Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 60mg/mL (14-mL or 20-mL single-dose vial)
Non-Small Cell Lung Cancer
Single agent
-
Adjuvant non-small cell lung cancer (NSCLC)
- Indicated as adjuvant treatment following resection and platinum-based chemotherapy for adults with stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells
- 840 mg IV q2Weeks or
- 1200 mg IV q3Weeks or
- 1680 mg IV q4Weeks
- Continue for up to 1 year OR unless disease progression or unacceptable toxicity
-
Metastatic NSCLC
- Indicated for first-line treatment of metastatic NSCLC 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 the tumor area [IC ≥10%]) with no EGFR or ALK genomic tumor aberrations
- Also, indicated for metastatic NSCLC in patients who have disease progression during or following platinum-containing chemotherapy
- 840 mg IV q2Weeks or
- 1200 mg IV q3Weeks or
- 1680 mg IV q4Weeks
- Continue until disease progression or unacceptable toxicity
Combination therapy with bevacizumab, paclitaxel, and carboplatin
- Indicated in combination with bevacizumab, paclitaxel, and carboplatin for first-line treatment of patients with metastatic nonsquamous NSCLC with no EGFR or ALK genomic tumor aberrations
- 1200 mg IV on Day 1 q3Weeks plus bevacizumab, paclitaxel, and carboplatin x 4-6 cycles
- Refer to prescribing information for bevacizumab, paclitaxel, and carboplatin for recommended dosing information
-
After completion of chemotherapy cycles 4-6 with bevacizumab
- Atezolizumab 1200 mg IV, followed by bevacizumab on Day 1 q3Weeks; continue until disease progression or unacceptable toxicity
-
Atezolizumab dose following completion of 4-6 cycles, and if bevacizumab is discontinued
- 840 mg IV q2Weeks or
- 1200 mg IV q3Weeks or
- 1680 mg IV q4Weeks
- Continue until disease progression or unacceptable toxicity
Combination therapy with paclitaxel protein-bound and carboplatin
- Indicated in combination with paclitaxel protein-bound and carboplatin for first-line treatment of patients with metastatic nonsquamous NSCLC with no EGFR or ALK genomic tumor aberrations
- Atezolizumab 1200 mg on day 1 q3Weeks plus paclitaxel protein-bound and carboplatin x 4-6 cycles for each 21-day cycle
- Refer to prescribing information for paclitaxel protein-bound and carboplatin for recommended dosing information
-
Atezolizumab dose following completion of 4-6 cycles
- 840 mg IV q2Weeks or
- 1200 mg IV q3Weeks or
- 1680 mg IV q4Weeks
- Continue until disease progression or unacceptable toxicity
Small Cell Lung Cancer
Indication in combination with carboplatin and etoposide for first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC)
1200 mg IV on Day 1 q3Weeks
Continue until disease progression or unacceptable toxicity
Refer to prescribing information for chemotherapy agents administered in combination for recommended dosing information
Following completion of 4 cycles of carboplatin and etoposide
- 840 mg IV q2Weeks or
- 1200 mg IV q3Weeks or
- 1680 mg IV q4Weeks
- Continue until disease progression or unacceptable toxicity
Hepatocellular Carcinoma
Indicated in combination with bevacizumab for unresectable or metastatic hepatocellular carcinoma (HCC) in patients who have not received prior systemic therapy
Atezolizumab 1200 mg IV on Day 1 (administered before bevacizumab), plus
Bevacizumab 15 mg/kg IV on Day 1
Repeat every 3 weeks until disease progression or unacceptable toxicity
Refer to prescribing information for bevacizumab for recommended dosing information
Atezolizumab dose if bevacizumab discontinued for toxicity
- 840 mg IV q2Weeks or
- 1200 mg IV q3Weeks or
- 1680 mg IV q4Weeks
- Continue until disease progression or unacceptable toxicity
Melanoma
Indicated for unresectable or metastatic BRAF V600 mutation-positive melanoma in combination with cobimetinib and vemurafenib
Each cycle is 28 days
Before initiating atezolizumab
- Cobimetinib: 60 mg PO qDay on Days 1-21, PLUS
- Vemurafenib: 960 mg PO BID on Days 1-21, THEN, 720 mg PO BID on Days 22-28
- Refer to prescribing information for cobimetinib and vemurafenib prior to initiation
Cycle 1 and onwards
- Atezolizumab 840 mg IV on Days 1 and 15, PLUS
- Cobimetinib 60 mg PO qDay on Days 1-21 plus vemurafenib 720 mg PO BID on Days 1-28
- Continue until disease progression or unacceptable toxicity
Urothelial Carcinoma
Indication was voluntary withdrawn in the U.S. by manufacturer on November 29, 2022
The decision was made to remove the indication after the phase 3 IMvigor130 trial failed to reach its co-primary endpoint of overall survival (OS) when comparing atezolizumab plus chemotherapy to chemotherapy alone in patients with metastatic urothelial carcinoma.
These results were the designated postmarketing requirement for the manufacturer to convert its accelerated approval of atezolizumab to a regular approval
Failure to meet this requirement led to the decision to remove the indication after consulting the FDA
Triple-Negative Breast Cancer
On October 7, 2021, FDA removed approval for atezolizumab, in combination with paclitaxel protein-bound, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumor area)
Alveolar Soft Part Sarcoma
Indicated as a single agent, for unresectable or metastatic alveolar soft part sarcoma (ASPS)
840 mg IV q2Weeks, or
1,200 mg IV q3Weeks, or
1,680 mg IV q4Weeks
Continue until disease progression or unacceptable toxicity
Dosage Modifications
No dose reductions are recommended
Pneumonitis
- Grade 2: Withhold therapy; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
- Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
- Grade 3 or 4: Permanently discontinue
Colitis
- Grade 2 or 3: Withhold therapy; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
- Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
- Grade 4: Permanently discontinue
Hepatitis with no tumor involvement of the liver
- AST or ALT increases to >3 and ≤8x ULN or total bilirubin increases to >1.5 and <3x ULN: Withhold therapy; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
- Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
- AST or ALT increases to >8x ULN or total bilirubin increases to >3x ULN: Permanently discontinue
Hepatitis with tumor involvement of the liver
-
Withhold therapy
- Baseline AST or ALT >1 and ≤3x ULN and increases to >5 and ≤10x ULN
- Baseline AST or ALT >3 and ≤5x ULN and increases to >8 and ≤10x ULN
- Resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
- Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
-
Permanently discontinue
- AST or ALT increases to >10x ULN or total bilirubin increases to >3x ULN
Endocrinopathies
- Grade 3 or 4: Withhold until clinically stable or permanently discontinue depending on severity
Nephritis with renal dysfunction
- Grade 2 or 3 increased blood creatinine: Withhold therapy; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
- Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
- Grade 4 increased blood creatinine: Permanently discontinue
Exfoliative dermatologic conditions
- Suspected Steven Johnson Syndrome (SJS), toxic epidermal necrosis (TEN), or Drug Rash with Eosinophilia and Systemic Symptoms (DRESS): Withhold therapy
- Confirmed SJS, TEN, or DRESS: Permanently discontinue
Myocarditis
- Grade 2, 3, or 4: Permanently discontinue
Neurologic toxicities
- Grade 2: Withhold therapy; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
- Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
- Grade 3 or 4: Permanently discontinue
Infusion-related reactions
- Grade 1 or 2: Interrupt or slow infusion rate
- Grade 3 or 4: Permanently discontinue
Renal impairment
- Mild or moderate (eGFR 30-89 mL/min/1.73 m2): No dose adjustment is recommended
- Severe (eGFR <20 mL/min/1.73 m2): Not studied
Hepatic impairment
- Mild: No dose adjustment is recommended
- Moderate-to-severe: Not studied
Dosing Considerations
Patient selection
- Select patients based on PD-L1 expression on tumor infiltrating immune cells for treatment of urothelial carcinoma, NSCLC, and melanoma
- Select patients with unresectable or metastatic melanoma after confirming the presence of a BRAF V600 mutation
- Information on FDA-approved tests for PD-L1 expression are available at: http://www.fda.gov/CompanionDiagnostics
Dosage Forms & Strengths
injectable solution
- 60mg/mL (14-mL or 20-mL single-dose vial)
Alveolar Soft Part Sarcoma
Indicated as a single agent, for unresectable or metastatic alveolar soft part sarcoma (ASPS) in adults and pediatric patients aged ≥2 years
15 mg/kg (not to exceed 1,200 mg) IV q3Weeks
Continue until disease progression or unacceptable toxicity
Dosage Modifications
No dose reductions are recommended
Pneumonitis
- Grade 2: Withhold therapy; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
- Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
- Grade 3 or 4: Permanently discontinue
Colitis
- Grade 2 or 3: Withhold therapy; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
- Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
- Grade 4: Permanently discontinue
Hepatitis with no tumor involvement of the liver
- AST or ALT increases to >3 and ≤8x ULN or total bilirubin increases to >1.5 and <3x ULN: Withhold therapy; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
- Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
- AST or ALT increases to >8x ULN or total bilirubin increases to >3x ULN: Permanently discontinue
Hepatitis with tumor involvement of the liver
- Withhold therapy
- Baseline AST or ALT >1 and ≤3x ULN and increases to >5 and ≤10x ULN
- Baseline AST or ALT >3 and ≤5x ULN and increases to >8 and ≤10x ULN
- Resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
- Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
- Permanently discontinue
- AST or ALT increases to >10x ULN or total bilirubin increases to >3x ULN
Endocrinopathies
- Grade 3 or 4: Withhold until clinically stable or permanently discontinue depending on severity
Nephritis with renal dysfunction
- Grade 2 or 3 increased blood creatinine: Withhold therapy; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
- Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
- Grade 4 increased blood creatinine: Permanently discontinue
Exfoliative dermatologic conditions
- Suspected Steven Johnson Syndrome (SJS), toxic epidermal necrosis (TEN), or Drug Rash with Eosinophilia and Systemic Symptoms (DRESS): Withhold therapy
- Confirmed SJS, TEN, or DRESS: Permanently discontinue
Myocarditis
- Grade 2, 3, or 4: Permanently discontinue
Neurologic toxicities
- Grade 2: Withhold therapy; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
- Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
- Grade 3 or 4: Permanently discontinue
Infusion-related reactions
- Grade 1 or 2: Interrupt or slow infusion rate
- Grade 3 or 4: Permanently discontinue
Renal impairment
- Mild or moderate (eGFR 30-89 mL/min/1.73 m2): No dose adjustment is recommended
- Severe (eGFR <20 mL/min/1.73 m2): Not studied
Hepatic impairment
- Mild: No dose adjustment is recommended
- Moderate-to-severe: Not studied
Adverse Effects
All grades of severity are listed unless otherwise indicated
>10% (NSCLC [in combination with bevacizumab, paclitaxel, and carboplatin])
Anemia (67-83%)
Hyperglycemia (61%)
Neuropathy (56%)
Increased BUN (52%)
Neutropenia (52%)
Fatigue/asthenia (44-50%)
Lymphocytopenia (49%)
Alopecia (48%)
Lymphopenia (48%)
Hypoalbuminemia (40-48%)
Hyponatremia (38-42%)
Myalgia/pain (42%)
Hypomagnesemia (26-42%)
Increased AST (31-40%)
Nausea (18-39%)
Increased alkaline phosphatase (39%)
Increased ALT (27-37%)
Diarrhea (16-33%)
Neutropenia, Grade 3 or 4 (31%)
Increased TSH (30%)
Constipation (18-30%)
Decreased appetite (23-29%)
Hyperkalemia (28%)
Increased creatinine (23-28%)
Hypocalcemia (26%)
Arthralgia (26%)
Cough (20-26%)
Hypertension (25%)
Hyperphosphatemia (25%)
Hypophosphatemia (25%)
Hypokalemia (23%)
Rash (12-23%)
Dyspnea (22%)
Pyrexia (18-19%)
Vomiting (19%)
Epistaxis (17%)
Lymphopenia, Grade 3 or 4 (17%)
Proteinuria (16%)
Headache (16%)
Arthralgia (1-12%)
>10% (TNBC)
Alopecia (56%)
Fatigue (47%)
Peripheral neuropathies (47%)
Nausea (46%)
Diarrhea (33%)
Anemia (28%)
Constipation (25%)
Headache (23%)
Neutropenia (21%)
Vomiting (20%)
Decreased appetite (20%)
Pyrexia (19%)
Arthralgia (18%)
Rash (17%)
Peripheral edema (15%)
Back pain (15%)
Myalgia (14%)
Pruritus (14%)
Dizziness (14%)
Dysgeusia (14%)
Hypothyroidism (14%)
Decreased neutrophils (13%)
Urinary tract infection (12%)
Asthenia (12%)
Pain in extremity (11%)
Upper respiratory infection (11%)
Nasopharyngitis (11%)
>10% (SCLC)
Anemia (94%)
Neutropenia (73%)
Hyperglycemia (67%)
Thrombocytopenia (58%)
Lymphopenia (46%)
Neutropenia, Grade 3-4 (45%)
Increased alkaline phosphatase (38%)
Fatigue/asthenia (39%)
Nausea (38%)
Alopecia (37%)
Hyponatremia (34%)
Hypoalbuminemia (32%)
Hypomagnesemia (31%)
Decreased TSH (28%)
Decreased appetite (27%)
Constipation (26%)
Hypocalcemia (26%)
Increased ALT (26%)
Increased AST (22%)
Increased blood creatinine (22%)
Neutropenia (22%)
Hyperphosphatemia (21%)
Increased TSH (21%)
Thrombocytopenia, Grade 3-4 (20%)
Vomiting (20%)
Anemia, Grade 3-4 (17%)
Hyponatremia, Grade 3-4 (15%)
Lymphopenia, Grade 3-4 (14%)
Hyperglycemia, Grade 3-4 (10%)
>10% (HCC)
Increased AST (86%)
Increased alkaline phosphatase (70%)
Decreased platelet (68%)
Decreased lymphocytes (62%)
Increased ALT (62%)
Decreased albumin (60%)
Decreased hemoglobin (58%)
Decreased sodium (54%)
Increased glucose (48%)
Decreased leukocytes (32%)
Decreased calcium (30%)
Hypertension (30%)
Decreased phosphorus (26%)
Fatigue/asthenia (26%)
Decreased neutrophil (23%)
Increased potassium (23%)
Hypomagnesemia (22%)
Proteinuria (20%)
Pruritus (19%)
Diarrhea (19%)
Decreased appetite (18%)
Pyrexia (18%)
Increased AST, Grade 3-4 (16%)
Hypertension, Grade 3-4 (15%)
Constipation (13%)
Decreased lymphocytes, Grade 3-4 (13%)
Decreased sodium, Grade 3-4 (13%)
Abdominal pain (12%)
Nausea (12%)
Rash (12%)
Cough (12%)
Infusion-related reactions (11%)
>10% (Melanoma [in combination with cobimetinib and vemurafenib])
Increased creatine kinase (88%)
Decreased lymphocytes (80%)
Increased AST (80%)
Increased ALT (79%)
Decreased hemoglobin (77%)
Increased triacylglycerol lipase (75%)
Increased alkaline phosphatase (73%)
Decreased phosphorus (67%)
Musculoskeletal pain (62%)
Increased amylase (51%)
Fatigue (51%)
Hepatotoxicity (50%)
Pyrexia (49%)
Increased blood urea nitrogen (47%)
Decreased albumin (43%)
Increased bilirubin (42%)
Decreased calcium (41%)
Decreased sodium (40%)
Decreased thyroid stimulating hormone (TSH) (38%)
Increased TSH (37%)
Decreased potassium (36%)
Decreased platelet (34%)
Increased triiodothyronine (33%)
Increased free thyroxine (32%)
Decreased total triiodothyronine (32%)
Nausea (30%)
Increased potassium (29%)
Decreased triiodothyronine (27%)
Decreased neutrophils (26%)
Edema (26%)
Stomatitis (23%)
Hypothyroidism (22%)
Increased Sodium (20%)
Hyperthyroidism (18%)
Hypertension (17%)
Grade 3 or 4
- Increased triacylglycerol lipase (46%)
- Decreased lymphocytes (24%)
- Increased creatinine kinase (22%)
- Decreased phosphorus (22%)
- Hepatoxicity (21%)
- Increased ALT (18%)
- Increased AST (13%)
- Increased amylase (13%)
1-10% (NSCLC [in combination with bevacizumab paclitaxel, and carboplatin])
Hyponatremia, Grade 3 or 4 (10%)
Anemia, Grade 3 or 4 (10%)
Hypertension, Grade 3 or 4 (9%)
Hypokalemia, Grade 3 or 4 (7%)
Fatigue/asthenia, Grade 3 or 4 (6%)
Diarrhea, Grade 3 or 4 (6%)
Increased ALT, Grade 3 or 4 (6%)
Nausea, Grade 3 or 4 (4%)
Decrease appetite, Grade 3 or 4 (4%)
Increased AST, Grade 3 or 4 (4%)
Hypophosphatemia, Grade 3 or 4 (4%)
Hyperkalemia, Grade 3 or 4 (3%)
Neuropathy, Grade 3 or 4 (3%)
Myalgia/pain, Grade 3 or 4 (1.3-3%)
Proteinuria, Grade 3 or 4 (3%)
Hypoalbuminemia, Grade 3 or 4 (3%)
Hypocalcemia, Grade 3 or 4 (3%)
Dyspnea, Grade 3 or 4 (2.8%)
Rash, Grade 3 or 4 (2%)
Hypomagnesemia, Grade 3 or 4 (2%)
Increased alkaline phosphatase, Grade 3 or 4 (2%)
Vomiting, Grade 3 or 4 (1%)
Epistaxis, Grade 3 or 4 (1%)
Increased creatinine (1%)
1-10% (TNBC)
Increased ALT (10%)
Abdominal pain (10%)
Neutropenia, Grade 3 or 4 (8%)
Decreased neutrophils, Grade 3 or 4 (4.6%)
Anemia, Grade 3 or 4 (2.9%)
Diarrhea, Grade 3 or 4 (1.3%)
Nausea, Grade 3 or 4 (1.1%)
1-10% (SCLC)
Fatigue/asthenia, Grade 3-4 (5%)
Hypomagnesemia, Grade 3-4 (5%)
Pneumonia (4.5%)
Increased blood creatinine, Grade 3-4 (4%)
Neutropenia, Grade 3 or 4 (3.5%)
Hypocalcemia, Grade 3-4 (3%)
Increased ALT, Grade 3-4 (3%)
Febrile neutropenia (2.5%)
Thrombocytopenia (2.5%)
Vomiting, Grade 3-4 (2%)
Increased AST, Grade 3-4 (1%)
Nausea, Grade 3-4 (1%)
Constipation, Grade 3-4 (1%)
Decreased appetite, Grade 3-4 (1%)
Increased alkaline phosphatase, Grade 3-4 (1%)
Hypoalbuminemia, Grade 3-4 (1%)
1-10% (HCC)
Increased glucose, Grade 3-4 (9%)
Increased ALT, Grade 3-4 (8%)
Increased bilirubin, Grade 3-4 (8%)
Decreased phosphorus, Grade 3-4 (4.7%)
Increased alkaline phosphatase, Grade 3-4 (4%)
Increased leukocytes, Grade 3-4 (3.4%)
Decreased hemoglobin, Grade 3-4 (3.1%)
Proteinuria, Grade 3-4 (3%)
Infusion-related reactions, Grade 3-4 (2.4%)
Decreased neutrophil (2.3%)
Fatigue/asthenia, Grade 3-4 (2%)
Increased potassium, Grade 3-4 (1.9%)
Diarrhea, Grade 3-4 (1.8%)
Decreased albumin, Grade 3-4 (1.5%)
Decreased appetite, Grade 3-4 (1.2%)
1-10% (Melanoma [in combination with cobimetinib and vemurafenib])
Infusion related reaction (10%)
Pneumonitis (10%)
Arrhythmias (<10%)
Ejection fraction decreased (<10%)
Electrocardiogram QT prolonged (<10%)
Uveitis (<10%)
Pancreatitis (<10%)
Pneumonia (<10%)
Urinary tract infection (<10%)
Hyperglycemia (<10%)
Dizziness (<10%)
Dysgeusia (<10%)
Syncope (<10%)
Dyspnea (<10%)
Oropharyngeal pain (<10%)
Grade 3 or 4
- Hypertension (10%)
- Increased alkaline phosphatase (6%)
- Decreased sodium (5%)
- Decreased potassium (5%)
- Musculoskeletal pain (4.3%)
- Increased bilirubin (3.1%)
- Fatigue (3%)
- Infusion-related reaction (2.6%)
- Pyrexia (1.7%)
- Stomatitis (1.3%)
- Increased potassium (1.3%)
- Decreased calcium (1.3%)
- Pneumonitis (1.3%)
<1% (NSCLC [in combination with bevacizumab paclitaxel, and carboplatin])
Headache, Grade 3 or 4
Pyrexia, Grade 3 or 4
Constipation, Grade 3 or 4
Cough, Grade 3 or 4
<1% (TNBC)
Alopecia, Grade 3 or 4
Rash, Grade 3 or 4
Pyrexia, Grade 3 or 4
Peripheral edema, Grade 3 or 4
Asthenia, Grade 3 or 4
Constipation, Grade 3 or 4
Vomiting, Grade 3 or 4
Abdominal pain, Grade 3 or 4
Headache, Grade 3 or 4
Dyspnea, Grade 3 or 4
Decreased appetite, Grade 3 or 4
Arthralgia, Grade 3 or 4
Myalgia, Grade 3 or 4
Pain in extremity, Grade 3 or 4
Urinary tract infection, Grade 3 or 4
<1% (HCC)
Decreased calcium, Grade 3-4 (0.3%)
<1% (Melanoma [in combination with cobimetinib and vemurafenib])
Grade 3 or 4
- Hyperthyroidism (<1%)
- Nausea (<1%)
- Edema (<1%)
- Decreased albumin (0.9%)
Postmarketing Reports
Cardiac: Myocarditis, pericarditis, pericardial effusion, cardiac tamponade
Dermatologic: Bullous dermatitis, pemphigoid, erythema multiforme, Stevens-Johnson Syndrome (SJS)/toxic epidermal necrolysis (TEN)
Gastrointestinal: Pancreatitis, including increases in serum amylase or lipase levels
General: Systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis
Hematological: Autoimmune hemolytic anemia, immune thrombocytopenic purpura
Musculoskeletal: Myositis, rhabdomyolysis
Neurological: Guillain-Barre syndrome, myasthenia syndrome/myasthenia gravis, demyelination, immune-related meningoencephalitis, aseptic meningitis, encephalitis, facial and abducens nerve paresis, polymyalgia rheumatica, autoimmune neuropathy, and Vogt-Koyanagi- Harada syndrome
Ophthalmological: Uveitis, iritis
Renal: Nephrotic syndrome, nephritis
Vascular: Vasculitis
Hyperthyroidism
Increased transaminases or alkaline phosphate
Infusion-related reactions
Warnings
Contraindications
None
Cautions
Immune-mediated pneumonitis or interstitial lung disease occurred; monitor for signs and symptoms of pneumonitis; incidence of pneumonitis is higher in patient who have received thoracic radiation
May cause liver test abnormalities and immune-mediated hepatitis; fatal cases reported; monitor for signs and symptoms of hepatitis, during and after discontinuation of therapy, including clinical chemistry monitoring
Immune-mediated colitis or diarrhea reported
May cause severe or life-threatening infusion-related reactions; monitor for signs and symptoms of infusion-related reactions
Severe infections (eg, sepsis, herpes encephalitis, mycobacterial infection) leading to retroperitoneal hemorrhage reported; most common infection was upper respiratory tract infection; monitor for signs and symptoms of infection
Hematologic/immune effects may include hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection
Uveitis, iritis, and other ocular inflammatory toxicities can occur; some cases can be associated with retinal detachment; various grades of visual impairment, including blindness, can occur; if uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss
Do not substitute paclitaxel protein-bound with paclitaxel in combination with drug in clinical practice for metastatic TNBC outside of controlled trials
Can cause fetal harm; advise females of reproductive potential of potential risk to a fetus and use of effective contraception
Immune-related endocrinopathies
- Immune-related myasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome, or meningoencephalitis reported; permanently discontinue for any grade
- Monitor for clinical signs and symptoms of meningitis or encephalitis
- Monitor for symptoms of motor and sensory neuropathy
- Symptomatic pancreatitis without an alternative etiology occurred in 0.1% of patients across clinical trials; pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis; monitor for signs and symptoms of acute pancreatitis
- Monitor for signs and symptoms of myocarditis
- Thyroid disorders may occur; thyroiditis can present with or without endocrinopathy; not reported to lead to permanent discontinuation; hypothyroidism can follow hyperthyroidism monitor thyroid function prior to and periodically during treatment; initiate hormone replacement therapy or medical management of hyperthyroidism as clinically indicated; continue therapy for hypothyroidism and interrupt for hyperthyroidism or permanently discontinue therapy based on severity
- Adrenal insufficiency may occur; monitor patients for clinical signs and symptoms of adrenal insufficiency
- Type 1 diabetes mellitus reported; monitor for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated; interrupt treatment based on severity
- Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic reported
- Hypoparathyroidism may occur
- Hypophysitis/hypopituitarism may occur; hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts; hypophysitis can cause hypopituitarism; withhold or permanently discontinue therapy depending on severity; for Grade 2 or higher hypophysitis, initiate prednisone 1-2 mg/kg/day or equivalents, followed by a taper and hormone replacement therapy as clinically indicated
FDA Safety Alert
- On 9/8/2020, FDA alerted health care professionals, oncology clinical investigators, and patients that the combination of atezolizumab and paclitaxel in previously untreated inoperable locally advanced or metastatic TNBC was ineffective
- Alert was based on results from the IMpassion131 trial, a doubled-blind, multicenter, placebo-controlled trial comparing atezolizumab or placebo in combination with paclitaxel for patients with metastatic TNBC
- In this trial, atezolizumab and paclitaxel did not significantly reduce the risk of cancer progression and death compared with placebo and paclitaxel in PD-L1-positive population
- Increase in risk of death observed in patients treated with atezolizumab plus paclitaxel compared with placebo and paclitaxel in PD-L1-positive population; the efficacy of atezolizumab in combination with paclitaxel in patients with unresectable locally advanced or metastatic TNBC has not been demonstrated
- Interim overall survival results favored paclitaxel and placebo, over paclitaxel and atezolizumab in both the PD-L1-positive population and total population
Immune-mediated adverse reactions
- Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue; reactions can occur at any time after starting a PD1/PD-L1 blocking antibody
- While immune-mediated adverse reactions usually manifest during treatment with PD-1/PD-L1 blocking antibodies, immune-mediated adverse reactions can also manifest after discontinuation of PD-1/PD-L1 blocking antibodies
- Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of PD-1/PD-L1 blocking antibodies; monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions
- Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment; in cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection
- Institute medical management promptly, including specialty consultation as appropriate; withhold or permanently discontinue therapy depending on severity; in general, if therapy requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less
- Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month; consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy
Complications of allogeneic HSCT
- Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody
- Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause)
- These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT
- Follow patients closely for evidence of transplant-related complications and intervene promptly; consider benefit versus risks of treatment with a PD-1/PD-L1 blocking antibody prior to or after an allogeneic HSCT
Colitis
- Drug can cause immune-mediated colitis that can present with diarrhea, abdominal pain, and lower gastrointestinal (GI) bleeding
- Cytomegalovirus (CMV) infection/ reactivation reported in patients with corticosteroid-refractory immune-mediated colitis
- In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies
Pregnancy
Pregnancy
Based on its mechanism of action, can cause fetal harm when administered during pregnancy
No available data on use in pregnant women
Animal data
- Animal studies have demonstrated that inhibition of the PD-L1/PD-1 pathway can lead to increased risk of immune-related rejection of the developing fetus, resulting in fetal death
Contraception
- Advise females of reproductive potential to use effective contraception during treatment and for at least 5 months following the last dose
Infertility
- Based on animal studies, atezolizumab may impair fertility in females of reproductive potential while receiving treatment
Lactation
Unknown if distributed in human breast milk
As human IgG is excreted in human milk, potential for absorption and harm to the infant is unknown
Advise lactating woman not to breastfeed during treatment and for at least 5 months after the last dose
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Monoclonal antibody to programmed cell death ligand-1 protein (PDL1); binding PDL1 blocks the interaction between PDL-1 and its ligands (including B7.1 receptors)
PDL-1
- PDL1 is expressed on the surface of activated T cells under normal conditions; binding PDL1 inhibits immune activation and reduces T-cell cytotoxic activity when bound
- This negative feedback loop is essential for maintaining normal immune responses and limits T-cell activity to protect normal cells during chronic inflammation
- Tumor cells may circumvent T-cell–mediated cytotoxicity by expressing PDL1 on the tumor itself or on tumor-infiltrating immune cells, resulting in the inhibition of immune-mediated killing of tumor cells
Absorption
Systemic accumulation over 2-3 cycles of repeated dosing
- Peak plasma concentration: 1.91-fold
- Minimum plasma concentration: 1.46-fold
- AUC: 2.75-fold
Steady state: 6-9 weeks
Distribution
Vd: 6.9 L
Elimination
Half-life: 27 days
Clearance: 0.2 L/day
Administration
IV Compatibilities
0.9% NaCl
IV Preparation
Visually inspect solution for particulate matter and discoloration prior to administration
Solution should appear colorless to slightly yellow; discard if cloudy, discolored, or particles observed
Do NOT shake vial
Dilution
- Withdraw required amount from vial
- Dilute to a final concentration between 3.2-16.8 mg/mL in a polyvinyl chloride, polyethylene, or polyolefin infusion bag containing 0.9% NaCl
- Dilute with 0.9% NaCl only
- Gently invert diluted solution; do not shake
- Discard partially used or empty vial
IV Administration
For IV infusion only; do not give as IV bolus or IV push
Administer through an IV line with or without a sterile, nonpyrogenic, low-protein binding in-line filter (pore size of 0.2-0.22 micron)
First IV infusion: Infuse over 60 min
Subsequent IV infusions: If first infusion is tolerated, may administer subsequent doses over 30 min
When administering in combination with chemotherapy, administer atezolizumab before chemotherapy when given on the same day
Do not coadminister with other drugs through the same IV line
Storage
Contains no preservatives
Do not freeze
Do not shake
Unopened vials
- Refrigerate at 2-8°C (36-46°F) in original carton to protect from light
Diluted infusion solution
- Administer immediately once prepared
-
If not used immediately, it can be stored by either:
- At room temperature for no more than 6 hr from time of preparation (includes infusion time) OR
- Refrigerate at 2-8°C (36-46°F) for no more than 24 hr
Images
BRAND | FORM. | UNIT PRICE | PILL IMAGE |
---|---|---|---|
Tecentriq intravenous - | 840 mg/14 mL (60 mg/mL) vial | ![]() |
Copyright © 2010 First DataBank, Inc.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.