#高警訊藥品

Metastatic urothelial carcinoma: 泌尿道上皮細胞癌
1. In patients not eligible for cisplatin-containing chemotherapy with PD-L1 expression
2. In patients not eligible for any platinum-containing chemotherapy regardless of PD-L1 status
3. With progression during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant chemotherapyView additional information
Non-small cell lung cancer, Metastatic: 非小細胞肺癌
1. With progression during or after platinum-based chemotherapy
2. Patients with ALK or EGFR genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving atezolizumab

Antineoplastic Agent

Distribution:
Vd: 6.9 L
Excretion:
1. Total body clearance: 0.2 L/day
2. Elimination Half Life: 27 days

Specific contraindications have not been determined

Fetal risk cannot be ruled out

Infant risk cannot be ruled out

Common
1. Gastrointestinal: Constipation, Decrease in appetite, Diarrhea, Immune-mediated, Nausea
2. Respiratory: Cough, Dyspnea
3. Other: Fatigue
Serious (Immune-mediated disease)
1. Cardiovascular: Myocarditis
2. Endocrine metabolic: Adrenal insufficiency, Adrenal insufficiency, Diabetes mellitus, Hyperthyroidism, Hypophysitis, Hypothyroidism, Thyroiditis
3. Gastrointestinal: Abdominal pain, Colitis, Pancreatitis
4. Hepatic: Hepatitis
5. Musculoskeletal: Eaton-Lambert syndrome, Myasthenia gravis
6. Neurologic: Aseptic meningitis, Encephalitis, Guillain-Barr syndrome
7. Renal: Hematuria, Urinary tract infectious disease
8. Respiratory: Interstitial lung disease, Pneumonitis
9. Other: Fever, Infectious disease, Infusion reaction

Metastatic urothelial carcinoma:
1200 mg once every 3 weeks, continue until disease progression or unacceptable toxicity
Non-small cell lung cancer, Metastatic:
1200 mg IV infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity; if first infusion is tolerated, may infuse all subsequent doses over 30 minutes

Safety and effectiveness not established in pediatric patients

eGFR >30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling; however, eGFR 30-89 had no clinically significant effect on the systemic exposure of atezolizumab.
eGFR <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Hepatic impairment prior to treatment

Mild impairment: (1) bilirubin ULN OR (2) bilirubin >1-1.5 times ULN and any AST
No dosage adjustments provided in the manufacturer's labeling; however, mild impairment had no clinically significant effect on the systemic exposure of atezolizumab.

Moderate to severe impairment:
No dosage adjustments provided in the manufacturer's labeling (has not been studied).
Hepatotoxicity during treatment

AST or ALT >3 to 8 times ULN OR total bilirubin >1.5 to 3 times ULN:
Withhold treatment. Administer high-dose systemic corticosteroids (prednisone 1 to 2 mg/kg daily or equivalent) followed by a corticosteroid taper.

AST or ALT >8 times ULN OR total bilirubin >3 times ULN:
Discontinue permanently. Administer high-dose systemic corticosteroids (prednisone 1 to 2 mg/kg daily or equivalent) followed by a corticosteroid taper.

protect from light, refrigerate between 2-8 degree C