JEMPERLI CONCENTRATE FOR SOLUTION FOR INFUSION 500MG/10ML

PCI SAN DIEGO, INC. - UNITED STATESGLAXO OPERATIONS UK LTD. (TRADING AS GLAXO WELLCOME OPERATIONS) (UNITED KINGDOM)🇸🇬 Health Sciences Authority

Approval Date: Oct 6, 2022
Approval ID: b577e7296ab7decb
Company: PCI SAN DIEGO, INC. - UNITED STATESGLAXO OPERATIONS UK LTD. (TRADING AS GLAXO WELLCOME OPERATIONS) (UNITED KINGDOM)
Type: Therapeutic

Approval Details

Approval Id: b577e7296ab7decb
Drug Name: JEMPERLI CONCENTRATE FOR SOLUTION FOR INFUSION 500MG/10ML
Product Name: JEMPERLI CONCENTRATE FOR SOLUTION FOR INFUSION 500MG/10ML
Approval Number: SIN16623P
Approval Date: 2022-10-06
Registrant: GLAXOSMITHKLINE PTE LTD
Licence Holder: GLAXOSMITHKLINE PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INFUSION, SOLUTION CONCENTRATE
Dosage: Dosage and Administration Pharmaceutical Form Concentrate for solution for infusion. Posology JEMPERLI in combination with carboplatin and paclitaxel When JEMPERLI is administered in combination with carboplatin and paclitaxel, refer to the full Prescribing Information for the combination products (see also Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The recommended dose as combination therapy is 500 mg dostarlimab administered as an intravenous infusion over 30 minutes every 3 weeks for 6 cycles followed by 1000 mg every 6 weeks for all cycles thereafter. The dosage regimen in combination with carboplatin and paclitaxel is presented in Table 1. <img src="/TGIF/Jemperli-Table1_100524.png" alt="Jemperli Dosage Table 1" /> Administration of JEMPERLI should continue according to the recommended dose and schedule until disease progression or unacceptable toxicity, or for a duration of up to 3 years (see Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). JEMPERLI monotherapy The recommended dose as monotherapy is 500 mg dostarlimab administered as an intravenous infusion over 30 minutes every 3 weeks for 4 cycles followed by 1000 mg every 6 weeks for all cycles thereafter. The dosage regimen as monotherapy is presented in Table 2. <img src="/TGIF/Jemperli-Table2_130125.png" alt="Jemperli Dosage Table 2" /> Administration of JEMPERLI should continue according to the recommended dose and schedule until disease progression or unacceptable toxicity. Dose modifications Dose reduction is not recommended. Dosing delay or discontinuation may be required based on individual safety and tolerability. Recommended modifications to manage adverse reactions are provided in Table 3. Detailed guidelines for the management of immune-related adverse reactions and infusion-related reactions are described in Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. <img src="/TGIF/Jemperli-Table3_150425.png" alt="Jemperli Dosage Table 3" /> Method of Administration JEMPERLI is for intravenous infusion only. JEMPERLI should be administered by intravenous infusion using an intravenous infusion pump over 30 minutes. JEMPERLI must not be administered as an intravenous push or bolus injection. For instructions on dilution of the medicinal product before administration, see Use and Handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Children The safety and efficacy of JEMPERLI in children and adolescents aged under 18 years have not been established. No data are available. Elderly No dose adjustment is recommended for patients who are 65 years of age or over. There are limited clinical data with JEMPERLI in patients 75 years of age or over. Renal impairment No dose adjustment is recommended for patients with mild or moderate renal impairment. There are limited data in patients with severe renal impairment or end-stage renal disease undergoing dialysis (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 recommended for patients with mild hepatic impairment. There are limited data in patients with moderate hepatic impairment and no data in patients with severe hepatic impairment (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Route Of Administration: INTRAVENOUS
Indication Info: Indications Endometrial cancer JEMPERLI is indicated in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy. JEMPERLI is indicated as monotherapy for the treatment of adult patients with recurrent or advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen.
Contraindications: Contraindications Hypersensitivity to the active substance or to any of the excipients (see List of Excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Atc Code: L01FF07
Atc Item Name: dostarlimab
Pharma Manufacturer Name: GLAXOSMITHKLINE PTE LTD

Active Ingredients

Dostarlimab

500mg/10mL

Dostarlimab

500mg/10mL

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Oct 6, 2022

Approval ID

b577e7296ab7decb

Type

Therapeutic

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