ANDEXXA

Generic Name/API: coagulation factor Xa (recombinant), inactivated-zhzo

Manufacturer: AstraZeneca AB

Packaging: 4 x Lyophilized powder for solution for intravenous injection

Strength: 200mg single-dose vials.

Storage: Unopened vials should be stored refrigerated at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATIONS
WHAT IS ANDEXXA?
ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is a prescription medicine used to treat adults who have developed life-threatening or serious bleeding while being treated with one of two specific blood thinner medications, apixaban (ELIQUIS) or rivaroxaban (XARELTO). ANDEXXA works as an antidote to these blood thinner medications, reversing their effects. ANDEXXA is given through an IV and can only be administered by a doctor or healthcare professional.

IMPORTANT SAFTEY INFORMATION
What is the most important information I should know about ANDEXXA?

ANDEXXA can cause serious side effects, including:

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

Development of Blood Clots: Treatment with ANDEXXA may increase your risk for forming blood clots, which could travel to other parts of the body, potentially leading to serious events such as a heart attack, stroke, or death.
In clinical studies, these risks were observed within 30 days after treatment with ANDEXXA.
Patients prescribed apixaban (ELIQUIS) or rivaroxaban (XARELTO) typically have medical conditions that put them at risk for developing blood clots. Giving an antidote to reverse the blood thinning effects of these medications puts patients back at risk for developing blood clots from their underlying medical condition. Restarting your blood thinner medication as soon as your healthcare provider feels it is appropriate may reduce this risk.
What are the most common side effects of ANDEXXA?

The most common side effects of ANDEXXA include urinary tract infections, pneumonia, and reactions related to the ANDEXXA infusion.
What are other possible side effects of ANDEXXA?

Other Infections: ANDEXXA may cause infections such as urinary tract infections or pneumonia.
Immune Response Risk: ANDEXXA could cause an immune response in the body. An immune response includes your body developing antibodies which have the potential to react with normal proteins in your blood or to ANDEXXA itself.
Infusion Reactions: Patients treated with ANDEXXA may have a reaction to the infusion. An infusion reaction may make you feel flush or hot, cause you to cough, make you feel short of breath, or cause changes in taste.
Talk to your doctor if you have a side effect that bothers you or does not go away. For more information, and to learn more about ANDEXXA, talk to your doctor or healthcare provider.

Tell your doctor if you are pregnant or breastfeeding. ANDEXXA has not been studied in women who are pregnant or breastfeeding.

You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, call 1-800-236-9933 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see accompanying full Prescribing Information for ANDEXXA, including Boxed Warning.

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