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ONDEXXYA (ANDEXANET ALFA)
Ondexxya (andexanet alfa) is a medication used for the treatment of patients
treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed
due to life-threatening or uncontrolled bleeding.
This is the first approved antidote for apixaban- or rivaroxaban-treated
patients with uncontrolled bleeds.
Ondexxya (andexanet alfa) was approved by the FDA in May 2018 under the trade
name Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo). It is
available to order as well. See Andexxa (coagulation factor Xa (recombinant),
inactivated-zhzo).
DISEASE INDICATIONS
Thromboembolism
MANUFACTURER
Alexion Pharmaceuticals
USAGE
Intravenous
MEDICINE APPROVED BY
* European Medical Agency (EMA)
* Food and Drug Administration (FDA)
PATIENTS HELPED
* Over 1.2 million patients reached
* More than 11,000 patients helped
* 100% successful deliveries to 88 countries
Category: Buy Haematology Medicines & Drugs Online Tags: Buy Ondexxya (andexanet
alfa) online, Ondexxya (andexanet alfa) for sale
* Description
* Reviews (0)
ONDEXXYA (ANDEXANET ALFA) FOR SALE – BUY ONDEXXYA (ANDEXANET ALFA) ONLINE
WHAT IS ONDEXXYA (ANDEXANET ALFA) FOR?
Ondexxya (andexanet alfa), is a Factor Xa inhibitor reversal agent indicated for
patients treated with rivaroxaban and apixaban, when rapid reversal of
anticoagulation is needed due to life-threatening or uncontrolled bleeding.[1]
It is available in lyophilized powder form in single-use vials of 200 mg or 100
mg of andexanet alfa.[1]
HOW DOES ONDEXXYA (ANDEXANET ALFA) WORK?
Factor Xa (FXa) inhibitors such as apixaban and rivaroxaban are widely used in
the clinic to prevent and to treat thromboembolism. Thromboembolism is
obstruction in vessels due to formation of blood clots. FXa is a protein that
helps blood clot, and its inhibitors are used to have an anticoagulant
(blood-thinning) effect. However, a complication of treatment with these
anticoagulants is major bleeding.[2]
Ondexxya (andexanet alfa) is a recombinant protein that has been designed to
bind to FXa inhibitors. It works by binding and sequestering FXa inhibitors,
making them unable to promote anticoagulation. Hereby it is able to rapidly
reverse their blood-thinning effect, and to stop bleeding.[2]
WHERE HAS ONDEXXYA (ANDEXANET ALFA) BEEN APPROVED?
Ondexxya (andexanet alfa) was approved for the reversal of the anticoagulating
effects of rivaroxaban and apixaban in patients with life-threatening or
uncontrolled bleeding by:
* The European Medicines Agency (EMA), Europe, on April 26, 2019.[3]
* The Food and Drug Administration (FDA), USA, with accelerated approval under
the brand name Andexxa (coagulation factor Xa (recombinant),
inactivated-zhzo) on May 3, 2018.[4]
This is the first and only approved antidote for apixaban- or
rivaroxaban-treated patients with uncontrolled bleeding.[3]
The EMA granted approval under conditional marketing authorisation, to support
the development of and early access to medicines that address unmet medical
needs of patients in the European Union.[3]
The FDA granted Andexxa with Orphan Drug and Breakthrough Therapy designations,
to support the development of medicines which treat a serious or
life-threatening condition and fill an unmet medical need.[4]
Please note that this medicine may have also been approved in other regions than
the ones we’ve listed. If you have a question about its approval in a specific
country feel free to contact our support team.
HOW IS ONDEXXYA (ANDEXANET ALFA) TAKEN?
The standard dosage is:[1]
* * Low dose:
* 400 mg, administered as an intravenous bolus at a target rate of 30
mg/min.
* Followed by administration of a continuous infusion of 4 mg/min for up to
120 minutes (480 mg).
* High dose:
* 800 mg, administered as an intravenous bolus at a target rate of 30
mg/min.
* Followed by administration of a continuous infusion of 8 mg/min for 120
minutes (960 mg).
The recommended dosing of Ondexxya is based on the specific FXa inhibitor
(apaxiban or rivaroxaban), dose and time since the patient last took the FXa
inhibitor.[1]
Patients being treated with (oral) anticoagulation drugs have underlying disease
states which puts them at increased risk of developing thromboembolism. Treating
patients with a reversal agent such as Ondexxya increases their thrombotic risk.
To reduce this risk, resumption of anticoagulant therapy should be considered as
soon as medically appropriate.[1]
Complete information about Ondexxya (andexanet alfa) dosage and administration
can be found in the official prescribing information listed in our references
section.[1]
Note: Please consult with your treating doctor for personalised dosing.
ARE THERE ANY KNOWN ADVERSE REACTIONS OR SIDE EFFECTS OF ONDEXXYA?
COMMON ADVERSE REACTIONS
The most common adverse reactions (≥5% of patients) listed in the prescribing
information include:[1]
* * * Urinary tract infections
* Pneumonia
SERIOUS ADVERSE REACTIONS
The serious adverse reactions listed in the prescribing information include:[1]
* * * Arterial and venous thromboembolic events
* Ischemic events, including myocardial infarction and ischemic stroke
* Cardiac arrest
* Sudden deaths
USE IN A SPECIFIC POPULATION
It is not yet known if Ondexxya affects an unborn baby. The manufacturer makes
no recommendation regarding use during pregnancy.[1]
For a comprehensive list of side effects and adverse reactions please refer to
the official prescribing information.[1]
REFERENCES
1. Full prescribing information [EMA]: Ondexxya (andexanet alfa) [PDF]
Alexion Pharmaceuticals, May 3, 2018
2. Andexanet Alfa for the Reversal of Factor Xa Inhibitor Activity
Siegal DM, New England Journal of Medicine, Dec 17, 2015
3. European Commission Grants Conditional Marketing Authorization for Portola
Pharmaceuticals’ Ondexxya™ (coagulation factor Xa (recombinant),
inactivated-zhzo), the First and Only Antidote for the Reversal of Factor Xa
Inhibitors
Portola Pharmaceuticals press release, April 26, 2019
4. U.S. FDA Approves Portola Pharmaceuticals’ Andexxa®, First and Only Antidote
for the Reversal of Factor Xa Inhibitors
Portola Pharmaceuticals press release, May 3, 2018
This content has been reviewed by a Medical Doctor.
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