ZEJULA FILM-COATED TABLET 200MG

CATALENT GREENVILLE INC. - UNITED STATESMILLMOUNT HEALTHCARE LTD (PRIMARY & SECONDARY PACKAGER) (IRELAND)🇸🇬 Health Sciences Authority

Approval Date: Apr 1, 2022
Approval ID: e66edfe4f9cc1475
Company: CATALENT GREENVILLE INC. - UNITED STATESMILLMOUNT HEALTHCARE LTD (PRIMARY & SECONDARY PACKAGER) (IRELAND)
Type: Therapeutic

Approval Details

Approval Id: e66edfe4f9cc1475
Drug Name: ZEJULA FILM-COATED TABLET 200MG
Product Name: ZEJULA FILM-COATED TABLET 200MG
Approval Number: SIN16460P
Approval Date: 2022-04-01
Registrant: GLAXOSMITHKLINE PTE LTD
Licence Holder: GLAXOSMITHKLINE PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED
Dosage: Dosage and Administration Pharmaceutical Form Tablet. Posology First-line ovarian cancer maintenance treatment The recommended starting dose of ZEJULA is 200 mg taken once daily. However, for those patients who weigh ≥ 77 kg and have baseline platelet count ≥ 150,000/microlitre, the recommended starting dose of ZEJULA is 300 mg taken once daily. For the maintenance treatment of advanced ovarian cancer, patients should start treatment with ZEJULA no later than 12 weeks after their most recent platinum-containing regimen. Recurrent ovarian cancer maintenance treatment The dose is 300 mg once daily. Patients with low body weight in recurrent ovarian cancer maintenance treatment Approximately 25 % of patients in the NOVA study weighed less than 58 kg, and approximately 25 % of patients weighed more than 77 kg. The incidence of Grade 3 or 4 ADRs was greater among low body weight patients (78 %) than high body weight patients (53 %). Only 13 % of low body weight patients remained at a dose of 300 mg beyond Cycle 3. A starting dose of 200 mg for patients weighing less than 58 kg may be considered. For the maintenance treatment of recurrent ovarian cancer, patients should start treatment with ZEJULA no later than 8 weeks after their most recent platinum-containing regimen. Patients should be encouraged to take their dose at approximately the same time each day. Bedtime administration may be a potential method for managing nausea. Treatment should be continued until disease progression or unacceptable toxicity. Missing dose If patients miss a dose, they should take their next dose at its regularly scheduled time. Dose adjustments for adverse reactions Recommendations for dose modifications for adverse reactions are provided in Tables 1, 2 and 3. In general, it is recommended to first interrupt the treatment (but no longer than 28 consecutive days) to allow the patient to recover from the adverse reaction and then restart at the same dose. In the case that the adverse reaction recurs, it is recommended to interrupt the treatment and then resume at the lower dose. If adverse reactions persist beyond a 28-day dose interruption, it is recommended that ZEJULA be discontinued. If adverse reactions are not manageable with this strategy of dose interruption and reduction, it is recommended that ZEJULA be discontinued. <img src="/TGIF/Zejula-Table1_120325.png" alt="Zejula Dosage Table 1" /> <img src="/TGIF/Zejula-Table2_120325.png" alt="Zejula Dosage Table 2" /> <img src="/TGIF/Zejula-Table3_120325.png" alt="Zejula Dosage Table 3" /> Method of Administration Swallow tablets whole with water. Do not chew or crush tablets. ZEJULA can be taken without regard to meals (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Children and Adolescents The safety and efficacy of ZEJULA in children and adolescents below 18 years of age have not yet been established. Elderly No dose adjustment is necessary for elderly patients (≥ 65 years). There are limited clinical data in patients aged 75 years or over. Renal impairment No dose adjustment is necessary for patients with mild to moderate renal impairment. There are no data in patients with severe renal impairment or end stage renal disease undergoing haemodialysis; use with caution in these patients (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Hepatic impairment No dose adjustment is needed in patients with mild hepatic impairment (either aspartate aminotransferase (AST) > upper limit of normal (ULN) and total bilirubin (TB) ≤ ULN or any AST and TB > 1.0x – 1.5x ULN). For patients with moderate hepatic impairment (any AST and TB > 1.5x – 3x ULN), the recommended starting dose of ZEJULA is 200 mg once daily. There are no data in patients with severe hepatic impairment (any AST and TB > 3x ULN); use with caution in these patients (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Route Of Administration: ORAL
Indication Info: Indications ZEJULA is indicated: <ul> <li>as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.</li> <li>as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. The overall survival benefit in patients without germline BRCA mutation ovarian cancer has not been demonstrated (see Clinical Studies section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> </ul>
Contraindications: Contraindications Hypersensitivity to the niraparib or to any of the excipients listed in Excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Breast-feeding (see Pregnancy and Lactation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Atc Code: L01XK02
Atc Item Name: niraparib
Pharma Manufacturer Name: GLAXOSMITHKLINE PTE LTD

Active Ingredients

Niraparib tosylate monohydrate eqv niraparib

200mg

NIRAPARIB TOSYLATE MONOHYDRATE EQV NIRAPARIB

200 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Apr 1, 2022

Approval ID

e66edfe4f9cc1475

Type

Therapeutic

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