Brand Name
Xarelto
Generic Name
Rivaroxaban
View Brand Information FDA approval date: July 01, 2011
Classification: Factor Xa Inhibitor
Form: Tablet, Kit, Granule, For
What is Xarelto (Rivaroxaban)?
XARELTO is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation.
Approved To Treat
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Brand Information
XARELTO (rivaroxaban)
1DOSAGE FORMS AND STRENGTHS
- 2.5 mg tablets: Round, light yellow, and film-coated with a triangle pointing down above a "2.5" marked on one side and "Xa" on the other side
- 10 mg tablets: Round, light red, biconvex and film-coated with a triangle pointing down above a "10" marked on one side and "Xa" on the other side
- 15 mg tablets: Round, red, biconvex, and film-coated with a triangle pointing down above a "15" marked on one side and "Xa" on the other side
- 20 mg tablets: Triangle-shaped, dark red, and film-coated with a triangle pointing down above a "20" marked on one side and "Xa" on the other side
- For oral suspension: white to off-white granules; once reconstituted, provide flavored white to off-white opaque liquid with a concentration of 1 mg/mL.
2CONTRAINDICATIONS
XARELTO is contraindicated in patients with:
- active pathological bleeding
- severe hypersensitivity reaction to XARELTO (e.g., anaphylactic reactions)
3ADVERSE REACTIONS
The following clinically significant adverse reactions are also discussed in other sections of the labeling:
- Increased Risk of Stroke After Discontinuation in Nonvalvular Atrial Fibrillation
- Bleeding Risk
- Spinal/Epidural Hematoma
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
During clinical development for the approved indications, 34,947 adult patients were exposed to XARELTO.
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of XARELTO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and lymphatic system disorders:agranulocytosis, thrombocytopenia
Hepatobiliary disorders:jaundice, cholestasis, hepatitis (including hepatocellular injury)
Immune system disorders:hypersensitivity, anaphylactic reaction, anaphylactic shock, angioedema
Nervous system disorders:hemiparesis
Renal disorders:Anticoagulant-related nephropathy
Respiratory, thoracic and mediastinal disorders:Eosinophilic pneumonia
Skin and subcutaneous tissue disorders:Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS)
Injury, poisoning and procedural complications:Atraumatic splenic rupture
4OVERDOSAGE
Overdose of XARELTO may lead to hemorrhage. Discontinue XARELTO and initiate appropriate therapy if bleeding complications associated with overdosage occur. Rivaroxaban systemic exposure is not further increased at single doses >50 mg due to limited absorption. The use of activated charcoal to reduce absorption in case of XARELTO overdose may be considered. Due to the high plasma protein binding, rivaroxaban is not dialyzable
5DESCRIPTION
Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in XARELTO
Rivaroxaban is a pure (
Each XARELTO tablet contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of XARELTO are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for XARELTO 2.5 mg is Opadry
XARELTO for oral suspension is supplied as granules in bottles containing 155 mg of rivaroxaban (1 mg of rivaroxaban per mL after reconstitution). The inactive ingredients are: anhydrous citric acid, hypromellose, mannitol, microcrystalline cellulose and carboxymethylcellulose sodium, sodium benzoate, sucralose, sweet and creamy flavor and xanthan gum.
6HOW SUPPLIED/STORAGE AND HANDLING
XARELTO
- 2.5 mg tablets are round, light yellow, and film-coated with a triangle pointing down above a "2.5" marked on one side and "Xa" on the other side. The tablets are supplied in the packages listed:
- 10 mg tablets are round, light red, biconvex film-coated tablets marked with a triangle pointing down above a "10" on one side, and "Xa" on the other side. The tablets are supplied in the packages listed:
- 15 mg tablets are round, red, biconvex film-coated tablets with a triangle pointing down above a "15" marked on one side and "Xa" on the other side. The tablets are supplied in the packages listed:
- 20 mg tablets are triangle-shaped, dark red film-coated tablets with a triangle pointing down above a "20" marked on one side and "Xa" on the other side. The tablets are supplied in the packages listed:
- Starter Pack for treatment of deep vein thrombosis and treatment of pulmonary embolism:
XARELTO
7PATIENT COUNSELING INFORMATION
For the tablets, advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide).
For the suspension, advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
8Instructions for Use XARELTO ® (zah-REL-toe) (rivaroxaban) for oral suspension
This Instructions for Use contains information on how to give a dose of XARELTO oral suspension.
Read this Instructions for Use before giving XARELTO and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your child's medical condition or treatment.
Important information:
- XARELTO suspension is for oral use only.
- Give XARELTO to your child exactly as prescribed by your doctor. The adult caregiver should give the dose. If you have questions, contact your doctor or pharmacist for more information on giving a dose.
- Only use the oral dosing syringe provided with XARELTO oral suspension.Contact your doctor or pharmacist if the oral dosing syringe is missing, lost or damaged.
Storage informationStore XARELTO oral suspension at room temperature between
Store the bottle upright with the oral dosing syringes in the original carton.
Keep XARELTO and all medicines out of reach of children.
XARELTO Oral Dosing Syringe:
XARELTO Bottle
Check "Discard after" date on the XARELTO bottle.
If "Discard after" date has passed,
Wash hands.
Wash your hands well with soap and warm water.
Shake bottle slowly for 10 seconds before each use.
Check XARELTO oral suspension.
If there are lumps or granules at the bottom of the bottle, shake the bottle
Find your dose line.
You can use either side of the syringe to set your dose.
If using mL side of syringe:
Top of the plunger should line up with the prescribed mL.
If using color side of syringe:
Top of the plunger should line up with the prescribed mL dose line at the
If your dose is more than 5 mL.
You will need to use the same syringe more than one time. Repeat Steps 4 and 5 to complete your dose. Ask your pharmacist if you are not sure.
Push plunger all the way in to remove air.
Insert oral dosing syringe into bottle adaptor.
Twist off the cap from the bottle.
Do notremove the bottle adaptor from the bottle.
Insert the syringe tip into the bottle adaptor.
Fill oral dosing syringe.
Turn the bottle upside down, as shown.
Pull the plunger to fill the oral dosing syringe
CAUTION:Make sure you have enough medicine for a full dose. Do not take a partial dose.
Tap syringe to move air bubbles to the top.
Doing this helps set the correct dose.
Adjust to your prescribed dose.
If using mL side of syringe:Push plunger to align with the prescribed dose line.
If using color side of syringe:Push plunger to align with the prescribed mL dose line at the bottom of the color band.
Remove oral dosing syringe.
Place the bottle on a flat surface.
Remove the oral dosing syringe from the bottle.
Give the dose.
Place the oral dosing syringe gently into the child's mouth with
This allows the child to swallow naturally.
Make sure the child swallows the full dose.
If your child vomits or spits out the medicine repeatedly, contact your child's doctor right away.
Close XARELTO bottle and rinse oral dosing syringe.
Rinse the oral dosing syringe with tap water and let it air dry.
Disposing XARELTO bottle and syringe
- Throw the XARELTO bottle away in your household trash.
- Throw away any used oral dosing syringe with the opening of a new XARELTO bottle.
- Do not pour XARELTO suspension down the drain(for example: sink, toilet, shower or tub).
- Do notrecycle the bottle.
Manufactured for:
For patent information: www.janssenpatents.com
© 2021 Janssen Pharmaceutical Companies
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
9PRINCIPAL DISPLAY PANEL - 2.5 mg Tablet Bottle Label
NDC 50458-577-60
Xarelto
Dispense the accompanying
Each tablet contains
Rx only
60 Tablets
10PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label
NDC 50458-580-30
Xarelto
Dispense the accompanying
Each tablet contains
Rx only
30 Tablets
11PRINCIPAL DISPLAY PANEL - 15 mg Tablet Bottle Label
NDC 50458-578-30
Xarelto
Dispense the accompanying
Each tablet contains
Rx only
30 Tablets
12PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Label
NDC 50458-579-30
Xarelto
Dispense the accompanying
Each tablet contains
Rx only
30 Tablets
13PRINCIPAL DISPLAY PANEL - Kit Carton
Xarelto
NDC 50458-584-51
Please see full Prescribing Information, including
Starter Pack
Days 1-21
Days 22-30
First 30-day supply
LIFT HERE TO OPEN
14PRINCIPAL DISPLAY PANEL - 1 mg/mL Bottle Carton
NDC 50458-575-01
Xarelto
1 mg/mL
Pharmacist:
- Must reconstitute before
- Counsel caregiver on proper use.
ATTENTION: Dispense the
For Oral Use Only
Rx only
