Rivaroxaban: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|genericName=generic name
|authorTag={{AL}}
|genericName=Rivaroxaban
|aOrAn=a
|aOrAn=a
|drugClass=Adrenergic receptor agonist
|drugClass=Factor Xa inhibitor
|indication=a list of indications, separated by commas.
|indication=reduction in the risk of [[stroke]] and systemic [[embolism]] in patients with nonvalvular [[atrial fibrillation]], treatment of [[deep vein thrombosis]] (DVT), [[pulmonary embolism]] (PE), reduction in the risk of recurrence of [[DVT]] and of [[PE]], and for the prophylaxis of [[DVT]], which may lead to [[PE]] in patients undergoing [[knee surgery|knee]] or [[hip replacement surgery]].
|hasBlackBoxWarning=Yes
|hasBlackBoxWarning=Yes
|adverseReactions=a list of adverse reactions, separated by commas.
|adverseReactions=[[bleeding]]
|blackBoxWarningTitle=Warning Title
|blackBoxWarningTitle=(A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS,
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
(B) SPINAL/EPIDURAL HEMATOMA
|blackBoxWarningBody=<i><span style="color:#FF0000;">PREMATURE DISCONTINUATION OF RIVAROXABAN INCREASES THE RISK OF THROMBOTIC EVENTS:</span></i> Premature discontinuation of any [[oral anticoagulant]], including rivaroxaban, increases the risk of [[thrombotic events]]. If [[anticoagulation]] with rivaroxaban is discontinued for a reason other than pathological [[bleeding]] or completion of a course of therapy, consider coverage with another [[anticoagulant]].
 
 
<i><span style="color:#FF0000;">SPINAL/EPIDURAL HEMATOMA:</span></i> Epidural or [[spinal hematomas]] have occurred in patients treated with rivaroxaban who are receiving neuraxial anesthesia or undergoing [[spinal puncture]]. These [[hematomas]] may result in long-term or permanent [[paralysis]]. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or [[spinal hematomas]] in these patients include:
* Use of indwelling [[epidural catheter]]s
* Concomitant use of other drugs that affect [[hemostasis]], such as [[non-steroidal anti-inflammatory drugs]] ([[NSAIDs]]), [[platelet inhibitors]], other [[anticoagulants]]
*A history of traumatic or repeated epidural or [[spinal punctures]]
*A history of spinal deformity or [[spinal surgery]]
*Optimal timing between the administration of rivaroxaban and neuraxial procedures is not known
 
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.
 
Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for [[thromboprophylaxis]]
|fdaLIADAdult======Condition 1=====
|fdaLIADAdult======Condition 1=====


Line 118: Line 132:


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


Line 208: Line 221:
|othersTitle=Others
|othersTitle=Others
|useInOthers=(Description)
|useInOthers=(Description)
|administration=(Oral/Intravenous/etc)
|administration=(Oral/Intravenous/etc)
|monitoring======Condition 1=====
|monitoring======Condition 1=====
Line 440: Line 452:
|howSupplied=(Description)
|howSupplied=(Description)
|fdaPatientInfo=(Patient Counseling Information)
|fdaPatientInfo=(Patient Counseling Information)
|nlmPatientInfo=(Link to patient information page)
|alcohol=Alcohol-Rivaroxaban interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|lookAlike=* (Paired Confused Name 1a) — (Paired Confused Name 1b)
|lookAlike=* (Paired Confused Name 1a) — (Paired Confused Name 1b)
* (Paired Confused Name 2a) — (Paired Confused Name 2b)
* (Paired Confused Name 2a) — (Paired Confused Name 2b)
* (Paired Confused Name 3a) — (Paired Confused Name 3b)
* (Paired Confused Name 3a) — (Paired Confused Name 3b)
|nlmPatientInfo=(Link to patient information page)
|drugShortage=Drug Shortage
|drugShortage=Drug Shortage
}}
}}

Revision as of 14:45, 2 July 2014

Rivaroxaban
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]; Associate Editor(s)-in-Chief: Alejandro Lemor, M.D. [2]

Disclaimer

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Black Box Warning

(A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA
See full prescribing information for complete Boxed Warning.
PREMATURE DISCONTINUATION OF RIVAROXABAN INCREASES THE RISK OF THROMBOTIC EVENTS: Premature discontinuation of any oral anticoagulant, including rivaroxaban, increases the risk of thrombotic events. If anticoagulation with rivaroxaban is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.


SPINAL/EPIDURAL HEMATOMA: Epidural or spinal hematomas have occurred in patients treated with rivaroxaban who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.

Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis

Overview

Rivaroxaban is a Factor Xa inhibitor that is FDA approved for the {{{indicationType}}} of reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), reduction in the risk of recurrence of DVT and of PE, and for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include bleeding.

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

  • Condition 1
  • Condition 2
  • Condition 3
  • Condition 4
  • Condition 5

Warnings

(A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA
See full prescribing information for complete Boxed Warning.
PREMATURE DISCONTINUATION OF RIVAROXABAN INCREASES THE RISK OF THROMBOTIC EVENTS: Premature discontinuation of any oral anticoagulant, including rivaroxaban, increases the risk of thrombotic events. If anticoagulation with rivaroxaban is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.


SPINAL/EPIDURAL HEMATOMA: Epidural or spinal hematomas have occurred in patients treated with rivaroxaban who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.

Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis
Conidition 1

(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

Solution

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Y-Site

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Admixture

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Syringe

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

TPN/TNA

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Overdosage

Acute Overdose

Signs and Symptoms

(Description)

Management

(Description)

Chronic Overdose

Signs and Symptoms

(Description)

Management

(Description)

Pharmacology

Chemical structure of Rivaroxaban
Rivaroxaban
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 Rivaroxaban Storage in the drug label.

Images

Drug Images

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

Patient Counseling Information

(Patient Counseling Information)

Precautions with Alcohol

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

Brand Names

There is limited information regarding Rivaroxaban 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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