Rivaroxaban

Pulmonary Embolism, Venous Thrombosis

DRUG STATUS

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Approvals

US(FDA), UK(BNF)

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Essential Medicine

NO

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Teratogenicity

Unlisted

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Pharmaceutical Class

Factor Xa Inhibitor

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Drug Ingredient

Rivaroxaban

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Summary

  • Rivaroxaban is used to prevent and treat blood clots in your legs (deep vein thrombosis) and lungs (pulmonary embolism). It's also used to reduce the risk of stroke in people with a heart condition called atrial fibrillation.

  • Rivaroxaban works by inhibiting a key enzyme in the blood clotting process called Factor Xa. By blocking this enzyme, it prevents the formation of blood clots.

  • The typical daily dosage for adults varies depending on the condition being treated. Usually, it's taken once daily, with doses ranging from 10 to 20 mg. For doses of 15 mg or more, it's recommended to take it with food.

  • Common side effects include bleeding, bruising, headache, dizziness, and stomach upset. Serious side effects may include severe bleeding, allergic reactions, liver problems, and kidney dysfunction.

  • Rivaroxaban should not be used by people with active bleeding, severe liver disease, or those who are allergic to it. It should also be avoided during pregnancy. Caution is required for individuals with kidney problems or those undergoing surgery.

Indications and Purpose

What is Rivaroxaban used for?

Rivaroxaban is a medication used to treat and prevent blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism). It is also used to prevent these clots from recurring after initial treatment.

How does Rivaroxaban work?

Rivaroxaban works by inhibiting Factor Xa, an enzyme crucial for the blood clotting process. By blocking Factor Xa, it prevents the conversion of prothrombin to thrombin, reducing the formation of fibrin clots. This helps prevent and treat blood clots, reducing the risk of conditions like deep vein thrombosis (DVT), pulmonary embolism (PE), and stroke.

Is Rivaroxaban effective?

Clinical trials have shown that Rivaroxaban effectively reduces the risk of blood clots, stroke, and systemic embolism. In studies like the ROCKET AF trial, it demonstrated similar or superior efficacy compared to warfarin in preventing strokes in atrial fibrillation patients. Rivaroxaban also proved effective in treating and preventing deep vein thrombosis (DVT) and pulmonary embolism (PE) with a favorable safety profile.

How does one know if Rivaroxaban is working?

The benefit of Rivaroxaban is evaluated through clinical trials and regular monitoring of patient outcomes. Key measures include reduced incidence of blood clots, strokes, and pulmonary embolism (PE). In addition, blood tests may be used to monitor clotting function and assess the drug’s effectiveness, although Rivaroxaban typically doesn’t require routine coagulation monitoring.

Directions for Use

What is the usual dose of Rivaroxaban?

For adults, the usual dose of rivaroxaban is:

  • Atrial Fibrillation: 20 mg once daily.
  • Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE):
  • Post-Surgery Prophylaxis: 10 mg once daily.

For children, dosing is based on weight:

  • Weight 20 to 29.9 kg: 2.5 mg twice daily.
  • Weight 30 to 49.9 kg: 7.5 mg once daily.
  • Weight ≥50 kg: 10 mg once daily.

Always consult a healthcare provider for personalized dosing

  • Initial: 15 mg twice daily for the first 21 days.
  • Maintenance: 20 mg once daily thereafter..

How do I take Rivaroxaban?

Rivaroxaban should be taken exactly as prescribed by a healthcare provider. For doses of 15 mg or higher, it should be taken with food to enhance absorption. There are no specific food restrictions, but it’s important to avoid excessive alcohol consumption as it may affect the medicine's effectiveness. Always take the medication at the same time each day for consistency.

For how long do I take Rivaroxaban?

  • Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE): Usually prescribed for at least 3 months. Treatment may be extended based on individual risk factors.
  • Post-Surgery Prophylaxis: Generally used for 2 to 5 weeks following hip or knee replacement surgery.
  • Atrial Fibrillation: Often requires long-term treatment, potentially for life, depending on the patient's risk profile.

How long does it take for Rivaroxaban to start working?

Rivaroxaban starts working within a few hours of taking it, meaning its blood-thinning effects begin relatively soon after ingestion.

How should I store Rivaroxaban?

Store the medication at normal room temperature between 68°F to 77°F (20°C to 25°C). It's okay if the temperature goes up to 86°F (30°C) or down to 59°F (15°C) for a short time. Do not freeze the medicine.

Warnings and Precautions

Who should avoid taking Rivaroxaban?

Rivaroxaban should not be used in people with active bleeding, severe liver disease, or those who are allergic to it. It should also be avoided during pregnancy unless prescribed. Caution is required for individuals with kidney problems or those undergoing surgery, as Rivaroxaban increases bleeding risk. It should not be combined with other blood thinners without medical supervision.

Can I take Rivaroxaban with other prescription drugs?

Rivaroxaban can interact with several prescription drugs, increasing the risk of bleeding. Notable interactions include:

  1. Antiplatelet drugs (e.g., aspirin, clopidogrel)
  2. Other anticoagulants (e.g., warfarin, heparin)
  3. Antifungals (e.g., ketoconazole)
  4. HIV medications (e.g., ritonavir)

Can I take Rivaroxaban with vitamins or supplements?

Rivaroxaban can interact with certain vitamins and supplements. High doses of vitamin E or fish oil may increase the risk of bleeding. St. John's Wort can reduce the effectiveness of Rivaroxaban by affecting its metabolism. Always consult a healthcare provider before taking vitamins or supplements while using Rivaroxaban to avoid potential interactions.

Can Rivaroxaban be taken safely while pregnant?

Rivaroxaban is a medicine that should not be taken by pregnant women. It can cause bleeding problems for both the mother and the baby. If you are pregnant or planning to become pregnant, talk to your doctor about other treatment options.

Can Rivaroxaban be taken safely while breastfeeding?

Talk to your doctor before taking rivaroxaban while breastfeeding. Rivaroxaban passes into breast milk in small amounts, but it's unlikely to harm your baby. However, your doctor may recommend a different medicine with more information available on its safety during breastfeeding.

Is Rivaroxaban safe for the elderly?

  • Lower Doses Recommended: A dose of 10 mg once daily is often better tolerated and may reduce bleeding risks, especially in patients aged 80 and older.
  • Increased Bleeding Risk: Elderly patients are at a higher risk for bleeding due to age-related factors such as renal impairment and increased coagulation factors.
  • No Official Dose Adjustment: Current guidelines do not recommend specific dose adjustments for the elderly, but careful monitoring is essential.
  • Individualized Therapy: Due to variability in tolerance and comorbidities, individualized dosing and regular reassessment of bleeding risks are crucial.

Is it safe to exercise while taking Rivaroxaban?

Exercise is safe but avoid high-risk activities that might cause injury or bruising, as Rivaroxaban increases bleeding risk. If you experience dizziness or unusual bleeding after physical activity, stop and consult your doctor.

Is it safe to drink alcohol while taking Rivaroxaban?

Avoid excessive alcohol consumption while on Rivaroxaban, as it increases the risk of stomach irritation and bleeding. Occasional, moderate alcohol intake may be acceptable—consult your doctor for personalized advice.