ANDEXXA
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Syed Hassan A. Kazmi BSc, MD [2]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Black Box Warning
|
Arterial and venous thromboembolic events, ischemic events, and cardiac events, including sudden death, have occurred during treatment with ANDEXXA. Resume anticoagulant therapy as soon as medically appropriate following treatment with ANDEXXA
See full prescribing information for complete Boxed Warning.
|
Overview
ANDEXXA is a Recombinant Factor Xa that is FDA approved for the Reversal agent 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. Continued approval for this indication may be contingent upon the results of studies to demonstrate an improvement in hemostasis in patients.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include urinary tract infection, pneumonia, and [infusion-related reactions.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding ANDEXXA FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding ANDEXXA FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
There is limited information regarding ANDEXXA Contraindications in the drug label.
Warnings
|
Arterial and venous thromboembolic events, ischemic events, and cardiac events, including sudden death, have occurred during treatment with ANDEXXA. Resume anticoagulant therapy as soon as medically appropriate following treatment with ANDEXXA
See full prescribing information for complete Boxed Warning.
|
There is limited information regarding ANDEXXA Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding ANDEXXA Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding ANDEXXA Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding ANDEXXA Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of ANDEXXA in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of ANDEXXA in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of ANDEXXA during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of ANDEXXA in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of ANDEXXA in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of ANDEXXA in geriatric settings.
Gender
There is no FDA guidance on the use of ANDEXXA with respect to specific gender populations.
Race
There is no FDA guidance on the use of ANDEXXA with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of ANDEXXA in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of ANDEXXA in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of ANDEXXA in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of ANDEXXA in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding ANDEXXA Administration in the drug label.
Monitoring
There is limited information regarding ANDEXXA Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of ANDEXXA and IV administrations.
Overdosage
There is limited information regarding ANDEXXA overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding ANDEXXA Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding ANDEXXA Mechanism of Action in the drug label.
Structure
There is limited information regarding ANDEXXA Structure in the drug label.
Pharmacodynamics
There is limited information regarding ANDEXXA Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding ANDEXXA Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding ANDEXXA Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding ANDEXXA Clinical Studies in the drug label.
How Supplied
There is limited information regarding ANDEXXA How Supplied in the drug label.
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
There is limited information regarding ANDEXXA Patient Counseling Information in the drug label.
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
There is limited information regarding ANDEXXA Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.