ZHONGBANG YOULAINING Rivaroxaban Tablets For Venous Thrombosis 10mg*10

[Drug Name]
Generic Name: Rivaroxaban Tablets
Trade Name: Youlaining Rivaroxaban Tablets 10mg x 10 Tablets

[Main Ingredient]
Rivaroxaban.

[Properties]
This product is a pink film-coated tablet that appears white to off-white after removal of the coating.

[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 deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults; for the reduction of the risk of recurrent DVT and/or PE in patients whose risk of recurrence persists after completing at least 6 months of initial treatment. (For patients with hemodynamically unstable PE, see [Precautions]). 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*10 tablets

[Dosage and Administration]
Rivaroxaban Administration: Oral. Rivaroxaban 10mg can be taken with or without food. Rivaroxaban 15mg or 20mg tablets should be taken with food. For the prevention of venous thrombosis in adult patients undergoing elective hip or knee replacement surgery: 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. For patients undergoing major hip surgery, the recommended treatment course is 35 days. For patients undergoing major knee surgery, the recommended treatment course is 12 days. If a dose is missed, the patient should take rivaroxaban immediately and continue taking it once daily the following day. For the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of recurrence, the recommended initial dose for the treatment of acute DVT or PE is 15mg twice daily for the first three weeks. After the initial treatment period, the recommended subsequent dose is 20mg orally once daily, administered at approximately the same time each day. Short-term treatment (at least 3 months) should be considered for patients with DVT or PE caused by significant transient risk factors (e.g., recent major surgery or trauma). Longer-term treatment should be considered for patients with DVT or PE caused by causes other than significant transient risk factors, patients with unprovoked DVT or PE, or patients with a history of recurrent DVT or PE. For patients at persistent risk of DVT and/or PE after completing at least 6 months of standard anticoagulant therapy, rivaroxaban 10 mg orally once daily is recommended to reduce the risk of recurrent DVT and/or PE. For patients at high risk of recurrent DVT or PE (e.g., those with complex comorbidities or those who experience recurrent DVT or PE while receiving rivaroxaban 10 mg once daily), rivaroxaban 20 mg once daily should be considered. The duration of treatment and dose selection should be determined on an individual basis after a careful assessment of the benefits of treatment versus the risk of bleeding (see [Precautions]). See Table 1 (see package insert for details). (Other details are provided in the package insert).

[Adverse Reactions]
See package insert for details.

[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 lesions or conditions that pose a significant risk of major bleeding, such as current or recent gastrointestinal ulcers, malignant tumors with a high bleeding risk, recent brain or spinal cord injury, recent brain, spinal, or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms, or major intraspinal or intracerebral vascular malformations. 4. Except in special circumstances for switching anticoagulants or administering unfractionated heparin (UFH) at doses required to maintain central venous or arterial catheter patency, concomitant treatment with any other anticoagulant, such as UFH, low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin biologics (fondaparinux, etc.), and oral anticoagulants (warfarin, apixaban, dabigatran, etc.), is contraindicated. 5. Patients with liver disease associated with coagulation abnormalities and clinically relevant bleeding risks, including patients with cirrhosis reaching ChilPugh class B and C. 6. Pregnant and lactating women.

[Precautions]
Close observation is recommended throughout anticoagulant therapy. Premature discontinuation of rivaroxaban increases the risk of thromboembolic events. Premature discontinuation of any oral anticoagulant, including rivaroxaban, in the absence of adequate alternative anticoagulant therapy increases the risk of thromboembolic events. In clinical trials, an increased incidence of stroke was observed during the conversion from rivaroxaban to warfarin in patients with non-valvular atrial fibrillation. If premature discontinuation of rivaroxaban is necessary due to pathological bleeding or reasons other than completion of treatment, consider administering an alternative anticoagulant. Risk of bleeding: Rivaroxaban increases the risk of bleeding and may cause severe or fatal bleeding. The risk of thromboembolic events must be weighed against the risk of bleeding when deciding whether to administer rivaroxaban to patients at increased bleeding risk. As with other anticoagulants, patients taking rivaroxaban should be closely observed for signs of bleeding. Caution is recommended in settings with a high risk of bleeding. If severe bleeding occurs, rivaroxaban must be discontinued. In clinical studies, patients receiving long-term rivaroxaban therapy experienced more mucosal bleeding (i.e., epistaxis, gingival bleeding, gastrointestinal bleeding, genitourinary bleeding (including abnormal vaginal bleeding or heavy menstruation)) and anemia compared with patients receiving VKA therapy. Therefore, in addition to adequate clinical observation, appropriate interpretation of laboratory hemoglobin/hematocrit test results can help detect occult bleeding, quantify overt bleeding, and determine its clinical relevance. Patients at increased risk of bleeding should be closely monitored for bleeding complications and signs and symptoms of anemia after treatment initiation. For the postoperative population, regular physical examinations, close monitoring of surgical wound drainage, and regular hemoglobin measurement can help detect bleeding promptly. Any unexplained decrease in hemoglobin or blood pressure should prompt investigation of the bleeding site. Signs and symptoms of blood loss should be promptly evaluated, and the need for blood replacement therapy should be considered. Rivaroxaban should be discontinued in patients with active pathological bleeding. The terminal elimination half-life of rivaroxaban in healthy subjects aged 20 to 45 years is 5 to 9 hours. Concomitant use of other medications that affect hemostasis may increase the risk of bleeding. These include aspirin, P2Y12 platelet inhibitors, other antithrombotic agents, fibrinolytics, and nonsteroidal anti-inflammatory drugs (NSAIDs). Concomitant use of combined P-gp and strong CYP3A4 inhibitors (e.g., ketoconazole and ritonavir) increases rivaroxaban exposure and may increase the risk of bleeding. Although routine exposure monitoring is not necessary during rivaroxaban therapy, in certain situations, such as overdose and emergency surgery, rivaroxaban levels can be measured using a standard anti-factor Xa assay, and knowledge of rivaroxaban exposure can aid clinical decision-making. Reversal of the anticoagulant effect: There is no specific antagonist for rivaroxaban. Due to its high binding to plasma proteins, rivaroxaban is not expected to be dialyzable. Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of rivaroxaban. Partial reversal of prolonged prothrombin time has been observed in healthy subjects following administration of prothrombin complex concentrate (PCC). The use of other procoagulant reversal agents, such as activated prothrombin complex concentrate (APCC) or recombinant factor VIla (rFVIla), has not been evaluated in trials. See [Overdose]. Spinal/Epidural Anesthesia or Puncture: Patients receiving antithrombotic medications to prevent thrombotic complications during neuraxial anesthesia (spinal/epidural anesthesia) or spinal/epidural puncture are at risk for epidural or spinal hematomas, which may result in long-term or permanent paralysis. Postoperative use of an indwelling epidural catheter or concomitant use of medications that affect hemostasis may increase the risk of these events. Trauma or repeated epidural or spinal punctures may also increase the risk. Patients should be observed regularly for signs and symptoms of neurologic impairment (e.g., numbness or weakness in the legs, bowel or bladder dysfunction). If neurologic impairment is observed, prompt diagnosis and treatment are necessary. Before performing neuraxial procedures in patients receiving anticoagulant therapy or those planned for anticoagulant therapy for thromboprophylaxis, physicians should weigh the potential benefits and risks. There is no clinical experience with the use of rivaroxaban 15 mg and 20 mg in these settings. To mitigate the potential bleeding risk associated with concomitant use of rivaroxaban with epidural anesthesia, spinal anesthesia/analgesia, or spinal puncture, the pharmacokinetic profile of rivaroxaban should be considered. The optimal time to place or remove an epidural catheter or perform a lumbar puncture is when the anticoagulant effect of rivaroxaban is low; however, the exact timing of achieving a sufficiently low anticoagulant effect in each patient is unknown. For epidural catheter removal, based on general pharmacokinetic properties, removal should be delayed for at least two half-lives, meaning at least 18 hours after the last rivaroxaban dose in younger patients and at least 26 hours after the last rivaroxaban dose in older patients. Rivaroxaban should be administered at least 6 hours after catheter removal. If an invasive puncture is performed, rivaroxaban administration should be delayed for 24 hours. Renal Impairment: Prevention of venous thrombosis in adult patients undergoing elective hip or knee replacement surgery: Avoid rivaroxaban in patients with a CrCl <30 mL/min, as elevated rivaroxaban exposure and enhanced pharmacodynamic effects are expected in this patient population. Closely observe and promptly evaluate patients with a CrCl 30-50 mL/min for any signs and symptoms of blood loss. Patients who develop acute renal failure while taking rivaroxaban must discontinue treatment. Treatment of DVT and PE to reduce the risk of recurrent DVT and PE: Avoid rivaroxaban in patients with a CrCl 30 mL/min, as elevated rivaroxaban exposure and enhanced pharmacodynamic effects are expected in this patient population. Use in adult patients with nonvalvular atrial fibrillation to reduce the risk of stroke and systemic embolism. Avoid rivaroxaban in patients with a CrCl <15 mL/min, as drug exposure is increased. Assess renal function regularly as clinically indicated (i.e., more frequently if renal function may be diminished) and adjust therapy accordingly. If acute renal failure occurs during rivaroxaban use, consider dose adjustment or discontinuation. Interactions with Other Drugs: Concomitant use of rivaroxaban is not recommended in patients taking systemic medications such as oxazolidinone antifungals (e.g., ketoconazole, itraconazole, voriconazole, and posaconazole) or HIV protease inhibitors (e.g., ritonavir). Because these drugs are potent inhibitors of CYP3A4 and P-gp, concomitant use may result in clinically significant increases in rivaroxaban plasma concentrations (average 2.6-fold), increasing the risk of bleeding. Caution is advised in patients taking concomitant medications that affect hemostasis, such as NSAIDs, acetylsalicylic acid (ASA), platelet aggregation inhibitors, or selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs). Appropriate prophylactic therapy should be considered in patients at risk for developing ulcerative gastrointestinal disease. Other Bleeding Risks: As with other antithrombotic drugs, rivaroxaban is not recommended for patients at increased risk of bleeding, including those with congenital or acquired bleeding disorders; uncontrolled severe hypertension; other gastrointestinal disorders without active ulcers that may lead to bleeding complications (e.g., inflammatory bowel disease, esophagitis, gastritis, and gastroesophageal reflux disease); vasculogenic retinopathy; and a history of bronchiectasis or pulmonary hemorrhage. Venous Thromboembolism Prevention in Hip Fracture Surgery: No interventional clinical studies have evaluated the efficacy and safety of rivaroxaban in patients undergoing hip fracture surgery. The safety and efficacy of rivaroxaban have not been studied in patients with prosthetic heart valves; therefore, there are no data to support that rivaroxaban provides adequate anticoagulation in this patient population. Rivaroxaban is not recommended for use in such patients. For patients with hemodynamically unstable PE or those requiring thrombolysis or pulmonary embolectomy, rivaroxaban is not recommended as an alternative to unfractionated heparin in patients with hemodynamically unstable PE or who may require thrombolysis or pulmonary embolectomy, as its safety and efficacy have not been studied in these clinical settings. Dosage recommendations before and after invasive procedures and surgeries (except elective hip or knee replacement surgery): If an invasive procedure or surgery is necessary, rivaroxaban should be discontinued for at least 24 hours before the intervention, if possible and based on the physician's clinical judgment. If the procedure cannot be postponed, the increased risk of bleeding should be weighed against the urgency of the intervention. Following the invasive procedure or surgery, rivaroxaban therapy should be resumed as soon as clinically possible and adequate hemostasis has been achieved. Excipient Information: Rivaroxaban tablets contain lactose. Patients with rare hereditary conditions of lactose or galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medication. Effects on the Ability to Drive and Use Machinery: Rivaroxaban has minimal effects on the ability to drive and use machinery. Syncope (frequency: rare) and dizziness (frequency: common) have been reported as adverse reactions. Patients experiencing these adverse reactions should not drive or operate machinery.