rivaroxaban

Rivaroxaban is an oral anticoagulant (blood thinner) that is used to prevent and treat blood clots. Blood clots formed in the heart are dangerous since they can travel to the brain and cause a stroke. Similarly, blood clots formed in the legs or lungs can be equally life threatening if not treated.

Rivaroxaban is a selective inhibitor of factor Xa, an enzyme necessary to form blood clots. It reduces the ability of blood to clot. The FDA approved rivaroxaban in July, 2011.

Rivaroxaban is a prescription medicine used to:

• reduce the risk of stroke and blood clots in patients with atrial fibrillation not due to a heart valve problem,
• treat and reduce the risk of deep vein thrombosis (DVT, blood clots in the veins of the legs) and pulmonary embolism (PE, blood clots in the lungs) and
• reduce the risk of blood clots in the legs and lungs of patients who have just had hip or knee replacement surgery.
• in combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular (CV) death, myocardial infarction [MI] and stroke) in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD).

The most common side effect of rivaroxaban is bleeding. The risk of bleeding is higher when rivaroxaban is taken with medicines such as aspirin or aspirin-containing products, nonsteroidal anti-inflammatory drugs (NSAIDS), warfarin (Jantoven), heparin, clopidogrel (Plavix), and other medicines used to prevent or treat blood clots.

Some rare but serious cases of bleeding and paralysis have been reported with the use of rivaroxaban in patients undergoing spinal or epidural procedures. Risk is highest in patients who have problems with their spine, use indwelling epidural catheters, have had spinal surgery, or use other medicines that prevent clotting or make them more likely to bleed.

Other common side effects of rivaroxaban include:

• Back pain
• Pruritus
• Elevated levels of liver enzymes

Serious side effects of rivaroxaban include:

• Severe bleeding
• Hepatitis
• Decreased platelets
• Allergic reactions
• Stevens-Johnson syndrome

• To reduce the risk of stroke in nonvalvular atrial fibrillation, patients with creatinine clearance (a measure of kidney function) >50 ml/min should be given 20 mg once a day with the evening meal. (Xarelto is better absorbed if it is given with food.)  Patients with creatinine clearance between 15 to 50 ml/min should be given 15 mg once a day with the evening meal.
• To treat blood DVT or pulmonary embolism, 15 mg is administered by mouth twice daily with food for the first 21 days, followed by 20 mg once daily with food for 6 months.
• To reduce the risk of recurrence of DVT or pulmonary embolism, 20 mg should be administered by mouth once daily with food.
• To prevent DVT following hip replacement surgery, 10 mg is administered by mouth once daily for 35 days.
• To prevent DVT following knee replacement surgery, 10 mg is administered by mouth once daily for 12 days.
• When switching from warfarin (Coumadin) to rivaroxaban, warfarin should be stopped and then rivaroxaban started as soon as the international normalized ratio (a measure of the effects of warfarin) is < 3.0.
• When switching from blood thinning medicines other than warfarin to rivaroxaban, rivaroxaban should be started up to 2 hours before or at the time of the next scheduled evening dose.
• Use of rivaroxaban is not recommended in patients with moderate (Child-Pugh B) and severe (Child-Pugh C) liver disease or another type of liver disease associated with blood disorders.
• To avoid serious side effects rivaroxaban should not be used in patients with significantly reduced kidney function defined as creatinine clearance <30 ml/min.
• Patients who are having difficulty swallowing whole tablets can crush the 10 mg, 15 mg, and 20 mg tablets and mix with applesauce immediately before use.
• Note: While the 15 and 20 mg tablets should be taken with food, the 10 mg tablets can be taken with or without food.

The CYP3A4 liver enzymes and P-glycoprotein (P-gp) drug transporter systems are primarily responsible for metabolizing and removing rivaroxaban from the body. Taking rivaroxaban with medicines that alter the activity of both the CYP3A4 enzymes and P-gp drug transporters may affect blood levels of rivaroxaban. Rivaroxaban should not be taken with:

• ketoconazole (Nizoral),
•  ritonavir (Norvir),
• clarithromycin (Biaxin),
• erythromycin (Ery-Tabs),
• fluconazole (Diflucan),
• carbamazepine (Tegretol),
• phenytoin (Dilantin),
• rifampin (Rimactane), or,
• St. John's Wort.

Rivaroxaban should not be used with other blood thinners due to the increased risk of bleeding.

• Due to the lack of conclusive safety data, rivaroxaban should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Rivaroxaban is classified as FDA pregnancy risk category C (animal studies show harm but there are no adequate studies in humans).
• It is not known if rivaroxaban is excreted in breast milk. Because many drugs enter human milk and have the potential of causing harm to the nursing baby, rivaroxaban should be used cautiously in nursing mothers.

Do I need a prescription for rivaroxaban?

Yes

What preparations of rivaroxaban are available?

Oral tablets: 10, 15, and 20 mg.

How should I keep rivaroxaban stored?

Tablets should be stored at room temperature, between 15 C to 30 C (59 F to 86 F).