ANDEXXA 200 mg/20mL
andexanet alfa · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · AstraZeneca Pharmaceuticals LP
ANDEXXA is a injection, powder, lyophilized, for solution containing andexanet alfa at 200 mg/20mL, taken intravenous. Manufactured by AstraZeneca Pharmaceuticals LP.
Key Facts
- Brand Name
- ANDEXXA
- Generic Name
- andexanet alfa
- NDC Code (Product)
0310-3200- Manufacturer
- AstraZeneca Pharmaceuticals LP
- Strength
- 200 mg/20mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA125586
- Marketing Start
- 07/12/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ANDEXXA is 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 [see Clinical Studies (14) ] . 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. 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 ) 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 , 14 ) Limitations of Use ANDEXXA…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For intravenous (IV) use only. • Dose ANDEXXA based on the specific FXa inhibitor, dose of FXa inhibitor, and time since the patient's last dose of FXa inhibitor. ( 2 ) • Administer as an IV bolus, with a target rate of 30 mg/min, followed by continuous infusion for 120 minutes. ( 2.3 ) • There are two dosing regimens: Dose The safety and effectiveness of more than one dose have not been evaluated. ( 2.1 ) Initial IV Bolus Follow-On IV Infusion Low Dose 400 mg at a target rate of 30 mg/min 4 mg/min for 120 minutes High Dose 800 mg at a target rate of 30 mg/min 8 mg/min for 120 minutes 2.1 Dose For intravenous (IV) use only. There are two dosing regimens (see Table 1 ). The safety and efficacy of an additional dose have not been established. Table 1: ANDEXXA Dosing Regimens Dose The safety and effectiveness of more than one dose have not been evaluated. 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 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 120 minutes (960 mg) 9 (4 vials bolus + 5 vials infusion) The …
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Do not use unfractionated heparin following ANDEXXA administration due to unresponsiveness characterized by non-prolongation of activated clotting times ( 7.1 ). See full prescribing information for details on drug interactions. 7.1 Use with Unfractionated Heparin Unresponsiveness to unfractionated heparin has occurred following ANDEXXA administration, characterized by non-prolongation of activated clotting times and requirement for increased dosing of heparin. Do not use unfractionated heparin following ANDEXXA administration. 7.2 Interference with Anti-FXa Activity Test Current commercial clinical anti-FXa-activity assays are unsuitable for measuring FXa activity following administration of ANDEXXA. Due to the reversible binding of ANDEXXA to the FXa inhibitor, the high sample dilution currently used in commercial clinical assays promotes dissociation of the inhibitor from ANDEXXA, resulting in detection of erroneously elevated anti-FXa activity levels, thereby causing a underestimation of the reversal activity of ANDEXXA.
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions (≥ 5%) in bleeding patients receiving ANDEXXA were urinary tract infections and pneumonia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The most common adverse reactions (≥ 5%) in bleeding patients receiving ANDEXXA were urinary tract infections and pneumonia. In Study 3 (ANNEXA-4), four hundred and seventy-seven patients with acute major bleeding were enrolled and received ANDEXXA. Of these 477 patients, 419 patients were treated with apixaban (245/419; 58.5%) or rivaroxaban (174/419; 41.5%). Most patients had received apixaban or rivaroxaban as anticoagulation treatment for atrial fibrillation (348/419; 83%) or venous thromboembolism (65/419; 16%). In the majority of patients, ANDEXXA was used to reverse anticoagulant therapy following eith…
Frequently Asked Questions
What is ANDEXXA used for?
ANDEXXA contains andexanet alfa. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is ANDEXXA a controlled substance?
ANDEXXA is not classified as a controlled substance by the DEA.
What is the generic name for ANDEXXA?
The generic name for ANDEXXA is andexanet alfa. There are no other listed brand versions of andexanet alfa.
What is the NDC code for ANDEXXA 200 mg/20mL?
The NDC (National Drug Code) for ANDEXXA 200 mg/20mL is 0310-3200, listed by AstraZeneca Pharmaceuticals LP.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)