Andexxa TM
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.
Active ingredients: andexanet alfa
Pack: Andexxa 200 mg powder for injection, 4 vials
Brand name
(ARTG)
: ANDEXXA andexanet alfa 200 mg powder for injection vialDownload the Consumer Medicine Information Leaflet
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
What this medicine is used for
(ARTG)
ANDEXXA (andexanet alfa) has provisional approval in Australia for adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.,The decision to approve this indication has been made on the basis of haemostatic efficacy and reduction in anti-FXa activity. Continued approval of this indication depends on verification and description of benefit in a confirmatory trial.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, powder for
- Intravenous
- White-to-off-white lyophilised powder. After reconstitution the dosage form is a clear, colourless to slightly yellow solution.
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Shelf lifetime is 4 Years.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is
- 4 pack
- 5 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient andexanet alfa
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
