ANDEXXA: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{HK}}
|genericName=ANDEXXA
|genericName=ANDEXXA
|aOrAn=a
|aOrAn=a
|drugClass=Recombinant Factor Xa
|drugClass=Factor Xa reversal agent
|indicationType=Reversal agent
|indication=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
|indication=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.
|hasBlackBoxWarning=Yes
|hasBlackBoxWarning=Yes
|adverseReactions=[[urinary tract infection]], [[pneumonia]], and [infusion-related reactions
|adverseReactions= urinary tract infections, pneumonia, infusion-related reactions
|blackBoxWarningTitle=WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS.
|blackBoxWarningTitle=WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS
|blackBoxWarningBody=''<span style="color:#FF0000;"></span>''
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
Treatment with ANDEXXA has been associated with serious and life-threatening adverse events, including:  
|fdaLIADAdult======Condition 1=====
*Arterial and venous thromboembolic events
 
*Ischemic events, including myocardial infarction and ischemic stroke
* Dosing Information
*Cardiac arrest
 
*Sudden deaths
:* (Dosage)
*Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed.
 
=====Condition 2=====
 
* Dosing Information
 
:* (Dosage)
|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
 
:* (Dosage)
|fdaLIADPed======Condition 1=====
 
* Dosing Information
 
:* (Dosage)
 
=====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=====
 
(Description)
|clinicalTrials=======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=(Description)
|drugInteractions=* 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)
|useInPregnancyFDA=(Description)
|useInPregnancyAUS=(Description)
|useInLaborDelivery=(Description)
|useInNursing=(Description)
|useInPed=(Description)
|useInGeri=(Description)
|useInGender=(Description)
|useInRace=(Description)
|useInRenalImpair=(Description)
|useInHepaticImpair=(Description)
|useInReproPotential=(Description)
|useInImmunocomp=(Description)
|othersTitle=Others
|useInOthers=(Description)
|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)
 
|overdose====Acute Overdose===
 
====Signs and Symptoms====
 
(Description)
 
====Management====
 
(Description)
 
===Chronic Overdose===
 
====Signs and Symptoms====
 
(Description)
 
====Management====
 
(Description)
|drugBox={{Drugbox2
| verifiedrevid =
| IUPAC_name =
| image =
| drug_name =
 
<!--Clinical data-->
| tradename =
| MedlinePlus =
| licence_US =
| pregnancy_AU =
| pregnancy_US =
| legal_status =
| routes_of_administration =
 
<!--Pharmacokinetic data-->
| bioavailability =
| metabolism =
| elimination_half-life =
| excretion =
 
<!--Identifiers-->
| CAS_number_Ref =
| CAS_number =
| ATC_prefix =
| ATC_suffix =
| PubChem =
| IUPHAR_ligand =
| DrugBank_Ref =
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| ChEBI_Ref =
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<!--Chemical data-->
| C= | H= | N= | O=
| molecular_weight =
| smiles =
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}}
|mechAction=(Description)
|structure=(Description with picture)
|PD=(Description)
|PK=(Description)
|nonClinToxic=(Description)
|clinicalStudies======Condition 1=====
(Description)
=====Condition 2=====


==INDICATIONS AND USAGE==
(Description)
* ANDEXXA is indicated for patients treated with rivaroxaban and 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 to demonstrate an improvement in hemostasis in patients.
'''Limitation of Use'''
* 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 and rivaroxaban.


==DOSAGE AND ADMINISTRATION==
=====Condition 3=====
'''For intravenous use only.'''
 
===Dose===
(Description)
* There are two dosing regimens
|howSupplied=(Description)
* The safety and efficacy of an additional dose has not been established
|fdaPatientInfo=(Patient Counseling Information)
** Low Dose: 400 mg at a target rate of 30 mg/min; Follow-On infusion: 4 mg/min for up to 120 minutes
|nlmPatientInfo=(Link to patient information page)
** High Dose: 800 mg at a target rate of 30 mg/min; Follow-On infusion: 8 mg/min for up to 120 minutes
|lookAlike=* (Paired Confused Name 1a) — (Paired Confused Name 1b)
* (Paired Confused Name 2a) — (Paired Confused Name 2b)
* (Paired Confused Name 3a) — (Paired Confused Name 3b)
|drugShortage=Drug Shortage
}}

Revision as of 20:03, 6 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];

Disclaimer

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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.
Condition Name: (Content)

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)

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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)

Non–Guideline-Supported Use

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)
Condition 3
  • Dosing Information
  • (Dosage)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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)

Non–Guideline-Supported Use

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)
Condition 3
  • Dosing Information
  • (Dosage)

Contraindications

CONTRAINDICATIONS

Warnings

WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
Conidition 1

(Description)

Conidition 2

(Description)

Conidition 3

(Description)

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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