Frequently Asked Questions
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. 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.*1
*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.
FXa inhibitor–related major bleeds can occur in several sites:2-4
- Intracranial Hemorrhage — intracerebral, subdural, subarachnoid
- Bleeding at a Critical Site — intraocular, pericardial, intraspinal, intra-articular
- Major Bleeding with Hemodynamic Instability — gastrointestinal, retroperitoneal, genitourinary tract bleed
- Major Trauma — blunt or penetrating injury
*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.
Learn MoreANDEXXA provides rapid, specific reversal for apixaban- or rivaroxaban-related life-threatening or uncontrolled bleeds in just 2 minutes following an initial bolus and sustained throughout a 2-hour IV infusion.1
ANNEXA-A and ANNEXXA-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
ANNEXA-A and ANNEXA-R were two Phase 3 prospective, randomized, placebo-controlled studies conducted in healthy volunteers (50-73 years old)
- ANNEXA-A (N=31) included only apixaban-treated subjects
- ANNEXA-R (N=39) included only rivaroxaban-treated subjects
ANNEXA-4 was a Phase 3b/4 multinational, prospective, single-arm, open-label study of ANDEXXA patients taking FXa inhibitors who presented with acute major bleeding (N=352)
| Dose* | Initial IV Bolus | Follow-On IV Infusion | Total Number of 200 mg Vials |
|---|---|---|---|
| Low Dose | 400 mg at a target rate of 30 mg/min | 4 mg/min for up to 120 minutes (480 mg) | 5 (2 vials bolus + 3 vials infusion) |
| High Dose | 800 mg at a target rate of 30 mg/min | 8 mg/min for up to 120 minutes (960 mg) | 9 (4 vials bolus + 5 vials infusion) |
| Drug FXa Inhibitor |
Dose Strength of Last Dose |
Time Since Last Dose Taken |
|
|---|---|---|---|
| <8 Hours or Unknown | ≥8 Hours | ||
| ELIQUIS® (apixaban) |
≤5mg | Low Dose | Low Dose |
| >5 mg or Unknown | High Dose | Low Dose | |
| XARELTO® (rivaroxban) |
≤10 mg | Low Dose | Low Dose |
| >10 mg or Unknown | High Dose | Low Dose | |
Carton NDC Number: 69853-0102-1
Carton Configuration: 4 single-use vials per carton, each vial containing 200 mg
Vial Cap Color: Vials have a red, flip-off cap
Medicare (Part A) will reimburse eligible claims for administration of ANDEXXA in hospital inpatient settings under ICD-10-PCS Codes XW03372 and XW04372.8
Medicare (Part B): Effective July 1, 2020, the Centers for Medicare and Medicaid Services (CMS) has granted ANDEXXA its permanent J-code (J7169), facilitating reimbursement in all hospital outpatient departments and freestanding emergency facilities in the United States.9
In addition to the MS-DRG payment, Medicare New Technology Add-on Payment (NTAP) may facilitate an additional payment.8
The specifics of coverage may vary by payer and can be specific to the patient’s unique plan. Please reference the individual patient’s plan to determine applicable coverage requirements.
ANDEXXA is currently available through these distributors:
- ASD Healthcare®
- BioCare SD®
- CardinalHealth™
- FFF Enterprises
- McKesson
- Prodigy Health
Additional questions?
For additional questions, please call 1-866-777-5947.
References:
1. Andexxa (prescribing information). Boston, MA: Alexion Pharmaceuticals, Inc.; 2021. 2. Tomaselli GF, Mahaffey KW, Cuker A, et al. 2017 ACC expert consensus decision pathway on management of bleeding in patients on oral anticoagulants: a report of the American College of Cardiology Task Force on expert consensus decision pathways. J Am Coll Cardiol. 2017;70(24):3042-3067. 3. Steffel J, Verhamme P, Potpara TS, et al; for the ESC Scientific Document Group. The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Eur Heart J. 2018;39(16):1330-1393. 4. Raval AN, Cigarroa JE, Chung MK, et al. Management of patients on non-vitamin K antagonist oral anticoagulants in the acute care and periprocedural setting: a scientific statement from the American Heart Association. Circulation. 2017;135(10):e604-e633. 5. Siegal DM, Curnutte JT, Connolly SJ, et al. Andexanet alfa for the reversal of factor Xa inhibitor activity. N Engl J Med. 2015;373(25):2413-2424. 6. Data on file. Alexion Pharmaceuticals, Inc. 7. Morales-Vidal S, Schneck MJ, Flaster M, Biller J, et al; Direct thrombin inhibitors and factor Xa inhibitors in patients with cerebrovascular disease, Expert Rev Neurother. 2012;12(2):179-190. 8. Centers for Medicare & Medicaid Services (CMS). Medicare program; hospital inpatient prospective payment systems for acute care hospitals and the long-term care hospital prospective payment system and policy changes and fiscal year 2020 rates; quality reporting requirements for specific providers; Medicare and Medicaid promoting interoperability programs requirements for eligible hospitals and critical access hospitals. Fed Regist. 2019;84(159):42044-42701. 9. Centers for Medicare & Medicaid Services (CMS). Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) Application Summaries and Coding Decisions: First Quarter, 2020 Coding Cycle for Drug and Biological Products. https://www.cms.gov/files/document/2020-hcpcs-application-summary-quarter-1-2020-drugs-and-biologicals.pdf. Published Q1 2020. Accessed April 8, 2020.