Abbreviated Product Information

TECENTRIQ^® CONCENTRATE FOR SOLUTION FOR INFUSION 840MG/14ML

TECENTRIQ^® CONCENTRATE FOR SOLUTION FOR INFUSION 1200MG/20ML

Indications:

Monotherapy for both 840mg and 1200mg

Urothelial Carcinoma (UC)
Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma after prior platinum-containing chemotherapy, or who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5%.

Non-Small cell lung cancer (NSCLC)
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. Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PD-L1 expression ≥ 50% tumour cells (TC) or ≥ 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC.

Combination therapy

840mg only:
Breast Cancer (BC)
Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.

1200mg only:
Non-Small cell lung cancer (NSCLC)
Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (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 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.

Small cell lung cancer (SCLC)
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).

Hepatocellular carcinoma (HCC)
Tecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Dosage and Administration: Patients with previously untreated 1L UC and 1L NSCLC should be selected for treatment based on the tumour expression of PD-L1 confirmed by a validated test.

840mg dose:

Monotherapy: The recommended dose of Tecentriq is 840 mg administered intravenously every two weeks, or 1,680 mg administered intravenously every four weeks.

Tecentriq in combination with nab-paclitaxel in 1L mTNBC: The recommended dose of Tecentriq is 840 mg administered by intravenous infusion, followed by 100 mg/m2 nab-paclitaxel. For each 28-day cycle, Tecentriq is administered on days 1 and 15, and nab-paclitaxel is administered on days 1, 8, and 15.

1200mg dose:

Monotherapy: The recommended dose of Tecentriq is 1,200 mg administered intravenously q3w.

Combination therapy: During the induction phase, the recommended dose of
Tecentriq is 1,200 mg administered by intravenous (IV) infusion:
Tecentriq in combination with bevacizumab, paclitaxel, and carboplatin – followed by bevacizumab, paclitaxel, and then carboplatin every three weeks for four or six cycles. The induction phase is followed by a maintenance phase without chemotherapy in which 1,200 mg Tecentriq followed by bevacizumab, is administered by IV infusion q3w.

Tecentriq in combination with nab-paclitaxel and carboplatin- followed by nab-paclitaxel and carboplatin every three weeks for four or six cycles. For each 21-day cycle, Tecentriq, nab paclitaxel, and carboplatin are administered on day 1. In addition, nab paclitaxel is administered on days 8 and 15. The induction phase is followed by a maintenance phase without chemotherapy in which 1,200 mg Tecentriq is administered by IV infusion q3w.

Tecentriq in combination with carboplatin and etoposide: followed by carboplatin, and then etoposide administered by IV infusion on day 1. Etoposide is also administered by IV infusion on days 2 and 3. This regimen is administered every three weeks for four cycles. The induction phase is followed by a maintenance phase without chemotherapy in which 1,200 mg Tecentriq is administered by IV infusion q3w.

Tecentriq in combination with bevacizumab (for HCC): The recommended dose of Tecentriq is 1,200mg followed by bevacizumab 15 mg/kg of body weight, administered by IV infusion q3w.

For 2L NSCLC and 2L UC, it is recommended that patients are treated with Tecentriq until loss of clinical benefit or unmanageable toxicity. For 1L NSCLC, 1L UC and TNBC, it is recommended that patients are treated with Tecentriq until disease progression or unmanageable toxicity. For ES-SCLC and for first-line NSCLC, in patients given Tecentriq in combination with carboplatin and nab-paclitaxel, it is recommended that patients are treated with Tecentriq until disease progression or unmanageable toxicity.

Please refer to the full prescribing information for dosage and dose modifications.

Warnings and Precautions: Immune-Related Pneumonitis: Monitor patients for signs and symptoms of pneumonitis. Immune-Related Hepatitis: Monitor patients for signs and symptoms of hepatitis. AST, ALT and bilirubin should be monitored prior to initiation of treatment, periodically during treatment with atezolizumab and as indicated based on clinical evaluation. Immune-Related Colitis: Monitor patients for signs and symptoms of diarrhea or colitis. Immune-Related Endocrinopathies: Hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis and type 1 diabetes mellitus, including diabetic ketoacidosis have been observed in clinical trials with atezolizumab. Monitor patients for clinical signs and symptoms of endocrinopathies. Thyroid function should be monitored prior to and periodically during treatment with atezolizumab. Immune-related meningoencephalitis: Patients should be monitored for clinical signs and symptoms of meningitis or encephalitis. Immune-related neuropathies: Patients should be monitored for symptoms of motor and sensory neuropathy. Immune- related Pancreatitis: Patients should be closely monitored for signs and symptoms of acute pancreatitis. Immune- related Myocarditis: Patients should be monitored for signs and symptoms of myocarditis. Immune- related Nephritis: Patients should be monitored for changes in renal function. Immune- related myositis: Patients should be monitored for signs and symptoms of myositis. Infusion related reactions: Patients with Grade 1 or 2 infusion related reactions may continue to receive atezolizumab with close monitoring; premedication with antipyretic and antihistamines may be considered. Immune-related severe cutaneous adverse reactions: Monitor patients for suspected severe skin reactions and other causes should be excluded. Refer patients to a specialist for further diagnosis and management for suspected SCARs. Autoimmune Hemolytic Anemia: Patients should be monitored for signs and symptoms of drug-induced AIHA. Disease-specific precautions: Physicians should carefully consider the combined risks of the four-drug regimen of atezolizumab bevacizumab, paclitaxel, and carboplatin before initiating treatment. Neutropenia and peripheral neuropathies occurring during treatment with atezolizumab and nabpaclitaxel may be reversible with interruptions of atezolizumab and/or nab-paclitaxel. Please refer to the full prescribing information for the management of immune-related adverse reactions.

Contraindications: Hypersensitivity to atezolizumab or to any of the excipients.

Please refer to the full prescribing information for full list of excipients.

Adverse Effects:
All therapies, very common adverse reactions: decreased appetite, dyspnea, cough, nausea, diarrhea, vomiting, rash, pruritus, arthralgia, back pain, musculoskeletal pain, pyrexia, fatigue, headache and asthenia. Common Adverse reactions: hyperthyroidism, infusion-related reaction, hypokalaemia, hyponatraemia, AST increased, ALT increased, blood creatinine increased. In monotherapy, Very Common Adverse reactions: urinary tract infection. Common Adverse reactions: thrombocytopenia, hypothyroidism, hyperglycaemia, hypotension, pneumonitis, hypoxia, nasal congestion, nasopharyngitis, abdominal pain, colitis, dysphagia, oropharyngeal pain, hepatitis, dry skin, , influzenza like illness and chills. Atezolizumab given in combination with other medicinal products, Very Common Adverse reactions: lung infection, anaemia, thrombocytopenia, neutropenia, leukopenia, hypothyroidism, peripheral neuropathy, hypertension, peripheral oedema, alopecia and constipation. Common Adverse reactions: sepsis,lymphopenia, dizziness, hypomagnesaemia, syncope, dysphonia, stomatitis, dysgeusia, blood alkaline phosphatase increased and proteinuria.

Please refer to Undesirable Effects section of the full prescribing information for more details.

Full prescribing information should be consulted prior to prescribing.

Date of preparation: Sep 2021