Tecentriq

Tecentriq

atezolizumab

Manufacturer:

Roche

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Atezolizumab
Indications/Uses
Non-small cell lung cancer (NSCLC): 1st-line metastatic non-squamous NSCLC w/ no EGFR or ALK genomic tumor aberrations in combination w/ Avastin, paclitaxel & carboplatin, or in combination w/ nab-paclitaxel & carboplatin; patients w/ metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients w/ EGFR or ALK genomic tumour aberrations should have disease progression on approved therapy for these aberrations prior to initiation of therapy; 1st-line metastatic NSCLC monotherapy in adult patients whose tumors have high PD-L1 expression [PD-L1 stained ≥50% of tumor cells (TC ≥50%) or PD-L1 stained tumor-infiltrating immune cells (IC) covering ≥10% of tumor area (IC ≥10%)], w/ no EGFR or ALK genomic tumor aberrations. Small cell lung cancer (SCLC): 1st-line extensive-stage SCLC in combination w/ carboplatin & etoposide. Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumor have PD-L1 expression ≥1% & who have not received prior chemotherapy for metastatic disease, in combination w/ nab-paclitaxel. In combination w/ Avastin for unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
Dosage/Direction for Use
IV infusion Monotherapy: NSCLC 840 mg every 2 wk or 1,200 mg every 3 wk or 1,680 mg every 4 wk. Initial infusion over 60 min, if tolerated, all subsequent infusions may be administered over 30 min. Combination therapy: 1st-line non-squamous NSCLC In combination w/ Avastin, paclitaxel & carboplatin: 1,200 mg during induction phase, followed by Avastin, paclitaxel then carboplatin every 3 wk for 4 or 6 cycles. Followed by maintenance phase w/o chemotherapy: 1,200 mg followed by Avastin every 3 wk. In combination w/ nab-paclitaxel & carboplatin: 1,200 mg during induction phase, followed by nab-paclitaxel & carboplatin on day 1 every 3 wk for 4 or 6 cycles of each 21-day cycle. In addition, nab-paclitaxel is administered on days 8 & 15. Followed by maintenance phase w/o chemotherapy: 1,200 mg every 3 wk. 1st-line extensive-stage SCLC 1,200 mg during induction phase, followed by carboplatin then etoposide on day 1-3 every 3 wk for 4 cycles. Followed by maintenance phase w/o chemotherapy: 1,200 mg every 3 wk. 1st-line TNBC 840 mg on days 1 & 15 followed by nab-paclitaxel 100 mg/m2 on days 1, 8 & 15 for each 28-day cycle. HCC 1,200 mg followed by Avastin 15 mg/kg on the same day every 3 wk. If Avastin is discontinued, administer Tecentriq as 840 mg every 2 wk, 1,200 mg every 3 wk or 1,680 mg every 4 wk.
Contraindications
Special Precautions
Not to be inj as IV push or bolus. Discontinue use in case grade 3 or 4 events occur. Infusion-related reactions. Monitor for signs & symptoms of immune-related pneumonitis, hepatitis, colitis or diarrhea, endocrinopathies, meningitis or encephalitis, motor & sensory neuropathy, acute pancreatitis, myocarditis, myositis, nephritis, suspected severe skin reactions. Patients w/ autoimmune disease. Severe hepatic impairment. May impair female fertility. Women of childbearing potential should use effective contraception during & for 5 mth after treatment. Not recommended during pregnancy & lactation. Childn & adolescents <18 yr.
Adverse Reactions
Diarrhea, nausea, vomiting; fatigue, asthenia, pyrexia; UTI; decreased appetite; arthralgia, back & musculoskeletal pain; headache; cough, dyspnea; rash, pruritus; anemia, neutropenia, thrombocytopenia, leukopenia; hypothyroidism; constipation; peripheral oedema; lung infection; peripheral neuropathy; nasopharyngitis; alopecia; HTN. Dysphagia, colitis, abdominal & oropharyngeal pain; chills, flu-like illness, infusion-related reaction; increased ALT & AST, hepatitis; hypersensitivity; hypokalemia, hyponatremia, hyperglycemia; increased blood creatinine; hypoxia, pneumonitis, nasopharyngitis; dry skin; hypotension; lymphophenia; hyperthyroidism; stomatitis; increased blood alkaline phosphatase; hypomagnesemia; dizziness, dysegusia, syncope; proteinuria; dysphonia.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01XC32 - atezolizumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Tecentriq soln for infusion 1,200 mg/20 mL
Packing/Price
((single-use)) 1's
Form
Tecentriq soln for infusion 840 mg/14 mL
Packing/Price
(single-use) 1's
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