TECENTRIQ CONCENTRATE FOR SOLUTION FOR INFUSION 840MG/14ML

F. HOFFMANN-LA ROCHE LTD (SWITZERLAND)🇸🇬 Health Sciences Authority

Approval Date: Jun 25, 2020
Approval ID: 704bd35cab5776ed
Company: F. HOFFMANN-LA ROCHE LTD (SWITZERLAND)
Type: Therapeutic

Approval Details

Approval Id: 704bd35cab5776ed
Drug Name: TECENTRIQ CONCENTRATE FOR SOLUTION FOR INFUSION 840MG/14ML
Product Name: TECENTRIQ CONCENTRATE FOR SOLUTION FOR INFUSION 840MG/14ML
Approval Number: SIN15964P
Approval Date: 2020-06-25
Registrant: ROCHE SINGAPORE PTE. LTD.
Licence Holder: ROCHE SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INFUSION, SOLUTION CONCENTRATE
Dosage: 2.2 DOSAGE AND ADMINISTRATION General Substitution by any other biological medicinal product requires the consent of the prescribing physician. Tecentriq must be administered under the supervision of a qualified healthcare professional. It is important to check the product labels to ensure that the correct formulation (Tecentriq IV or Tecentriq SC) is being administered to the patient as prescribed. Patients currently receiving Tecentriq IV can switch to Tecentriq SC (or vice versa). The safety and efficacy of alternating or switching between Tecentriq and products that are biosimilar but not deemed interchangeable to Tecentriq has not been established. Therefore, the benefit/risk of alternating or switching need to be carefully considered. Tecentriq IV Tecentriq IV formulation is not intended for subcutaneous administration. Tecentriq IV formulation must be administered as an intravenous infusion. Do not administer as an IV push or bolus. Do not co-administer other medicinal products through the same infusion line. The initial dose of Tecentriq must be administered over 60 minutes. If the first infusion is tolerated all subsequent infusions may be administered over 30 minutes. Tecentriq SC Tecentriq SC formulation is not intended for intravenous administration. Tecentriq SC must be administered as a subcutaneous injection only (see section 4.2 Special Instructions for Use, Handling and Disposal – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Prior to administration, remove Tecentriq SC from refrigeration and allow the solution to reach room temperature. Administer 15 mL of Tecentriq SC solution subcutaneously in the thigh in approximately 7 minutes. Use of a SC infusion set (e.g. winged / butterfly) is recommended. DO NOT administer the remaining residual hold-up volume in the tubing to the patient. The injection site should be alternated between the left and right thigh only. New injections should be given at least 2.5 cm from the previous site on healthy skin and never into areas where the skin is red, bruised, tender, or hard. During the treatment course with Tecentriq SC, other medications for subcutaneous administration should preferably be injected at different sites. Patient Selection If specified in the indication, adult patients should be selected for treatment based on the tumor expression of PD-L1 confirmed by a validated test (see section 3.1.2 Clinical / Efficacy Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). <img src="/TGIF/Tecentriq-Table1_200825.png" alt="Tecentriq Dosage Table 1" /> <img src="/TGIF/Tecentriq-Table2_190924.png" alt="Tecentriq Dosage Table 2" /> Tecentriq combination therapy For the use of Tecentriq in combination therapy, please also refer to the full prescribing information for the combination product. Tecentriq should be administered prior to the combination therapy if given on the same day. Delayed or Missed Doses If a planned dose of Tecentriq is missed, it should be administered as soon as possible. The schedule of administration should be adjusted to maintain the appropriate interval between doses. Dose Modifications No dose reductions of Tecentriq are recommended. Dose modifications for immune-mediated adverse reactions Recommendations for specific adverse drug reactions (see sections 2.4.1 Warnings and Precautions, General and 2.6.1 Undesirable Effects, Clinical Trials – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) are presented in Table 3. <img src="/TGIF/Tecentriq-Table3_200825.png" alt="Tecentriq Dosage Table 3" /> For other immune-mediated reactions, based on the type and severity of the reaction, treatment with Tecentriq should be withheld for Grades 2 or 3 immune-mediated adverse reactions and corticosteroid therapy (1–2 mg/kg/day prednisone or equivalent) should be initiated. If symptoms improve to ≤ Grade 1, taper corticosteroids as clinically indicated. Treatment with Tecentriq may be resumed if the event improves to ≤ Grade 1 within 12 weeks, and corticosteroids have been reduced to ≤ 10 mg oral prednisone or equivalent per day. Treatment with Tecentriq should be permanently discontinued for Grade 4 immune-mediated adverse reactions, or when unable to reduce corticosteroid dose to the equivalent of ≤ 10 mg prednisone per day within 12 weeks after onset. 2.2.1 Special Dosage Instructions Pediatric Use The safety and efficacy of Tecentriq in children and adolescents below 18 years of age have not been established. (see section 2.5.4 Pediatric Use, and 3.2.5 Pharmacokinetics in Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) Geriatric Use Based on a population pharmacokinetic analysis, no dose adjustment of Tecentriq is required in patients ≥ 65 years of age (see sections 2.5.5 Geriatric Use, and 3.2.5 Pharmacokinetics in Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Renal Impairment Based on a population pharmacokinetic analysis, no dose adjustment is required in patients with renal impairment (see section 3.2.5 Pharmacokinetics in Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Hepatic impairment Based on a population pharmacokinetic analysis, no dose adjustment is required for patients with mild or moderate hepatic impairment. There are no data in patients with severe hepatic impairment (see section 3.2.5 Pharmacokinetics in Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Route Of Administration: INTRAVENOUS
Indication Info: 2.1 THERAPEUTIC INDICATION(S) Tecentriq IV and Tecentriq SC Early-stage non-small cell lung cancer Tecentriq as monotherapy is indicated as adjuvant treatment following complete resection for adult patients with Stage II to IIIA (7th edition of the UICC/AJCC-staging system) non-small cell lung cancer (NSCLC) whose tumours have PD-L1 expression on ≥ 50% of tumour cells (TC) and whose disease has not progressed following platinum-based adjuvant chemotherapy (see Section 3.1.2 Clinical / Efficacy Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Metastatic non-small cell lung cancer Tecentriq, in combination with Avastin, paclitaxel and carboplatin, is indicated for the treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC) who had not received prior chemotherapy. Tecentriq as monotherapy is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on approved therapy for these aberrations prior to receiving Tecentriq. Tecentriq, in combination with nab-paclitaxel and carboplatin, is indicated for first-line treatment of patients with metastatic non-squamous NSCLC who do not have EGFR or ALK genomic tumor aberrations. Tecentriq as monotherapy is indicated for the first-line treatment of patients with metastatic NSCLC whose tumors have a PD-L1 expression ≥ 50% tumor cells (TC) or ≥ 10% tumor-infiltrating immune cells (IC) and who do not have EGFR or ALK genomic tumor aberrations. Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with NSCLC who are ineligible for platinum-based chemotherapy and who do not have EGFR or ALK genomic tumor aberrations, who have: <ul> <li>locally advanced, unresectable NSCLC not amenable for definitive chemoradiotherapy, or</li> <li>metastatic NSCLC (see section 3.1.2 Clinical / Efficacy Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> </ul> Small cell lung cancer Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). Triple-negative breast cancer Tecentriq, in combination with nab-paclitaxel, is indicated for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors have PD-L1 expression of ≥1% on IC, and who have not received prior chemotherapy for metastatic disease. Hepatocellular carcinoma Tecentriq, in combination with Avastin, is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
Contraindications: 2.3 CONTRAINDICATIONS Tecentriq is contraindicated in patients with a known hypersensitivity to atezolizumab or any of the excipients.
Atc Code: L01FF05
Atc Item Name: atezolizumab
Pharma Manufacturer Name: ROCHE SINGAPORE PTE. LTD.

Active Ingredients

Atezolizumab

840mg/14ml

Atezolizumab

840mg/14ml

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Jun 25, 2020

Approval ID

704bd35cab5776ed

Type

Therapeutic

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