ESTAELTO FILM COATED TABLETS 10MG

ZENTIVA PRIVATE LIMITED (INDIA)🇸🇬 Health Sciences Authority

Approval Date: May 30, 2025
Approval ID: 6c0efaa817c04ba0
Company: ZENTIVA PRIVATE LIMITED (INDIA)
Type: Therapeutic

Approval Details

Approval Id: 6c0efaa817c04ba0
Drug Name: ESTAELTO FILM COATED TABLETS 10MG
Product Name: ESTAELTO FILM COATED TABLETS 10MG
Approval Number: SIN17249P
Approval Date: 2025-05-30
Registrant: WELLESTA HEALTHCARE (SINGAPORE) PTE LTD
Licence Holder: WELLESTA HEALTHCARE (SINGAPORE) PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED
Dosage: 4.2 Posology and method of administration Posology Prevention of VTE in patients undergoing total hip or total knee replacement surgery The recommended dose is 10 mg rivaroxaban taken orally once daily. The initial dose should be taken within 6 to 10 hours after surgery, provided that haemostasis has been established. The duration of treatment depends on the individual risk of the patient for venous thromboembolism which is determined by the type of orthopaedic surgery. <ul> <li>For patients undergoing major hip surgery, a treatment duration of 5 weeks is recommended.</li> <li>For patients undergoing major knee surgery, a treatment duration of 2 weeks is recommended.</li> </ul> If a dose is missed the patient should take the 10mg Estaelto dose immediately and then continue the following day with once daily intake as before. Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE The recommended dose for the initial treatment of acute DVT or PE is 15 mg twice daily for the first three weeks followed by 20 mg once daily for the continued treatment and prevention of recurrent DVT and PE. Short duration of therapy (at least 3 months) should be considered in patients with DVT or PE provoked by major transient risk factors (i.e. recent major surgery or trauma). Longer duration of therapy should be considered in patients with provoked DVT or PE not related to major transient risk factors, unprovoked DVT or PE, or a history of recurrent DVT or PE. When extended prevention of recurrent DVT and PE is indicated (following completion of at least 6 months therapy for DVT or PE), the recommended dose is 10 mg once daily. In patients in whom the risk of recurrent DVT or PE is considered high, such as those with complicated comorbidities, or who have developed recurrent DVT or PE on extended prevention with Estaelto 10 mg once daily, a dose of Estaelto 20 mg once daily should be considered. The duration of therapy and dose selection should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). <img src="/TGIF/Estaelto10mg-Table1.png" alt="Estaelto 10 mg Dosage Table 1" /> If a dose is missed during the 15 mg twice daily treatment phase (day 1 – 21), the patient should take Estaelto immediately to ensure intake of 30 mg Estaelto per day. In this case two 15 mg tablets may be taken at once. The patient should continue with the regular 15 mg twice daily intake as recommended on the following day. If a dose is missed during the once daily treatment phase, the patient should take Estaelto immediately, and continue on the following day with the once daily intake as recommended. The dose should not be doubled within the same day to make up for a missed dose. Converting from Vitamin K Antagonists (VKA) to Estaelto For patients treated for DVT, PE and prevention of recurrence, VKA treatment should be stopped and Estaelto therapy should be initiated once the INR is ≤ 2.5. When converting patients from VKAs to Estaelto, International Normalised Ratio (INR) values will be falsely elevated after the intake of Estaelto. The INR is not valid to measure the anticoagulant activity of Estaelto, and therefore should not be used (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Converting from Estaelto to Vitamin K antagonists (VKA) There is a potential for inadequate anticoagulation during the transition from Estaelto to VKA. Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant. It should be noted that Estaelto can contribute to an elevated INR. In patients converting from Estaelto to VKA, VKA should be given concurrently until the INR is ≥ 2.0. For the first two days of the conversion period, standard initial dosing of VKA should be used followed by VKA dosing, as guided by INR testing. While patients are on both Estaelto and VKA the INR should not be tested earlier than 24 hours after the previous dose but prior to the next dose of Estaelto. Once Estaelto is discontinued INR testing may be done reliably at least 24 hours after the last dose (see sections 4.5 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Converting from parenteral anticoagulants to Estaelto For patients currently receiving a parenteral anticoagulant, discontinue the parenteral anticoagulant and start Estaelto 0 to 2 hours before the time that the next scheduled administration of the parenteral medicinal product (e.g. low molecular weight heparins) would be due or at the time of discontinuation of a continuously administered parenteral medicinal product (e.g. intravenous unfractionated heparin). Converting from Estaelto to parenteral anticoagulants Discontinue Estaelto and give the first dose of parenteral anticoagulant at the time the next Estaelto dose would be taken. Special populations Renal impairment Limited clinical data for patients with severe renal impairment (creatinine clearance 15 – 29 ml/min) indicate that rivaroxaban plasma concentrations are significantly increased. Therefore, Estaelto is to be used with caution in these patients. Use is not recommended in patients with creatinine clearance < 15 ml/min (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). <ul class="dash"> <li>For the prevention of VTE in adult patients undergoing elective hip or knee replacement surgery, no dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 50 – 80 ml/min) or moderate renal impairment (creatinine clearance 30 – 49 ml/min) (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> <li>For the treatment of DVT, treatment of PE and prevention of recurrent DVT and PE, no dose adjustment from the recommended dose is necessary in patients with mild renal impairment (creatinine clearance 50 – 80 ml/min) (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). In patients with moderate (creatinine clearance 30 – 49 ml/min) or severe (creatinine clearance 15 – 29 ml/min) renal impairment: patients should be treated with 15 mg twice daily for the first 3 weeks. Thereafter, when the recommended dose is 20 mg once daily, a reduction of the dose from 20 mg once daily to 15 mg once daily should be considered if the patient’s assessed risk for bleeding outweighs the risk for recurrent DVT and PE. The recommendation for the use of 15 mg is based on PK modelling and has not been studied in this clinical setting (see sections 4.4, 5.1 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). When the recommended dose is 10 mg once daily, no dose adjustment from the recommended dose is necessary.</li> </ul> Hepatic impairment Estaelto is contraindicated in patients with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk (see sections 4.3 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Estaelto may be used with caution in cirrhotic patients with moderate hepatic impairment (Child Pugh B) if it is not associated with coagulopathy. No dose adjustment is necessary in patients with other hepatic diseases. Elderly population No dose adjustment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Body weight No dose adjustment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Gender No dose adjustment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Paediatric population The safety and efficacy of rivaroxaban 10 mg tablets in children aged 0 to 18 years have not been established. No data are available. Therefore, Estaelto 10 mg tablets are not recommended for use in children below 18 years of age. Method of administration Estaelto is for oral use. The tablets can be taken with or without food (see sections 4.5 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Crushing of tablets For patients who are unable to swallow whole tablets, Estaelto tablet may be crushed and mixed with water or apple puree immediately prior to use and administered orally. The crushed tablet may also be given through gastric tubes (see sections 5.2 and 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Route Of Administration: ORAL
Indication Info: 4.1 Therapeutic indications Prevention of venous thromboembolism (VTE) in patients undergoing total hip or total knee replacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.)
Contraindications: 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Active clinically significant bleeding. Lesion or condition, if considered to be a significant risk for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities. Concomitant treatment with any other anticoagulants, e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexilate, apixaban, etc.) except under specific circumstances of switching anticoagulant therapy (see section 4.2) or when UFH is given at doses necessary to maintain an open central venous or arterial catheter (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Pregnancy and breast-feeding (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

May 30, 2025

Approval ID

6c0efaa817c04ba0

Type

Therapeutic

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