Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic UC:
Tecentriq as monotherapy is indicated as adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with NSCLC with a high risk of recurrence whose tumours have PD-L1 expression on ≥50% of tumour cells (TC) and who do not have EGFR mutant or ALK-positive NSCLC (see section 5.1 for selection criteria).
Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC. In patients with EGFR-mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5.1).
Tecentriq, in combination with nab-paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC who do not have EGFR-mutant or ALK-positive NSCLC (see section 5.1).
Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumours have a PD-L1 expression ≥50% TC or ≥10% tumour-infiltrating immune cells (IC) and who do not have EGFR-mutant or ALK-positive NSCLC (see section 5.1).
Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with advanced NSCLC who are ineligible for platinum-based therapy (see section 5.1 for selection criteria).
Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy. Patients with EGFR-mutant or ALK-positive NSCLC should also have received targeted therapies before receiving Tecentriq (see section 5.1).
Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (see section 5.1).
Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumours have PD-L1 expression ≥1% and who have not received prior chemotherapy for metastatic disease.
Tecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable HCC who have not received prior systemic therapy (see section 5.1).
Tecentriq must be initiated and supervised by physicians experienced in the treatment of cancer.
If specified in the indication, patient selection for treatment with Tecentriq based on the tumour expression of PD-L1 should be confirmed by a validated test (see sections 4.1 and 5.1).
Patients with previously untreated TNBC should be selected for treatment based on the tumour expression of PD-L1 confirmed by a validated test (see section 5.1).
The recommended dose of Tecentriq is either 840 mg administered intravenously every two weeks, or 1 200 mg administered intravenously every three weeks, or 1 680 mg administered intravenously every four weeks, as presented in Table 1.
When Tecentriq is administered in combination therapy please also refer to the full prescribing information for the combination products (see also section 5.1).
Table 1. Recommended dose for Tecentriq by intravenous administration:
| Indication | Recommended dose and schedule | Duration of treatment |
|---|---|---|
| Tecentriq monotherapy | ||
| 1L UC | • 840 mg every 2 weeks or • 1 200 mg every 3 weeks or • 1 680 mg every 4 weeks | Until disease progression or unmanageable toxicity |
| 1L metastatic NSCLC | ||
| 1L platinum-ineligible NSCLC | ||
| Early-stage NSCLC | • 840 mg every 2 weeks or • 1 200 mg every 3 weeks or • 1 680 mg every 4 weeks | For 1 year unless disease recurrence or unacceptable toxicity. Treatment duration for more than 1 year was not studied. |
| 2L UC | • 840 mg every 2 weeks or • 1 200 mg every 3 weeks or • 1 680 mg every 4 weeks | Until loss of clinical benefit or unmanageable toxicity |
| 2L NSCLC | ||
| Tecentriq combination therapy | ||
| 1L non-squamous NSCLC with bevacizumab, paclitaxel, and carboplatin | Induction and maintenance phases: • 840 mg every 2 weeks or • 1 200 mg every 3 weeks or • 1 680 mg every 4 weeks Tecentriq should be administered first when given on the same day. Induction phase for combination partners (four or six cycles): Bevacizumab, paclitaxel, and then carboplatin are administered every three weeks. Maintenance phase (without chemotherapy): Bevacizumab every 3 weeks. | Until disease progression or unmanageable toxicity. Atypical responses (i.e., an initial disease progression followed by tumour shrinkage) have been observed with continued Tecentriq treatment after disease progression. Treatment beyond disease progression may be considered at the discretion of the physician. |
| 1L non-squamous NSCLC with nab-paclitaxel and carboplatin | Induction and maintenance phases: • 840 mg every 2 weeks or • 1 200 mg every 3 weeks or • 1 680 mg every 4 weeks Tecentriq should be administered first when given on the same day. Induction phase for combination partners (four or six cycles): Nab- paclitaxel, and carboplatin are administered on day 1; in addition, nab-paclitaxel is administered on days 8 and 15 of each 3-weekly cycle. | Until disease progression or unmanageable toxicity. Atypical responses (i.e., an initial disease progression followed by tumour shrinkage) have been observed with continued Tecentriq treatment after disease progression. Treatment beyond disease progression may be considered at the discretion of the physician. |
| 1L ES-SCLC with carboplatin and etoposide | Induction and maintenance phases: • 840 mg every 2 weeks or • 1 200 mg every 3 weeks or • 1 680 mg every 4 weeks Tecentriq should be administered first when given on the same day. Induction phase for combination partners (four cycles): Carboplatin, and then etoposide are administered on day 1; etoposide is also administered on days 2 and 3 of each 3-weekly cycle. | Until disease progression or unmanageable toxicity. Atypical responses (i.e., an initial disease progression followed by tumour shrinkage) have been observed with continued Tecentriq treatment after disease progression. Treatment beyond disease progression may be considered at the discretion of the physician. |
| 1L unresectable locally advanced or metastatic TNBC with nab-paclitaxel | • 840 mg every 2 weeks or • 1 200 mg every 3 weeks or • 1 680 mg every 4 weeks Tecentriq should be administered prior to nab-paclitaxel when given on the same day. Nab-paclitaxel should be administered at 100 mg/m² on days 1, 8, and 15 of each 28-day cycle. | Until disease progression or unmanageable toxicity. |
| Advanced or unresectable HCC with bevacizumab | • 840 mg every 2 weeks or • 1 200 mg every 3 weeks or • 1 680 mg every 4 weeks Tecentriq should be administered prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg body weight (bw) every 3 weeks. | Until loss of clinical benefit or unmanageable toxicity. |
If a planned dose of Tecentriq is missed, it should be administered as soon as possible. The schedule of administration must be adjusted to maintain the appropriate interval between doses.
Dose reductions of Tecentriq are not recommended.
Table 2. Dose modification advice for Tecentriq:
| Immune-mediated adverse reaction | Severity | Treatment modification |
|---|---|---|
| Pneumonitis | Grade 2 | Withhold Tecentriq Treatment may be resumed when the event improves to Grade 0 or Grade 1 within 12 weeks, and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day |
| Grade 3 or 4 | Permanently discontinue Tecentriq | |
| Hepatitis in patients without HCC | Grade 2: (ALT or AST > 3 to 5 x upper limit of normal [ULN] or blood bilirubin > 1.5 to 3 x ULN) | Withhold Tecentriq Treatment may be resumed when the event improves to Grade 0 or Grade 1 within 12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day |
| Grade 3 or 4: (ALT or AST > 5 x ULN or blood bilirubin > 3 x ULN) | Permanently discontinue Tecentriq | |
| Hepatitis in patients with HCC | If AST/ALT is within normal limits at baseline and increases to > 3 x to ≤ 10x ULN or If AST/ALT is > 1 to ≤ 3 x ULN at baseline and increases to > 5x to ≤ 10x ULN or If AST/ALT is > 3 x to ≤ 5 x ULN at baseline and increases to >8 x to ≤ 10x ULN | Withhold Tecentriq Treatment may be resumed when the event improves to Grade 0 or Grade 1 within 12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day |
| If AST/ALT increases to > 10 x ULN or total bilirubin increases to > 3 x ULN | Permanently discontinue Tecentriq | |
| Colitis | Grade 2 or 3 Diarrhoea (increase of ≥ 4 stools/day over baseline) or Symptomatic Colitis | Withhold Tecentriq Treatment may be resumed when the event improves to Grade 0 or Grade 1 within 12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day |
| Grade 4 Diarrhoea or Colitis (life threatening; urgent intervention indicated) | Permanently discontinue Tecentriq | |
| Hypothyroidism or hyperthyroidism | Symptomatic | Withhold Tecentriq Hypothyroidism: Treatment may be resumed when symptoms are controlled by thyroid replacement therapy and TSH levels are decreasing Hyperthyroidism: Treatment may be resumed when symptoms are controlled by anti- thyroid medicinal product and thyroid function is improving |
| Adrenal insufficiency | Symptomatic | Withhold Tecentriq Treatment may be resumed when the symptoms improve to Grade 0 or Grade 1 within 12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day and patient is stable on replacement therapy |
| Hypophysitis | Grade 2 or 3 | Withhold Tecentriq Treatment may be resumed when the symptoms improve to Grade 0 or Grade 1 within 12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day and patient is stable on replacement therapy |
| Grade 4 | Permanently discontinue Tecentriq | |
| Type 1 diabetes mellitus | Grade 3 or 4 hyperglycaemia (fasting glucose > 250 mg/dL or 13.9 mmol/L) | Withhold Tecentriq Treatment may be resumed when metabolic control is achieved on insulin replacement therapy |
| Rash/Severe cutaneous adverse reactions | Grade 3 or suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)1 | Withhold Tecentriq Treatment may be resumed when the symptoms improve to Grade 0 or Grade 1 within 12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day |
| Grade 4 or confirmed Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)1 | Permanently discontinue Tecentriq | |
| Myasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome, Meningoencephalitis and Facial paresis | Facial paresis Grade 1 or 2 | Withhold Tecentriq Treatment may be resumed if the event fully resolves. If the event does not fully resolve while withholding Tecentriq, permanently discontinue Tecentriq |
| All Grades Myasthenic syndrome/myasthenia gravis, Guillain Barré syndrome and Meningoencephalitis or Facial paresis Grade 3 or 4 | Permanently discontinue Tecentriq | |
| Myelitis | Grade 2, 3, or 4 | Permanently discontinue Tecentriq |
| Pancreatitis | Grade 3 or 4 serum amylase or lipase levels increased (> 2 x ULN) or Grade 2 or 3 pancreatitis | Withhold Tecentriq Treatment may be resumed when serum amylase and lipase levels improve to Grade 0 or Grade 1 within 12 weeks, or symptoms of pancreatitis have resolved, and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day |
| Grade 4 or any grade of recurrent pancreatitis | Permanently discontinue Tecentriq | |
| Myocarditis | Grade 2 or above | Permanently discontinue Tecentriq |
| Nephritis | Grade 2: (creatinine level > 1.5 to 3.0 x baseline or > 1.5 to 3.0 x ULN) | Withhold Tecentriq Treatment may be resumed when the event improves to Grade 0 or Grade 1 within 12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day |
| Grade 3 or 4: (creatinine level > 3.0 x baseline or > 3.0 x ULN) | Permanently discontinue Tecentriq | |
| Myositis | Grade 2 or 3 | Withhold Tecentriq |
| Grade 4 or Grade 3 recurrent myositis | Permanently discontinue Tecentriq | |
| Pericardial disorders | Grade 1 pericarditis | Withhold Tecentriq^2^ |
| Grade 2 or above | Permanently discontinue Tecentriq | |
| Haemophagocytic lymphohistiocytosis | Suspected haemophagocytic lymphohistiocytosis^1^ | Permanently discontinue Tecentriq |
| Other immune-mediated adverse reactions | Grade 2 or Grade 3 | Withhold until adverse reactions recovers to Grade 0-1 within 12 weeks, and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day |
| Grade 4 or recurrent Grade 3 | Permanently discontinue Tecentriq (except endocrinopathies controlled with replacement hormones) | |
| Other adverse reactions | Severity | Treatment modification |
| Infusion-related reactions | Grade 1 or 2 R | educe infusion rate or interrupt. Treatment may be resumed when the event is resolved |
| Grade 3 or 4 | Permanently discontinue Tecentriq |
Note: Toxicity should be graded with the current version of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
1 Regardless of severity.
2 Conduct a detailed cardiac evaluation to determine the etiology and manage appropriately.
The safety and efficacy of Tecentriq in children and adolescents aged below 18 years have not been established. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Based on a population pharmacokinetic analysis, no dose adjustment of Tecentriq is required in patients ≥65 years of age (see sections 4.8 and 5.1).
Due to increased haematologic toxicities observed in Asian patients in IMpower150, it is recommended that the starting dose of paclitaxel should be 175 mg/m² every three weeks.
Based on a population pharmacokinetic analysis, no dose adjustment is required in patients with mild or moderate renal impairment (see section 5.2). Data from patients with severe renal impairment are too limited to draw conclusions on this population.
Based on a population pharmacokinetic analysis, no dose adjustment is required for patients with mild or moderate hepatic impairment. Tecentriq has not been studied in patients with severe hepatic impairment (see section 5.2).
Patients with ECOG performance status ≥2 were excluded from the clinical trials in NSCLC, TNBC, ES-SCLC, 2nd line UC and HCC (see sections 4.4 and 5.1).
It is important to check the product labels to ensure that the correct formulation (intravenous or subcutaneous) is being administered to the patient, as prescribed.
Tecentriq intravenous formulation is not intended for subcutaneous administration and should be administered via an intravenous infusion only. The infusions must not be administered as an intravenous push or bolus.
The initial dose of Tecentriq must be administered over 60 minutes. If the first infusion is well tolerated, all subsequent infusions may be administered over 30 minutes.
For instructions on dilution and handling of the medicinal product before administration, see section 6.6.
There is no information on overdose with atezolizumab.
In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.
Unopened vial:
3 years.
Diluted solution:
Chemical and physical in-use stability has been demonstrated for up to 24 hours at ≤30°C and for up to 30 days at 2°C to 8°C from the time of preparation.
From a microbiological point of view, the prepared solution for infusion should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C or 8 hours at ambient temperature (≤25°C) unless dilution has taken place in controlled and validated aseptic conditions.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3.
Type I glass vial with a butyl rubber stopper and an aluminium seal with a plastic grey or aqua flip-off cap containing 14 mL or 20 mL of concentrate solution for infusion.
Pack of one vial.
Tecentriq does not contain any antimicrobial preservative or bacteriostatic agents and should be prepared by a healthcare professional using aseptic technique to ensure the sterility of prepared solutions. Use a sterile needle and syringe to prepare Tecentriq.
Aseptic handling must be ensured when preparing the infusion. Preparation should be:
Do not shake.
For the recommended dose of 840 mg: fourteen mL of Tecentriq concentrate should be withdrawn from the vial and diluted into a polyvinyl chloride (PVC), polyolefin (PO), polyethylene (PE), or polypropylene (PP) infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection.
For the recommended dose of 1 200 mg: twenty mL of Tecentriq concentrate should be withdrawn from the vial and diluted into a polyvinyl chloride (PVC), polyolefin (PO), polyethylene (PE) or polypropylene (PP) infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection.
For the recommended dose of 1 680 mg: twenty-eight mL of Tecentriq concentrate should be withdrawn from two vials of Tecentriq 840 mg and diluted into a polyvinyl chloride (PVC), polyolefin (PO), polyethylene (PE), or polypropylene (PP) infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection.
After dilution, the final concentration of the diluted solution should be between 3.2 and 16.8 mg/mL.
The bag should be gently inverted to mix the solution in order to avoid foaming. Once the infusion is prepared it should be administered immediately (see section 6.3). Parenteral medicinal products should be inspected visually for particulates and discolouration prior to administration. If particulates or discoloration are observed, the solution should not be used.
No incompatibilities have been observed between Tecentriq and intravenous bags with product-contacting surfaces of PVC, PO, PE, or PP. In addition, no incompatibilities have been observed with in-line filter membranes composed of polyethersulfone or polysulfone, and infusion sets and other infusion aids composed of PVC, PE, polybutadiene, or polyetherurethane. The use of in-line filter membranes is optional.
Do not co-administer other medicinal products through the same infusion line.
The release of Tecentriq in the environment should be minimised. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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