NUBEQA FILM-COATED TABLET 300MG

ORION OYJ / ORION CORPORATION / ORION PHARMA (ESPOO) - FINLANDORION OYJ / ORION CORPORATION / ORION PHARMA (PRIMARY AND SECONDARY PACKAGING) - FINLANDORION OYJ/ORION CORPORATION/ORION PHARMA (TURKU) (FINLAND)🇸🇬 Health Sciences Authority

Approval Date: Feb 11, 2021
Approval ID: a3bd902f3254e16b
Company: ORION OYJ / ORION CORPORATION / ORION PHARMA (ESPOO) - FINLANDORION OYJ / ORION CORPORATION / ORION PHARMA (PRIMARY AND SECONDARY PACKAGING) - FINLANDORION OYJ/ORION CORPORATION/ORION PHARMA (TURKU) (FINLAND)
Type: Therapeutic

Approval Details

Approval Id: a3bd902f3254e16b
Drug Name: NUBEQA FILM-COATED TABLET 300MG
Product Name: NUBEQA FILM-COATED TABLET 300MG
Approval Number: SIN16103P
Approval Date: 2021-02-11
Registrant: BAYER (SOUTH EAST ASIA) PTE LTD
Licence Holder: BAYER (SOUTH EAST ASIA) PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED
Dosage: 4.2 Posology and method of administration nmCRPC and mHSPC Treatment should be initiated and supervised by a specialist physician experienced in treatment of prostate cancer. Posology The recommended dose is 600 mg darolutamide (two tablets of 300 mg) taken twice daily, equivalent to a total daily dose of 1200 mg (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Darolutamide should be continued until disease progression or unacceptable toxicity. Medical castration with a luteinising hormone releasing hormone (LHRH) analogue should be continued during treatment of patients not surgically castrated. mHSPC mHSPC patients should start darolutamide in combination with docetaxel (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The first of 6 cycles of docetaxel should be administered within 6 weeks after the start of darolutamide treatment. The recommendations in the product information of docetaxel should be followed. Treatment with darolutamide should be continued until disease progression or unacceptable toxicity even if a cycle of docetaxel is delayed, interrupted, or discontinued. Missed dose If a dose is missed, the dose should be taken as soon as the patient remembers prior to the next scheduled dose. The patient should not take two doses together to make up for a missed dose. Dose modification If a patient experiences a ≥ Grade 3 toxicity or an intolerable adverse reaction related to darolutamide, (see sections 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), dosing should be withheld or reduced to 300 mg twice daily until symptoms improve. Treatment may then be resumed at a dose of 600 mg twice daily. Dose reduction below 300 mg twice daily is not recommended, because efficacy has not been established. Special populations Elderly No dose adjustment is necessary in elderly patients (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Renal impairment No dose adjustment is necessary for patients with mild or moderate renal impairment. For patients with severe renal impairment (eGFR 15–29 mL/min/1.73 m2) not receiving haemodialysis, the recommended starting dose is 300 mg twice daily (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Hepatic impairment No dose adjustment is necessary for patients with mild hepatic impairment. The available data on darolutamide pharmacokinetics in moderate hepatic impairment is limited. Darolutamide has not been studied in patients with severe hepatic impairment. For patients with moderate hepatic impairment (Child-Pugh Class B), the recommended starting dose is 300 mg twice daily (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Paediatric population There is no relevant use of darolutamide in the paediatric population. Method of administration NUBEQA is for oral use. The tablets should be taken whole with food (see section 5.2 – 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 NUBEQA is indicated for the treatment of adult men with <ul class="dash"> <li>nonmetastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> <li>metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel. (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> </ul>
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. Women who are or may become pregnant (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Atc Code: L02BB06
Atc Item Name: darolutamide
Pharma Manufacturer Name: BAYER (SOUTH EAST ASIA) PTE LTD

Active Ingredients

Darolutamide milled

300mg

DAROLUTAMIDE MILLED

300 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Feb 11, 2021

Approval ID

a3bd902f3254e16b

Type

Therapeutic

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