Rivaroxaban

Begin after ≥5 days parenteral anticoagulation. All doses are with feeding/food. Suspension is 1 mg/mL: numeric mg equals mL, not a total-day volume. Below 6 months, birth gestation must be ≥37 weeks, oral feeding ≥10 days and current weight ≥2.6 kg. Review weight regularly, especially <12 kg. Twice-daily doses are about 12 hours apart; three-times-daily about 8 hours apart.

This is a separate regimen and may be taken with or without food. Each entry is the dose per administration, not a daily total. No pediatric regimen is inferred from the adult 2.5 mg tablet.

VTE generally continues ≥3 months, with extension to 12 months if needed; for catheter-related thrombosis below age 2, ≥1 month with possible extension to 3 months. Individualize further treatment by bleeding/recurrence risk. If vomiting/spitting within 30 minutes, give a new dose; after >30 minutes do not repeat. Contact the clinician if repeated. Once-daily missed doses: give only the same day, otherwise skip, never double. Twice daily: a missed morning dose may be given with the evening dose; a missed evening dose may be given only that evening. Three times daily: skip a missed dose and resume usual timing.

Adult 2.5 mg twice daily: take the next scheduled single dose. Adult 15 mg twice daily: take promptly to achieve 30 mg that day; two 15 mg tablets may be taken together. Adult once daily: take promptly that day, without doubling. Adults unable to swallow may crush tablets in applesauce; 15/20 mg must be followed by food. Gastric tube: confirm gastric placement, crush in 50 mL water; 15/20 mg requires immediate enteral feed. Avoid delivery distal to the stomach. Pediatric tablets must not be split; use suspension if unable to swallow the appropriate whole tablet. Suspension gastric-tube dosing requires flushing, with feeding for VTE but not necessarily Fontan.

A prescriber must plan transitions. Warfarin→rivaroxaban: start after warfarin cessation when INR <3.0 adults / <2.5 children. Adult reverse transition may use parenteral anticoagulant plus warfarin when the next rivaroxaban dose is due; pediatric reverse transition uses ≥2 days overlap, INR before the next rivaroxaban dose, continuing until INR ≥2.0. INR is reliable ≥24 hours after stopping rivaroxaban. Other rapid-onset anticoagulants generally replace rivaroxaban at its next scheduled dose; start rivaroxaban 0–2 hours before the next other-agent dose and omit that dose, or at stopping continuous IV heparin. If interruption is needed for surgery, the label specifies ≥24 hours before and restart after adequate hemostasis; neuraxial procedures require their own individualized protocol, not a universal 24-hour rule.

Active pathological bleeding or severe rivaroxaban hypersensitivity, such as anaphylaxis. Renal/hepatic and interaction restrictions are additional label warnings, not silently recategorized as contraindications.

Premature cessation increases thrombotic events; consider another anticoagulant when stopping for reasons other than pathological bleeding or completing treatment. Neuraxial procedures can produce spinal/epidural hematoma and permanent paralysis; monitor for neurologic impairment and obtain urgent treatment.

Bleeding is the most common adverse effect; clinically important uterine/menstrual bleeding can occur. Pediatric trials also reported vomiting, limb pain/fatigue or cough/rash depending on indication. Serious postmarketing reports include allergy, liver injury, blood-cell disorders, anticoagulant-related kidney injury and severe skin reactions. Overdose requires urgent medical care; stop for associated bleeding and use specialist supportive/hemostatic management, with charcoal considered for recent ingestion. Dialysis is ineffective; vitamin K/protamine do not reverse its effect. Current U.S. label states no specific reversal agent is available; FDA states AstraZeneca ended U.S. Andexxa sales/manufacture December 22, 2025. Do not rely on older availability claims.

• Avoid combined P-gp/strong CYP3A inhibitors such as ketoconazole or ritonavir; they raise exposure/bleeding risk. The label gives a clarithromycin exception based on PK data, not a universal rule for every inhibitor.
• With CrCl 15 to <80 mL/min, combined P-gp/moderate CYP3A inhibitors (e.g., erythromycin) should not be used unless benefit justifies risk.
• Avoid combined P-gp/strong CYP3A inducers such as carbamazepine, phenytoin, rifampin and St. John’s wort: reduced exposure can increase thrombosis.
• Other anticoagulants, aspirin/other antiplatelets, NSAIDs and SSRIs/SNRIs increase bleeding risk. CAD/PAD aspirin combination is indication-specific; do not independently add or remove it.

Calculate adult creatinine clearance using actual weight. VTE treatment/recurrent-risk reduction and surgical/medical prophylaxis avoid CrCl <15; at 15–<30, clinical data are limited and close bleeding observation is needed. AF pivotal evidence below 30 is absent; dialysis dosing is based on exposure, with clinical stroke/bleeding benefit unknown. CAD/PAD trials excluded CrCl <15 and provide no dialysis outcome evidence despite the no-adjustment table. These limitations require specialist assessment. Avoid Child-Pugh B/C or any liver disease with coagulopathy.

Age ≥1: no adjustment for mild renal impairment (eGFR 50 to ≤80 mL/min/1.73 m²); avoid eGFR <50. Below age 1, avoid serum creatinine above the label’s age-specific 97.5th percentile; exact age/table assessment is required, not an adult CrCl substitution. Pediatric hepatic-impairment data are absent. Infant gestation/feeding/weight eligibility applies below 6 months, and Fontan prophylaxis begins at age 2. The 2.5 mg tablet is not recommended for pediatric use.

Pregnancy dose is unstudied; limited data do not establish developmental safety. Use only when benefit justifies maternal/fetal risks, including pregnancy/delivery hemorrhage, with a specialist plan. Rivaroxaban is detected in human milk; infant-effect/milk-production data are insufficient, so discuss feeding benefits and risks. Discuss pregnancy plans and abnormal uterine bleeding. Older adults have higher absolute bleeding and thrombotic event rates; assess renal function and comorbidity rather than using an age-only dose reduction.

Selectively inhibits free factor Xa and prothrombinase without an antithrombin cofactor, reducing thrombin generation. It has no direct platelet-aggregation effect.

Adult peak / food

Peak ~2–4 hours. 2.5/10 mg bioavailability ~80–100%, food independent; 15/20 mg must be taken with food.

Protein binding

Approximately 92–95%; high binding makes dialysis ineffective.

Metabolism / elimination

CYP3A4/5, CYP2J2 and hydrolysis; P-gp/BCRP substrate. About 36% recovered unchanged in urine in a radiolabeled-dose study.

Adult half-life

5–9 hours in younger adults; 11–13 hours in older studied adults.

Pediatric exposure

Weight/frequency schedules are indication-specific; half-life decreases with younger age.

Assess signs of bleeding, hemoglobin/hematocrit when blood loss is suspected, renal function periodically and more often with possible decline, hepatic restrictions and interactions. Review dose/food/timing and adherence at each transition. Monitor pediatric weight and adjust the applicable table. Standard clotting tests are not reliable dose targets; the label does not recommend routine anti-Xa monitoring. Notify the team before surgery, dental or spinal procedures.

Do not stop without a plan. Obtain urgent care for uncontrolled bleeding, black stools, vomiting blood, fainting or new neurologic symptoms after a spinal procedure. Confirm whether food is required and use the schedule-specific missed-dose rule. For suspension, use only the supplied oral syringe; shake slowly for 10 seconds before dosing, avoid foam and repeat if lumps/granules remain. The caregiver should verify mg/mL and give the full dose; seek advice for repeated vomiting. Review all prescription, OTC and herbal medicines.

Ingredient / route

Rivaroxaban 20 mg · oral tablet.

Appearance / imprint

Dark red triangle, film coated; downward triangle / 20 and Xa.

Manufacturer for label

Janssen Pharmaceuticals; licensed from Bayer.

Example NDC

50458-579-30 · bottle of 30.

U.S. status

Prescription anticoagulant; current NDA product labeling.

Tablets

2.5, 10, 15 and 20 mg. Pediatric use requires the exact whole-tablet regimen; never split to construct small doses.

Oral suspension

1 mg/mL after pharmacy reconstitution; granule bottle contains 155 mg, NDC 50458-575-01, with two oral syringes.

Adult VTE starter pack

NDC 50458-584-51: 42 tablets of 15 mg plus 9 tablets of 20 mg; a 30-day pack does not determine total treatment duration.

Tablets/granules/reconstituted liquid: 20–25°C, excursions 15–30°C; do not freeze granules/liquid. Pharmacist adds 150 mL purified water to granules and shakes 60 seconds; do not add flavor. Dispense upright in original bottle with supplied syringes and a discard date 60 days after reconstitution. At home shake slowly 10 seconds before use. Crushed adult tablets are stable in water/applesauce for up to 4 hours; follow food/gastric-tube instructions.