Tecentriq

Tecentriq Adverse Reactions

atezolizumab

Manufacturer:

Roche

Distributor:

Zuellig Pharma
Full Prescribing Info
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 (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Tecentriq monotherapy: The safety of Tecentriq monotherapy is based on pooled data in 3178 patients with multiple tumor types, with supporting data from the estimated cumulative exposure in >13000 patients across all clinical trials. Table 13 summarizes the adverse drug reactions (ADRs) that have been reported in association with the use of Tecentriq. (See Table 13.)

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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 14. ADRs with a clinically relevant difference when compared to monotherapy (refer to Table 13) are also presented. (See Table 14.)

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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: 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 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 22.0+ months; + denotes a censored value). 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 colitis: Colitis occurred in 1.1% (34/3178) of patients who received Tecentriq monotherapy. The median time to onset was 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 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).
Hyperthyroidism occurred in 0.9% (30/3178) of patients who received Tecentriq. 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 4.9% (23/473) of patients who received Tecentriq in combination with carboplatin and nab-paclitaxel. Hyperthyroidism led to discontinuation in 1 (0.2%) patient.
Adrenal Insufficiency: Adrenal insufficiency occurred in 0.4% (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.
Adrenal insufficiency occurred in 1.5% (7/473) of patients who received Tecentriq in combination with carboplatin and nab-paclitaxel. Adrenal insufficiency requiring the use of corticosteroids occurred in 0.8% (4/473) of patients receiving Tecentriq in combination with carboplatin and nab-paclitaxel.
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 Avastin, 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 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 led to discontinuation of Tecentriq in 4 (0.1%) patients.
Immune-mediated neuropathies: Neuropathies, including 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 pancreatitis: Pancreatitis, including amylase increased and lipase increased, 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 the discontinuation of Tecentriq in 3 (<0.1%) patients. Pancreatitis requiring the use of corticosteroids occurred in 0.1% (4/3178) 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 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 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 of the first event 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.
Post-marketing Experience: No new adverse drug reactions have been identified from post-marketing experience.
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