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Indications and Usage for RIVIX®
RIVIX® is a factor Xa inhibitor indicated for:
- Treatment of deep vein thrombosis (DVT)
- Treatment of Pulmonary Embolism
- Reduction in the risk of recurrence of Deep Vein Thrombosis
How to Use RIVIX®
- The 15 mg and 20 mg RIVIX® tablets should be taken with food. For patients who are unable to swallow whole tablets, 15 mg or 20 mg RIVIX tablets may be crushed and mixed with applesauce or water immediately prior to use and administered orally. After the administration of a crushed RIVIX® 15 mg or 20 mg tablet, the dose should be immediately followed by food.
- For patients with atrial fibrillation, RIVIX® should be taken with the evening meal.
- If you miss a dose of RIVIX®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
Dosage and Administration
| Indication |
Dosage |
| Prophylaxis of Deep Vein Thrombosis |
10 mg once daily
(The initial dose should be taken 6 to 10 hours after surgery provided that hemostasis has been established.)
|
| For patients undergoing hip replacement surgery |
Treatment duration of 35 days is recommended. |
| For patients undergoing knee replacement surgery |
Treatment duration of 12 days is recommended. |
| Treatment of DVT and/or PE |
15 mg twice daily, for first 21 days
▼after 21 days, transition to ▼
20 mg once daily, for remaining treatment
|
| Atrial Fibrillation |
20 mg once daily |
| Reduction in the Risk of Recurrence of DVT and of PE |
20 mg once daily |
| Indication |
Renal Considerations |
Dosage |
| Treatment of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), and Reduction in the Risk of Recurrence of DVT and of PE |
(CrCl) <30 mL/min |
Avoid Use |
| Atrial Fibrillation |
CrCl 15 to 30 mL/min |
15 mg once daily |
NOTE: Avoid the use of RIVIX® in patients with CrCl <15 mL/min.
Avoid the use of RIVIX® in patients with moderate and severe hepatic impairment.
Before taking RIVIX®
Before taking RIVIX®, tell your doctor about all of your medical conditions, including if you:
- are allergic to Rivaroxaban or any of the ingredients in RIVIX®
- are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed.
- have or ever had active clinically significant bleeding
- have liver or kidney problems
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, especially tell your doctor if you take:
- NSAIDs
- Ketoconazole
- Ritonavir
- Rifampin
- Phenytoin
- Carbamazepine
- Aspirin
- Warfarin
- Heparin
- Clopidogrel
- Itraconazole
- Prasugrel
- Enoxaparin
- Voriconazole
Warnings
- If anticoagulation must be discontinued to reduce the risk of bleeding with surgical procedures, RIVIX® should be stopped at least 24 hours before the procedure to reduce the risk of bleeding.
- RIVIX® increases the risk of bleeding and can cause serious or fatal bleeding. while taking this medicine, promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement.
Pregnancy and Breast-feeding
Pregnancy Category C
- In pregnant women, RIVIX® should be used only if the potential benefit justifies the potential risk to the mother and fetus.
- There are insufficient data to determine the effects of RIVIX® on the breastfed child or on milk production, take RIVIX® exactly as prescribed by your doctor.
Side Effects
Check with your doctor immediately if any of the following side effects occur while taking RIVIX®:
- Bleeding
- Digestive difficulties (Diarrhea, Nausea, vomiting, and Constipation)
- Back pain
- Fatigue
- Hives
- Itching
- Muscle spasm
- Anaphylaxis shock
- Syncope
Storage
- Store RIVIX® below 30˚C and away from heat, moisture, and light.
- Keep out of the reach of children.