Tecentriq Adverse Reactions

Clinical Trials: The corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000).
Tecentriq monotherapy: The safety of Tecentriq monotherapy is based on pooled data on 3178 patients with multiple tumor types, with supporting data from the estimated cumulative exposure on >13000 patients across all clinical trials. Tables 18a and 18b summarize the adverse drug reactions (ADRs) that have been reported in association with the use of Tecentriq. (See Tables 18a and 18b.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Tecentriq combination therapy: Additional ADRs identified in clinical trials (not reported in monotherapy trials) associated with the use of Tecentriq in combination therapy across multiple indications are summarized in Table 19. ADRs with a clinically relevant difference when compared to monotherapy (refer to Tables 18a and 18b) are also presented. (See Table 19.)

Click on icon to see table/diagram/image

Additional information for selected adverse reactions: The data as follows reflect information for significant adverse reactions for Tecentriq monotherapy. Details for the significant adverse reactions for Tecentriq when given in combination are presented if clinically relevant differences were noted in comparison to Tecentriq monotherapy. See General under Precautions for management of the following: Haemophagocytic lymphohistiocytosis: Haemophagocytic lymphohistiocytosis (HLH) occurred in <0.1% (1/3178) of patients who received Tecentriq monotherapy. The time to onset was 1.6 months. The duration was 1.4 months. HLH led to discontinuation of Tecentriq in 1 (<0.1%) patient. The patient did not require the use of corticosteroids.
Immune-mediated pericardial disorders: Pericardial disorders occurred in 1.4% (45/3178) of patients who received Tecentriq monotherapy. The median time to onset was 1.4 months (range 0.2 to 17.5 months). The median duration was 1.4 months (range 0 to 19.3 months). Pericardial disorders led to discontinuation of Tecentriq in 3 (<0.1%) patients. Pericardial disorders requiring the use of corticosteroids occurred in 0.2% (7/3178) patients.
Immune-mediated endocrinopathies: Thyroid Disorders: Hypothyroidism occurred in 5.2% (164/3178) of patients who received Tecentriq monotherapy. The median time to onset was 4.9 months (range 0 to 31.3 months). Hypothyroidism occurred in 24.3% (134/552) of patients who received Tecentriq with bevacizumab.
Hyperthyroidism occurred in 0.9% (30/3178) of patients who received Tecentriq monotherapy. The median time to onset was 2.1 months (range 0.7 to 15.7 months). The median duration was 2.6 months (range: 0+ to 17.1+ months; + denotes a censored value). Hyperthyroidism occurred in 6.3% (35/552) of patients who received Tecentriq with bevacizumab.
Adrenal Insufficiency: Adrenal insufficiency occurred in 0.3% (11/3178) of patients who received Tecentriq monotherapy. The median time to onset was 5.5 months (range: 0.1 to 19.0 months). The median duration was 16.8 months (range: 0 to 16.8 months). Adrenal insufficiency led to discontinuation of Tecentriq in 1 (<0.1%) patient. Adrenal insufficiency requiring the use of corticosteroids occurred in 0.3% (9/3178) of patients receiving Tecentriq.
Hypophysitis: Hypophysitis occurred in <0.1% (2/3178) of patients who received Tecentriq monotherapy. The median time to onset was 7.2 months (range: 0.8 to 13.7 months). One patient required the use of corticosteroids and treatment with Tecentriq was discontinued.
Hypophysitis occurred in 0.8% (3/393) of patients who received Tecentriq with bevacizumab, paclitaxel, and carboplatin. The median time to onset was 7.7 months (range: 5.0 to 8.8 months). Two patients required the use of corticosteroids. Hypophysitis lead to the discontinuation of treatment in one patient.
Diabetes Mellitus: Diabetes mellitus occurred in 0.3% (10/3178) of patients who received Tecentriq monotherapy. The median time to onset was 4.2 months (range 0.1 to 9.9 months). The median duration was 1.6 months (range: 0.1 to 15.2+ months; + denotes a censored value). Diabetes mellitus led to the discontinuation of Tecentriq in 3 (< 0.1%) patients.
Immune-mediated colitis: Colitis occurred in 1.1% (34/3178) of patients who received Tecentriq. The median time to onset 4.7 months (range 0.5 to 17.2 months). The median duration was 1.2 months (range: 0.1 to 17.8+ months; + denotes a censored value). Colitis led to discontinuation of Tecentriq in 8 (0.3%) patients. Colitis requiring the use of corticosteroids occurred in 0.6% (19/3178) of patients receiving Tecentriq.
Immune-mediated pancreatitis: Pancreatitis, including increased amylase and lipase levels, occurred in 0.6% (18/3178) of patients who received Tecentriq monotherapy. The median time to onset was 5.0 months (range: 0.3 to 16.9 months). The median duration was 0.8 months (range 0.1 to 12.0+ months; + denotes a censored value). Pancreatitis led to discontinuation of Tecentriq in 3 (<0.1%) patients. Pancreatitis requiring the use of corticosteroids occurred in 0.1% (4/3174) of patients receiving Tecentriq.
Immune-mediated hepatitis: Hepatitis occurred in 2.0 (62/3178) of patients who received Tecentriq monotherapy. Of the 62 patients, two events were fatal. The median time to onset was 1.5 months; (range: 0.2 to 18.8 months). The median duration was 2.1 months (range: 0 to 22.2+ months; + denotes a censored). Hepatitis led to discontinuation of Tecentriq in 6 (0.2%) patients. Hepatitis requiring the use of corticosteroids occurred in 0.6% (18/3178) of patients receiving Tecentriq.
Immune-mediated myositis: Myositis occurred in 0.4% (13/3178) of patients who received Tecentriq monotherapy. The median time to onset was 5.1 months (range: 0.7 to 11.0 months). The median duration was 5.0 months (range 0.7 to 22.6+ months, + denotes a censored value). Myositis led to discontinuation of Tecentriq in 1 (<0.1%) patient. Myositis requiring the use of corticosteroids occurred in 0.2% (7/3178) of patients receiving Tecentriq.
Immune-mediated meningoencephalitis: Meningoencephalitis occurred in 0.4% (14/3178) of patients who received Tecentriq monotherapy. The median time to onset was 0.5 months (range 0 to 12.5 months). The median duration was 0.7 months (range 0.2 to 14.5 months; + denotes a censored value). Meningoencephalitis requiring the use of corticosteroids occurred in 0.2% (6/3178) of patients receiving Tecentriq and all led to discontinuation of Tecentriq in 4 (0.1%) patients.
Immune-mediated neuropathies: Guillain-Barré syndrome and demyelinating polyneuropathy: Guillain-Barré syndrome and demyelinating polyneuropathy, occurred in 0.2% (5/3178) of patients who received Tecentriq monotherapy. The median time to onset was 7.0 months (range: 0.6 to 8.1 months). The median duration was 8.0 months (0.6 to 8.3+ months; + denotes a censored value). Guillain-Barré syndrome led to the discontinuation of Tecentriq in 1 (< 0.1%) patient. Guillain-Barré syndrome requiring the use of corticosteroids occurred in < 0.1% (2/3178) of patients receiving Tecentriq.
Immune-mediated facial paresis: Facial Paresis occurred in <0.1% (1/3178) of patients who received Tecentriq monotherapy. The time to onset was 0.95 months. The duration was 1.1 months. The event did not require the use of corticosteroids and the event did not lead to discontinuation of Tecentriq.
Immune-mediated myelitis: Myelitis occurred in <0.1% (1/3178) of patients who received Tecentriq monotherapy. The time to onset was 0.76 months. The event required the use of corticosteroids but did not lead to discontinuation of Tecentriq.
Immune-mediated nephritis: Nephritis, occurred in <0.1% (3/3178) of patients who received Tecentriq monotherapy. The median time to onset was 13.1 months (range: 9.0 to 17.5 months). The median duration was 2.8 months (range 0.5 to 9.5+ months; + denotes a censored value).
Nephritis led to discontinuation of Tecentriq in 2 (<0.1%) patients. One patient required the use of corticosteroids.
Immune-mediated pneumonitis: Pneumonitis occurred in 2.7% (87/3178) of patients who received Tecentriq monotherapy. Of the 87 patients, one event was fatal. The median time to onset was 3.4 months (range: 0.1 to 24.8 months). The median duration was 1.4 months (range: 0 to 21.2+ months; + denotes a censored value). Pneumonitis led to discontinuation of Tecentriq in 12 (0.4%) patients. Pneumonitis requiring the use of corticosteroids occurred in 1.6% (51/3178) of patients receiving Tecentriq.
Immune-mediated severe cutaneous adverse reactions: Severe cutaneous adverse reactions (SCARs) occurred in 0.7% (22/3178) of patients who received Tecentriq monotherapy. The median time to onset was 5.9 months (range 0.1 to 15.5 months). The median duration was 1.6 months (range 0 to 22.1+ months; + denotes a censored value). SCARs led to discontinuation of Tecentriq in 3 (<0.1%) patients. SCARs requiring the use of systemic corticosteroids occurred in 0.2% (6/3178) of patients receiving Tecentriq monotherapy.
Postmarketing Experience: The following adverse drug reactions have been identified from post marketing surveillance with TECENTRIQ (see Table 20). Adverse drug reactions from post marketing surveillance are listed by MedDRA system organ class. (See Table 20.)

Click on icon to see table/diagram/image