ANDEXXA: Difference between revisions

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:* For Apixaban ≤ 5 mg, '''give low dose ANDEXXA''' if the timing of FXa inhibitor last dose before ANDEXXA initiation is < 8 hours, unknown or ≥ 8 hours
:* For Apixaban ≤ 5 mg, '''give low dose ANDEXXA''' if the timing of FXa inhibitor last dose before ANDEXXA initiation is < 8 hours, unknown or ≥ 8 hours
:* For Apixaban > 5 mg / Unknown high dose, '''give high dose ANDEXXA''' if the timing of FXa inhibitor last dose before ANDEXXA initiation is < 8 hours or unknown and '''give low dose ANDEXXA''' if the timing of FXa inhibitor last dose before ANDEXXA initiation is ≥ 8 Hours
:* For Apixaban > 5 mg / Unknown high dose, '''give high dose ANDEXXA''' if the timing of FXa inhibitor last dose before ANDEXXA initiation is < 8 hours or unknown and '''give low dose ANDEXXA''' if the timing of FXa inhibitor last dose before ANDEXXA initiation is ≥ 8 Hours
|offLabelAdultGuideSupport======Condition 1=====
* Developed by: (Organisation)
* Class of Recommendation: (Class) (Link)
* Strength of Evidence: (Category A/B/C) (Link)
* Dosing Information/Recommendation
:* (Dosage)
=====Condition 2=====
* Developed by: (Organisation)
* Class of Recommendation: (Class) (Link)
* Strength of Evidence: (Category A/B/C) (Link)
* Dosing Information/Recommendation
:* (Dosage)
|offLabelAdultNoGuideSupport======Condition 1=====
* Dosing Information
:* (Dosage)
=====Condition 2=====
* Dosing Information
:* (Dosage)
=====Condition 3=====


* Dosing Information
* Dosing Information
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* Dosing Information
* Dosing Information


:* (Dosage)
:* The safety and efficacy of ANDEXXA in the pediatric population have not been studied.
 
=====Condition 2=====
 
* Dosing Information
 
:* (Dosage)
|offLabelPedGuideSupport======Condition 1=====
 
* Developed by: (Organisation)
 
* Class of Recommendation: (Class) (Link)
 
* Strength of Evidence: (Category A/B/C) (Link)
 
* Dosing Information/Recommendation
 
:* (Dosage)
 
=====Condition 2=====
 
* Developed by: (Organisation)
 
* Class of Recommendation: (Class) (Link)
 
* Strength of Evidence: (Category A/B/C) (Link)
 
* Dosing Information/Recommendation
 
:* (Dosage)
|offLabelPedNoGuideSupport======Condition 1=====
 
* Dosing Information
 
:* (Dosage)
 
=====Condition 2=====
 
* Dosing Information
 
:* (Dosage)
 
=====Condition 3=====
 
* Dosing Information
 
:* (Dosage)
|contraindications=CONTRAINDICATIONS
|warnings======Conidition 1=====
 
(Description)
 
=====Conidition 2=====
 
(Description)


=====Conidition 3=====
|contraindications= There are no contraindications to the use of ANDEXXA.
|warnings======Thromboembolic and Ischemic Risks=====
:* Arterial and venous thromboembolic events, ischemic events, and cardiac events, including sudden death, were observed within 30 days post-ANDEXXA administration in 33 of the 185 patients (18%) evaluable for safety in the ongoing ANNEXA-4 study. The median time to first event was 6 days. Of the 86 patients who were re-anticoagulated prior to a thrombotic event, 11 (12.7%) patients experienced a thromboembolic, ischemic event, cardiac event or death.
:* 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.


(Description)
|clinicalTrials=======Central Nervous System======
|clinicalTrials=======Central Nervous System======


Revision as of 15:24, 7 May 2018

ANDEXXA
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Black Box Warning

WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS
See full prescribing information for complete Boxed Warning.
  • Arterial and venous thromboembolic events
  • Ischemic events, including myocardial infarction and ischemic stroke
  • Cardiac arrest
  • Sudden death

Overview

ANDEXXA is a Factor Xa reversal agent that is FDA approved for the {{{indicationType}}} of ANDEXXA, coagulation factor Xa (recombinant), inactivated-zhzo is a recombinant modified human Factor Xa (FXa) protein indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. There is a Black Box Warning for this drug as shown here. Common adverse reactions include urinary tract infections, pneumonia, infusion-related reactions.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

ANDEXXA is indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
  • Dosing Information
  • There are two dosing regimens:
  • Low Dose: 400 mg at a target rate of 30 mg/min; Follow-On IV infusion: 4 mg/min for up to 120 minutes
  • High Dose: 800 mg at a target rate of 30 mg/min; Follow-On IV infusion: 8 mg/min for up to 120 minutes
ANDEXXA Dose Based on Rivaroxaban or Apixaban Dose
  • Dosing Information
  • For Rivaroxaban ≤ 10 mg, give low dose ANDEXXA if the timing of FXa inhibitor last dose before ANDEXXA initiation is < 8 hours, unknown or ≥ 8 hours
  • For Rivaroxaban > 10 mg / Unknown high dose, give high dose ANDEXXA if the timing of FXa inhibitor last dose before ANDEXXA initiation is < 8 hours or unknown and give low dose ANDEXXA if the timing of FXa inhibitor last dose before ANDEXXA initiation is ≥ 8 Hours
  • For Apixaban ≤ 5 mg, give low dose ANDEXXA if the timing of FXa inhibitor last dose before ANDEXXA initiation is < 8 hours, unknown or ≥ 8 hours
  • For Apixaban > 5 mg / Unknown high dose, give high dose ANDEXXA if the timing of FXa inhibitor last dose before ANDEXXA initiation is < 8 hours or unknown and give low dose ANDEXXA if the timing of FXa inhibitor last dose before ANDEXXA initiation is ≥ 8 Hours
  • Dosing Information
  • (Dosage)

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition 1
  • Dosing Information
  • The safety and efficacy of ANDEXXA in the pediatric population have not been studied.

Off-Label Use and Dosage (Pediatric)

Contraindications

There are no contraindications to the use of ANDEXXA.

Warnings

WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS
See full prescribing information for complete Boxed Warning.
  • Arterial and venous thromboembolic events
  • Ischemic events, including myocardial infarction and ischemic stroke
  • Cardiac arrest
  • Sudden death
Thromboembolic and Ischemic Risks
  • Arterial and venous thromboembolic events, ischemic events, and cardiac events, including sudden death, were observed within 30 days post-ANDEXXA administration in 33 of the 185 patients (18%) evaluable for safety in the ongoing ANNEXA-4 study. The median time to first event was 6 days. Of the 86 patients who were re-anticoagulated prior to a thrombotic event, 11 (12.7%) patients experienced a thromboembolic, ischemic event, cardiac event or death.
  • 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.

Adverse Reactions

Clinical Trials Experience

Central Nervous System
(list/description of adverse reactions)
Cardiovascular
(list/description of adverse reactions)
Respiratory
(list/description of adverse reactions)
Gastrointestinal
(list/description of adverse reactions)
Hypersensitive Reactions
(list/description of adverse reactions)
Miscellaneous
(list/description of adverse reactions)
Condition 2
Central Nervous System
(list/description of adverse reactions)
Cardiovascular
(list/description of adverse reactions)
Respiratory
(list/description of adverse reactions)
Gastrointestinal
(list/description of adverse reactions)
Hypersensitive Reactions
(list/description of adverse reactions)
Miscellaneous
(list/description of adverse reactions)

Postmarketing Experience

(Description)

Drug Interactions

  • Drug 1
  • Drug 2
  • Drug 3
  • Drug 4
  • Drug 5
Drug 1

(Description)

Drug 2

(Description)

Drug 3

(Description)

Drug 4

(Description)

Drug 5

(Description)

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): (Description)
Pregnancy Category (AUS): (Description)

Labor and Delivery

(Description)

Nursing Mothers

(Description)

Pediatric Use

(Description)

Geriatic Use

(Description)

Gender

(Description)

Race

(Description)

Renal Impairment

(Description)

Hepatic Impairment

(Description)

Females of Reproductive Potential and Males

(Description)

Immunocompromised Patients

(Description)

Others

(Description)

Administration and Monitoring

Administration

(Oral/Intravenous/etc)

Monitoring

Condition 1

(Description regarding monitoring, from Warnings section)

Condition 2

(Description regarding monitoring, from Warnings section)

Condition 3

(Description regarding monitoring, from Warnings section)

IV Compatibility

There is limited information regarding the compatibility of ANDEXXA and IV administrations.

Overdosage

Acute Overdose

Signs and Symptoms

(Description)

Management

(Description)

Chronic Overdose

Signs and Symptoms

(Description)

Management

(Description)

Pharmacology

ANDEXXA
Systematic (IUPAC) name
?
Identifiers
CAS number ?
ATC code ?
PubChem ?
Chemical data
Formula ?
Mol. mass ?
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Pregnancy cat.

?

Legal status
Routes ?

Mechanism of Action

(Description)

Structure

(Description with picture)

Pharmacodynamics

(Description)

Pharmacokinetics

(Description)

Nonclinical Toxicology

(Description)

Clinical Studies

Condition 1

(Description)

Condition 2

(Description)

Condition 3

(Description)

How Supplied

(Description)

Storage

There is limited information regarding ANDEXXA Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::ANDEXXA |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::ANDEXXA |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

(Patient Counseling Information)

Precautions with Alcohol

Alcohol-ANDEXXA interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding ANDEXXA Brand Names in the drug label.

Look-Alike Drug Names

  • (Paired Confused Name 1a) — (Paired Confused Name 1b)
  • (Paired Confused Name 2a) — (Paired Confused Name 2b)
  • (Paired Confused Name 3a) — (Paired Confused Name 3b)

Drug Shortage Status

Drug Shortage

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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