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Full Answer
What is Andexxa?
ANDEXXA is the only FDA-approved treatment for people who experience a major bleed while taking ELIQUIS® (apixaban) or XARELTO® (rivaroxaban). It reverses the effects of these blood thinners. ANDEXXA was studied in 3 clinical trials to see how it reversed blood thinning caused by ELIQUIS or XARELTO. thinning by 92% or more.*
Does Andexxa stop bleeding?
ANDEXXA has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban or rivaroxaban. The thromboembolic and ischemic risks were assessed in 352 bleeding subjects who received ANDEXXA.
Does Medicare or Medicaid cover Andexxa?
Medicare coverage is available for ANDEXXA. Centers for Medicare & Medicaid Services (CMS) increased New Technology Add-on Payments (NTAPs) in fiscal year 2020 to promote patient access and reimbursement confidence for “new” and “transformative technologies.”
Is the Andexxa price guide valid with insurance?
Prices are for cash paying customers only and are not valid with insurance plans. This Andexxa price guide is based on using the Drugs.com discount card which is accepted at most U.S. pharmacies.
What is Andexxa used for?
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Does medicare pay for ANDEXXA?
Medicare coverage is available for ANDEXXA.
When to use ANDEXXA?
ANDEXXA is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
How long does it take ANDEXXA to work?
ANDEXXA reverses anti-factor Xa (FXa) activity in 2 minutes following bolus and sustains reversal throughout the 2-hour IV infusion. * ANDEXXA helps you respond quickly when a specific reversal agent is needed.
How quickly does ANDEXXA work?
How quickly does ANDEXXA work? ANDEXXA provides rapid, specific reversal for rivaroxaban- or apixaban-related anticoagulation in just 2 minutes following an initial bolus, with sustained reductions throughout a 2-hour IV infusion.
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 do you mix Andexxa?
Reconstitute the 200 mg vial of ANDEXXA with 20 mL of Sterile Water for Injection (SWFI). Use a 20-mL (or larger) syringe and 20-gauge (or higher) needle. Slowly inject the SWFI, directing the solution onto the inside wall of the vial to minimize foaming.
What is the generic name for Andexxa?
Andexanet alfa is available under the following different brands and other names: coagulation factor Xa recombinant inactivated-zhzo and AndexXa.
What is Phytonadione the reversal drug for?
Oral or parenteral phytonadione is used to reverse excessive anticoagulation. Intravenous (IV) phytonadione, while effective, is associated with a small risk of serious anaphylactic reactions. Subcutaneous (SC) administration is safer, but there is little information on its relative efficacy in small doses.
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Eliquis Antidote | Eliquis Reversal | Showard Law Firm
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ANNEXA - Wiki Journal Club
Siegal DM, et al. "Andexanet alfa for the reversal of factor Xa inhibitor activity". The New England Journal of Medicine. 2015. 373(25):2413-2424. PubMed • Full text • PDF
What is the purpose of andexxa?
Monitor patients treated with ANDEXXA for signs and symptoms of arterial and venous thromboembolic events, ischemic events, and cardiac arrest. To reduce thromboembolic risk, resume anticoagulant therapy as soon as medically appropriate following treatment with ANDEXXA.
What are the most common adverse reactions to andexxa?
The most common adverse reactions (≥ 5%) in bleeding patients receiving ANDEXXA were urinary tract infections and pneumonia.
What is annexexa-r?
*ANNEXA-A and ANNEXA-R were two Phase 3 studies designed to establish the efficacy and safety of ANDEXXA for the reversal of anticoagulation with apixaban or rivaroxaban in older, healthy volunteers vs placebo. The primary endpoint of both studies was mean percent change in anti-FXa activity, from baseline to nadir, for the low-dose and high-dose regimens of bolus followed by continuous infusion. In ANNEXA-A and ANNEXA-R, 23/31 and 26/39 patients received ANDEXXA respectively. 1
How many subjects were anticoagulated with apixaban?
Seventy-one subjects were anticoagulated with apixaban and had baseline levels of anti-FXa activity > 150 ng/mL. Nineteen subjects who were anticoagulated with rivaroxaban had elevated baseline anti-FXa activity levels >300 ng/mL. Forty-eight of the 71 apixaban-treated subjects (68%) experienced a > 90% decrease from baseline anti-FXa activity after administration of ANDEXXA. Ten of the 19 rivaroxaban subjects (53%) experienced a > 90% decrease from baseline anti-FXa activity after administration of ANDEXXA.
What is a recombinant XA?
ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant modified human factor Xa (FXa) protein indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.1.
Does Andexxa have anti-FXA?
The time course of anti-FXa activity following ANDEXXA administration was consistent among the healthy volunteer studies and the ANNEXA-4 study in bleeding patients. Compared to baseline, there was a rapid and substantial decrease in anti-FXa activity corresponding to the ANDEXXA bolus. This decrease was sustained through the end of the ANDEXXA continuous infusion. The anti-FXa activity returned to the placebo levels approximately two hours after completion of a bolus or continuous infusion. Subsequently, the anti-FXa activity decreased at a rate similar to the clearance of the FXa inhibitors.
Is AndexXA effective for bleeding?
Limitations of Use: ANDEXXA has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban or rivaroxaban. 1.
What is the purpose of andexxa?
Monitor patients treated with ANDEXXA for signs and symptoms of arterial and venous thromboembolic events, ischemic events, and cardiac arrest. To reduce thromboembolic risk, resume anticoagulant therapy as soon as medically appropriate following treatment with ANDEXXA.
What are the most common adverse reactions to andexxa?
The most common adverse reactions (≥ 5%) in bleeding patients receiving ANDEXXA were urinary tract infections and pneumonia.
How many subjects were anticoagulated with apixaban?
Seventy-one subjects were anticoagulated with apixaban and had baseline levels of anti-FXa activity > 150 ng/mL. Nineteen subjects who were anticoagulated with rivaroxaban had elevated baseline anti-FXa activity levels >300 ng/mL. Forty-eight of the 71 apixaban-treated subjects (68%) experienced a > 90% decrease from baseline anti-FXa activity after administration of ANDEXXA. Ten of the 19 rivaroxaban subjects (53%) experienced a > 90% decrease from baseline anti-FXa activity after administration of ANDEXXA.
Does Andexxa have anti-FXA?
The time course of anti-FXa activity following ANDEXXA administration was consistent among the healthy volunteer studies and the ANNEXA-4 study in bleeding patients. Compared to baseline, there was a rapid and substantial decrease in anti-FXa activity corresponding to the ANDEXXA bolus. This decrease was sustained through the end of the ANDEXXA continuous infusion. The anti-FXa activity returned to the placebo levels approximately two hours after completion of a bolus or continuous infusion. Subsequently, the anti-FXa activity decreased at a rate similar to the clearance of the FXa inhibitors.
Is AndexXA effective for bleeding?
ANDEXXA has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban or rivaroxaban.
Does Alexion have a warranty?
This information is not intended to be definitive or exhaustive, and Alexion makes no warranties or guarantees as to the accuracy or appropriateness of this information.
Is anti-FXA approved under accelerated approval?
This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers. An improvement in hemostasis has not been established. Continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients.
What is andexxa used for?
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.
How long does it take to see a risk after taking Andexxa?
In clinical studies, these risks were observed within 30 days after treatment with ANDEXXA.
How to report adverse reactions to Alexion?
To report SUSPECTED ADVERSE REACTIONS, contact Alexion Pharmaceuticals, Inc. at 1-844-259-6783 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Does Andexxa cause a heart attack?
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.
Can Andexxa cause pneumonia?
Other Infections: ANDEXXA may cause infections such as urinary tract infections or pneumonia.
Can Andexxa cause shortness of breath?
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.
How many doses of andexanet alfa?
There are two dosing regimens (Low or High dose) of andexanet alfa based on the last dose and timing of rivaroxaban or apixaban.
What is Andexanet alpha?
A recombinant modified human coagulation factor Xa that binds to and sequesters factor Xa inhibitors (such as rivaroxaban and apixaban) to neutralize their anticoagulant effects as measured by anti-Xa activity. Andexanet alpha may have “off-target” prothrombotic effects, possibly resulting from its effects on Tissue Factor Pathway Inhibitor (TFPI).
How long does it take for anti-XA to rebound?
Anti-Xa activity can rebound after completing the infusion of andexanet. Clinical trials suggest peak anti-Xa activity at 4 hours after infusion, then decrease at a rate similar to clearance of the factor Xa inhibitor. The safety and efficacy of repeated doses of andexanet alfa have not been established.
Is Andexanet added to UW?
*****Andexanet alfa (Andexxa) was NOT ADDED to the UW Medicine formulary at this time due to unclear risk vs benefit and high cost. Providers should continue to order 4F-PCC (Kcentra) for urgent reversal of anti-Xa inhibitors per UW Medicine guidelines.*****
Can you adjust Andexanet dose?
There are no recommendations for dose adjustments due to renal or hepatic dysfunction. Andexanet may have off-target prothrombotic effects; therefore, therapeutic anticoagulation should be restarted as soon as clinically appropriate after treatment with andexanet.
What are the most common adverse reactions to Andexxa?from drugs.com
The most common adverse reactions (≥ 5%) in bleeding subjects receiving Andexxa were urinary tract infections and pneumonia.
What is the study of Andexxa?from drugs.com
The ANNEXA-4 study is an ongoing multinational, prospective, open-label study using Andexxa in subjects presenting with acute major bleeding and who have recently received an FXa inhibitor. To date, safety data are available for 352 subjects. Sixty-three percent of the 352 subjects were 75 years or older. Subjects had received either apixaban (194/352; 55%) or rivaroxaban (128/352; 36%) as anticoagulation treatment for atrial fibrillation (286/352; 81%) or venous thromboembolism (87/352; 25%). In the majority of subjects, Andexxa was used to reverse anticoagulant therapy following either an intracranial hemorrhage (227; 64%) or a gastrointestinal bleed (90; 26%), with the remaining 35 subjects (10%) experiencing bleeding at other sites. Subjects were assessed at a Day 30 follow-up visit following infusion with Andexxa.
What do I need to tell my doctor BEFORE I take Andexanet Alfa?from drugs.com
If you are allergic to andexanet alfa; any part of andexanet alfa; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
How is this medicine (Andexanet Alfa) best taken?from drugs.com
Use andexanet alfa as ordered by your doctor. Read all information given to you. Follow all instructions closely.
What are some side effects that I need to call my doctor about right away?from drugs.com
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
How much Andexxa is in a vial?from drugs.com
Andexxa is available as a white to off-white lyophilized powder in single-use vials of 200 mg of coagulation factor Xa (recombinant), inactivated-zhzo.
What is the effect of FXA inhibitor therapy on thromboembolic events?from drugs.com
Reversing FXa inhibitor therapy exposes patients to the thrombotic risk of their underlying disease. To reduce the risk of thrombosis, resume anticoagulant therapy as soon as medically appropriate following treatment with Andexxa.
What is andexxa used for?
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.
What are the side effects of andexxa?
The most common side effects of ANDEXXA include urinary tract infections, pneumonia, and reactions related to the ANDEXXA infusion.
How to report adverse reactions to Alexion?
To report SUSPECTED ADVERSE REACTIONS, contact Alexion Pharmaceuticals, Inc. at 1-844-259-6783 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
How long does it take to see a risk after taking Andexxa?
In clinical studies, these risks were observed within 30 days after treatment with ANDEXXA.
Does Andexxa cause a heart attack?
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.
Can Andexxa cause shortness of breath?
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.
What is Andexxa used for?
Andexxa (coagulation factor Xa) is a member of the anticoagulant reversal agents drug class and is commonly used for Reversal of Anticoagulation.
How much does a free drug card save?
The free Drugs.com Discount Card works like a coupon and can save you up to 80% or more off the cost of prescription medicines, over-the-counter drugs and pet prescriptions.
Is Andexxa valid with insurance?
Prices are for cash paying customers only and are not valid with insurance plans. This Andexxa price guide is based on using the Drugs.com discount card which is accepted at most U.S. pharmacies.
Does Andexxa have a coupon?
Andexxa Coupons and Rebates. Andexxa offers may be in the form of a printable coupon, rebate, savings card, trial offer, or free samples. Some offers may be printed right from a website, others require registration, completing a questionnaire, or obtaining a sample from the doctor's office.
