RIVAROXABAN 15 mg Tablet, Film Coated, 30-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Factor Xa Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Rivaroxaban is used to: prevent and treat deep vein thrombosis (DVT; a blood clot) and pulmonary embolism (PE; a blood clot in the lung). lower the risk of a heart attack, stroke, or death in people with coronary artery disease (narrowing of the blood vessels that bring blood to the heart) or peripheral arterial disease (poor blood flow to the arms and legs). Rivaroxaban is in a class of medications called factor Xa inhibitors. It works by blocking a natural substance that helps blood clots to form.
Read the full MedlinePlus article ↗- Yes, rivaroxaban is a blood thinner, but it covers a pretty wide range of conditions. It's used to treat blood clots in the legs (DVT) and lungs (pulmonary embolism), prevent those...
- What exactly is rivaroxaban used for — is it just a blood thinner?
- It depends on the strength you've been prescribed. Certain higher-strength tablets need to be taken with food — food helps your body absorb enough of the medication. Lower-strength...
- Do I need to take rivaroxaban with food?
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII Q662QK8M3B
Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
11 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $4.05 | $121.43 / 30 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Rivaroxaban 15 mg 14445-0183-10 | Indoco | 10 tablets | — | AB | FDA listed | — |
| Rivaroxaban 15 mgthis 46708-0347-30 | Alembic | 30 tablets | — | AB | FDA listed | — |
| Xarelto 15 mg 50458-0578-07 | Janssen | 7 tablets | — | AB | FDA listed | — |
| Xarelto 15 mg 55154-1424-08 | Cardinal | 2070 tablets | — | AB | FDA listed | — |
| rivaroxaban 15 mg 55488-0541-01 | Changzhou | 30 tablets | — | AB | FDA listed | — |
| Rivaroxaban 15 mg 62332-0347-10 | Alembic | 10 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 46708-0347-10 | 100 BLISTER PACK in 1 CARTON (46708-347-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 2025-05-21 | Active |
| 46708-0347-30 You're viewing this | 30 TABLET, FILM COATED in 1 BOTTLE (46708-347-30) | 2025-05-14 | Active |
| 46708-0347-90 | 90 TABLET, FILM COATED in 1 BOTTLE (46708-347-90) | 2025-05-14 | Active |
| 46708-0347-91 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-347-91) | 2025-05-14 | Active |
Pack size FAQ
What quantity is in NDC 46708-0347-30?
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🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: (A) PREMATURE DISCONTINUATION OF RIVAROXABAN TABLETS INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA A. Premature discontinuation of rivaroxaban tablets increases the risk of thrombotic events Premature discontinuation of any oral anticoagulant, including rivaroxaban tablets, increases the risk of thrombotic events. If anticoagulation with rivaroxaban tablets are discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.3, 2.4), Warnings and Precautions (5.1), and Clinical Studies (14.1)].
B. Spinal/epidural hematoma Epidural or spinal hematomas have occurred in patients treated with rivaroxaban tablets 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 catheters • 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 tablets and neuraxial procedures is not known [see Warnings and Precautions (5.2, 5.3) and Adverse Reactions (6.2)].
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary [see Warnings and Precautions (5.3)]. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and Precautions (5.3)].
WARNING: (A) PREMATURE DISCONTINUATION OF RIVAROXABAN TABLETS INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete boxed warning. (A) Premature discontinuation of rivaroxaban tablets increases the risk of thrombotic events Premature discontinuation of any oral anticoagulant, including rivaroxaban tablets, increases the risk of thrombotic events. To reduce this risk, consider coverage with another anticoagulant if rivaroxaban tablets are discontinued for a reason other than pathological bleeding or completion of a course of therapy.
( 2.2 , 2.3 , 5.1 , 14.1 ) (B) Spinal/epidural hematoma Epidural or spinal hematomas have occurred in patients treated with rivaroxaban tablets who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. ( 5.2 , 5.3 , 6.2 ) Monitor patients frequently for signs and symptoms of neurological impairment and if observed, treat urgently.
Consider the benefits and risks before neuraxial intervention in patients who are or who need to be anticoagulated. ( 5.3 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Rivaroxaban tablet is a factor Xa inhibitor indicated: • to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1 ) • for treatment of deep vein thrombosis (DVT) ( 1.2 ) • for treatment of pulmonary embolism (PE) ( 1.3 ) • for reduction in the risk of recurrence of DVT or PE ( 1.4 ) • for prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5 ) • for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6 ) • to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) ( 1.7 ) • to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD ( 1.8 ) • for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years ( 1.9 ) • for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure ( 1.10 )
1.1Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation Rivaroxaban tablets are indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. There are limited data on the relative effectiveness of rivaroxaban tablets and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled [see Clinical Studies (14.1)].
1.2Treatment of Deep Vein Thrombosis Rivaroxaban tablets are indicated for the treatment of deep vein thrombosis (DVT).
1.3Treatment of Pulmonary Embolism Rivaroxaban tablets are indicated for the treatment of pulmonary embolism (PE).
1.4Reduction in the Risk of Recurrence of Deep Vein Thrombosis and/or Pulmonary Embolism Rivaroxaban tablets are indicated for the reduction in the risk of recurrence of DVT and/or PE in adult patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months.
1.5Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery Rivaroxaban tablets are indicated for the prophylaxis of DVT, which may lead to PE in adult patients undergoing knee or hip replacement surgery.
1.6Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding Rivaroxaban tablets are indicated for the prophylaxis of venous thromboembolism (VTE) and VTE related death during hospitalization and post hospital discharge in adult patients admitted for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE and not at high risk of bleeding [see Warnings and Precautions (5.2) and Clinical Studies (14.5)].
1.7Reduction of Risk of Major Cardiovascular Events in Patients with Coronary Artery Disease (CAD) Rivaroxaban tablets, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction and stroke) in adult patients with coronary artery disease.
1.8Reduction of Risk of Major Thrombotic Vascular Events in Patients with Peripheral Artery Disease (PAD), Including Patients after Lower Extremity Revascularization due to Symptomatic PAD Rivaroxaban tablets, in combination with aspirin, is indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology) in adult patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD.
1.9Treatment of Venous Thromboembolism and Reduction in Risk of Recurrent Venous Thromboembolism in Pediatric Patients Rivaroxaban tablets are indicated for the treatment of venous thromboembolism (VTE) an…
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Nonvalvular Atrial Fibrillation : 15 or 20 mg, once daily with food ( 2.1 ) • Treatment of DVT and/or PE : 15 mg orally twice daily with food for the first 21 days followed by 20 mg orally once daily with food for the remaining treatment ( 2.1 ) • Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE : 10 mg once daily with or without food, after at least 6 months of standard anticoagulant treatment ( 2.1 ) • Prophylaxis of DVT Following Hip or Knee Replacement Surgery : 10 mg orally once daily with or without food ( 2.1 ) • Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding : 10 mg once daily, with or without food, in hospital and after hospital discharge for a total recommended duration of 31 to 39 days ( 2.1 ) • CAD or PAD : 2.5 mg orally twice daily with or without food, in combination with aspirin (75 to 100 mg) once daily ( 2.1 ) • Pediatric Patients : See dosing recommendations in the Full Prescribing Information ( 2.2 )
2.1Recommended Dosage in Adults Table 1: Recommended Dosage in Adults Indication Renal Considerations * Dosage Food/Timing † Reduction in Risk of Stroke in Nonvalvular Atrial Fibrillation CrCl >50 mL/min 20 mg once daily Take with evening meal CrCl ≤50 mL/min ‡ 15 mg once daily Take with evening meal Treatment of DVT and /or PE CrCl ≥ 15 mL/min ‡ 15 mg twice daily ▼after 21 days, transition to ▼ 20 mg once daily Take with food, at the same time each day CrCl < 15 mL/min Avoid Use Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE CrCl ≥ 15 mL/min ‡ 10 mg once daily, after at least 6 months of standard anticoagulant treatment Take with or without food CrCl < 15 mL/min Avoid Use Prophylaxis of DVT Following: - Hip Replacement Surgery § CrCl ≥ 15 mL/min ‡ 10 mg once daily for 35 days, 6 to10 hours after surgery once hemostasis has been established Take with or without food CrCl < 15 mL/min Avoid Use - Knee replacement Surgery § CrCl ≥ 15 mL/min ‡ 10 mg once daily for 12 days, 6 to10 hours after surgery once hemostasis has been established Take with or without food CrCl < 15 mL/min Avoid Use Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding CrCl ≥ 15 mL/min ‡ 10 mg once daily, in hospital and after hospital discharge, for a total recommended duration of 31 to 39 days Take with or without food CrCl < 15 mL/min Avoid Use Reduction of Risk of Major Cardiovascular Events (CV Death, MI, and Stroke) in CAD No dose adjustment needed based on CrCl 2.5 mg twice daily , plus aspirin (75 to 100 mg) once daily Take with or without food Reduction of Risk of Major Thrombotic Vascular Events in PAD, Including Patients after Lower Extremity Revascularization due to Symptomatic PAD No dose adjustment needed based on CrCl 2.5 mg twice daily , plus aspirin (75 to 100 mg) once daily.
When starting therapy after a successful lower extremity revascularization procedure, initiate once hemostasis has been established. Take with or without food * Calculate CrCl based on actual weight. [See Warnings and Precautions (5.4) and Use in Specific Populations (8.6)] † See Clinical Pharmacology (12.3) ‡ Patients with CrCl <30 mL/min were not studied, but administration of rivaroxaban tablets are expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min) [see Use in Specific Populations (8.6)] § See Dosage and Administration (2.4)
2.2Recommended Dosage in Pediatric Patients Treatment of Venous Thromboembolism and Reduction in Risk of Recurrent Venous Thromboembolism in Pediatric Patients Table 2: Recommended Dosage in Pediatric Patients Birth to Less than 18 Years for Treatment of and Reduction in Risk of Recurrent VTE *,† Dosage Form Body Weight Dosage Total Daily Dose ‡ Once a Day § Tablets 30…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS • 2.5 mg tablets: Light yellow to yellow round biconvex film-coated tablets debossed with “9” on one side and “C” on other side. • 10 mg tablets: Round, pink, biconvex film-coated tablets debossed with “L” on one side and “10” on the other side. • 15 mg tablets: Round, brown, film-coated biconvex tablets debossed with‘504’ on one side and plain on the other side. • 20 mg tablets: Triangle shaped, brown, film-coated tablets debossed with ‘505’ on one side and plain on the other side. Tablets: 2.5 mg, 10 mg, 15 mg, and 20 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Rivaroxaban tablets are contraindicated in patients with: · active pathological bleeding [see Warnings and Precautions (5.2)] · severe hypersensitivity reaction to rivaroxaban tablets (e.g., anaphylactic reactions) [see Adverse Reactions (6.2)] · Active pathological bleeding ( 4 ) · Severe hypersensitivity reaction to rivaroxaban tablets ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Risk of bleeding: Rivaroxaban tablets can cause serious and fatal bleeding. An agent to reverse the activity of rivaroxaban is available. ( 5.2 ) Pregnancy-related hemorrhage: Use rivaroxaban tablets with caution in pregnant women due to the potential for obstetric hemorrhage and/or emergent delivery.( 5.7 , 8.1 ) Prosthetic heart valves: Rivaroxaban tablets use not recommended.
( 5.8 ) Increased Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome: Rivaroxaban tablets use not recommended. ( 5.10 )
5.1Increased Risk of Thrombotic Events after Premature Discontinuation Premature discontinuation of any oral anticoagulant, including rivaroxaban tablets, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from rivaroxaban tablets to warfarin in clinical trials in atrial fibrillation patients. If rivaroxaban tablets are discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.3, 2.4) and Clinical Studies (14.1)] .
5.2Risk of Bleeding Rivaroxaban tablets increases the risk of bleeding, including in any organ, and can cause serious or fatal bleeding. In deciding whether to prescribe rivaroxaban tablets to patients at increased risk of bleeding, the risk of thrombotic events should be weighed against the risk of bleeding. Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement.
Discontinue rivaroxaban tablets in patients with active pathological hemorrhage. The terminal elimination half-life of rivaroxaban is 5 to 9 hours in healthy subjects aged 20 to 45 years. Concomitant use of other drugs that impair hemostasis increases the risk of bleeding.
These include aspirin, P2Y 12 platelet inhibitors, dual antiplatelet therapy, other antithrombotic agents, fibrinolytic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) [see Drug Interactions (7.4)], selective serotonin reuptake inhibitors, and serotonin norepinephrine reuptake inhibitors . Concomitant use of drugs that are known combined P-gp and strong CYP3A inhibitors increases rivaroxaban exposure and may increase bleeding risk [see Drug Interactions (7.2)] . Risk of Hemorrhage in Acutely Ill Medical Patients at High Risk of Bleeding Acutely ill medical patients with the following conditions are at increased risk of bleeding with the use of rivaroxaban tablets for primary VTE prophylaxis: history of bronchiectasis, pulmonary cavitation, or pulmonary hemorrhage, active cancer (i.e., undergoing acute, in-hospital cancer treatment), active gastroduodenal ulcer in the three months prior to treatment, history of bleeding in the three months prior to treatment, or dual antiplatelet therapy.
Rivaroxaban tablets are not for use for primary VTE prophylaxis in these hospitalized, acutely ill medical patients at high risk of bleeding. Reversal of Anticoagulant Effect An agent to reverse the anti-factor Xa activity of rivaroxaban is available. Because of high plasma protein binding, rivaroxaban is not dialyzable [see Clinical Pharmacology (12.3)] .
Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of rivaroxaban. Use of procoagulant reversal agents, such as prothrombin complex concentrate (PCC), activated prothrombin complex concentrate or recombinant factor VIIa, may be considered but has not been evaluated in clinical efficacy and safety studies. Monitoring for the anticoagulation effect of rivaroxaban using a clotting test (PT, INR or aPTT) or anti-factor Xa (FXa) activity is not recommended.
5.3Spinal/Epidural Anesthesia or Puncture When neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture is employed, patients treated with anticoagulant agents for prevention of thromboembolic complications are at risk of developing an ep…
🤒 Adverse Reactions ▾
6 ADVERSE 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 [see Boxed Warning and Warnings and Precautions (5.1)] · Bleeding Risk [see Warnings and Precautions (5.2, 5.4, 5.5, 5.6, 5.7)] · Spinal/Epidural Hematoma [see Boxed Warning and Warnings and Precautions (5.3)] • The most common adverse reaction (>5%) in adult patients was bleeding. ( 6.1 ) • The most common adverse reactions (>10%) in pediatric patients were bleeding, cough, vomiting, and gastroenteritis.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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 rivaroxaban tablets. Hemorrhage The most common adverse reactions with rivaroxaban tablets were bleeding complications [see Warnings and Precautions (5.2)] .
Nonvalvular Atrial Fibrillation In the ROCKET AF trial, the most frequent adverse reactions associated with permanent drug discontinuation were bleeding events, with incidence rates of 4.3% for rivaroxaban tablets vs. 3.1% for warfarin. The incidence of discontinuations for non-bleeding adverse events was similar in both treatment groups.
Table 5 shows the number of patients experiencing various types of bleeding events in the ROCKET AF trial. Table 5: Bleeding Events in ROCKET AF* - On Treatment Plus 2 Days Parameter Rivaroxaban Tablets N = 7111 n (%/year) Warfarin N = 7125 n (%/year) Rivaroxaban Tablets vs. Warfarin HR (95% CI) Major Bleeding † 395 (3.6) 386 (3.5) 1.04 (0.9, 1.2) Intracranial Hemorrhage (ICH) ‡ 55 (0.5) 84 (0.7) 0.67 (0.47, 0.93) Hemorrhagic Stroke § 36 (0.3) 58 (0.5) 0.63 (0.42, 0.96) Other ICH 19 (0.2) 26 (0.2) 0.74 (0.41, 1.34) Gastrointestinal (GI) ¶ 221 (2) 140 (1.2) 1.61 (1.3, 1.99) Fatal Bleeding # 27 (0.2) 55 (0.5) 0.5 (0.31, 0.79) ICH 24 (0.2) 42 (0.4) 0.58 (0.35, 0.96) Non-intracranial 3 (0) 13 (0.1) 0.23 (0.07, 0.82) Abbreviations: HR = Hazard Ratio, CI = Confidence interval, CRNM = Clinically Relevant Non-Major. * Major bleeding events within each subcategory were counted once per patient, but patients may have contributed events to multiple subcategories.
These events occurred during treatment or within 2 days of stopping treatment. † Defined as clinically overt bleeding associated with a decrease in hemoglobin of ≥2 g/dL, a transfusion of ≥2 units of packed red blood cells or whole blood, bleeding at a critical site, or with a fatal outcome. ‡ Intracranial bleeding events included intraparenchymal, intraventricular, subdural, subarachnoid and/or epidural hematoma. § Hemorrhagic stroke in this table specifically refers to non-traumatic intraparenchymal and/or intraventricular hematoma in patients on treatment plus 2 days. ¶ Gastrointestinal bleeding events included upper GI, lower GI, and rectal bleeding. # Fatal bleeding is adjudicated death with the primary cause of death from bleeding.
Figure 1 shows the risk of major bleeding events across major subgroups. Figure 1: Risk of Major Bleeding Events by Baseline Characteristics in ROCKET AF – On Treatment Plus 2 Days Note: The figure above presents effects in various subgroups all of which are baseline characteristics and all of which were pre-specified (diabetic status was not pre-specified in the subgroup but was a criterion for the CHADS2 score). The 95% confidence limits that are shown do not take into account how many comparisons were made, nor do they reflect the effect of a particular factor after adjustment for all other factors.
Apparent homogeneity or heterogeneity among groups…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Avoid combined P-gp and strong CYP3A inhibitors and inducers ( 7.2 , 7.3 ) Anticoagulants: Avoid concomitant use ( 7.4 )
7.1General Inhibition and Induction Properties Rivaroxaban is a substrate of CYP3A4/5, CYP2J2, and the P-gp and ATP-binding cassette G2 (ABCG2) transporters. Combined P-gp and strong CYP3A inhibitors increase exposure to rivaroxaban and may increase the risk of bleeding. Combined P-gp and strong CYP3A inducers decrease exposure to rivaroxaban and may increase the risk of thromboembolic events.
7.2Drugs that Inhibit Cytochrome P450 3A Enzymes and Drug Transport Systems Interaction with Combined P-gp and Strong CYP3A Inhibitors Avoid concomitant administration of rivaroxaban tablets with known combined P-gp and strong CYP3A inhibitors (e.g., ketoconazole and ritonavir) [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.3)] . Although clarithromycin is a combined P-gp and strong CYP3A inhibitor, pharmacokinetic data suggests that no precautions are necessary with concomitant administration with rivaroxaban tablets as the change in exposure is unlikely to affect the bleeding risk [see Clinical Pharmacology (12.3)] .
Interaction with Combined P-gp and Moderate CYP3A Inhibitors in Patients with Renal Impairment Rivaroxaban tablets should not be used in patients with CrCl 15 to <80 mL/min who are receiving concomitant combined P-gp and moderate CYP3A inhibitors (e.g., erythromycin) unless the potential benefit justifies the potential risk [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.3)] .
7.3Drugs that Induce Cytochrome P450 3A Enzymes and Drug Transport Systems Avoid concomitant use of rivaroxaban tablets with drugs that are combined P-gp and strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin, St. John’s wort) [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.3)] .
7.4Anticoagulants and NSAIDs/Aspirin Coadministration of enoxaparin, warfarin, aspirin clopidogrel and chronic NSAID use may increase the risk of bleeding [see Clinical Pharmacology (12.3)]. Avoid concurrent use of rivaroxaban tablets with other anticoagulants due to increased bleeding risk unless benefit outweighs risk. Promptly evaluate any signs or symptoms of blood loss if patients are treated concomitantly with aspirin, other platelet aggregation inhibitors, or NSAIDs [see Warnings and Precautions (5.2)] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Renal impairment: Avoid or adjust dose ( 8.6 ) Hepatic impairment: Avoid use in Child-Pugh B and C hepatic impairment or hepatic disease associated with coagulopathy ( 8.7 )
8.1Pregnancy Risk Summary The limited available data on rivaroxaban tablets in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. Use rivaroxaban tablets with caution in pregnant patients because of the potential for pregnancy related hemorrhage and/or emergent delivery. The anticoagulant effect of rivaroxaban tablets cannot be reliably monitored with standard laboratory testing.
Consider the benefits and risks of rivaroxaban tablets for the mother and possible risks to the fetus when prescribing rivaroxaban tablets to a pregnant woman [see Warnings and Precautions (5.2, 5.7)] . Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnancy is a risk factor for venous thromboembolism and that risk is increased in women with inherited or acquired thrombophilias. Pregnant women with thromboembolic disease have an increased risk of maternal complications including pre-eclampsia.
Maternal thromboembolic disease increases the risk for intrauterine growth restriction, placental abruption and early and late pregnancy loss. Fetal/Neonatal Adverse Reactions Based on the pharmacologic activity of Factor Xa inhibitors and the potential to cross the placenta, bleeding may occur at any site in the fetus and/or neonate. Labor or Delivery All patients receiving anticoagulants, including pregnant women, are at risk for bleeding and this risk may be increased during labor or delivery [see Warnings and Precautions (5.7)].
The risk of bleeding should be balanced with the risk of thrombotic events when considering the use of rivaroxaban tablets in this setting. Data Human Data There are no adequate or well-controlled studies of rivaroxaban tablets in pregnant women, and dosing for pregnant women has not been established. Post-marketing experience is currently insufficient to determine a rivaroxaban-associated risk for major birth defects or miscarriage.
In an in vitro placenta perfusion model, unbound rivaroxaban was rapidly transferred across the human placenta. Animal Data Rivaroxaban crosses the placenta in animals. Rivaroxaban increased fetal toxicity (increased resorptions, decreased number of live fetuses, and decreased fetal body weight) when pregnant rabbits were given oral doses of ≥10 mg/kg rivaroxaban during the period of organogenesis.
This dose corresponds to about 4 times the human exposure of unbound drug, based on AUC comparisons at the highest recommended human dose of 20 mg/day. Fetal body weights decreased when pregnant rats were given oral doses of 120 mg/kg during the period of organogenesis. This dose corresponds to about 14 times the human exposure of unbound drug.
In rats, peripartal maternal bleeding and maternal and fetal death occurred at the rivaroxaban dose of 40 mg/kg (about 6 times maximum human exposure of the unbound drug at the human dose of 20 mg/day).
8.2Lactation Risk Summary Rivaroxaban has been detected in human milk. There are insufficient data to determine the effects of rivaroxaban on the breastfed child or on milk production. Rivaroxaban and/or its metabolites were present in the milk of rats.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for rivaroxaban tablets and any potential adverse effects on the breastfed infant from rivaroxaban tablets or from the underlying maternal condi…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary The limited available data on rivaroxaban tablets in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. Use rivaroxaban tablets with caution in pregnant patients because of the potential for pregnancy related hemorrhage and/or emergent delivery. The anticoagulant effect of rivaroxaban tablets cannot be reliably monitored with standard laboratory testing.
Consider the benefits and risks of rivaroxaban tablets for the mother and possible risks to the fetus when prescribing rivaroxaban tablets to a pregnant woman [see Warnings and Precautions (5.2, 5.7)] . Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnancy is a risk factor for venous thromboembolism and that risk is increased in women with inherited or acquired thrombophilias. Pregnant women with thromboembolic disease have an increased risk of maternal complications including pre-eclampsia.
Maternal thromboembolic disease increases the risk for intrauterine growth restriction, placental abruption and early and late pregnancy loss. Fetal/Neonatal Adverse Reactions Based on the pharmacologic activity of Factor Xa inhibitors and the potential to cross the placenta, bleeding may occur at any site in the fetus and/or neonate. Labor or Delivery All patients receiving anticoagulants, including pregnant women, are at risk for bleeding and this risk may be increased during labor or delivery [see Warnings and Precautions (5.7)].
The risk of bleeding should be balanced with the risk of thrombotic events when considering the use of rivaroxaban tablets in this setting. Data Human Data There are no adequate or well-controlled studies of rivaroxaban tablets in pregnant women, and dosing for pregnant women has not been established. Post-marketing experience is currently insufficient to determine a rivaroxaban-associated risk for major birth defects or miscarriage.
In an in vitro placenta perfusion model, unbound rivaroxaban was rapidly transferred across the human placenta. Animal Data Rivaroxaban crosses the placenta in animals. Rivaroxaban increased fetal toxicity (increased resorptions, decreased number of live fetuses, and decreased fetal body weight) when pregnant rabbits were given oral doses of ≥10 mg/kg rivaroxaban during the period of organogenesis.
This dose corresponds to about 4 times the human exposure of unbound drug, based on AUC comparisons at the highest recommended human dose of 20 mg/day. Fetal body weights decreased when pregnant rats were given oral doses of 120 mg/kg during the period of organogenesis. This dose corresponds to about 14 times the human exposure of unbound drug.
In rats, peripartal maternal bleeding and maternal and fetal death occurred at the rivaroxaban dose of 40 mg/kg (about 6 times maximum human exposure of the unbound drug at the human dose of 20 mg/day).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of rivaroxaban tablets have been established in pediatric patients from birth to less than 18 years for the treatment of VTE and the reduction in risk of recurrent VTE. Use of rivaroxaban tablets are supported in these age groups by evidence from adequate and well-controlled studies of rivaroxaban tablets in adults with additional pharmacokinetic, safety and efficacy data from a multicenter, prospective, open-label, active-controlled randomized study in 500 pediatric patients from birth to less than 18 years of age.
Rivaroxaban tablets was not studied and therefore dosing cannot be reliably determined or recommended in children less than 6 months who were less than 37 weeks of gestation at birth; had less than 10 days of oral feeding, or had a body weight of less than 2.6 kg [see Dosage and Administration (2.2), Adverse Reactions (6.1), Clinical Pharmacology (12.3) and Clinical Studies (14.8)]. The safety and effectiveness of rivaroxaban tablets have been established for use in pediatric patients aged 2 years and older with congenital heart disease who have undergone the Fontan procedure.
Use of rivaroxaban tablets are supported in these age groups by evidence from adequate and well-controlled studies of rivaroxaban tablets in adults with additional data from a multicenter, prospective, open-label, active controlled study in 112 pediatric patients to evaluate the single- and multiple-dose pharmacokinetic properties of rivaroxaban tablets and the safety and efficacy of rivaroxaban tablets when used for thromboprophylaxis for 12 months in children with single ventricle physiology who had the Fontan procedure [see Dosage and Administration (2.2), Adverse Reactions (6.1), Clinical Pharmacology (12.3) and Clinical Studies (14.9)].
Clinical studies that evaluated safety, efficacy, pharmacokinetic and pharmacodynamic data support the use of rivaroxaban tablets 10 mg, 15 mg, and 20 mg tablets in pediatric patients. For the rivaroxaban tablets 2.5 mg tablets, there are no safety, efficacy, pharmacokinetic and pharmacodynamic data to support the use in pediatric patients. Therefore, rivaroxaban tablets 2.5 mg tablets are not recommended for use in pediatric patients.
Although not all adverse reactions identified in the adult population have been observed in clinical trials of children and adolescent patients, the same warnings and precautions for adults should be considered for children and adolescents.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of adult patients in clinical trials for the approved indications of rivaroxaban tablets (N=64,943 patients), 64 percent were 65 years and over, with 27 percent 75 years and over. In clinical trials the efficacy of rivaroxaban tablets in the elderly (65 years or older) was similar to that seen in patients younger than 65 years. Both thrombotic and bleeding event rates were higher in these older patients [see Clinical Pharmacology (12.3) and Clinical Studies (14)] .
🆘 Overdosage ▾
10 OVERDOSAGE Overdose of rivaroxaban tablets may lead to hemorrhage. Discontinue rivaroxaban tablets 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 rivaroxaban tablets overdose may be considered. Due to the high plasma protein binding, rivaroxaban is not dialyzable [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)] . Partial reversal of laboratory anticoagulation parameters may be achieved with use of plasma products.
An agent to reverse the anti-factor Xa activity of rivaroxaban is available.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Rivaroxaban tablets are a selective inhibitor of FXa. It does not require a cofactor (such as Anti-thrombin III) for activity. Rivaroxaban inhibits free FXa and prothrombinase activity. Rivaroxaban has no direct effect on platelet aggregation, but indirectly inhibits platelet aggregation induced by thrombin. By inhibiting FXa, rivaroxaban decreases thrombin generation.
12.2Pharmacodynamics Rivaroxaban produces dose-dependent inhibition of FXa activity. Clotting tests, such as prothrombin time (PT), activated partial thromboplastin time (aPTT) and HepTest ® , are also prolonged dose-dependently. In children treated with rivaroxaban, the correlation between anti-factor Xa to plasma concentrations is linear with a slope close to 1.
Monitoring for anticoagulation effect of rivaroxaban using anti-FXa activity or a clotting test is not recommended. Specific Populations Renal Impairment The relationship between systemic exposure and pharmacodynamic activity of rivaroxaban was altered in adult subjects with renal impairment relative to healthy control subjects [see Use in Specific Populations (8.6)] . Table 18: Percentage Increase in Rivaroxaban PK and PD Measures in Adult Subjects with Renal Impairment Relative to Healthy Subjects from Clinical Pharmacology Studies Measure Parameter Creatinine Clearance (mL/min) 50 to 79 30 to 49 15 to 29 ESRD (on dialysis)* ESRD (post-dialysis)* Exposure AUC 44 52 64 47 56 FXa Inhibition AUEC 50 86 100 49 33 PT Prolongation AUEC 33 116 144 112 158 * Separate stand-alone study.
PT = Prothrombin time; FXa = Coagulation factor Xa; AUC = Area under the plasma concentration-time curve; AUEC = Area under the effect-time curve Hepatic Impairment Anti-Factor Xa activity was similar in adult subjects with normal hepatic function and in mild hepatic impairment (Child-Pugh A class). There is no clear understanding of the impact of hepatic impairment beyond this degree on the coagulation cascade and its relationship to efficacy and safety.
12.3Pharmacokinetics Absorption The absolute bioavailability of rivaroxaban is dose-dependent. For the 2.5 mg and 10 mg dose, it is estimated to be 80% to 100% and is not affected by food. Rivaroxaban tablets 2.5 mg and 10 mg tablets can be taken with or without food.
Rivaroxaban tablets 20 mg administered in the fasted state has an absolute bioavailability of approximately 66%. Coadministration of rivaroxaban tablets with food increases the bioavailability of the 20 mg dose (mean AUC and C max increasing by 39% and 76% respectively with food). Rivaroxaban tablets 15 mg and 20 mg tablets should be taken with food [see Dosage and Administration (2.1)] .
The maximum concentrations (C max ) of rivaroxaban appear 2 to 4 hours after tablet intake. The pharmacokinetics of rivaroxaban were not affected by drugs altering gastric pH. Coadministration of rivaroxaban tablets (30 mg single dose) with the H 2 -receptor antagonist ranitidine (150 mg twice daily), the antacid aluminum hydroxide/magnesium hydroxide (10 mL) or rivaroxaban tablets (20 mg single dose) with the PPI omeprazole (40 mg once daily) did not show an effect on the bioavailability and exposure of rivaroxaban (see Figure 4).
Absorption of rivaroxaban is dependent on the site of drug release in the GI tract. A 29% and 56% decrease in AUC and C max compared to tablet was reported when rivaroxaban granulate is released in the proximal small intestine. Exposure is further reduced when drug is released in the distal small intestine, or ascending colon.
Avoid administration of rivaroxaban distal to the stomach which can result in reduced absorption and related drug exposure. In a study with 44 healthy subjects, both mean AUC and C max values for 20 mg rivaroxaban administered orally as a crushed tablet mixed in applesauce were comparable to that after the whole tablet. However, for the crushed tablet suspended in water and administered via an NG tube followed by a liquid meal…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Rivaroxaban tablets are a selective inhibitor of FXa. It does not require a cofactor (such as Anti-thrombin III) for activity. Rivaroxaban inhibits free FXa and prothrombinase activity. Rivaroxaban has no direct effect on platelet aggregation, but indirectly inhibits platelet aggregation induced by thrombin. By inhibiting FXa, rivaroxaban decreases thrombin generation.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Rivaroxaban tablets, USP are available in the strengths and packages listed below: 2.5 mg tablets: Light yellow to yellow round biconvex film-coated tablets debossed with “9” on one side and “C” on other side. NDC 46708-683-60 Bottle of 60 tablets with child-resistant closure NDC 46708-683-45 Bottle of 180 tablets with child-resistant closure NDC 46708-683-91 Bottle of 1000 tablets NDC 46708-683-10 100 (10 x 10) tablets unit dose blister pack 10 mg tablets are round, pink, biconvex film-coated tablets debossed with “L” on one side and “10” on the other side.
The tablets are supplied in the packages listed: NDC 46708-346-30 Bottle of 30 tablets with child-resistant closure NDC 46708-346-90 Bottle of 90 tablets with child-resistant closure NDC 46708-346-91 Bottle of 1000 tablets NDC 46708-346-10 100 (10 x 10) tablets unit dose blister pack 15 mg tablets are round, brown, film-coated biconvex tablets debossed with ‘504’ on one side and plain on the other side. The tablets are supplied in the packages listed: NDC 46708-347-30 Bottle of 30 tablets with child-resistant closure NDC 46708-347-90 Bottle of 90 tablets with child-resistant closure NDC 46708-347-91 Bottle of 1000 tablets NDC 46708-347-10 100 (10 x 10) tablets unit dose blister pack 20 mg tablets are triangle shaped, brown, film-coated tablets debossed with ‘505’ on one side and plain on the other side.
The tablets are supplied in the packages listed: NDC 46708-348-30 Bottle of 30 tablets with child-resistant closure NDC 46708-348-90 Bottle of 90 tablets with child-resistant closure NDC 46708-348-91 Bottle of 1000 tablets NDC 46708-348-10 100 (10 x 10) tablets unit dose blister pack Starter Pack for treatment of deep vein thrombosis and treatment of pulmonary embolism: NDC 46708-240-51 30-day starter blister pack containing 51 tablets: 42 tablets of 15 mg and 9 tablets of 20 mg Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Preserve in well-closed containers. Keep out of the reach of children.
📋 Description ▾
11 DESCRIPTION Rivaroxaban, USP, a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban, USP is C 19 H 18 ClN 3 O 5 S and the molecular weight is 435.88. The structural formula is: Rivaroxaban, USP is a pure ( S )-enantiomer.
It is an white to yellowish powder. Rivaroxaban, USP is soluble in dimethyl sulfoxide, practically insoluble to very slightly soluble in acetone and water. Each rivaroxaban tablet, USP contains 2.5 mg, 10 mg, 15 mg or 20 mg of rivaroxaban, USP.
The inactive ingredients of rivaroxaban tablets, USP are: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban 2.5 mg tablet is Opadry ® Yellow containing D&C yellow #10 aluminium lake, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol 6000, titanium dioxide, and for rivaroxaban 10 mg tablet is Opadry ® Pink containing hypromellose, iron oxide red, polyethylene glycol 6000, talc, titanium dioxide, and for rivaroxaban 15 mg tablet and 20 mg tablet is Opadry ® Brown containing hypromellose, iron oxide black, iron oxide red, polyethylene glycol 8000, and titanium dioxide.
FDA approved dissolution test specifications differ from USP. rivaroxaban-str
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION For the tablets, advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide). Instructions for Patient Use • Advise patients to take rivaroxaban tablets only as directed. • Remind patients to not discontinue rivaroxaban tablets without first talking to their healthcare professional. Adults • Advise patients with atrial fibrillation to take rivaroxaban tablet once daily with the evening meal. • Advise patients for initial treatment of DVT and/or PE to take rivaroxaban 15 mg or 20 mg tablets with food at approximately the same time every day [see Dosage and Administration (2.1)]. • Advise patients who are at a continued risk of recurrent DVT and/or PE after at least 6 months of initial treatment, to take rivaroxaban tablet 10 mg once daily with or without food [see Dosage and Administration (2.1)]. • Advise patients who cannot swallow the tablet whole to crush rivaroxaban tablets and combine with a small amount of applesauce followed by food [see Dosage and Administration (2.6)]. • For patients requiring an NG tube or gastric feeding tube, instruct the patient or caregiver to crush the rivaroxaban tablet and mix it with a small amount of water before administering via the tube [see Dosage and Administration (2.6)]. • If a dose is missed, advise the patient according to the instructions in the Full Prescribing Information based on their dosing schedule [see Dosage and Administration (2.5)].
Pediatric Patients • The adult caregiver should administer the dose. • Advise the caregiver whether the dose needs to be taken with food or not [see Dosage and Administration (2.2)]. • Advise the caregiver the tablet must not be split in an attempt to provide a fraction of a tablet dose [see Dosage and Administration (2.2)]. • If a child vomits or spits up the dose within 30 minutes after receiving the dose, a new dose should be given. However, if the child vomits more than 30 minutes after the dose is taken, the dose should not be re-administered and the next dose should be taken as scheduled.
If a child vomits or spits up the dose repeatedly, the caregiver should contact the child’s doctor right away [see Dosage and Administration (2.2)]. • For children who are unable to swallow whole tablets, rivaroxaban oral suspension may be used. • If a dose is missed, advise the patient according to the instructions in the Full Prescribing Information based on their dosing schedule [see Dosage and Administration (2.5)]. Bleeding Risks • Advise patients to report any unusual bleeding or bruising to their physician. Inform patients that it might take them longer than usual to stop bleeding, and that they may bruise and/or bleed more easily when they are treated with rivaroxaban tablets [see Warnings and Precautions (5.2)]. • If patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDs or platelet inhibitors, advise patients to watch for signs and symptoms of spinal or epidural hematoma, such as back pain, tingling, numbness (especially in the lower limbs), muscle weakness, and stool or urine incontinence.
If any of these symptoms occur, advise the patient to contact his or her physician immediately [see Boxed Warning]. Invasive or Surgical Procedures Instruct patients to inform their healthcare professional that they are taking rivaroxaban tablets before any invasive procedure (including dental procedures) is scheduled. Concomitant Medication and Herbals Advise patients to inform their physicians and dentists if they are taking, or plan to take, any prescription or over-the-counter drugs or herbals, so their healthcare professionals can evaluate potential interactions [see Drug Interactions (7)].
Pregnancy and Pregnancy-Related Hemorrhage • Advise patients to inform their physician immediately if they become pregnant or intend to become pregnant during treatment with rivaroxaban tablets [see Use in Specific Populations (8.1)] . •…
💬 Medication Guide ▾
MEDICATION GUIDE Rivaroxaban (RIV-a-ROX-a-ban) Tablets What is the most important information I should know about rivaroxaban tablets? Rivaroxaban tablets may cause serious side effects, including: • Increased risk of blood clots if you stop taking rivaroxaban tablets. People with atrial fibrillation (a type of irregular heart beat) that is not caused by a heart valve problem (non-valvular) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body.
Rivaroxaban tablet lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking rivaroxaban tablets, you may have increased risk of forming a clot in your blood. Do not stop taking rivaroxaban tablets without talking to the doctor who prescribes it for you.
Stopping rivaroxaban tablets increases your risk of having a stroke. If you have to stop taking rivaroxaban tablets, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming. • Increased risk of bleeding. Rivaroxaban tablets can cause bleeding which can be serious and may lead to death.
This is because rivaroxaban tablet is a blood thinner medicine (anticoagulant) that lowers blood clotting. During treatment with rivaroxaban tablets you are likely to bruise more easily, and it may take longer for bleeding to stop. You may have a higher risk of bleeding if you take rivaroxaban tablets and have certain other medical problems.
You may have a higher risk of bleeding if you take rivaroxaban tablets and take other medicines that increase your risk of bleeding, including: o aspirin or aspirin containing products o long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs) o warfarin sodium (Coumadin ® , Jantoven ® ) o any medicine that contains heparin o clopidogrel (Plavix ® ) o selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) o other medicines to prevent or treat blood clots Tell your doctor if you take any of these medicines.
Ask your doctor or pharmacist if you are not sure if your medicine is one listed above. Call your doctor or get medical help right away if you or your child develop any of these signs or symptoms of bleeding: o unexpected bleeding or bleeding that lasts a long time, such as: ▪ nose bleeds that happen often ▪ unusual bleeding from the gums ▪ menstrual bleeding that is heavier than normal or vaginal bleeding o bleeding that is severe or you cannot control o red, pink or brown urine o bright red or black stools (looks like tar) o cough up blood or blood clots o vomit blood or your vomit looks like “coffee grounds” o headaches, feeling dizzy or weak o pain, swelling, or new drainage at wound sites o left upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder or diffuse abdominal discomfort (these may be symptoms of rupture of the spleen) • Spinal or epidural blood clots (hematoma).
People who take a blood thinner medicine (anticoagulant) like rivaroxaban tablets, and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if: o a thin tube called an epidural catheter is placed in your back to give you certain medicine o you take NSAIDs or a medicine to prevent blood from clotting o you have a history of difficult or repeated epidural or spinal punctures o you have a history of problems with your spine or have had surgery on your spine If you take rivaroxaban tablets and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots.
Tell your doctor right away if you have: • back pain • muscle weakness (especially in your legs and feet) • tingling • loss of control o…