ONDEXXYA 200 MG POWDER FOR SOLUTION FOR INFUSION
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Introduction
Package Leaflet: Information for the Patient and User
Ondexxya 200mg powder for solution for infusion
andexanet alfa
This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.
Read all of this leaflet carefully, because it contains important information for you. Note that this medicine is mainly used in emergency situations where your doctor has decided that you need it.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.
Contents of the pack
- What Ondexxya is and what it is used for
- What you need to know before you are given Ondexxya
- How Ondexxya is given
- Possible side effects
- Storage of Ondexxya
- Contents of the pack and other information
1. What Ondexxya is and what it is used for
Ondexxya contains the active substance andexanet alfa. It reverses the effects of certain anticoagulants called factor Xa inhibitors (apixaban or rivaroxaban). Factor Xa inhibitors are given to prevent blood clots in blood vessels. Your doctor may decide to give you Ondexxya to quickly reverse the effects of the anticoagulant in case of a potentially life-threatening or uncontrolled bleeding.
2. What you need to know before you are given 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
Reversal of the factor Xa inhibitor effect with Ondexxya may increase the risk of blood clots. After treatment with Ondexxya, your doctor will decide when to restart anticoagulant treatment.
The potential procoagulant effect of andexanet alfa may carry an additional risk of developing thrombosis.
If you experience a side effect during administration of Ondexxya by intravenous infusion, your doctor may decide to reduce the infusion rate or stop treatment. Your doctor may give you an antihistamine to alleviate side effects (see section 4).
Ondexxya should be avoided if you are scheduled for surgery that requires anticoagulation with heparin.
Children and adolescents
No data are available 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 has only been developed to reverse the effects of factor Xa inhibitor medicines. It is unlikely that Ondexxya will interfere with the effect of other medicines, or that other medicines will interfere with Ondexxya.
Treatment with Ondexxya should be avoided if anticoagulation with heparin is required. Ondexxya causes lack of response to heparin.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor.
Ondexxya is not recommended during pregnancy or in women of childbearing potential who are not using contraception.
Do not breast-feed your child while taking this medicine. It is not known whether andexanet alfa passes into breast milk.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive or use machines.
3. How Ondexxya is given
This medicine is for hospital use only.
Your doctor or nurse will give you this medicine by injection or infusion into a vein.
Your doctor or nurse will decide the dose of medicine you need. This is based on the anticoagulant medicine you are taking, as well as the dose and time since you last took the anticoagulant.
After administration of Ondexxya, your doctor will decide when to restart anticoagulant treatment.
At the end of this leaflet are detailed instructions for your doctor or nurse on how to administer Ondexxya (see "Instructions for use").
If you have any further questions on the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
List of side effects observed in people with bleeding
Common(may affect up to 1 in 10 people)
- Stroke
- Myocardial infarction
- Blood clots in legs, arms, lungs 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, difficulty breathing, confusion or agitation.
Reporting of side effects
If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Ondexxya
This medicine is stored in the hospital, and these instructions are intended only for hospital personnel.
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 CAD/EXP.
The expiry date is the last day of the month shown.
Store in a refrigerator (between 2°C and 8°C).
Do not freeze.
Once reconstituted, Ondexxya is for immediate use.
6. Container Contents and Additional Information
Ondexxya Composition
- The active ingredient is andexanet alfa.
- The other components are tris base, tris hydrochloride, L-arginine hydrochloride, sucrose, mannitol, and polysorbate 80.
Product Appearance and Container Contents
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 clear, colorless, or slightly yellow.
Each container contains four or five vials.
Only some pack sizes may be marketed.
Marketing Authorization Holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden
Manufacturer
Alexion Pharma International Operations Limited
Alexion Dublin Manufacturing Facility
College Business and Technology Park
Blanchardstown Rd North
Dublin D15 R925
Ireland
You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:
België/Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 11 | Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660550 |
| Luxembourg/Luxemburg AstraZeneca S.A./N.V. Tél/Tel: +32 2 370 48 11 |
Ceská republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 111 | Magyarország AstraZeneca Kft. Tel.: +36 1 883 6500 |
Danmark AstraZeneca A/S Tlf: +45 43 66 64 62 | Malta Associated Drug Co. Ltd Tel: +356 2277 8000 |
Deutschland AstraZeneca GmbH Tel: +49 40 809034100 | Nederland AstraZeneca BV Tel: +31 85 808 9900 |
Eesti AstraZeneca Tel: +372 6549 600 | Norge AstraZeneca AS Tlf: +47 21 00 64 00 |
Ελλάδα AstraZeneca A.E. Τηλ: +30 210 6871500 | Österreich AstraZeneca Österreich GmbH Tel: +43 1 711 31 0 |
España AstraZeneca Farmacéutica Spain, S.A. Tel: +34 91 301 91 00 | Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 00 |
France AstraZeneca Tél: +33 1 41 29 40 00 | Portugal AstraZeneca Produtos Farmacêuticos, Lda. Tel: +351 21 434 61 00 |
Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 000 | România AstraZeneca Pharma SRL Tel: +40 21 317 60 41 |
Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100 | Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 600 |
Ísland Vistor hf. Sími: +354 535 7000 | Slovenská republika AstraZeneca AB, o.z. Tel: +421 2 5737 7777 |
Italia AstraZeneca S.p.A. Tel: +39 02 00704500 | Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23 010 |
Κύπρος Αλκήτωρ Φαρμακευτική Λτδ Τηλ: +357 22490305 | Sverige AstraZeneca AB Tel: +46 8 553 26 000 |
Latvija SIA AstraZeneca Latvija Tel: +371 67377100 | United Kingdom (Northern Ireland) AstraZeneca UK Ltd Tel: +44 1582 836 836 |
Date of Last Revision of this Leaflet:
This medicinal product has been authorized with a "conditional approval". This type of approval means that more information on this medicinal product is expected.
The European Medicines Agency will review the new information on this medicinal product at least once a year and this leaflet will be updated as necessary.
Other Sources of Information
Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.
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This information is intended only for healthcare professionals:
Andexanet has not been shown to be effective for, and is not indicated for, the treatment of bleeding associated with any factor Xa inhibitor other than rivaroxaban or apixaban. It also does not reverse the effects of non-factor Xa inhibitors.
Posology and Method of Administration:
Andexanet alfa is administered as an intravenous (IV) bolus at a target rate of approximately 30 mg/min for 15 (low dose) or 30 minutes (high dose), followed immediately by a continuous IV infusion of 4 mg (low dose) or 8 mg (high dose) per minute for 120 minutes (see Table 1).
Table 1: Administration Schedule
Initial IV Bolus | Continuous IV Infusion | Total Number of 200 mg Vials Required | |
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 |
The dose recommendations are based on the effects of andexanet alfa in healthy volunteers who received a direct factor Xa inhibitor, and on the ability to reverse anti-factor Xa activity levels. The dose was used in a study with patients with acute major bleeding.
Reversal of Apixaban
The recommended administration schedule for andexanet alfa depends on the dose of apixaban the patient is taking at the time of anticoagulant reversal, as well as the time since the last dose of apixaban (see Table 2). If the concentration of the last dose of anticoagulant or the interval between the last dose and the bleeding episode is unknown, no dose recommendation is available. The measurement of the baseline anti-factor Xa level should support the clinical decision to initiate treatment (if such a level is available within an acceptable timeframe).
Table 2: Summary of Dosing for Reversal of Apixaban
Factor Xa Inhibitor | Last Dose of Factor Xa Inhibitor | Time Since Last Dose of Factor Xa Inhibitor Before Start of Andexanet Alfa Treatment | |
<8hours | ≥8hours | ||
Apixaban | ≤ 5 mg | Low Dose | Low Dose |
> 5 mg | High Dose |
Reversal of Rivaroxaban
The recommended administration schedule for andexanet alfa depends on the dose of rivaroxaban the patient is taking at the time of anticoagulant reversal, as well as the time since the last dose of rivaroxaban (see Table 3). If the concentration of the last dose of anticoagulant or the interval between the last dose and the bleeding episode is unknown, no dose recommendation is available. The measurement of the baseline anti-factor Xa level should support the clinical decision to initiate treatment (if such a level is available within an acceptable timeframe).
Table 3: Summary of Dosing for Reversal of Rivaroxaban
Factor Xa Inhibitor | Last Dose of Factor Xa Inhibitor | Time Since Last Dose of Factor Xa Inhibitor Before Start of Andexanet Alfa Treatment | |
<8hours | ≥8hours | ||
Rivaroxaban | ≤ 10 mg | Low Dose | Low Dose |
> 10 mg | High Dose |
Patients treated with a factor Xa inhibitor have an underlying condition that predisposes them to thromboembolic events. Treatment for reversal of a factor Xa inhibitor exposes patients to the thrombotic risk of their underlying condition. To reduce this risk, consideration should be given to resuming anticoagulant treatment as soon as medically appropriate.
Instructions for Use:
After reconstituting andexanet alfa, the 10 mg/ml solution is transferred without further dilution to large-volume sterile syringes if a syringe pump is used for administration or to empty intravenous infusion bags made of polyolefin (PO) or polyvinyl chloride (PVC) suitable for the administration. Before IV administration, an in-line filter with low protein binding of polyethersulfone (PES) or equivalent of 0.2 or 0.22 microns should be used.
The chemical and physical in-use stability of the reconstituted solutions has been demonstrated for at least eight hours at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, it is the responsibility of the user to ensure the storage times and conditions before use.
Reconstitution
Before starting reconstitution, you need to have:
- The number of vials calculated as indicated in Table 1.
- The same number of syringes with 20 ml (or more) of solvent and a 20-gauge (or larger) needle.
- Alcohol swabs.
- A large sterile syringe (50 ml or more). If administration is done with a syringe pump, multiple syringes should be used to contain the final volume of the reconstituted product.
- Intravenous infusion bags made of polyolefin (PO) or polyvinyl chloride (PVC) (150 ml or more) to contain the volume of the reconstituted medicinal product (if administration is done with intravenous infusion bags).
- Water for injections
- An in-line filter with low protein binding of polyethersulfone (PES) or equivalent of 0.2 or 0.22 microns.
It is not necessary for andexanet alfa to reach room temperature before reconstitution or administration to the patient. Use an aseptic technique during reconstitution.
Reconstitute each vial by following the instructions below:
- Remove the caps from all the vials.
- Wipe the rubber stoppers of the vials with an alcohol swab.
- Draw 20 ml of water for injections with a 20 ml (or larger) syringe and a 20-gauge (or larger) needle.
- Pierce the center of the rubber stopper with the needle of the syringe.
- Press the plunger down to slowly inject the 20 ml of water for injections into the vial. Direct the stream to the inner wall of the vial to minimize foam generation.
- Gently swirl each vial with circular movements until all the powder is dissolved. DO NOT SHAKE the vials as this may generate foam. The dissolution time for each vial is approximately 3 to 5 minutes.
- Before administration, check if the solution contains particles or has changed color. Do not use it if it contains opaque particles or has changed color.
- To achieve effective reconstitution of the required dose and minimize errors, inject 20 ml of water for injections into each vial that will be needed before proceeding to the next step.
- Use andexanet alfa within eight hours after reconstitution if stored at room temperature.
Administration with a Syringe Pump
- After reconstituting all the required vials, withdraw the reconstituted solution from each vial with a large-volume syringe (50 ml or more) with a 20-gauge (or larger) needle.
- Prepare the bolus and infusion in two separate large-volume syringes.
- Due to the additional volume, both the high-dose bolus and infusion should be divided into additional syringes (two syringes for each).
- To avoid unintentional air transfer, hold the needle with the syringe upright and do not lower the syringe between withdrawals from the vials.
- Assemble the necessary ancillary equipment (e.g., extension tubes, in-line filter with low protein binding of polyethersulfone (PES) or equivalent of 0.2 or 0.22 microns, continuous infusion pump) for administration.
- Administer the reconstituted solution at the appropriate rate.
- Discard used syringes, needles, and vials, as well as any unused reconstituted solution.
Administration using Intravenous Infusion Bags
- After reconstituting all the required vials, withdraw the reconstituted solution from each vial with a large-volume syringe (50 ml or more) with a 20-gauge (or larger) needle.
- Transfer the reconstituted solution from the syringe to the appropriate intravenous infusion bags made of polyolefin (PO) or polyvinyl chloride (PVC).
- Repeat steps 1 and 2 as needed to transfer all the volume of the bolus and infusion to intravenous infusion bags made of PO or PVC.
- It is recommended to divide the bolus and infusion into two separate bags to ensure the correct administration rate. However, it is also permissible to use one intravenous infusion bag made of PO or PVC for the bolus and infusion.
- Assemble the necessary ancillary equipment (e.g., extension tubes, in-line filter with low protein binding of polyethersulfone (PES) or equivalent of 0.2 or 0.22 microns, IV pump) for administration.
- Administer the reconstituted solution at the appropriate rate.
Disposal
All used syringes, needles, and vials, as well as any unused reconstituted solution, should be disposed of in accordance with local regulations.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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