Tecentriq Special Precautions

General: In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
Haemophagocytic lymphohistiocytosis: Haemophagocytic lymphohistiocytosis (HLH), including fatal cases, has been reported in patients receiving Tecentriq (see Clinical Trials and Postmarketing Experience under Adverse Reactions). HLH should be considered when the presentation of cytokine release syndrome is atypical or prolonged. Patients should be monitored for clinical signs and symptoms of HLH. Refer to Dosage & Administration for recommended dose modifications.
Immune-mediated myocarditis: Myocarditis, including fatal cases, has been observed in clinical trials with Tecentriq (see Clinical Trials under Adverse Reactions). Patients should be monitored for signs and symptoms of myocarditis. Myocarditis may also be a clinical manifestation of myositis and should be managed accordingly. Refer to Dosage & Administration for recommended dose modifications.
Immune-mediated pericardial disorders: Pericardial disorders, including pericarditis, pericardial effusion and cardiac tamponade, some leading to fatal outcomes, have been observed in clinical trials with Tecentriq (see Clinical Trials and Postmarketing Experience under Adverse Reactions). Patients should be monitored for clinical signs and symptoms of pericardial disorders. Refer to Dosage & Administration for recommended dose modifications.
Immune-mediated endocrinopathies: Hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis, and type 1 diabetes mellitus, including diabetic ketoacidosis, have been observed in clinical trials with Tecentriq (see Clinical Trials under Adverse Reactions). Patients should be monitored for clinical signs and symptoms of endocrinopathies. Monitor thyroid function prior to and periodically during treatment with Tecentriq. Consider appropriate management of patients with abnormal thyroid function tests at baseline. Patients with abnormal thyroid function tests who are asymptomatic may receive Tecentriq. Refer to Dosage & Administration for recommended dose modifications.
Immune-mediated colitis: Cases of diarrhea or colitis have been observed in clinical trials with Tecentriq (see Clinical Trials under Adverse Reactions). Patients should be monitored for signs and symptoms of colitis. Refer to Dosage & Administration for recommended dose modifications.
Immune-mediated pancreatitis: Pancreatitis, including increases in serum amylase and lipase levels, has been observed in clinical trials with Tecentriq (see Clinical Trials under Adverse Reactions). Patients should be closely monitored for signs and symptoms that are suggestive of acute pancreatitis. Refer to Dosage & Administration for recommended dose modifications.
Infusion-related reactions: Infusion-related reactions (IRRs) have been observed in clinical trials with Tecentriq (see Clinical Trials under Adverse Reactions). Refer to Dosage & Administration for recommended dose modifications.
Immune-mediated hepatitis: Cases of hepatitis, some leading to fatal outcomes, have been observed in clinical trials with Tecentriq (see Clinical Trials under Adverse Reactions). Patients should be monitored for signs and symptoms of hepatitis. Monitor aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin prior to and periodically during treatment with Tecentriq. Consider appropriate management of patients with abnormal liver function tests (LFTs) at baseline. Refer to Dosage & Administration for recommended dose modifications.
Immune-mediated myositis: Case of myositis, including fatal cases, have been observed in clinical trials with Tecentriq (see Clinical Trials under Adverse Reactions). Patients should be monitored for the signs and symptoms of myositis. Patients with possible myositis should be monitored for signs of myocarditis. Refer to Dosage & Administration for recommended dose modifications.
Immune-mediated meningoencephalitis: Meningoencephalitis has been observed in clinical trials with Tecentriq (see Clinical Trials under Adverse Reactions). Patients should be monitored for clinical signs and symptoms of meningitis or encephalitis. Refer to Dosage & Administration for recommended dose modifications.
Immune-mediated neuropathies: Myasthenic syndrome/myasthenia gravis or Guillain-Barré syndrome, which may be life threatening, and facial paresis were observed in patients receiving Tecentriq (see Clinical Trials under Adverse Reactions). Patients should be monitored for symptoms of motor and sensory neuropathy. Refer to Dosage & Administration for recommended dose modifications.
Immune-mediated myelitis: Myelitis has been observed in clinical trials with Tecentriq (see Clinical Trials and Postmarketing Experience under Adverse Reactions). Patients should be closely monitored for signs and symptoms that are suggestive of myelitis. Refer to Dosage & Administration for recommended dose modifications.
Immune-mediated nephritis: Nephritis has been observed in clinical trials with Tecentriq (see Clinical Trials under Adverse Reactions). Patients should be monitored for changes in renal function. Refer to Dosage & Administration for recommended dose modifications.
Immune-mediated pneumonitis: Cases of pneumonitis, including fatal cases, have been observed in clinical trials with Tecentriq (see Clinical Trials under Adverse Reactions). Patients should be monitored for signs and symptoms of pneumonitis. Refer to Dosage & Administration for recommended dose modifications.
Immune-mediated severe cutaneous adverse reactions: Immune-mediated severe cutaneous adverse reactions (SCARs), including cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in patients receiving Tecentriq. Patients should be monitored for suspected severe skin reactions and other causes should be excluded. Based on the severity of the adverse reaction, Tecentriq should be withheld for Grade 3 skin reactions until recovery to Grade ≤ 1 or permanently discontinued for Grade 4 skin reactions, and corticosteroids should be administered (see Dosage & Administration).
For suspected SCARs, patients should be referred to a specialist for further diagnosis and management. Tecentriq should be withheld for patients with suspected SJS or TEN. For confirmed SJS or TEN, Tecentriq should be permanently discontinued.
Caution should be used when considering the use of Tecentriq in a patient who has previously experienced a severe or life-threatening skin adverse reaction on prior treatment with other immune-stimulatory anticancer agents.
Special populations: Patients with autoimmune disease were excluded from clinical trials with Tecentriq. In the absence of data, Tecentriq should be used with caution in patients with autoimmune disease, after assessment of the potential risk/benefit.
Renal Impairment: See Special Dosage Instructions under Dosage & Administration, and PHARMACOLOGY: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions.
Hepatic Impairment: See Special Dosage Instructions under Dosage & Administration, and PHARMACOLOGY: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions.
Ability to Drive and Use Machines: No studies on the effects on the ability to drive and to use machines have been performed.
Use in Pregnancy: Embryo-fetal toxicity: Based on the mechanism of action, the use of Tecentriq may cause fetal harm. Animal studies have demonstrated that inhibition of the PD-L1/PD-1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death.
Pregnant women should be advised of the potential risk to the fetus. Women of childbearing potential should be advised to use highly effective contraception during treatment with Tecentriq and for 5 months after the last dose (see Females and Males of Reproductive Potential under Use in Pregnancy & Lactation, and PHARMACOLOGY: Toxicology: Nonclinical Safety: Reproductive Toxicity under Actions).
Use in Children: Tecentriq is not approved for use in the patients under the age of 18 years. The safety and efficacy of Tecentriq in this population has not been established. Tecentriq did not demonstrate clinical benefit in pediatric patients in a clinical trial (see PHARMACOLOGY: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions).
Use in the Elderly: No overall differences in safety or efficacy were observed between patients ≥ 65 years of age and younger patients (see Special Dosage Instructions under Dosage & Administration, and PHARMACOLOGY: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions).