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Drug overview for ANDEXXA (coagulation factor xa,inactivated-zhzo (recombinant)):
Generic name: coagulation factor Xa,inactivated-zhzo (recombinant)
Drug class: Anticoagulant Reversal Agent for Factor Xa Inhibitors
Therapeutic class: Antidotes and other Reversal Agents
Coagulation factor Xa (recombinant), inactivated-zhzo (also known as andexanet alfa) is a recombinant modified human factor Xa protein that is a specific reversal agent for the anticoagulant effects of apixaban or rivaroxaban.
No enhanced Uses information available for this drug.
Generic name: coagulation factor Xa,inactivated-zhzo (recombinant)
Drug class: Anticoagulant Reversal Agent for Factor Xa Inhibitors
Therapeutic class: Antidotes and other Reversal Agents
Coagulation factor Xa (recombinant), inactivated-zhzo (also known as andexanet alfa) is a recombinant modified human factor Xa protein that is a specific reversal agent for the anticoagulant effects of apixaban or rivaroxaban.
No enhanced Uses information available for this drug.
DRUG IMAGES
ANDEXXA 200 MG VIAL
The following indications for ANDEXXA (coagulation factor xa,inactivated-zhzo (recombinant)) have been approved by the FDA:
Indications:
Reversal of apixaban anticoagulation
Reversal of rivaroxaban anticoagulation
Professional Synonyms:
None.
Indications:
Reversal of apixaban anticoagulation
Reversal of rivaroxaban anticoagulation
Professional Synonyms:
None.
The following dosing information is available for ANDEXXA (coagulation factor xa,inactivated-zhzo (recombinant)):
The recommended dosage of coagulation factor Xa (recombinant), inactivated-zhzo is based on the specific factor Xa inhibitor, dose of the factor Xa inhibitor, and the time since the patient's last dose of the factor Xa inhibitor. (See Table 1.) There are 2 recommended dosage regimens for coagulation factor Xa (recombinant), inactivated-zhzo: a low-dose and a high-dose regimen. The low-dose regimen consists of an initial IV bolus dose of 400 mg administered at a target rate of 30 mg/minute followed by a continuous IV infusion of 4 mg/minute for 120 minutes (480 mg).
The high-dose regimen consists of an initial IV bolus dose of 800 mg administered at a target rate of 30 mg/minute followed by a continuous IV infusion of 8 mg/minute for 120 minutes (960 mg). The safety and efficacy of additional doses of coagulation factor Xa (recombinant), inactivated-zhzo have not been established.
Table 1. Factor Xa (Recombinant), Inactivated-zhzo Dosage Based on Apixaban or Rivaroxaban Dose and Timing
Factor Xa Factor Xa Timing of Last Timing of Last Inhibitor Inhibitor Last Dose of Factor Xa Dose of Factor Xa Dose Inhibitor Inhibitor <8 Hours or >=8 Hours Unknown Apixaban <=5 mg Low dose Low dose >5 mg or unknown High dose Low dose Rivaroxaban <=10 mg Low dose Low dose >10 mg or unknown High dose Low dose
Patients receiving therapy with a factor Xa inhibitor have underlying disease states that predispose them to thromboembolic events, and reversing the effects of factor Xa inhibitor therapy increases the risk of thromboembolic events. To reduce thromboembolic risk, anticoagulant therapy should be resumed as soon as medically appropriate following treatment with coagulation factor Xa (recombinant), inactivated-zhzo.
The high-dose regimen consists of an initial IV bolus dose of 800 mg administered at a target rate of 30 mg/minute followed by a continuous IV infusion of 8 mg/minute for 120 minutes (960 mg). The safety and efficacy of additional doses of coagulation factor Xa (recombinant), inactivated-zhzo have not been established.
Table 1. Factor Xa (Recombinant), Inactivated-zhzo Dosage Based on Apixaban or Rivaroxaban Dose and Timing
Factor Xa Factor Xa Timing of Last Timing of Last Inhibitor Inhibitor Last Dose of Factor Xa Dose of Factor Xa Dose Inhibitor Inhibitor <8 Hours or >=8 Hours Unknown Apixaban <=5 mg Low dose Low dose >5 mg or unknown High dose Low dose Rivaroxaban <=10 mg Low dose Low dose >10 mg or unknown High dose Low dose
Patients receiving therapy with a factor Xa inhibitor have underlying disease states that predispose them to thromboembolic events, and reversing the effects of factor Xa inhibitor therapy increases the risk of thromboembolic events. To reduce thromboembolic risk, anticoagulant therapy should be resumed as soon as medically appropriate following treatment with coagulation factor Xa (recombinant), inactivated-zhzo.
Coagulation factor Xa (recombinant), inactivated-zhzo is administered as an initial direct IV (''bolus'') injection (target rate of 30 mg/minute) from a prepared IV infusion bag, followed by a continuous IV infusion. The continuous infusion should be initiated within 2 minutes after the bolus dose and should be continued for 120 minutes. Unopened vials of coagulation factor Xa (recombinant), inactivated-zhzo lyophilized powder for injection should be stored refrigerated at 2-8degreesC and should not be frozen.
The lyophilized drug must be reconstituted prior to administration as directed by the manufacturer. The drug is reconstituted, using a 20-mL (or larger) syringe and a 20-gauge (or smaller in diameter, e.g., 21-gauge) needle, by adding 20 mL of sterile water for injection to a vial labeled as containing 200 mg of coagulation factor Xa (recombinant), inactivated-zhzo; the resultant solution contains 10 mg/mL of coagulation factor Xa (recombinant), inactivated-zhzo. The vial should be gently swirled (not shaken) to aid reconstitution (typical dissolution time for each vial is 3-5 minutes) and inspected for any evidence of particulate matter.
The reconstituted solution should be clear, colorless to slightly yellow, and free from visible particles. The appropriate number of vials needed for the required dose should be reconstituted in succession to reduce the total reconstitution time. To prepare the IV bolus dose, the required dosing volume should be withdrawn from the reconstituted vial(s) using a 40-mL (or larger) syringe with a 20-gauge (or smaller in diameter, e.g., 21-gauge) needle and transferred into an empty polyolefin or PVC IV bag with a volume of 250 mL or less.
Similarly, to prepare the continuous infusion, the appropriate amount of reconstituted solution should be transferred to an empty polyolefin or PVC IV bag with a volume of 250 mL or less; more than one 40- to 60-mL syringe, or an equivalent 100-mL syringe, may be used to transfer the reconstituted solution to the empty IV bag. An inline 0.2- or 0.22-microm
polyethersulfone or equivalent low protein-binding filter should be used during IV administration. Reconstituted solutions of coagulation factor Xa (recombinant), inactivated-zhzo are stable at room temperature for up to 8 hours or may be stored refrigerated (2-8degreesC) for up to 24 hours. Reconstituted solutions in IV bags are stable at room temperature for up to 8 hours.
The lyophilized drug must be reconstituted prior to administration as directed by the manufacturer. The drug is reconstituted, using a 20-mL (or larger) syringe and a 20-gauge (or smaller in diameter, e.g., 21-gauge) needle, by adding 20 mL of sterile water for injection to a vial labeled as containing 200 mg of coagulation factor Xa (recombinant), inactivated-zhzo; the resultant solution contains 10 mg/mL of coagulation factor Xa (recombinant), inactivated-zhzo. The vial should be gently swirled (not shaken) to aid reconstitution (typical dissolution time for each vial is 3-5 minutes) and inspected for any evidence of particulate matter.
The reconstituted solution should be clear, colorless to slightly yellow, and free from visible particles. The appropriate number of vials needed for the required dose should be reconstituted in succession to reduce the total reconstitution time. To prepare the IV bolus dose, the required dosing volume should be withdrawn from the reconstituted vial(s) using a 40-mL (or larger) syringe with a 20-gauge (or smaller in diameter, e.g., 21-gauge) needle and transferred into an empty polyolefin or PVC IV bag with a volume of 250 mL or less.
Similarly, to prepare the continuous infusion, the appropriate amount of reconstituted solution should be transferred to an empty polyolefin or PVC IV bag with a volume of 250 mL or less; more than one 40- to 60-mL syringe, or an equivalent 100-mL syringe, may be used to transfer the reconstituted solution to the empty IV bag. An inline 0.2- or 0.22-microm
polyethersulfone or equivalent low protein-binding filter should be used during IV administration. Reconstituted solutions of coagulation factor Xa (recombinant), inactivated-zhzo are stable at room temperature for up to 8 hours or may be stored refrigerated (2-8degreesC) for up to 24 hours. Reconstituted solutions in IV bags are stable at room temperature for up to 8 hours.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for ANDEXXA (coagulation factor xa,inactivated-zhzo (recombinant)):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Heparin/Coagulation Factor Xa, Inactivated (Andexanet) SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Inactivated coagulation factor Xa may bind to the heparin-antithrombin III (ATIII) complex, resulting in heparin unresponsiveness.(1) CLINICAL EFFECTS: Inactivated coagulation factor Xa may inhibit the anticoagulant effect of heparin. The extent and duration of this interaction is unknown.(1,2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Avoid the use of inactivated coagulation factor Xa prior to heparinization.(1,2) If anticoagulation is anticipated before the inactivated coagulation factor Xa has been given, consider the use of 4-factor prothrombin complex concentration for factor X inhibitor reversal.(3) If anticoagulation is needed after inactivated coagulation factor Xa has been given, consider an alternative anticoagulant to heparin, like argatroban or bivalirudin.(3) DISCUSSION: A 70-year-old man on rivaroxaban for atrial fibrillation presented with a ruptured abdominal aortic aneurysm (AAA). He was given inactivated coagulation factor Xa to reverse anticoagulation and taken to surgery for AAA repair. During the procedure, he received a total of 14,000 units of unfractionated heparin (UFH) without a change in his activated clotting time (ACT). The patient developed an iliac artery thrombus thought to be a result of the failure to achieve therapeutic anticoagulation during the procedure.(3,4) A 72-year-old man on apixaban for atrial fibrillation underwent an elective radiofrequency ablation procedure complicated by cardiac tamponade. Inactivated coagulation factor Xa was started to reverse anticoagulation. Subsequently, a left ventricular free wall rupture was discovered, and the patient was placed under cardiopulmonary bypass (CPB) for repair. Despite administration of 80,000 units of UFH, the patient's ACT was minimally increased and thrombi formed in the operating field and CPB circuit. Inactivated coagulation factor Xa was stopped and antithrombin III 1,000 units was given, leading to an out of range ACT (>999 seconds). ACT subsequently normalized after administration of protamine sulphate.(5) |
HEPARIN FLUSH, HEPARIN LOCK, HEPARIN SODIUM, HEPARIN SODIUM IN 0.45% NACL, HEPARIN SODIUM-0.45% NACL, HEPARIN SODIUM-0.9% NACL, HEPARIN SODIUM-D5W |
There are 0 moderate interactions.
The following contraindication information is available for ANDEXXA (coagulation factor xa,inactivated-zhzo (recombinant)):
Drug contraindication overview.
*None.
*None.
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| No disease contraindications |
The following adverse reaction information is available for ANDEXXA (coagulation factor xa,inactivated-zhzo (recombinant)):
Adverse reaction overview.
Adverse effects reported in at least 5% of patients receiving coagulation factor Xa (recombinant), inactivated-zhzo in clinical trials were urinary tract infections and pneumonia.
Adverse effects reported in at least 5% of patients receiving coagulation factor Xa (recombinant), inactivated-zhzo in clinical trials were urinary tract infections and pneumonia.
There are 9 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Pneumonia Venous thrombosis |
Acute arterial thromboembolism Acute myocardial infarction Cardiogenic shock Cerebrovascular accident Chronic heart failure Pulmonary thromboembolism Ventricular tachycardia |
| Rare/Very Rare |
|---|
| None. |
There are 5 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Urinary tract infection |
Cough Dysgeusia Dyspnea Flushing |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for ANDEXXA (coagulation factor xa,inactivated-zhzo (recombinant)):
Safety and efficacy of coagulation factor Xa (recombinant), inactivated-zhzo have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no adequate and well-controlled studies of coagulation factor Xa (recombinant), inactivated-zhzo in pregnant women. Animal reproductive studies conducted with the drug are lacking. Safety and efficacy of during labor and delivery have not been established.
It is not known whether coagulation factor Xa (recombinant), inactivated-zhzo is distributed into human milk. The benefits of breast-feeding and the clinical need for coagulation factor Xa (recombinant), inactivated-zhzo in the woman should be considered along with any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.
Clinical experience has not revealed age-related differences in safety or efficacy; however, the possibility that some older patients may exhibit increased sensitivity to coagulation factor Xa (recombinant), inactivated-zhzo cannot be ruled out. No differences in the pharmacokinetics of coagulation factor Xa (recombinant), inactivated-zhzo were observed in patients 65 years of age and older compared with younger patients (18-45 years of age).
The following prioritized warning is available for ANDEXXA (coagulation factor xa,inactivated-zhzo (recombinant)):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ANDEXXA (coagulation factor xa,inactivated-zhzo (recombinant))'s list of indications:
| Reversal of apixaban anticoagulation | |
| T45.511 | Poisoning by anticoagulants, accidental (unintentional) |
| T45.511A | Poisoning by anticoagulants, accidental (unintentional), initial encounter |
| T45.511D | Poisoning by anticoagulants, accidental (unintentional), subsequent encounter |
| T45.511S | Poisoning by anticoagulants, accidental (unintentional), sequela |
| T45.512 | Poisoning by anticoagulants, intentional self-harm |
| T45.512A | Poisoning by anticoagulants, intentional self-harm, initial encounter |
| T45.512D | Poisoning by anticoagulants, intentional self-harm, subsequent encounter |
| T45.512S | Poisoning by anticoagulants, intentional self-harm, sequela |
| T45.513 | Poisoning by anticoagulants, assault |
| T45.513A | Poisoning by anticoagulants, assault, initial encounter |
| T45.513D | Poisoning by anticoagulants, assault, subsequent encounter |
| T45.513S | Poisoning by anticoagulants, assault, sequela |
| T45.514 | Poisoning by anticoagulants, undetermined |
| T45.514A | Poisoning by anticoagulants, undetermined, initial encounter |
| T45.514D | Poisoning by anticoagulants, undetermined, subsequent encounter |
| T45.514S | Poisoning by anticoagulants, undetermined, sequela |
| Reversal of rivaroxaban anticoagulation | |
| T45.511 | Poisoning by anticoagulants, accidental (unintentional) |
| T45.511A | Poisoning by anticoagulants, accidental (unintentional), initial encounter |
| T45.511D | Poisoning by anticoagulants, accidental (unintentional), subsequent encounter |
| T45.511S | Poisoning by anticoagulants, accidental (unintentional), sequela |
| T45.512 | Poisoning by anticoagulants, intentional self-harm |
| T45.512A | Poisoning by anticoagulants, intentional self-harm, initial encounter |
| T45.512D | Poisoning by anticoagulants, intentional self-harm, subsequent encounter |
| T45.512S | Poisoning by anticoagulants, intentional self-harm, sequela |
| T45.513 | Poisoning by anticoagulants, assault |
| T45.513A | Poisoning by anticoagulants, assault, initial encounter |
| T45.513D | Poisoning by anticoagulants, assault, subsequent encounter |
| T45.513S | Poisoning by anticoagulants, assault, sequela |
| T45.514 | Poisoning by anticoagulants, undetermined |
| T45.514A | Poisoning by anticoagulants, undetermined, initial encounter |
| T45.514D | Poisoning by anticoagulants, undetermined, subsequent encounter |
| T45.514S | Poisoning by anticoagulants, undetermined, sequela |
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