that has elapsed since your last dose of the blood-thinning medicine.
After receiving Ondexxya, your doctor will decide when you can start treatment with blood thinners again.
Detailed instructions for the doctor or nurse on how to take Ondexxya can be found at the end of this information (see “Handling instructions”).
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common adverse reactions observed with Ondexxya in clinical trials in healthy subjects were infusion-related reactions, usually with mild symptoms such as redness, feeling hot (a very common side effect that may affect more than 1 user in 10). Headache, cough, or shortness of breath (common side effects that may affect up to 1 in 10 people), occurred within minutes to a few hours after infusion. In clinical trials in patients with life-threatening bleeding, fever and stroke have been observed in up to 1 in 10 users; transient ischemic attack ( TIA)- one type of stroke ), heart attack, and blood clots in the bones or lungs can occur in up to 1 in 100 users (less common side effects ).
List of possible side effects
Very common (may affect more than 1 user in 10)
- redness or feeling of heat
- effects on markers of blood coagulation (clotting of the blood): some markers affecting blood coagulation were elevated for a short period and then returned to normal. No blood clots were seen in these healthy individuals
Common (may affect up to 1 in 10 people)
- hives
- dizziness
- fast or irregular heartbeat
- pain or discomfort in the stomach
- dry mouth
- taste disorders
- nausea
- chest discomfort
- feel frozen
- heavy sweating
- itching
- back pain
- muscle twitching
How to store Ondexxya
This medicine is stored in the hospital and these instructions are for hospital staff only.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial and carton after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
Do not freeze.
After reconstitution, Ondexxya should be used immediately.
Contents of the package and other information
Content declaration
- The active substance is andexane alfa.
- The other ingredients are trometamol, trometamol hydrochloride, L ‑ arginine hydrochloride, sucrose, mannitol and polysorbate 80.
What the medicine looks like and contents of the pack
Ondexxya is supplied in glass vials as a white to off-white powder for solution for infusion and is prepared (dissolved) before use. The reconstituted solution is a clear, colorless, or slightly yellowish solution.
Each pack contains four vials.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Alexion Europe SAS
103-105 rue Anatole France
92300 Levallois-Perret
France
Manufacturer:
Alexion Pharma International Operations Unlimited Company
Alexion Dublin Manufacturing Facility
College Business and Technology Park
Blanchardstown Rd North
Dublin D15 R925
Ireland
This medicine has been given a “conditional authorization”. This means that there will be more information about the medicine. The European Medicines Agency reviews new information on this medicine at least every year and updates this summary of product characteristics as needed.