rivaroxaban granule 155 mg For Suspension, 1 bottle
🆔 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
- 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...
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🧪 Inactive Ingredients / Excipients
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Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
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Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
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A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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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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Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
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Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
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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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.748 | — |
| Medicaid paysCMS SDUD · 12 mo | $2.31 | — |
| Medicare drug plans payPart D · Q2 2026 | $2.63 | — |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Rivaroxaban 155 mg 67877-0882-71 | Ascend | 1 granule | $1.748 | AB | Availability likely | — |
| rivaroxaban granule 155 mgthis 70748-0355-01 | Lupin | 1 bottle | $1.748 | AB | Availability likely | — |
| Xarelto 155 mg 50458-0575-01 | Janssen | 1 granule | $3.774 | AB | Availability likely | +116% |
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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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🗺️ Medicaid utilization & spend
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70748-0355-01 You're viewing this | 1 BOTTLE in 1 CARTON (70748-355-01) / 1 FOR SUSPENSION in 1 BOTTLE | 2025-09-29 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: (A) PREMATURE DISCONTINUATION OF RIVAROXABAN FOR ORAL SUSPENSION INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA A. Premature discontinuation of rivaroxaban for oral suspension increases the risk of thrombotic events Premature discontinuation of any oral anticoagulant, including rivaroxaban for oral suspension, increases the risk of thrombotic events. If anticoagulation with rivaroxaban for oral suspension is 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 Warnings and Precautions ( 5.1 ).
B. Spinal/epidural hematoma Epidural or spinal hematomas have occurred in patients treated with rivaroxaban for oral suspension 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 for oral suspension 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 FOR ORAL SUSPENSION INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete boxed warning. (A) Premature discontinuation of rivaroxaban for oral suspension increases the risk of thrombotic events Premature discontinuation of any oral anticoagulant, including rivaroxaban for oral suspension, increases the risk of thrombotic events. To reduce this risk, consider coverage with another anticoagulant if rivaroxaban for oral suspension is discontinued for a reason other than pathological bleeding or completion of a course of therapy.
( 2.2 , 2.3 , 5.1 ). (B) Spinal/epidural hematoma Epidural or spinal hematomas have occurred in patients treated with rivaroxaban for oral suspension 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 for oral suspension is a factor Xa inhibitor indicated: 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 )
1.9Treatment of Venous Thromboembolism and Reduction in Risk of Recurrent Venous Thromboembolism in Pediatric Patients Rivaroxaban for oral suspension is indicated for the treatment of venous thromboembolism (VTE) and the reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years after at least 5 days of initial parenteral anticoagulant treatment.
1.10Thromboprophylaxis in Pediatric Patients with Congenital Heart Disease after the Fontan Procedure Rivaroxaban for oral suspension is indicated for thromboprophylaxis in pediatric patients aged 2 years and older with congenital heart disease who have undergone the Fontan procedure.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Pediatric Patients : See dosing recommendations in the Full Prescribing Information ( 2.2 )
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 1 mg Rivaroxaban for Oral Suspension = 1 mL Suspension Dosage Total Daily Dose‡ Once a Day§ 2 Times a Day§ 3 Times a Day§ Oral Suspension Only 2.6 kg to 2.9 kg 0.8 mg 2.4 mg 3 kg to 3.9 kg 0.9 mg 2.7 mg 4 kg to 4.9 kg 1.4 mg 4.2 mg 5 kg to 6.9 kg 1.6 mg 4.8 mg 7 kg to 7.9 kg 1.8 mg 5.4 mg 8 kg to 8.9 kg 2.4 mg 7.2 mg 9 kg to 9.9 kg 2.8 mg 8.4 mg 10 kg to 11.9 kg 3 mg 9 mg 12 kg to 29.9 kg 5 mg 10 mg Oral Suspension 30 kg to 49.9 kg 15 mg 15 mg ≥50 kg 20 mg 20 mg * Initiate rivaroxaban for oral suspension treatment following at least 5 days of initial parenteral anticoagulation therapy. † Patients <6 months of age should meet the following criteria: at birth were at least 37 weeks of gestation, have had at least 10 days of oral feeding, and weigh ≥2.6 kg at the time of dosing. ‡ All doses should be taken with feeding or with food since exposures match that of 20 mg daily dose in adults. § Once a day: approximately 24 hours apart; 2 times a day: approximately 12 hours apart; 3 times a day: approximately 8 hours apart Dosing of rivaroxaban for oral suspension was not studied and therefore dosing cannot be reliably determined in the following patient populations.
Its use is therefore not recommended in children less than 6 months of age with any of the following: Less than 37 weeks of gestation at birth Less than 10 days of oral feeding Body weight of less than 2.6 kg. To increase absorption, all doses should be taken with feeding or with food. Monitor the child's weight and review the dose regularly, especially for children below 12 kg.
This is to ensure a therapeutic dose is maintained. All Pediatric Patients (except <2 years old with catheter-related thrombosis) : Therapy with rivaroxaban for oral suspension should be continued for at least 3 months in children with thrombosis. Treatment can be extended up to 12 months when clinically necessary.
The benefit of continued therapy beyond 3 months should be assessed on an individual basis taking into account the risk for recurrent thrombosis versus the potential risk of bleeding. Pediatric Patients <2 Years Old with Catheter-Related Thrombosis: Therapy with rivaroxaban for oral suspension should be continued for at least 1 month in children less than 2 years old with catheter-related thrombosis. Treatment can be extended up to 3 months when clinically necessary.
The benefit of continued therapy beyond 1 month should be assessed on an individual basis taking into account the risk for recurrent thrombosis versus the potential risk of bleeding. Thromboprophylaxis in Pediatric Patients with Congenital Heart Disease after the Fontan Procedure Table 3: Recommended Dosage for Thromboprophylaxis in Pediatric Patients with Congenital Heart Disease * All doses can be taken with or without food since exposures match that of 10 mg daily dose in adults. † Once a day: approximately 24 hours apart; 2 times a day: approximately 12 hours apart.
Dosage Form Body Weight 1 mg Rivaroxaban for Oral Suspension = 1 mL Suspension Dosage Total Daily Dose* Once a Day † 2 Times a Day † Oral Suspension Only 7 kg to 7.9 kg 1.1 mg 2.2 mg 8 kg to 9.9 kg 1.6 mg 3.2 mg 10 kg to 11.9 kg 1.7 mg 3.4 mg 12 kg to 19.9 kg 2 mg 4 mg 20 kg to 29.9 kg 2.5 mg 5 mg 30 kg to 49.9 kg 7.5 mg 7.5 mg Oral Suspension ≥50 kg 10 mg 10 mg Administration in Pediatric Patients Food Effect: For the treatment of VTE in children, the dose should be taken with food to increase absorption. For thromboprophylaxis after Fontan procedure, the dose can be taken with or without food.
Vomit or Spit Up: If the pat…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS For oral suspension: white to off-white granules; once reconstituted, provide white to off-white flavored opaque liquid with a concentration of 1 mg/mL. For Oral Suspension : 1 mg/mL once reconstituted ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Rivaroxaban for oral suspension is contraindicated in patients with: active pathological bleeding [see Warnings and Precautions ( 5.2 )] severe hypersensitivity reaction to rivaroxaban for oral suspension (e.g., anaphylactic reactions) [see Adverse Reactions ( 6.2 )] Active pathological bleeding ( 4 ) Severe hypersensitivity reaction to rivaroxaban for oral suspension ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Risk of Bleeding : Rivaroxaban for oral suspension can cause serious and fatal bleeding. ( 5.2 ) Pregnancy-Related Hemorrhage : Use rivaroxaban for oral suspension with caution in pregnant women due to the potential for obstetric hemorrhage and/or emergent delivery. ( 5.7 , 8.1 ) Prosthetic Heart Valves : Rivaroxaban for oral suspension use not recommended.
( 5.8 ) Increased Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome : Rivaroxaban for oral suspension use not recommended. ( 5.10 )
5.1Increased Risk of Thrombotic Events after Premature Discontinuation Premature discontinuation of any oral anticoagulant, including rivaroxaban for oral suspension, 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 another indication in patients. If rivaroxaban for oral suspension is 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 )] .
5.2Risk of Bleeding Rivaroxaban for oral suspension increases the risk of bleeding, including in any organ, and can cause serious or fatal bleeding. In deciding whether to prescribe rivaroxaban for oral suspension 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 for oral suspension 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 for oral suspension 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 for oral suspension is not for use for primary VTE prophylaxis in these hospitalized, acutely ill medical patients at high risk of bleeding.
Reversal of Anticoagulant Effect A specific agent to reverse the anti-factor Xa activity of rivaroxaban is not 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. Reversal of Anticoagulant Effect A specific agent to reverse the anti-factor Xa activity of rivaroxaban is not available.
Because of high plasma protein binding, rivaroxaban is not di…
🤒 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 Another Indication [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 reactions (>10 %) in pediatric patients were bleeding, cough, vomiting, and gastroenteritis.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561, or 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. Pediatric Patients Treatment of Venous Thromboembolism and Reduction in Risk of Recurrent Venous Thromboembolism in Pediatric Patients: The safety assessment is based on data from the EINSTEIN Junior Phase 3 study in 491 patients from birth to less than 18 years of age.
Patients were randomized 2:1 to receive body weight- adjusted doses of rivaroxaban for oral suspension or comparator (unfractionated heparin, low molecular weight heparin, fondaparinux or VKA). Discontinuation due to bleeding events occurred in 6 (1.8 %) patients in the rivaroxaban for oral suspension group and 3 (1.9 %) patients in the comparator group. Table 14 shows the number of patients experiencing bleeding events in the EINSTEIN Junior study.
In female patients who had experienced menarche, ages 12 to <18 years of age, menorrhagia occurred in 23 (27 %) female patients in the rivaroxaban for oral suspension group and 5 (10 %) female patients in the comparator group. Table 14: Bleeding Events in EINSTEIN Junior Study–Safety Analysis Set - Main Treatment Period * * These events occurred after randomization until 3 months of treatment (1 month for patients <2 years with central venous catheter-related VTE (CVC-VTE). Patients may have more than one event. † Treatment schedule: body weight-adjusted doses of rivaroxaban for oral suspension; randomized 2:1 (rivaroxaban for oral suspension: Comparator). ‡ Unfractionated heparin (UFH), low molecular weight heparin (LMWH), fondaparinux or VKA. § 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. ¶ Defined as clinically overt bleeding, which did not meet the criteria for major bleeding, but was associated with medical intervention, unscheduled contact with a physician, temporary cessation of treatment, discomfort for the patient, or impairment of activities of daily life.
Parameter Rivaroxaban for Oral Suspension † N=329 n (%) Comparator Group ‡ N=162 n (%) Major bleeding § 0 2 (1.2) Clinically relevant non-major bleeding ¶ 10 (3) 1 (0.6) Trivial bleeding 113 (34.3) 44 (27.2) Any bleeding 119 (36.2) 45 (27.8) Non-bleeding adverse reactions reported in ≥5 % of rivaroxaban for oral suspension -treated patients are shown in Table 15. Table 15: Other Adverse Reactions * Reported in Rivaroxaban for Oral Suspension-Treated Patients by ≥5 % in EINSTEIN Junior Study * Adverse reaction with Relative Risk >1.5 for rivaroxaban for oral suspension versus comparator. † The following terms were combined: fatigue, asthenia.
Adverse Reaction Rivaroxaban for Oral Suspension N=329 n (%) Comparator Group N=162 n (%) Pain in extremity 23 (7) 7 (4.3) Fatigue † 23 (7) 7 (4.3) A clinically relevant adverse reaction in rivaroxaban for oral suspension -treated patients was vomiting (10.6 % in the rivaroxaban for oral suspension group vs 8 % in the comparator group). Thromboprophylaxis in Pediatric Patients with Con…
🔄 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, the latter also known as breast cancer resistance protein (BCRP). 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 for oral suspension 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 for oral suspension 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 for oral suspension 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 for oral suspension 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 for oral suspension 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 for oral suspension in pregnant women are insufficient to inform a drug- associated risk of adverse developmental outcomes. Use rivaroxaban for oral suspension with caution in pregnant patients because of the potential for pregnancy related hemorrhage and/or emergent delivery. The anticoagulant effect of rivaroxaban for oral suspension cannot be reliably monitored with standard laboratory testing.
Consider the benefits and risks of rivaroxaban for oral suspension for the mother and possible risks to the fetus when prescribing rivaroxaban for oral suspension 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 for oral suspension in this setting. Data Human Data: There are no adequate or well-controlled studies of rivaroxaban for oral suspension 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 for oral suspension and any p…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary The limited available data on rivaroxaban for oral suspension in pregnant women are insufficient to inform a drug- associated risk of adverse developmental outcomes. Use rivaroxaban for oral suspension with caution in pregnant patients because of the potential for pregnancy related hemorrhage and/or emergent delivery. The anticoagulant effect of rivaroxaban for oral suspension cannot be reliably monitored with standard laboratory testing.
Consider the benefits and risks of rivaroxaban for oral suspension for the mother and possible risks to the fetus when prescribing rivaroxaban for oral suspension 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 for oral suspension in this setting. Data Human Data: There are no adequate or well-controlled studies of rivaroxaban for oral suspension 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 for oral suspension 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 for oral suspension is supported in these age groups by evidence from adequate and well-controlled studies of rivaroxaban 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 for oral suspension 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 for oral suspension 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 for oral suspension is supported in these age groups by evidence from adequate and well- controlled studies of rivaroxaban 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 for oral suspension and the safety and efficacy of rivaroxaban for oral suspension 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 )] .
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.
🆘 Overdosage ▾
10 OVERDOSAGE Overdose of rivaroxaban for oral suspension may lead to hemorrhage. Discontinue rivaroxaban for oral suspension 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 for oral suspension 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.
A specific agent to reverse the anti-factor Xa activity of rivaroxaban is not available.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Rivaroxaban is 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. Cardiac Electrophysiology: In a thorough QT study in healthy men and women aged 50 years and older, no QTc prolonging effects were observed for rivaroxaban (15 mg and 45 mg, single dose).
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 2.5 mg and 10 mg tablets can be taken with or without food.
Rivaroxaban 20 mg administered in the fasted state has an absolute bioavailability of approximately 66%. Coadministration of rivaroxaban with food increases the bioavailability of the 20 mg dose (mean AUC and C max increasing by 39 % and 76 % respectively with food). Rivaroxaban 15 mg and 20 mg tablets should be taken with food .
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 (30 mg single dose) with the H2-receptor antagonist ranitidine (150 mg twice daily), the antacid aluminum hydroxide/magnesium hydroxide (10 mL) or rivaroxaban (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 3).
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…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Rivaroxaban is 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 for oral suspension is available in the strength and package listed below: NDC 70748-355-01 Supplied as white to off-white granules in translucent HDPE bottle containing 155 mg rivaroxaban packaged with two oral dosing syringes. After reconstitution with 150 mL of purified water, 1 mL of the suspension contains 1 mg rivaroxaban. Discard reconstituted suspension after "Discard after" date written on the bottle.
Storage of granules and reconstituted suspension: Store at room temperature between 20°C and 25°C (68°F and 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Do not freeze the granules or reconstituted suspension. Keep out of the reach of children.
📋 Description ▾
11 DESCRIPTION Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban for oral suspension 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 is C 19 H 18 ClN 3 O 5 S and the molecular weight is 435.88. The structural formula is: Rivaroxaban is a pure ( S )-enantiomer.
It is white to yellowish powder. Rivaroxaban is soluble in dimethylsulfoxide and practically insoluble in water. Rivaroxaban 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, carboxymethylcellulose sodium, hydroxypropyl methyl cellulose, mannitol, microcrystalline cellulose, sodium benzoate, sucralose, tutti frutti flavor and xanthan gum. Image
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION For the suspension, advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Instructions for Patient Use Advise patients to take rivaroxaban for oral suspension only as directed. Remind patients to not discontinue rivaroxaban for oral suspension without first talking to their healthcare professional.
Pediatric Patients: The adult caregiver should administer the dose. Advise caregivers to use the syringes provided in the original carton. Advise the caregiver whether the dose needs to be taken with food or not [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 for 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 for oral suspension [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 for oral suspension 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 for oral suspension [see Use in Specific Populations ( 8.1 )] . Advise pregnant women receiving rivaroxaban for oral suspension to immediately report to their physician any bleeding or symptoms of blood loss [see Warnings and Precautions ( 5.7 )] . Lactation Advise patients to discuss with their physician the benefits and risks of rivaroxaban for oral suspension for the mother and for the child if they are nursing or intend to nurse during anticoagulant treatment [see Use in Specific Populations ( 8.2 )] .
Females and Males of Reproductive Potential Advise patients who can become pregnant to discuss pregnancy planning with their physician [see Use in Specific Populations ( 8.3 )] . LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc. Manufactured for: Lupin Pharmaceuticals, Inc.
Naples, FL 34108, United States Manufactured by: Lupin Limited Chhatrapati Sambhajinagar - 431 210 India Revised: April 2026 Image
💬 Medication Guide ▾
MEDICATION GUIDE Rivaroxaban (RIV-a-ROX-a-ban) for Oral Suspension What is the most important information I should know about rivaroxaban for oral suspension? Rivaroxaban for oral suspension may cause serious side effects, including: Increased risk of blood clots if you stop taking rivaroxaban for oral suspension . 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 for oral suspension lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking rivaroxaban for oral suspension, you may have increased risk of forming a clot in your blood. Do not stop taking rivaroxaban for oral suspension without talking to the doctor who prescribes it for you.
Stopping rivaroxaban for oral suspension increases your risk of having a stroke . If you have to stop taking rivaroxaban for oral suspension, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming. Increased risk of bleeding.
Rivaroxaban for oral suspension can cause bleeding which can be serious and may lead to death. This is because rivaroxaban for oral suspension is a blood thinner medicine (anticoagulant) that lowers blood clotting. During treatment with rivaroxaban for oral suspension 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 for oral suspension and have certain other medical problems. You may have a higher risk of bleeding if you take rivaroxaban for oral suspension and take other medicines that increase your risk of bleeding, including: ○ aspirin or aspirin containing products ○ long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs) ○ warfarin sodium (Coumadin ® , Jantoven ® ) ○ any medicine that contains heparin ○ clopidogrel (Plavix ® ) ○ selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) ○ 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: ○ 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 ○ bleeding that is severe or you cannot control ○ red, pink or brown urine ○ bright red or black stools (looks like tar) ○ cough up blood or blood clots ○ vomit blood or your vomit looks like "coffee grounds" ○ headaches, feeling dizzy or weak ○ pain, swelling, or new drainage at wound sites ○ 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 for oral suspension, 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: a thin tube called an epidural catheter is placed in your back to give you certain medicine you take NSAIDs or a medicine to prevent blood from clotting you have a history of difficult or repeated epidural or spinal punctures you have a history of problems with your spine or have had surgery on your spine If you take rivaroxaban for oral suspension and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symp…