Overview
Rivaroxaban is an anticoagulant and the first orally active direct factor Xa inhibitor. Unlike warfarin, routine lab monitoring of INR is not necessary. However there is no antidote available in the event of a major bleed. Only the 10 mg tablet can be taken without regard to food. The 15 mg and 20 mg tablet should be taken with food. FDA approved on July 1, 2011.
Background
Rivaroxaban is an anticoagulant and the first orally active direct factor Xa inhibitor. Unlike warfarin, routine lab monitoring of INR is not necessary. However there is no antidote available in the event of a major bleed. Only the 10 mg tablet can be taken without regard to food. The 15 mg and 20 mg tablet should be taken with food. FDA approved on July 1, 2011.
Indication
Rivaroxaban is indicated for the prevention of venous thromboembolic events (VTE) in patients who have undergone total hips replacements and total knee replacement surgery; prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE); to reduce risk of recurrent DVT and/or PE. Rivaroxaban is also indicated, in combination with aspirin, for reducing the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease. Its use is also not recommended in those with severe renal impairment (<30mL/min). Rivaroxaban is also indicated for the treatment and prevention of VTE in pediatric patients (from birth to 18 years of age) and for thromboprophylaxis in pediatric patients ≥2 years old with congenital heart disease following the Fontan procedure.
Associated Conditions
- Cardiovascular Mortality
- Deep Vein Thrombosis
- Deep vein thrombosis recurrent
- Major Adverse Cardiovascular Events
- Myocardial Infarction
- Pulmonary Embolism
- Recurrent Pulmonary Embolism (Disorder)
- Recurrent Venous Thromboembolism
- Stroke
- Systemic Embolism
- Thrombosis
- Venous Thromboembolism
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/05/18 | Phase 4 | Recruiting | |||
2025/05/08 | Early Phase 1 | Not yet recruiting | |||
2025/05/01 | Phase 4 | Not yet recruiting | |||
2025/02/18 | Phase 1 | Not yet recruiting | |||
2025/02/06 | Phase 4 | Recruiting | |||
2024/11/14 | Not Applicable | Recruiting | |||
2024/10/21 | Phase 4 | Not yet recruiting | Emily McDonald | ||
2024/08/30 | Phase 3 | Not yet recruiting | Wuhan Union Hospital, China | ||
2024/08/16 | Phase 1 | Completed | Dexa Medica Group | ||
2024/08/16 | Phase 1 | Completed | Dexa Medica Group |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Janssen Pharmaceuticals, Inc. | 50458-579 | ORAL | 20 mg in 1 1 | 11/21/2023 | |
A-S Medication Solutions | 50090-3639 | ORAL | 20 mg in 1 1 | 10/15/2018 | |
Alembic Pharmaceuticals Limited | 46708-683 | ORAL | 2.5 mg in 1 1 | 1/30/2025 | |
Cardinal Health 107, LLC | 55154-1423 | ORAL | 20 mg in 1 1 | 11/9/2021 | |
Alembic Pharmaceuticals Limited | 46708-346 | ORAL | 10 mg in 1 1 | 1/30/2025 | |
A-S Medication Solutions | 50090-3625 | ORAL | 10 mg in 1 1 | 11/21/2023 | |
A-S Medication Solutions | 50090-4469 | ORAL | 10 mg in 1 1 | 11/19/2019 | |
Janssen Pharmaceuticals, Inc. | 50458-575 | ORAL | 155 mg in 1 1 | 11/21/2023 | |
Janssen Pharmaceuticals, Inc. | 50458-580 | ORAL | 10 mg in 1 1 | 11/21/2023 | |
Janssen Pharmaceuticals, Inc. | 50458-577 | ORAL | 2.5 mg in 1 1 | 11/21/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 11/16/2020 | ||
Authorised | 9/30/2008 | ||
Authorised | 11/12/2021 | ||
Authorised | 11/12/2021 | ||
Authorised | 11/12/2021 | ||
Authorised | 11/12/2021 | ||
Authorised | 9/30/2008 | ||
Authorised | 11/16/2020 | ||
Authorised | 11/12/2021 | ||
Authorised | 11/12/2021 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
INVAROX FILM COATED TABLET 2.5MG | SIN16979P | TABLET, FILM COATED | 2.5mg | 3/22/2024 | |
Xarelto Film Coated Tablet 2.5mg | SIN14455P | TABLET, FILM COATED | 2.5mg | 12/6/2013 | |
INVAROX FILM COATED TABLET 15MG | SIN16977P | TABLET, FILM COATED | 15mg | 3/22/2024 | |
Xarelto Film Coated Tablet 10 mg | SIN13567P | TABLET, FILM COATED | 10.00 mg | 11/5/2008 | |
Xarelto Film-Coated Tablet 15 mg | SIN14118P | TABLET, FILM COATED | 15.00 mg | 3/13/2012 | |
INVAROX FILM COATED TABLET 10MG | SIN16978P | TABLET, FILM COATED | 10mg | 3/22/2024 | |
INVAROX FILM COATED TABLET 20MG | SIN16975P | TABLET, FILM COATED | 20mg | 3/22/2024 | |
Xarelto Film-Coated Tablet 20 mg | SIN14119P | TABLET, FILM COATED | 20.00 mg | 3/13/2012 | |
XARELTO GRANULES FOR ORAL SUSPENSION 1MG/ML | SIN16487P | GRANULE, FOR SUSPENSION | 1.0mg/ml | 5/6/2022 | |
RIVASON-20 RIVAROXABAN TABLETS Ph.Eur. 20MG | Unison Pharmaceuticals Pvt. Ltd. | SIN17168P | TABLET, FILM COATED | 20mg | 1/17/2025 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Rivaroxaban for Suspension | 国药准字HJ20220044 | 化学药品 | 干混悬剂 | 4/29/2022 | |
Rivaroxaban for Suspension | 国药准字HJ20220045 | 化学药品 | 干混悬剂 | 4/29/2022 | |
Rivaroxaban Granules | 国药准字H20258003 | 化学药品 | 颗粒剂 | 1/8/2025 | |
Rivaroxaban Granules | 国药准字H20243387 | 化学药品 | 颗粒剂 | 7/30/2024 | |
Rivaroxaban Granules | 国药准字H20243982 | 化学药品 | 颗粒剂 | 6/11/2024 | |
Rivaroxaban Granules | 国药准字H20243981 | 化学药品 | 颗粒剂 | 6/11/2024 | |
Rivaroxaban Granules | 国药准字H20254065 | 化学药品 | 颗粒剂 | 5/13/2025 | |
Rivaroxaban Tablets | 国药准字H20247255 | 化学药品 | 片剂 | 10/29/2024 | |
Rivaroxaban Tablets | 国药准字H20227005 | 化学药品 | 片剂 | 1/18/2022 | |
Rivaroxaban Tablets | 国药准字H20258041 | 化学药品 | 片剂 | 3/25/2025 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
RALTEG 20 TABLETS 20MG | N/A | i & c (hong kong) limited | N/A | N/A | 2/14/2025 |
XARELTO TABLETS 10MG | N/A | N/A | N/A | 9/4/2024 | |
XARELTO TABLETS 20MG | N/A | N/A | N/A | 9/4/2024 | |
RIVACRYST TABLETS 20MG | N/A | N/A | N/A | 9/30/2024 | |
RALTEG 10 TABLETS 10MG | N/A | i & c (hong kong) limited | N/A | N/A | 2/14/2025 |
RIVACRYST TABLETS 10MG | N/A | N/A | N/A | 9/30/2024 | |
RALTEG 15 TABLETS 15MG | N/A | i & c (hong kong) limited | N/A | N/A | 2/14/2025 |
XARELTO TABLETS 15MG | N/A | N/A | N/A | 9/4/2024 | |
RIVACRYST TABLETS 15MG | N/A | N/A | N/A | 9/30/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
XARELTO rivaroxaban 2.5 mg film-coated tablet blister pack | 298198 | Medicine | A | 1/11/2019 | |
PHARMACOR RIVAROXABAN rivaroxaban 15 mg film-coated tablet blister pack | 398430 | Medicine | A | 3/28/2024 | |
RIVAROXABAN INTAS rivaroxaban 10 mg film-coated tablet bottle | 333031 | Medicine | A | 1/31/2023 | |
RIXAVERA rivaroxaban 10 mg film-coated tablet blister pack | 333025 | Medicine | A | 1/31/2023 | |
ROXARELTO rivaroxaban 15 mg film-coated tablet bottle | 333022 | Medicine | A | 1/31/2023 | |
RIVAROXABAN-RZ rivaroxaban 10 mg tablet blister pack | 290216 | Medicine | A | 1/4/2023 | |
RIVAROXABAN LUPIN rivaroxaban 20 mg tablet blister pack | 392323 | Medicine | A | 3/4/2024 | |
RIVAROXABAN LUPIN rivaroxaban 2.5 mg tablet blister pack | 392320 | Medicine | A | 3/4/2024 | |
RIVALEMBIC rivaroxaban 15 mg film-coated tablet blister pack | 399016 | Medicine | A | 10/3/2023 | |
RIVALEMBIC rivaroxaban 20 mg film-coated tablet blister pack | 399017 | Medicine | A | 10/3/2023 |