Generic medicine

Rivaroxaban: Brands, Price & Uses in Bangladesh

Rivaroxaban is a direct-acting oral anticoagulant (a Factor Xa inhibitor) approved for the following indications: FDA-approved indications Reduction of risk of stroke and systemic embolism in…

Forms:Tablet

About Rivaroxaban

Indications of Rivaroxaban

Rivaroxaban is a direct-acting oral anticoagulant (a Factor Xa inhibitor) approved for the following indications:

FDA-approved indications

  • Reduction of risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
  • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
  • Reduction in the risk of recurrence of DVT and/or PE following at least 6 months of initial anticoagulant treatment.
  • Prophylaxis of DVT, which may lead to PE, in patients undergoing hip or knee replacement surgery.
  • Prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients at risk for thromboembolic complications who are not at high bleeding risk.
  • In combination with low-dose aspirin, reduction of risk of major cardiovascular events (cardiovascular death, myocardial infarction, stroke) in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD).

Pediatric indications

  • Treatment of VTE and reduction in risk of recurrent VTE in pediatric patients from birth to less than 18 years of age, after at least 5 days of initial parenteral anticoagulation.
  • Thromboprophylaxis in pediatric patients 2 years of age and older after the Fontan procedure.

Use of Rivaroxaban for any indication should be guided by a qualified physician based on individual risk assessment.

Dosage & Administration of Rivaroxaban

Dosage of Rivaroxaban by Indication (Adults)

IndicationRecommended Dose
Stroke/systemic embolism prevention in non-valvular atrial fibrillation20 mg once daily with the evening meal; 15 mg once daily if creatinine clearance (CrCl) is 15-50 mL/min
Treatment of DVT/PE15 mg twice daily with food for the first 21 days, then 20 mg once daily with food for the remaining treatment duration
Reduction in risk of recurrent DVT/PE (after ≥6 months treatment)10 mg once daily; 20 mg once daily may be considered in patients at high risk of recurrence
DVT prophylaxis after hip replacement surgery10 mg once daily for 35 days, starting 6-10 hours after surgery
DVT prophylaxis after knee replacement surgery10 mg once daily for 12 days, starting 6-10 hours after surgery
VTE prophylaxis in acutely ill medical patients10 mg once daily for 31-39 days
Chronic CAD or PAD (with low-dose aspirin 75-100 mg/day)2.5 mg twice daily

Renal Impairment

Dose adjustment or avoidance of Rivaroxaban is required depending on indication and creatinine clearance (CrCl); see the table above. Use is generally avoided when CrCl is below 15 mL/min due to lack of clinical data. Renal function should be assessed before starting Rivaroxaban and monitored periodically, especially in elderly or renally impaired patients.

Hepatic Impairment

Rivaroxaban is not recommended in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment, or any hepatic disease associated with coagulopathy, due to increased bleeding risk.

Missed Dose

If a dose of Rivaroxaban is missed, it should be taken as soon as possible on the same day; the missed dose should not be doubled the next day. Patients should consult their physician if unsure.

Side Effects of Rivaroxaban

Most Common

  • Bleeding (the most common adverse reaction overall) — may present as bruising, nosebleeds, gum bleeding, blood in urine or stool, or heavier menstrual bleeding.
  • Nausea
  • Elevated liver enzymes (transaminases)

Serious/Less Common

  • Major bleeding, including gastrointestinal hemorrhage and intracranial hemorrhage
  • Epidural or spinal hematoma in patients undergoing neuraxial anesthesia or spinal puncture (see Precautions and Warnings)
  • Hypersensitivity reactions, including rash, pruritus, and rarely angioedema or anaphylaxis
  • Anemia

Patients taking Rivaroxaban should seek immediate medical attention for signs of serious bleeding (unusual bruising, pink/brown urine, red/black stools, coughing or vomiting blood, severe headache, dizziness, or weakness).

Contraindications of Rivaroxaban

  • Known hypersensitivity to Rivaroxaban or any excipient of the formulation.
  • Active, clinically significant pathological bleeding.
  • Severe hepatic impairment or any hepatic disease associated with coagulopathy and clinically relevant bleeding risk.

Renal impairment, concurrent use with other anticoagulants, and other bleeding-risk conditions are important precautions for Rivaroxaban rather than absolute contraindications — see Precautions and Warnings.

Frequently Asked Questions about Rivaroxaban

What is Rivaroxaban used for?

Rivaroxaban is an anticoagulant (blood thinner) used to prevent stroke in people with atrial fibrillation, and to treat and prevent blood clots such as deep vein thrombosis (DVT) and pulmonary embolism (PE). It is also used after hip or knee replacement surgery to prevent blood clots, and in combination with low-dose aspirin to reduce the risk of heart attack, stroke, and cardiovascular death in people with chronic coronary or peripheral artery disease.

Can I stop taking Rivaroxaban if I feel fine?

No. Do not stop taking Rivaroxaban without first talking to your physician. Stopping Rivaroxaban suddenly, especially in atrial fibrillation, significantly increases the risk of stroke and other blood clot-related events. If your doctor needs you to stop Rivaroxaban for a reason other than bleeding, they may switch you to another anticoagulant to keep you protected during the transition.

Do I need regular blood tests while taking Rivaroxaban?

Unlike warfarin, Rivaroxaban does not require routine coagulation (INR) monitoring. However, your physician may periodically check your kidney and liver function, and complete blood count, to ensure the medicine remains safe for you.

Is it safe to take Rivaroxaban if I need surgery or a dental procedure?

You must inform every healthcare provider, including your surgeon, dentist, or anesthesiologist, that you are taking Rivaroxaban before any procedure. Rivaroxaban is usually stopped at least 24 hours before elective surgery to reduce bleeding risk, and particular caution is needed around spinal or epidural anesthesia because of a risk of spinal or epidural hematoma, which can rarely cause long-term or permanent paralysis. Only restart Rivaroxaban after surgery when your doctor confirms it is safe to do so.

Can I take Rivaroxaban during pregnancy or while breastfeeding?

Rivaroxaban is generally not recommended during pregnancy because its safety has not been established and it may increase bleeding risk for both mother and baby; it should be used only if your physician determines the benefit clearly outweighs the risk. Whether Rivaroxaban passes into breast milk in significant amounts is not fully known, so breastfeeding mothers should consult their physician, who may recommend avoiding breastfeeding or avoiding Rivaroxaban while nursing.

What should I do if I miss a dose or think I've taken too much Rivaroxaban?

If you miss a dose of Rivaroxaban, take it as soon as you remember on the same day; do not double the dose the next day. If you suspect you have taken too much Rivaroxaban or notice signs of serious bleeding (such as blood in urine or stool, black stools, severe headache, or unusual bruising), seek immediate medical attention or contact emergency services right away.

Disclaimer

The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.

DoctorBlogArticles