TECENTRIQ CONCENTRATE FOR SOLUTION FOR INFUSION 1200 MG/ 20 ML [SIN15425P]

Product Info

TECENTRIQ CONCENTRATE FOR SOLUTION FOR INFUSION 1200 MG/ 20 ML

[SIN15425P]

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.

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 (ESSCLC).

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.

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 may transition to Tecentriq SC.

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
Early-stage NSCLC, 1L metastatic NSCLC
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).

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.

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).

2.3 CONTRAINDICATIONS
Tecentriq is contraindicated in patients with a known hypersensitivity to atezolizumab or any of the excipients.