Product Overview
[Drug Name]
Generic Name: Rivaroxaban Tablets
Trade Name: YiLeTong Rivaroxaban Tablets 10mg*5 Tablets
Pinyin Code: YiLeTong LiFaShaBanPian 10mg*5 Tablets
[Main Ingredients]
See package insert for details
[Indications/Main Functions]
1. For the prevention of venous thrombosis (VTE) in adult patients undergoing elective hip or knee replacement surgery. 2. For the treatment of venous thrombosis (DVT) in adults, reducing the risk of DVT recurrence and pulmonary embolism (PE) after acute DVT. 3. For the reduction of the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation and one or more risk factors (e.g., congestive heart failure, hypertension, age ≥75 years, diabetes, history of stroke or transient ischemic attack).
[Specifications]
10mg*5 tablets (YiLeTong)
[Dosage and Administration]
1. The recommended dose is rivaroxaban 10mg orally once daily. If wound bleeding has stopped, the first dose should be taken between 6 and 10 hours after surgery. The length of treatment depends on each patient's risk of venous thromboembolism, specifically the type of orthopedic surgery they undergo. For patients undergoing major hip surgery, a 5-week treatment course is recommended. For patients undergoing major knee surgery, a 2-week treatment course is recommended. If a dose is missed, patients should immediately take rivaroxaban and continue taking it once daily the following day. Patients can take rivaroxaban with or without meals.
[Adverse Reactions]
The safety of rivaroxaban 10 mg was evaluated in three phase 1 studies. A total of 4,571 patients undergoing major lower limb orthopedic surgery (total hip replacement or total knee replacement) received rivaroxaban for up to 39 days. Approximately 14% of treated patients experienced adverse reactions. Bleeding and anemia occurred in approximately 3.3% and 1% of patients, respectively. Other common adverse reactions include nausea, elevated GGT, and elevated transaminases. Adverse reactions should be interpreted in the context of the procedure. Due to its pharmacological mode of action, rivaroxaban tablets may increase the risk of occult or overt bleeding in some tissues or organs, potentially leading to posthemorrhagic anemia. Signs, symptoms, and severity of bleeding (including potential fatal outcomes) may vary depending on the site, degree, or extent of bleeding. The risk of bleeding may be increased in certain patient groups, such as those with uncontrolled severe arterial hypertension and/or those taking concomitant medications that affect hemostasis. Hemorrhagic complications may manifest as weakness, asthenia, pallor, dizziness, headache, or unexplained swelling. Therefore, the possibility of bleeding should be considered when evaluating patients receiving anticoagulants. Table 1 below lists adverse reactions from the three phase I studies by system organ class (MedDRA) and frequency. Frequency definitions are as follows: Common: ≥1/100 to <1/10; Uncommon: ≥1/1,000 to <1/100; Rare: ≥1/10,000 to <1/1,000; Unknown: No estimate can be made based on available data.
[Contraindications]
Rivaroxaban is contraindicated in the following patients: 1. Patients with hypersensitivity to rivaroxaban or any of the excipients in the tablets. 2. Patients with clinically significant active bleeding. 3. Patients with liver disease with coagulation abnormalities and a clinically relevant bleeding risk. 4. Pregnant and lactating women.
[Precautions]
1. Bleeding Risk: As detailed below, some subgroups of patients are at increased risk of bleeding. After initiation of treatment, these patients should be closely monitored for signs of bleeding complications. This can be achieved through regular physical examinations, close monitoring of surgical wound drainage, and periodic hemoglobin measurements. Any unexplained decrease in hemoglobin or blood pressure should prompt investigation of the source of bleeding. 2. Renal Impairment: In patients with severe renal impairment (creatinine clearance <30 mL/min), rivaroxaban blood concentrations may be significantly elevated, leading to an increased risk of bleeding. Rivaroxaban is not recommended for patients with a creatinine clearance <15 mL/min. Rivaroxaban should be used with caution in patients with a creatinine clearance of 15-29 mL/min. Patients with moderate renal impairment (creatinine clearance 30-49 mL/min) should use rivaroxaban with caution when taking other medications that may increase rivaroxaban blood concentrations.
3. Hepatic Impairment: In patients with cirrhosis and moderate hepatic impairment (Child-Pugh B class), rivaroxaban blood concentrations may be significantly elevated, leading to an increased risk of bleeding. Rivaroxaban tablets are contraindicated in patients with liver disease associated with coagulation abnormalities and a clinically relevant risk of bleeding. For patients with cirrhosis and moderate hepatic impairment (Child-Pugh B class), rivaroxaban may be used with caution if the patient does not have coagulation abnormalities. 4. Interaction with other drugs: In the case of azole-antifungal agents (such as ketoconazole, itraconazole, voriconazole and posaconazole).
