Properties:
- RIVAROX® is an anticoagulant and the first orally active direct factor Xa inhibitor.
- Unlike warfarin, routine lab monitoring of INR is not necessary. Only the
10 mg tablet can be taken without regard to food. The 15 mg and 20 mg
tablet should be taken with food.
Indications, dosage and administration:
Nonvalvular Atrial Fibrillation: 15 or 20 mg, once daily with food (2.1)
• Treatment of DVT and/or PE: 15 mg orally twice daily with food for the first 21 days
followed by 20 mg orally once daily with food for the remaining treatment (2.1)
• Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued
risk for DVT and/or PE: 10 mg once daily with or without food, after at least
6 months of standard anticoagulant treatment (2.1)
• Prophylaxis of DVT Following Hip or Knee Replacement Surgery: 10 mg orally
once daily with or without food (2.1)
• Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic
Complications Not at High Risk of Bleeding: 10 mg once daily, with or without
food, in hospital and after hospital discharge for a total recommended duration
of 31 to 39 days (2.1)
• CAD or PAD: 2.5 mg orally twice daily with or without food, in combination with
aspirin (75-100 mg) once daily (2.1)
• Pediatric Patients: See dosing recommendations in the Full Prescribing
Nonvalvular Atrial Fibrillation: 15 or 20 mg, once daily with food (2.1)
• Treatment of DVT and/or PE: 15 mg orally twice daily with food for the first 21 days
followed by 20 mg orally once daily with food for the remaining treatment (2.1)
• Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued
risk for DVT and/or PE: 10 mg once daily with or without food, after at least
6 months of standard anticoagulant treatment (2.1)
• Prophylaxis of DVT Following Hip or Knee Replacement Surgery: 10 mg orally
once daily with or without food (2.1)
• Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic
Complications Not at High Risk of Bleeding: 10 mg once daily, with or without
food, in hospital and after hospital discharge for a total recommended duration
of 31 to 39 days (2.1)
• CAD or PAD: 2.5 mg orally twice daily with or without food, in combination with
aspirin (75-100 mg) once daily (2.1)
• Pediatric Patients: See dosing recommendations in the Full Prescribing
Composition:
- Each film-coated tablet of RIVAROX® contains:
Rivaroxaban 2.5 mg.
Rivaroxaban 10 mg.
Rivaroxaban 15 mg.
Rivaroxaban 20 mg.
Contraindications:
- Active pathological bleeding [see Warnings and Precautions].
- Severe hypersensitivity reaction to RIVAROX® (e.g., anaphylactic reactions).
Drug interactions:
- Avoid concomitant administration of RIVAROX® with known combined P-gp and
strong CYP3A inhibitors (e.g., ketoconazole and ritonavir).
- Avoid concomitant use of RIVAROX® with drugs that are combined P-gp and
strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin, St. John’s wort).
- Coadministration of RIVAROX® with enoxaparin, warfarin, aspirin, clopidogrel
and chronic NSAID may increase the risk of bleeding.
- Risk of Pregnancy-Related Hemorrhage:
Use RIVAROX® with caution in pregnant women due to the potential for obstetric
hemorrhage and/or emergent delivery.
- Patients with Prosthetic Heart Valves:
RIVAROX® use not recommended.
- Acute PE in Hemodynamically Unstable Patients or Patients Who Require
Adverse reactions:
Like all medicines, Rivaroxaban can cause side effects, although not everyone gets
them. Like other similar medicines (antithrombotic agents), Rivaroxaban may cause
bleeding which may potentially be life threatening. Excessive bleeding may lead to
a sudden drop in blood pressure (shock). In some cases, the bleeding may not be
obvious.
Tell your doctor immediately if you experience any of the following side effects:
• long or excessive bleeding
• Exceptional weakness, tiredness, paleness, dizziness, headache, unexplained
swelling, breathlessness, chest pain or angina pectoris, which may be signs of
bleeding.
- Increased Risk of Thrombotic Events after Premature
Discontinuation:
If RIVAROX® is discontinued for a reason other than pathological bleeding or
completion of a course of therapy, consider coverage with another anticoagulant.
- Risk of Bleeding: and can cause serious or fatal bleeding.
• Concomitant use of other drugs that impair hemostasis increases the risk of bleeding
(e.g. aspirin, antiplatelet; fibrinolytic therapy and NSAIDs).
• the following conditions are at increased risk of bleeding with the use of
RIVAROX® for primary VTE prophylaxis: history of bronchiectasis, pulmonary
cavitation, or pulmonary hemorrhage, active cancer (i.e. undergoing acute,
in-hospital cancer treatment), active gastroduodenal ulcer in the three months prior
to treatment, history of bleeding in the three months prior to treatment, or dual
antiplatelet therapy.
- Spinal/Epidural Anesthesia or Puncture: is employed, patients are at risk of
developing an epidural or spinal hematoma which can result in long-term or
permanent paralysis.
Tell your doctor immediately if you experience skin reactions such as:
• Spreading intense skin rash, blisters or mucosal lesions, e.g. in the mouth or eyes
(Stevens Johnson syndrome/toxic epidermal necrolysis).
• A drug reaction that causes rash, fever, inflammation of internal organs, hematologic
abnormalities and systemic illness (DRESS syndrome).
Tell your doctor immediately if you experience any of the following side effects:
• Swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and
breathing difficulties; sudden drop in blood pressure.
Overall list of possible side effects:
• reduction in red blood cells which can make the skin pale and cause weakness or
breathlessness
• bleeding in the stomach or bowel, urogenital bleeding, nose bleed, bleeding in the
gum.
• bleeding into the eye (including bleeding from the whites of the eyes)
• bleeding into tissue or a cavity of the body (hematoma, bruising)
• coughing up blood.
• bleeding from the skin or under the skin.
• bleeding following an operation.
• oozing of blood or fluid from surgical wound.
• swelling in the limbs.
• pain in the limbs.
• impaired function of the kidneys (may be seen in tests performed by your doctor).
• fever.
• stomach ache, indigestion, feeling or being sick, constipation, diarrhea.
• low blood pressure (symptoms may be feeling dizzy or fainting when standing up).
• decreased general strength and energy (weakness, tiredness), headache, dizziness
• rash, itchy skin.
• blood tests may show an increase in some liver enzymes.
• fainting.
this includes any possible side effects not listed in this leaflet. you can report side
effect directly via the: hhttp\\www.modernpharmaye.com\adrs.pdf
and send to us on: adrs@modernpharmaye.com
- Use in Patients with Renal Impairment:
Periodically assess renal function as clinically indicated (i.e., more frequently in
situations in which renal function may decline) and adjust therapy accordingly [see
indications, Dosage and Administration table].
- Use in Patients with Hepatic Impairment:
No clinical data are available for patients with severe hepatic impairment.
- Use with P-gp and Strong CYP3A Inhibitors or Inducers:
Avoid concomitant use of RIVAROX® with known combined P-gp and
strong CYP3A inhibitors (e.g. ketoconazole and ritonavir) or strong CYP3A inducer
(e.g., carbamazepine, phenytoin, rifampin, St. John’s wort).
Packaging:
- RIVAROX® 2.5 Tablets (Blister of 10 Tablets, Pack of three blisters).
- RIVAROX® 10 Tablets (Blister of 10 Tablets, Pack of three blisters).
- RIVAROX® 15 Tablets (Blister of 10 Tablets, Pack of three blisters).
- RIVAROX® 20 Tablets (Blister of 10 Tablets, Pack of three blisters).
Storage:
- Store in a dry place at a temperature not exceeding 25 ºC.
- Keep out of the reach of children.
