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atezolizumab.md

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Atezolizumab

Tecentriq inj 1200mg/20mL

臨採
TAH Drug Code ITEC
Indications Locally advanced or metastatic urothelial carcinoma (UC) after prior chemotherapy, or for those considered cisplatin ineligible & whose tumours have a PD-L1 expression ?5%, or those not eligible for any platinum-containing chemotherapy regardless of tumor PD-L1 expression level. 1st-line treatment in combination w/ bevacizumab, paclitaxel & carboplatin for metastatic non-squamous non-small cell lung cancer (NSCLC) w/ no EGFR or ALK genomic tumor aberrations. Locally advanced or metastatic NSCLC after prior chemotherapy. Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in combination w/ nab-paclitaxel, for those whose tumors have PD-L1 expression ?1% & who have not received prior chemotherapy for metastatic disease.
Dosing 840 mg IV every 2 weeks or 1200 mg IV every 3 weeks, or 1680 mg IV every 4 weeks infused over 60 minutes; if the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes. [Non-squamous NSCLC] In combination with bevacizumab, paclitaxel, & carboplatin: 1200 mg by IV infusion, followed by bevacizumab, paclitaxel, & then carboplatin every 3 weeks for 4 or 6 cycles during induction phase, then, followed by maintenance phase without chemotherapy and bevazicumab, in which 840 mg IV every 2 weeks or 1200 mg IV every 3 weeks, or 1680 mg IV every 4 weeks. [Triple-negative breast cancer] In combination with nab-paclitaxel: 840 mg by IV infusion, followed by 100 mg/m2 nab-paclitaxel. For each 28-day cycle Tecentriq is administered on days 1 & 15, & nab-paclitaxel is administered on days 1, 8 & 15. [Small cell lung cancer, SCLC] 1200 mg by IV infusion, followed by carboplatin AUC 5 mg/mL/min IV on day 1 and etoposide 100 mg/m2 IV on days 1 through 3 of each 21-day cycle for maximum of 4 cycles. [Liver carcinoma] 1200 mg by IV infusion, followed by 15mg/kg bevacizumab every 3 weeks; continue until disease progression or unacceptable toxicity.
Hepatic Impairment Dose adjustment not necessary
Renal Impairment Dose adjustment not necessary
Contraindications Hypersensitivity.
Adverse Effects Common: Hypertension (17-43%), Alopecia (32-48%), Rash (0.6-75%), Constipation (12-36%), Decrease in appetite (15-30%), Diarrhea (11-43%), Nausea (12-50%), Arthralgia (11-26%), Asthenia (25-51%), Neuropathy (33-56%), Urinary tract infectious disease (<10%), Cough (Up to 27%), Dyspnea (Up to 33%), Fatigue (14-61%) Serious: Myocarditis, Pericarditis, Vasculitis, Erythroderma, Stevens-Johnson syndrome, Toxic epidermal necrolysis, Adrenal insufficiency (0.4-1.2%), Hyperthyroidism (0.8-18%), Hypoparathyroidism, Hypophysitis (<0.1%), Hypothyroidism (4.9-26%), Thyroiditis (0.2-1.2%), Type 1 diabetes mellitus (0.3%), Abdominal pain (12-25%), Colitis (1%), Duodenitis, Gastritis, Pancreatitis (<10%), Aplastic anemia, Hemolytic anemia (Rare), Hemophagocytic lymphohistiocytosis, Histiocytic necrotizing lymphadenitis, Immune thrombocytopenia, Hepatitis (1.8-6.1%), Veno-occlusive disease of the liver, Drug reaction with eosinophilia and systemic symptoms, Graft versus host disease, Sarcoidosis, Systemic inflammatory response syndrome, Transplanted organ rejection, Arthritis, Eaton-Lambert syndrome, Myasthenia gravis, Myositis, Polymyalgia rheumatica, Polymyositis, Rhabdomyolysis, Cerebral infarction, Demyelination of spinal cord, Encephalitis, Guillain-Barre syndrome, Meningitis, Myelitis, Iritis, Myasthenia gravis, ocular, Uveitis (<10%), Visual impairment, Vogt-Koyanagi-Harada disease, Acute renal failure (2.2%), Nephritis (Up to 1.3%), Chronic obstructive pulmonary disease, Pneumonitis (3-13%), Cancer (2.2%), Disorder characterized by fever, steroid-requiring, Fever (14-49%), Infectious disease, Inflammatory disease of mucous membrane, Infusion reaction (1.3-11%), Sepsis, Sepsis due to Staphylococcus, Septic shock
Pregnancy Contraindicated
Lactation Contraindicated
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