- Approval Id
- c98d36f44d98af40
- Drug Name
- LOQTORZI CONCENTRATE FOR SOLUTION FOR INFUSION 240MG/6ML
- Product Name
- LOQTORZI CONCENTRATE FOR SOLUTION FOR INFUSION 240MG/6ML
- Approval Number
- SIN17212P
- Approval Date
- 2025-03-26
- Registrant
- TA BIOSCIENCES PTE. LTD.
- Licence Holder
- TA BIOSCIENCES PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INFUSION, SOLUTION CONCENTRATE
- Dosage
- <p><strong>4.2 DOSE AND METHOD OF ADMINISTRATION</strong></p>
<p>The recommended dosing regimen of LOQTORZI is 240 mg every 3 weeks (Q3W). Treatment should continue until disease progression, unacceptable toxicity or up to a maximum duration of 24 months.</p>
<p><strong>Dosage modifications</strong></p>
<p>No dose reductions of LOQTORZI are recommended. Withold or discontinue LOQTORZI to manage adverse reactions as described in Table 1.</p>
<img src="/TGIF/Loqtorzi-Table1_130525.png" alt="Loqtorzi Dosage Table 1" /><br><br>
<p><strong>Administration</strong></p>
<p>Administer diluted solution intravenously via an infusion pump using an in-line aseptic filter (0.2 micron or 0.22 micron pore size).</p>
<p><em><strong>First Infusion</strong></em>: Infuse over at least 60 minutes.</p>
<p><strong><em>Subsequent infusions</em>:</strong> If no infusion-related reactions occurred during the first infusion, subsequent infusions may be administered over 30 minutes. (See Dosage modifications)</p>
<p>Do not co-administer other medicines through the same intravenous line.</p>
<p>When administered on the same day as chemotherapy, LOQTORZI should be administered prior to chemotherapy.</p>
<p>Refer to the Product Information for cisplatin and gemcitabine for recommended dosing information.</p>
<p><strong>Preparation for intravenous infusion</strong></p>
<p>Visually inspect the solution for particulate matter and discoloration. The solution is clear to slightly opalescent, colourless to slightly yellow. Discard the vial if visible particles are observed.</p>
<p>Withdraw the required volume of LOQTORZI and inject slowly into a 100 mL or 250 mL infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection for infusion using aseptic technique. Mix diluted solution by gentle inversion. Do not shake. The final concentration of the diluted solution should be between 1 mg/mL to 3 mg/mL.</p>
<p>Each vial is for use in one patient on one occasion only. Discard any unused portion left in the vial.</p>
<p>Refer to section 6.4 Special precautions for storage, if the diluted solution is not administered immediately – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p><strong>Special populations</strong></p>
<p><em><strong>Elderly</strong></em></p>
<p>No dose adjustment is recommended for patients who are 65 years of age or older (see section 5.2 Pharmacokinetic properties – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em><strong>Renal impairment</strong></em></p>
<p>No dose adjustment is needed for patients with mild or moderate renal impairment. There are no data in patients with severe renal impairment for dosing recommendations (see section 5.2 Pharmacokinetic properties – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em><strong>Hepatic impairment</strong></em></p>
<p>No dose adjustment is recommended for patients with mild hepatic impairment. There are no data in patients with moderate or severe hepatic impairment for dosing recommendations (see section 5.2 Pharmacokinetic properties – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em><strong>Paediatric population</strong></em></p>
<p>The safety and efficacy of toripalimab in children and adolescents under 18 years of age have not been established. No data are available.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1 THERAPEUTIC INDICATIONS</strong></p>
<p>LOQTORZI, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma.</p>
- Contraindications
- <p><strong>4.3 CONTRAINDICATIONS</strong></p>
<p>Severe hypersensitivity to the active ingredient or to any excipients listed in section 6.1 List of excipients – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Atc Code
- L01FF13
- Pharma Manufacturer Name
- TA BIOSCIENCES PTE. LTD.
- Company Detail Path
- /organization/ta-biosciences-pte-ltd
