Andexxa

Andexxa is a prescription medication used in patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

Andexxa belongs to a group of drugs called Factor Xa Inhibitor Antidotes. It acts as a decoy, binding to factor Xa inhibitors and neutralizing their anticoagulant effect.

This medication comes in an injectable form to be given directly into the vein by a healthcare provider. 

Common side effects of Andexxa include urinary tract infections, pneumonia, and infusion-related reactions.

Andexxa is a prescription medication used to reverse life-threatening or uncontrolled bleeding in patients on rivaroxaban and apixaban.

The safety and efficacy of Andexxa in the pediatric population have not been studied.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Andexxa. See the “Andexxa Precautions” section.

Common side effects of Andexxa include the following:

• Urinary tract infections
• Pneumonia
• Infusion-related reactions (flushing, feeling hot, cough, dysgeusia, dyspnea)

This is not a complete list of Andexxa side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Andexxa including the following:

• Blood clots. Symptoms can range from swelling, pain or tenderness in the leg to shortness of breath, pain with deep breathing, and coughing up blood.
• Lack of blood flow to the brain. This can lead to a stroke. Symptoms include:
  • Fatigue
  • Shortness of breath
  • Dizziness
  • Chest pain
• Heart problems, such as heart attack, can lead to sudden death.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Andexxa, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Andexxa, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Andexxa or any of the ingredients
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Andexxa should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Andexxa crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Andexxa.

Receive this medication as directed by your healthcare provider.

Andexxa comes in powder form which is then reconstituted to be injected into a vein by a healthcare professional.

The recommended Andexxa dosage is based on the factor Xa inhibitor taken, its dose, and the time since the last factor Xa inhibitor dose.

Two dosage regimens are recommended.

Patients taking ≤10 mg of rivaroxaban or ≤5 mg of apixaban per dose should receive the low-dose regimen, a 400-mg IV bolus dose of andexanet alfa, followed by a 4 mg/minute continuous infusion for up to 120 minutes.

Patients taking >10 mg of rivaroxaban or >5 mg of apixaban per dose should receive the high-dose regimen, an 800-mg IV bolus dose of andexanet alfa, followed by an 8 mg/minute continuous infusion for up to 120 minutes if their last dose was <8 hours before starting andexanet alfa; if the last dose was ≥8 hours before starting andexanet alfa, the low-dose regimen should be used. If the dose and/or timing since the last dose of the factor Xa inhibitor is unknown, the high-dose regimen should be used. The optimal dosage of andexanet alfa for patients taking other factor Xa inhibitors has not been established.

If Andexxa is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Unopened vials should be stored refrigerated at 2°C to 8°C (36°F to 46°F).

DO NOT FREEZE.

WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS

Treatment with Andexxa has been associated with serious and life-threatening adverse events, including:

• Arterial and venous thromboembolic events
• Ischemic events, including myocardial infarction and ischemic stroke
• Cardiac arrest
• Sudden deaths

Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed.