What does Andexxa treat?
Andexxa is used to treat uncontrolled bleeding in people who take the anticoagulants rivaroxaban (Xarelto) and apixaban (Eliquis). Andexxa was approved by the US Food and Drug Administration (FDA) on an “accelerated” basis.
How fast does Andexxa work?
IN JUST 2 MINUTES. ANDEXXA® is the first and only FDA-approved specific reversal agent for ELIQUIS® (apixaban) or XARELTO® (rivaroxaban) related life-threatening or uncontrolled bleeding.
What is Andexanet Alfa used for?
Andexanet alfa is indicated for anticoagulation reversal in life-threatening or uncontrolled bleeding in patients treated with rivaroxaban or apixaban. The drug received accelerated approval based on studies showing the significant change in anti-factor Xa activity in healthy volunteers.
What does Andexxa reversal?
Based on an interim analysis of an ongoing single-arm trial, andexanet alfa (Andexxa) can rapidly reverse the anticoagulant effect of apixaban (Eliquis), rivaroxaban (Xarelto), and (off-label) enoxaparin (Lovenox, and generics) in patients with active major bleeding.
What are the side effects of Andexxa?
What are the side effects of Andexxa (Coagulation Factor Xa)?
- pain or burning when you urinate;
- cough with mucus, chest pain, and shortness of breath;
- fever, chills; or.
- continued bleeding after treatment.
How much does Andexxa cost?
The cost for Andexxa intravenous powder for injection (recombinant, inactivated 200 mg) is around $22,978 for a supply of 4 powder for injection, depending on the pharmacy you visit….Intravenous Powder For Injection.
| Quantity | Per unit | Price |
|---|---|---|
| 4 | $5,744.38 | $22,977.50 |
Why is ANDEXXA not used?
They also had safety concerns given the in vitro effects and clinical thrombosis rates of up to 18% in early studies. FDA clinical reviewer and supervisors recommended against approval of Andexxa because they believe the “safety and efficacy data for ANDEXXA are not adequate to support approval” [3].
How much does ANDEXXA cost?
Is Andexanet Alfa FDA approved?
On 3 May 2018, andexanet alfa received US FDA accelerated approval for patients treated with rivaroxaban or apixaban who require reversal of the anticoagulant effects in life-threatening or uncontrolled bleeding [6].
How much does Andexanet cost?
The median projected cost of andexanet was $22,120/patient, compared to $5670/patient for 4F-PCC (P < 0.001). The median hospital reimbursement was $11,492/hospitalization.
How long does Andexxa last?
The reconstituted solution contains coagulation factor Xa (recombinant), inactivated-zhzo at a concentration of 10 mg/mL. Reconstituted ANDEXXA in vials is stable at room temperature for up to eight hours, or may be stored for up to 24 hours at 2°C to 8°C.
Can FFP reverse Eliquis?
FFP will not reverse apixaban effect but can be used as volume replacement in case of major bleeding. Planning for elective surgery or invasive procedures should involve balancing the intervention-associated bleeding risk and thrombotic risk associated with anticoagulant interruption in each individual.