Rivaroxaban

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Success Rate
(as defined by FDA)

Approved on FDA label^* for

Common Side Effects

Risk of Death

Rivaroxaban
(Xarelto)

95.9%

Cardiovascular Events Prevention

0.1% - 1.0%

Rivaroxaban
(Xarelto)

98.9% (Hip) 90.3% (Knee)

Deep Vein Thrombosis or Pulmonary Embolism - Hip or Knee Surgery

0.1% - 1.0%

Rivaroxaban
(Xarelto)

98.8%

Deep Vein Thrombosis or Pulmonary Embolism - Reduce Recurrence

0.1% - 1.0%

Rivaroxaban
(Xarelto)

97.9%

Deep Vein Thrombosis or Pulmonary Embolism - Treatment

0.1% - 1.0%

Rivaroxaban
(Xarelto)

96.4%

Stroke Prevention - Atrial Fibrillation

0.1% - 1.0%

Rivaroxaban

Success Rate for

Approved label for

Common Side Effects of

Risk of Death for

Rivaroxaban

Success Rate for

Approved label for

Common Side Effects of

Risk of Death for

Rivaroxaban

Success Rate for

Approved label for

Common Side Effects of

Risk of Death for

Rivaroxaban

Success Rate for

Approved label for

Common Side Effects of

Risk of Death for

Rivaroxaban

Success Rate for

Approved label for

Common Side Effects of

Risk of Death for

* If your condition is not listed in this table, your doctor may have prescribed this drug to you off-label. Doctors prescribe drugs off-label for unapproved uses, believing the drugs to be effective and safe as supported by scientific evidence, expert consensus, or practice guidelines. An estimated 20% of all drugs are prescribed off-label.

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Ranking

Telephone

Address

Website Link

University of Texas MD Anderson Cancer Center

888-512-7249, #2

1515 Holcombe Blvd.
Houston, TX 77030
United States

Cancer

Memorial Sloan-Kettering Cancer Center

800-525-2225

1275 York Avenue
New York, NY 10065
United States

Cancer

Mayo Clinic

800-446-2279

200 1st Street, SW
Rochester, MN 55905
United States

Cancer

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Success Rate (as defined by FDA)

FDA Definition of Success

The evidence for the efficacy and safety of XARELTO for the reduction in the risk of stroke, myocardial infarction, or cardiovascular death in patients with coronary artery disease (CAD) or peripheral artery disease (PAD) was derived from the double-blind Cardiovascular OutcoMes for People using Anticoagulation StrategieS trial (COMPASS) [NCT10776424]. The mean age was 68 years and 21% of the subject population were ≥75 years. Of the included patients, 91% had CAD, 27% had PAD, and 18% had both CAD and PAD. Of the patients with CAD, 69% had prior MI, 60% had prior percutaneous transluminal coronary angioplasty (PTCA)/atherectomy/ percutaneous coronary intervention (PCI), and 26% had history of coronary artery bypass grafting (CABG) prior to study. Of the patients with PAD, 49% had intermittent claudication, 27% had peripheral artery bypass surgery or peripheral percutaneous transluminal angioplasty, 26% had asymptomatic carotid artery stenosis > 50%, and 4% had limb or foot amputation for arterial vascular disease.

The mean duration of follow-up was 23 months. Relative to aspirin alone, XARELTO plus aspirin reduced the rate of the primary composite outcome of stroke, myocardial infarction or cardiovascular death. The benefit was observed early with a constant treatment effect over the entire treatment period.

Over the course of 23 months, 4.1% of the subjects suffered Stroke, Myocardial Infarction or Cardiovascular death on Xarelto plus aspirin vs. 5.4% with aspirin alone.

Sourced from:

FDA label, Section 14.5

Approved on FDA Label for Rivaroxaban

FDA Definition of Success

Over the course of 23 months, 4.1% of the subjects suffered Stroke, Myocardial Infarction or Cardiovascular death on Xarelto plus aspirin vs. 5.4% with aspirin alone.

Sourced from:

FDA label, Section 14.5

Common Side Effects for Rivaroxaban

Cardiovascular

Frequency

Anemia

1% to 10%

Anxiety reaction

1% to 10%

Any bleeding

10% or more

Arthralgia

1% to 10%

Back pain

1% to 10%

Blister

1% to 10%

Constipation

1% to 10%

Contusion

1% to 10%

Cutaneous hemorrhage

1% to 10%

Decreased general strength and energy

1% to 10%

Deep vein thrombosis

1% to 10%

Diarrhea

1% to 10%

Dizziness

1% to 10%

Dyspepsia

1% to 10%

Dyspnea

1% to 10%

Ecchymosis

1% to 10%

Epistaxis

1% to 10%

Eye hemorrhage

1% to 10%

Fever

1% to 10%

Gastrointestinal bleeding

1% to 10%

Gastrointestinal hemorrhage

1% to 10%

Gingival bleeding,

1% to 10%

Headache

1% to 10%

Hematoma

1% to 10%

Hemoptysis

1% to 10%

Hypertension

1% to 10%

Hypotension

1% to 10%

Increase in transaminases

1% to 10%

Increased muscle tone and cramping

1% to 10%

Muscle spasm

1% to 10%

Nausea

1% to 10%

Oropharyngeal pain

1% to 10%

Osteoarthritis

1% to 10%

Pain in extremity

1% to 10%

Peripheral edema

1% to 10%

Pruritus

1% to 10%

Rash

1% to 10%

Renal impairment

1% to 10%

Sleep disorder

1% to 10%

Sinusitis

1% to 10%

Subcutaneous hemorrhage

1% to 10%

Syncope

1% to 10%

Tachycardia

1% to 10%

Toothache

1% to 10%

Upper abdominal pain

1% to 10%

Urinary retention

1% to 10%

Urogenital tract hemorrhaging

1% to 10%

Vaginal hemorrhage

1% to 10%

Vomiting

1% to 10%

Wound hemorrhage

1% to 10%

Wound secretion

1% to 10%

Sourced from Drugs.com. The side effects above have reportedly occurred most often. To learn about side effects occurring less than 1% of the time or whose frequency is unknown, please consult Drugs.com.

Risk of Death for Rivaroxaban

Death is a side effect that can occur 0.1% to 1% of the time with this drug.

Sourced from:

Drugs.com

Success Rate (as defined by FDA)

FDA Definition of Success

XARELTO was studied in 9011 patients (4487 XARELTO-treated, 4524 enoxaparin-treated patients) in the Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE, Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip or Knee Replacement (RECORD 1, 2, and 3) [NCT00329628, NCT00332020, NCT00361894] studies.

There were several Records with varied results. In one Record for Total Hip Replacement Surgery, the Total VTE with Xarelto was 1.1% while Enoxaparin was 3.9%, including 0.2% and 2.1% Major VTE, respectively. In one Record for Total Knee Replacement Surgery, the Total VTE with Xarelto was 9.7% while Enoxaparin was 18.8%, including 1.0% and 2.5% Major VTE, respectively.

Sourced from:

FDA label, Section 14.4

Approved on FDA Label for Rivaroxaban

FDA Definition of Success

XARELTO was studied in 9011 patients (4487 XARELTO-treated, 4524 enoxaparin-treated patients) in the REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE, Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip or Knee Replacement (RECORD 1, 2, and 3) [NCT00329628, NCT00332020, NCT00361894] studies.

Sourced from:

FDA label, Section 14.4

Common Side Effects for Rivaroxaban

Cardiovascular

Frequency

Anemia

1% to 10%

Anxiety reaction

1% to 10%

Any bleeding

10% or more

Arthralgia

1% to 10%

Back pain

1% to 10%

Blister

1% to 10%

Constipation

1% to 10%

Contusion

1% to 10%

Cutaneous hemorrhage

1% to 10%

Decreased general strength and energy

1% to 10%

Deep vein thrombosis

1% to 10%

Diarrhea

1% to 10%

Dizziness

1% to 10%

Dyspepsia

1% to 10%

Dyspnea

1% to 10%

Ecchymosis

1% to 10%

Epistaxis

1% to 10%

Eye hemorrhage

1% to 10%

Fever

1% to 10%

Gastrointestinal bleeding

1% to 10%

Gastrointestinal hemorrhage

1% to 10%

Gingival bleeding,

1% to 10%

Headache

1% to 10%

Hematoma

1% to 10%

Hemoptysis

1% to 10%

Hypertension

1% to 10%

Hypotension

1% to 10%

Increase in transaminases

1% to 10%

Increased muscle tone and cramping

1% to 10%

Muscle spasm

1% to 10%

Nausea

1% to 10%

Oropharyngeal pain

1% to 10%

Osteoarthritis

1% to 10%

Pain in extremity

1% to 10%

Peripheral edema

1% to 10%

Pruritus

1% to 10%

Rash

1% to 10%

Renal impairment

1% to 10%

Sleep disorder

1% to 10%

Sinusitis

1% to 10%

Subcutaneous hemorrhage

1% to 10%

Syncope

1% to 10%

Tachycardia

1% to 10%

Toothache

1% to 10%

Upper abdominal pain

1% to 10%

Urinary retention

1% to 10%

Urogenital tract hemorrhaging

1% to 10%

Vaginal hemorrhage

1% to 10%

Vomiting

1% to 10%

Wound hemorrhage

1% to 10%

Wound secretion

1% to 10%

Risk of Death for Rivaroxaban

Death is a side effect that can occur 0.1% to 1% of the time with this drug.

Sourced from:

Drugs.com

Success Rate (as defined by FDA)

FDA Definition of Success

XARELTO for reduction in the risk of recurrence of DVT and of PE was evaluated in the EINSTEIN CHOICE study [NCT02064439], a multi-national, double-blind, superiority study comparing XARELTO (10 or 20 mg once daily with food) to 100 mg acetylsalicylic acid (aspirin) once daily in patients who had completed 6 to 12 months of anticoagulant treatment for DVT and/or PE following the acute event. Over 12 months, 1.2% of Xarelto subjects and 4.4% of Aspirin subjects had recurrent events.

Sourced from:

FDA label, Section 14.3

Approved on FDA Label for Rivaroxaban

FDA Definition of Success

Sourced from:

FDA label, Section 14.3

Common Side Effects for Rivaroxaban

Cardiovascular

Frequency

Anemia

1% to 10%

Anxiety reaction

1% to 10%

Any bleeding

10% or more

Arthralgia

1% to 10%

Back pain

1% to 10%

Blister

1% to 10%

Constipation

1% to 10%

Contusion

1% to 10%

Cutaneous hemorrhage

1% to 10%

Decreased general strength and energy

1% to 10%

Deep vein thrombosis

1% to 10%

Diarrhea

1% to 10%

Dizziness

1% to 10%

Dyspepsia

1% to 10%

Dyspnea

1% to 10%

Ecchymosis

1% to 10%

Epistaxis

1% to 10%

Eye hemorrhage

1% to 10%

Fever

1% to 10%

Gastrointestinal bleeding

1% to 10%

Gastrointestinal hemorrhage

1% to 10%

Gingival bleeding,

1% to 10%

Headache

1% to 10%

Hematoma

1% to 10%

Hemoptysis

1% to 10%

Hypertension

1% to 10%

Hypotension

1% to 10%

Increase in transaminases

1% to 10%

Increased muscle tone and cramping

1% to 10%

Muscle spasm

1% to 10%

Nausea

1% to 10%

Oropharyngeal pain

1% to 10%

Osteoarthritis

1% to 10%

Pain in extremity

1% to 10%

Peripheral edema

1% to 10%

Pruritus

1% to 10%

Rash

1% to 10%

Renal impairment

1% to 10%

Sleep disorder

1% to 10%

Sinusitis

1% to 10%

Subcutaneous hemorrhage

1% to 10%

Syncope

1% to 10%

Tachycardia

1% to 10%

Toothache

1% to 10%

Upper abdominal pain

1% to 10%

Urinary retention

1% to 10%

Urogenital tract hemorrhaging

1% to 10%

Vaginal hemorrhage

1% to 10%

Vomiting

1% to 10%

Wound hemorrhage

1% to 10%

Wound secretion

1% to 10%

Risk of Death for Rivaroxaban

Death is a side effect that can occur 0.1% to 1% of the time with this drug.

Sourced from:

Drugs.com

Success Rate (as defined by FDA)

FDA Definition of Success

XARELTO for the treatment of DVT and/or PE was studied in EINSTEIN DVT [NCT00440193] and EINSTEIN PE [NCT00439777], multi-national, open-label, non-inferiority studies comparing XARELTO (at an initial dose of 15 mg twice daily with food for the first three weeks, followed by XARELTO 20 mg once daily with food) to enoxaparin 1 mg/kg twice daily for at least five days with VKA and then continued with VKA only after the target INR (2.0-3.0) was reached. Patients who required thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent and patients with creatinine clearance <30 mL/min, significant liver disease, or active bleeding were excluded from the studies. The intended treatment duration was 3, 6, or 12 months based on investigator's assessment prior to randomization.

In the EINSTEIN DVT and EINSTEIN PE studies, 49% of patients had an idiopathic DVT/PE at baseline. Other risk factors included previous episode of DVT/PE (19%), recent surgery or trauma (18%), immobilization (16%), use of estrogen-containing drug (8%), known thrombophilic conditions (6%), or active cancer (5%). In the EINSTEIN DVT and EINSTEIN PE studies, XARELTO was demonstrated to be noninferior to enoxaparin/VKA for the primary composite endpoint of time to first occurrence of recurrent DVT or non-fatal or fatal PE.

The primary composite endpoint was the time to first occurrence of recurrent DVT or non-fatal or fata PE. For DVT, the Xarelto result was 2.1% and the Enoxaparin/VKA result 3.0%; and for PE, the Xarelto result was 2.1% and the Enoxaparin/VKA result 1.8%.

Sourced from:

FDA label, Section 14.2

Approved on FDA Label for Rivaroxaban

FDA Definition of Success

Sourced from:

FDA label, Section 14.2

Common Side Effects for Rivaroxaban

Cardiovascular

Frequency

Anemia

1% to 10%

Anxiety reaction

1% to 10%

Any bleeding

10% or more

Arthralgia

1% to 10%

Back pain

1% to 10%

Blister

1% to 10%

Constipation

1% to 10%

Contusion

1% to 10%

Cutaneous hemorrhage

1% to 10%

Decreased general strength and energy

1% to 10%

Deep vein thrombosis

1% to 10%

Diarrhea

1% to 10%

Dizziness

1% to 10%

Dyspepsia

1% to 10%

Dyspnea

1% to 10%

Ecchymosis

1% to 10%

Epistaxis

1% to 10%

Eye hemorrhage

1% to 10%

Fever

1% to 10%

Gastrointestinal bleeding

1% to 10%

Gastrointestinal hemorrhage

1% to 10%

Gingival bleeding,

1% to 10%

Headache

1% to 10%

Hematoma

1% to 10%

Hemoptysis

1% to 10%

Hypertension

1% to 10%

Hypotension

1% to 10%

Increase in transaminases

1% to 10%

Increased muscle tone and cramping

1% to 10%

Muscle spasm

1% to 10%

Nausea

1% to 10%

Oropharyngeal pain

1% to 10%

Osteoarthritis

1% to 10%

Pain in extremity

1% to 10%

Peripheral edema

1% to 10%

Pruritus

1% to 10%

Rash

1% to 10%

Renal impairment

1% to 10%

Sleep disorder

1% to 10%

Sinusitis

1% to 10%

Subcutaneous hemorrhage

1% to 10%

Syncope

1% to 10%

Tachycardia

1% to 10%

Toothache

1% to 10%

Upper abdominal pain

1% to 10%

Urinary retention

1% to 10%

Urogenital tract hemorrhaging

1% to 10%

Vaginal hemorrhage

1% to 10%

Vomiting

1% to 10%

Wound hemorrhage

1% to 10%

Wound secretion

1% to 10%

Risk of Death for Rivaroxaban

Death is a side effect that can occur 0.1% to 1% of the time with this drug.

Sourced from:

Drugs.com

Success Rate (as defined by FDA)

FDA Definition of Success

World-leading cardiologists employ these two easy-to-take tests to help determine if an anticoagulant is right for atrial fibrillation patients:

Test 1 and Test 2

FDA Definition of Success

The evidence for the efficacy and safety of XARELTO was derived from Rivaroxaban Once-daily oral direct factor Xa inhibition Compared with vitamin K antagonist for the prevention of stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) [NCT00403767], a multi-national, double-blind study comparing XARELTO (at a dose of 20 mg once daily with the evening meal in patients with CrCl >50 mL/min and 15 mg once daily with the evening meal in patients with CrCl 30 to 50 mL/min) to warfarin (titrated to INR 2.0 to 3.0) to reduce the risk of stroke and noncentral nervous system (CNS) systemic embolism in patients with nonvalvular atrial fibrillation (AF). Patients had to have one or more of the following additional risk factors for stroke:

a prior stroke (ischemic or unknown type), transient ischemic attack (TIA) or non-CNS systemic embolism, or
2 or more of the following risk factors:
- age ≥75 years,
- hypertension,
- heart failure or left ventricular ejection fraction ≤35%, or
- diabetes mellitus

In ROCKET AF, XARELTO was demonstrated non-inferior to warfarin for the primary composite endpoint of time to first occurrence of stroke (any type) or non-CNS systemic embolism [HR (95% CI): 0.88 (0.74, 1.03)], but superiority to warfarin was not demonstrated. There is insufficient experience to determine how XARELTO and warfarin compare when warfarin therapy is well-controlled.

The primary composite endpoint was the time to first occurrence of stroke (any type) or non-CNS systemic embolism. For Xarelto the result was 3.8% and for Warfarin 4.3%; and for stroke only, 3.6% and 4.0%, respectively.

Sourced from:

FDA label, Section 14.1

Approved on FDA Label for Rivaroxaban

FDA Definition of Success

World-leading cardiologists employ these two easy-to-take tests to help determine if an anticoagulant is right for atrial fibrillation patients:

Test 1 and Test 2

FDA Definition of Success

a prior stroke (ischemic or unknown type), transient ischemic attack (TIA) or non-CNS systemic embolism, or
2 or more of the following risk factors:
- age ≥75 years,
- hypertension,
- heart failure or left ventricular ejection fraction ≤35%, or
- diabetes mellitus

Sourced from:

FDA label, Section 14.1

Common Side Effects for Rivaroxaban

Cardiovascular

Frequency

Anemia

1% to 10%

Anxiety reaction

1% to 10%

Any bleeding

10% or more

Arthralgia

1% to 10%

Back pain

1% to 10%

Blister

1% to 10%

Constipation

1% to 10%

Contusion

1% to 10%

Cutaneous hemorrhage

1% to 10%

Decreased general strength and energy

1% to 10%

Deep vein thrombosis

1% to 10%

Diarrhea

1% to 10%

Dizziness

1% to 10%

Dyspepsia

1% to 10%

Dyspnea

1% to 10%

Ecchymosis

1% to 10%

Epistaxis

1% to 10%

Eye hemorrhage

1% to 10%

Fever

1% to 10%

Gastrointestinal bleeding

1% to 10%

Gastrointestinal hemorrhage

1% to 10%

Gingival bleeding,

1% to 10%

Headache

1% to 10%

Hematoma

1% to 10%

Hemoptysis

1% to 10%

Hypertension

1% to 10%

Hypotension

1% to 10%

Increase in transaminases

1% to 10%

Increased muscle tone and cramping

1% to 10%

Muscle spasm

1% to 10%

Nausea

1% to 10%

Oropharyngeal pain

1% to 10%

Osteoarthritis

1% to 10%

Pain in extremity

1% to 10%

Peripheral edema

1% to 10%

Pruritus

1% to 10%

Rash

1% to 10%

Renal impairment

1% to 10%

Sleep disorder

1% to 10%

Sinusitis

1% to 10%

Subcutaneous hemorrhage

1% to 10%

Syncope

1% to 10%

Tachycardia

1% to 10%

Toothache

1% to 10%

Upper abdominal pain

1% to 10%

Urinary retention

1% to 10%

Urogenital tract hemorrhaging

1% to 10%

Vaginal hemorrhage

1% to 10%

Vomiting

1% to 10%

Wound hemorrhage

1% to 10%

Wound secretion

1% to 10%

Disclaimer:

Risk of Death for Rivaroxaban

Death is a side effect that can occur 0.1% to 1% of the time with this drug.

Sourced from:

Drugs.com

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