Tecentriq

Atezolizumab

Monotherapy in locally advanced or metastatic urothelial carcinoma after prior chemotherapy, or in patients considered cisplatin ineligible & whose tumours have PD-L1 expression ≥5%; as adjuvant treatment following resection & platinum-based chemotherapy for patients w/ stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥1% of tumor cells (TC); for 1st-line treatment of patients w/ metastatic NSCLC whose tumors have PD-L1 expression ≥50% TC or ≥10% tumor-infiltrating immune cells (IC) & who do not have epidermal growth factor receptor (EGFR) or ALK genomic tumor aberrations; in locally advanced or metastatic NSCLC after prior chemotherapy. In combination w/ bevacizumab, paclitaxel & carboplatin as 1st-line treatment of metastatic non-squamous NSCLC w/ no EGFR or ALK genomic tumor aberrations. In combination w/ nab-paclitaxel & carboplatin for 1st-line treatment of adults w/ metastatic NSCLC who do not have EGFR or ALK genomic tumor aberrations. In combination w/ carboplatin & etoposide for 1st-line treatment of extensive-stage small cell lung cancer (ES-SCLC). In combination w/ nab-paclitaxel in patients w/ unresectable locally advanced or metastatic triple -ve breast cancer (TNBC) whose tumors have PD-L1 expression ≥1% on IC & who have not received prior chemotherapy for metastatic disease. In combination w/ bevacizumab in patients w/ unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

IV infusion Administer initial dose over 60 min. If 1st infusion is tolerated, administer all subsequent infusions over 30 min. Recommended dose: 840 mg every 2 wk, or 1,200 mg every 3 wk or 1,680 mg every 4 wk. 1st line non-squamous metastatic NSCLC In combination w/ bevacizumab, paclitaxel & carboplatin: Tecentriq followed by bevacizumab, paclitaxel & carboplatin every 3 wk for 4 or 6 cycles during induction phase. Followed by maintenance phase w/o chemotherapy in which Tecentriq is followed by bevazicumab administered every 3 wk. In combination w/ nab-paclitaxel & carboplatin: Tecentriq followed by nab-paclitaxel & carboplatin every 3 wk for 4 or 6 cycles during induction phase. For each 21-day cycle, administer nab-paclitaxel & carboplatin on day 1. In addition, administer nab-paclitaxel on days 8 & 15. 1st-line ES-SCLC In combination w/ carboplatin & etoposide: Tecentriq followed by carboplatin & etoposide IV infusion every 3 wk for 4 cycles during induction phase. Administer carboplatin & etoposide on day 1 of each cycle, & etoposide on days 2 & 3. 1st-line TNBC In combination w/ nab-paclitaxel: Tecentriq followed by nab-paclitaxel 100 mg/m² on days 1, 8 & 15 during each 28-day cycle. HCC In combination w/ bevacizumab: Tecentriq followed by bevacizumab 15 mg/kg every 3 wk.

Hypersensitivity.

Not to be administered as IV push or bolus. Permanently discontinue for Grade 4 skin reactions; confirmed SJS or TEN. Withhold treatment for Grade 3 skin reactions until recovery to Grade ≤1; suspected SJS or TEN. Haemophagocytic lymphohistiocytosis (HLH). Immune-mediated myocarditis; pericardial disorders including pericarditis, pericardial effusion & cardiac tamponade; endocrinopathies (eg, hypo-/hyperthyroidism, adrenal insufficiency, hypophysitis & type 1 DM including diabetic ketoacidosis); colitis or diarrhea; pancreatitis including increased serum amylase & lipase levels; hepatitis; myositis; meningoencephalitis; neuropathies including myasthenic syndrome/myasthenia gravis or Guillain-Barré syndrome; myelitis; nephritis; pneumonitis; severe cutaneous adverse reactions including SJS & TEN. Infusion-related reactions. Patients w/ abnormal thyroid function tests & LFTs at baseline; previous severe or life-threatening skin adverse reaction on prior treatment w/ other immune-stimulatory anticancer agents; autoimmune disease. Monitor for signs & symptoms of HLH; myocarditis; pericardial disorders; endocrinopathies; colitis; acute pancreatitis; hepatitis; myositis; meningitis or encephalitis; motor & sensory neuropathy; myelitis; pneumonitis; for suspected severe skin reactions. Monitor thyroid function, AST, ALT & bilirubin prior to & periodically during treatment; for changes in renal function. Moderate or severe hepatic impairment. Women of childbearing potential should use highly effective contraception during treatment & for at least 5 mth after last dose. Not recommended during pregnancy. Lactation. Potential risk to fetus. Not for use in childn & adolescents <18 yr.

Diarrhea, nausea, vomiting, constipation; fatigue, asthenia, pyrexia, peripheral oedema; UTI, lung infection; decreased appetite; arthralgia, back & musculoskeletal pain; headache, peripheral neuropathy; cough, dyspnea, nasopharyngitis; rash, pruritus, alopecia; anemia, neutropenia, thrombocytopenia, leukopenia; hypothyroidism; HTN. Lymphopenia; pericardial disorders; hyperthyroidism; dysphagia, colitis, abdominal & oropharyngeal pain, dry mouth, stomatitis; chills, flu-like illness, infusion-related reaction; increased ALT & AST, hepatitis; hypersensitivity; hypokalemia, hyponatremia, hyperglycemia, hypomagnesemia; increased creatinine, proteinuria; hypoxia, pneumonitis, dysphonia; dry skin; hypotension; increased blood alkaline phosphatase; dizziness, dysgeusia, syncope.

Targeted Cancer Therapy / Cancer Immunotherapy

L01FF05 - atezolizumab ; Belongs to the class of PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors. Used in the treatment of cancer.

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