Hemoxaban is used for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.
Each film-coated tablet contains:
Rivaroxaban BP – 20 mg
Excipients q.s.
Color: red iron oxide and titanium dioxide BP
Rivaroxaban is a highly selective direct Factor Xa inhibitor with oral bioavailability. Inhibition of Factor Xa interrupts both the intrinsic and extrinsic pathways of the coagulation cascade, inhibiting thrombin formation and clot development. Rivaroxaban does not inhibit thrombin (activated Factor II) and has no effect on platelets.
Adults:
Pediatric population:
Dosage:
Therapy with rivaroxaban should be continued long-term, provided the benefit of preventing stroke and systemic embolism outweighs the risk of bleeding.
If a dose is missed, the patient should take rivaroxaban immediately and continue the next day with once-daily dosing as recommended. The dose should not be doubled on the same day to make up for a missed dose.
Method of administration:
The most commonly reported adverse reactions with rivaroxaban are bleeding events. The most frequent are epistaxis (4.5%) and gastrointestinal bleeding (3.8%).
Due to its mechanism of action, rivaroxaban may increase the risk of occult or overt bleeding from any tissue or organ, which may lead to post-hemorrhagic anemia. Signs and symptoms vary depending on the location and severity of bleeding.
Mucosal bleeding (e.g., nose, gums, gastrointestinal or genitourinary tract, including abnormal vaginal or heavy menstrual bleeding) and anemia were observed more frequently during long-term treatment compared to vitamin K antagonist (VKA) therapy.
Monitoring hemoglobin/hematocrit levels may be useful for detecting occult bleeding.
Risk of bleeding may be increased in certain groups, such as patients with uncontrolled severe hypertension or those taking medications affecting hemostasis.
Menstrual bleeding may be intensified and/or prolonged.
Hemorrhagic complications may include weakness, pallor, dizziness, headache, unexplained swelling, shortness of breath, or unexplained shock.
In some cases, myocardial ischemia symptoms (e.g., chest pain or angina) have been observed secondary to anemia.
Serious complications such as compartment syndrome and renal failure due to hypoperfusion have been reported.
Pregnancy:
The safety and efficacy of rivaroxaban during pregnancy have not been established. Animal studies have shown reproductive toxicity. Due to potential risks (including bleeding and placental transfer), rivaroxaban is contraindicated during pregnancy. Women of childbearing potential should avoid becoming pregnant during treatment.
Breastfeeding:
Safety in breastfeeding women has not been established. Animal data indicate that rivaroxaban is excreted in milk. Therefore, it is contraindicated during breastfeeding. A decision should be made to discontinue breastfeeding or treatment.
Fertility:
No human studies have been conducted. Animal studies showed no effect on fertility.
Rare cases of overdose up to 1960 mg have been reported in adults. Patients should be monitored for bleeding or other adverse reactions.
Due to limited absorption, a ceiling effect is expected at doses ≥50 mg in adults without further increase in plasma exposure.
A specific reversal agent (andexanet alfa) is available for adults but not for children.
Activated charcoal may be considered to reduce absorption.
If bleeding occurs, rivaroxaban should be discontinued or treatment delayed.
Management depends on severity and location and may include:
If bleeding cannot be controlled, specific reversal agents (andexanet alfa) or procoagulants such as PCC, APCC, or recombinant factor VIIa may be used.
Protamine sulfate and vitamin K do not affect rivaroxaban activity.
Dialysis is ineffective due to high protein binding.
Store at a temperature not exceeding 25°C.
Keep out of reach of children.
