Xarelto

Xarelto (rivaroxaban) is an oral anticoagulant and a direct factor Xa inhibitor. It is used to prevent and treat blood clots such as deep vein thrombosis (DVT) and pulmonary embolism (PE) and to reduce the risk of stroke in patients with non-valvular atrial fibrillation. Unlike warfarin, Xarelto does not require routine blood monitoring.

2. Indications

  • Stroke Prevention in Non-Valvular Atrial Fibrillation (NVAF)
  • Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE)
  • Prevention of Recurrence of DVT and PE
  • Prevention of Venous Thromboembolism (VTE) After Surgery (e.g., hip or knee replacement)
  • Reduction of Cardiovascular Events in Coronary Artery Disease (CAD) and Peripheral Artery Disease (PAD)

3. Dosage

Adults:

  • Stroke Prevention in NVAF:
    • 20 mg once daily with food.
    • If CrCl 15–50 mL/min: Reduce to 15 mg once daily.
  • DVT/PE Treatment:
    • 15 mg twice daily with food for 21 days, followed by 20 mg once daily.
    • If CrCl <15 mL/min: Avoid use.
  • DVT/PE Prevention:
    • 10 mg once daily after initial treatment for at least 6 months.
  • Post-Surgical VTE Prevention (Hip/Knee Replacement):
    • 10 mg once daily for 14 days (knee) or 35 days (hip).
  • CAD/PAD Risk Reduction:
    • 2.5 mg twice daily with aspirin (75–100 mg daily).

Elderly:

  • No dose adjustment is required, but monitor renal function closely.

Children:

  • Approved for DVT/PE treatment in children ≥50 kg: 20 mg once daily.
  • <50 kg: Dosing based on weight.

Renal Impairment:

  • CrCl 15–50 mL/min: Dose reduction required.
  • CrCl <15 mL/min: Contraindicated.

Hepatic Impairment:

  • Avoid in moderate to severe hepatic impairment (Child-Pugh B or C).

4. Administration

  • Take with food to enhance absorption, especially doses of 15 mg or more.
  • For patients unable to swallow tablets, rivaroxaban may be crushed and mixed with water or apple puree.

5. Forms Available

  • Tablets: 2.5 mg, 10 mg, 15 mg, 20 mg

6. Side Effects

6.1 Common Side Effects:

  • Bleeding (e.g., nosebleeds, gum bleeding)
  • Bruising
  • Nausea

6.2 Less Common Side Effects:

  • Anaemia
  • Fatigue
  • Dizziness

6.3 Rare but Serious Side Effects:

  • Major bleeding (e.g., gastrointestinal, intracranial)
  • Severe allergic reactions (e.g., angioedema, rash)
  • Hepatotoxicity (liver enzyme elevations)

7. Warnings

  • Bleeding Risk: Use cautiously in patients with a high risk of bleeding.
  • Spinal/Epidural Haematoma: Increased risk in patients undergoing spinal puncture or epidural anaesthesia.
  • Renal Impairment: Adjust dose in moderate impairment; avoid in severe impairment.
  • Discontinuation Risk: Stopping rivaroxaban prematurely increases the risk of thrombotic events.

8. Precautions

  • Avoid in patients with active bleeding or severe liver disease associated with coagulopathy.
  • Use cautiously in elderly patients, who are at higher risk of bleeding.
  • Avoid in pregnancy and lactation unless the benefit outweighs the risk.

9. Interactions

  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): Increased rivaroxaban levels and bleeding risk.
  • CYP3A4 inducers (e.g., rifampin, carbamazepine): Reduced efficacy of rivaroxaban.
  • Anticoagulants/Antiplatelets (e.g., aspirin, clopidogrel): Increased bleeding risk.
  • NSAIDs: Higher risk of gastrointestinal bleeding.

10. Monitoring Parameters

  • Assess renal function (serum creatinine, CrCl) before and during treatment.
  • Monitor for signs of bleeding (e.g., haematuria, black stools).
  • Evaluate liver function if clinical signs of hepatotoxicity occur.

11. Use in Children

  • Approved for DVT/PE in children ≥50 kg with a dose of 20 mg once daily.
  • <50 kg: Dose based on weight.

12. Use in Pregnancy

  • Category C: Avoid unless benefits outweigh risks; limited safety data in pregnancy.

13. Use in Elderly

  • Safe for use in elderly patients at standard doses. Monitor closely for renal function and bleeding risks.

14. Use in Kidney Disease

  • CrCl 15–50 mL/min: Dose adjustment required.
  • CrCl <15 mL/min: Contraindicated.

15. Use in Liver Disease

  • Contraindicated in patients with significant liver disease associated with coagulopathy.

16. Patient Counselling Points

  • Take Xarelto exactly as prescribed, with food if required, and do not skip doses.
  • Inform your doctor if you notice unusual bleeding, bruising, or signs of severe bleeding (e.g., black stools, coughing up blood).
  • Avoid combining Xarelto with NSAIDs or other blood-thinning medications without medical advice.
  • Discuss any upcoming surgeries or dental procedures with your doctor, as Xarelto may need to be stopped beforehand.
  • Avoid alcohol, as it may increase the risk of bleeding.

17. Table of Brand Names, Manufacturer, and Prices in USD

Brand NameManufacturerStrength/Dosage FormPrice (USD)
XareltoBayer20 mg Tablet$450 (30 tablets)
Generic RivaroxabanVarious20 mg Tablet$300 (30 tablets)

18. 15 FAQs (Frequently Asked Questions)

1. What is Xarelto used for?
It is used to prevent and treat blood clots (DVT, PE) and reduce the risk of stroke in atrial fibrillation.

2. How does Xarelto work?
It inhibits factor Xa, preventing the formation of blood clots.

3. Can Xarelto cause bleeding?
Yes, bleeding is the most common side effect.

4. Should Xarelto be taken with food?
Yes, doses of 15 mg or more should be taken with food for optimal absorption.

5. Can Xarelto be used during pregnancy?
It is generally not recommended unless the benefits outweigh the risks.

6. What should I do if I miss a dose of Xarelto?
Take the missed dose as soon as you remember on the same day. Do not double doses.

7. Can Xarelto be stopped suddenly?
No, stopping abruptly increases the risk of blood clots. Consult your doctor before discontinuing.

8. Can Xarelto be taken with aspirin?
Yes, but only under medical supervision, as the combination increases bleeding risk.

9. Does Xarelto require blood monitoring?
Routine monitoring is not required, but periodic kidney and liver function tests may be needed.

10. Can Xarelto be crushed?
Yes, tablets can be crushed and mixed with water or puree for patients unable to swallow.

11. How long is Xarelto prescribed after surgery?
14 days for knee replacement and 35 days for hip replacement.

12. Can Xarelto cause liver problems?
Rarely, it may cause elevated liver enzymes or hepatotoxicity.

13. Is Xarelto safe for elderly patients?
Yes, but they should be monitored for bleeding risks.

14. Can Xarelto interact with antibiotics?
Yes, certain antibiotics (e.g., erythromycin) may increase bleeding risk.

15. What should I do if I experience severe bleeding on Xarelto?
Seek immediate medical attention.