Atezolizumab

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous [preservative free]:

Tecentriq: 840 mg/14 mL (14 mL); 1200 mg/20 mL (20 mL)

Pharmacology

Mechanism of Action

Atezolizumab is a humanized monoclonal antibody immune checkpoint inhibitor that binds to programmed death ligand 1 (PD-L1) to selectively prevent the interaction between the programmed cell death-1 (PD-1) and B7.1 (also known as CD80) receptors, while still allowing interaction between PD-L2 and PD-1. PD-L1 is an immune check point protein expressed on tumor cells and tumor infiltrating cells and down regulates anti-tumor t-cell function by binding to PD-1 and B7.1; blocking PD-1 and B7.1 interactions restores antitumor t-cell function (Fehrenbacher 2016; Rosenberg 2016).

Pharmacokinetics/Pharmacodynamics

Distribution

V_dss: 6.9 L

Excretion

Clearance: 0.2 L/day

Half-Life Elimination

27 days

Use: Labeled Indications

Breast cancer (triple-negative), unresectable locally advanced or metastatic: Treatment of unresectable locally advanced or metastatic triple-negative breast cancer (in combination with paclitaxel [protein bound]) in patients whose tumors express programmed death-ligand 1 (PD-L1) (PD-L1 stained infiltrating immune cells [IC] of any intensity covering ≥1% of the tumor area) as defined by an approved test.

Non-small cell lung cancer, metastatic:

First-line treatment (in combination with bevacizumab, paclitaxel, and carboplatin) of metastatic non-squamous non-small cell lung cancer (NSCLC) in patients with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

First-line treatment (in combination with paclitaxel [protein bound] and carboplatin) of metastatic NSCLC in patients with no EGFR or ALK genomic tumor aberrations.

Treatment (single-agent) of metastatic NSCLC in patients with disease progression during or following platinum-containing chemotherapy (patients with EGFR or ALK genomic aberrations should have disease progression on approved therapy for EGFR or ALK genomic tumor mutations prior to receiving atezolizumab).

Small cell lung cancer, extensive-stage: First-line treatment of extensive-stage small cell lung cancer (in combination with carboplatin and etoposide).

Urothelial carcinoma, locally advanced or metastatic: Treatment of locally advanced or metastatic urothelial carcinoma in patients who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (PD-L1 stained infiltrating IC covering ≥5% of the tumor area) as defined by an approved test, in patients who are not eligible for any platinum-containing therapy regardless of PD-L1 status, or in patients who have disease progression during or following any platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant chemotherapy.

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Additional contraindications (not in the US labeling): Hypersensitivity to atezolizumab or any component of the formulation

Dosage and Administration

Dosing: Adult

Breast cancer (triple-negative), locally advanced or metastatic: IV: 840 mg on days 1 and 15 every 4 weeks (in combination with paclitaxel [protein bound]) until disease progression or unacceptable toxicity; paclitaxel (protein bound) or atezolizumab may be discontinued for toxicity independently of each other (Schmid 2018). Note: Select patients for atezolizumab therapy based on the programmed death-ligand 1 (PD-L1) expression on tumor-infiltrating immune cells.

Non-small cell lung cancer (NSCLC), metastatic: IV:

First-line treatment, non-squamous NSCLC:

1,200 mg on day 1 every 3 weeks (in combination with bevacizumab, paclitaxel, and carboplatin) for 4 to 6 cycles, followed by atezolizumab 1,200 mg on day 1 (followed by bevacizumab) every 3 weeks until disease progression or unacceptable toxicity (Socinski 2018); if bevacizumab is discontinued after the 4 to 6 cycles of combination chemotherapy, atezolizumab may be continued as a single agent at 840 mg once every 2 weeks or 1,200 mg once every 3 weeks or 1,680 mg once every 4 weeks until disease progression or unacceptable toxicity.

1,200 mg on day 1 every 3 weeks (in combination with paclitaxel [protein bound] and carboplatin) for 4 to 6 cycles (West 2019); after the 4 to 6 cycles of induction combination chemotherapy, atezolizumab may be continued as a single agent at 840 mg once every 2 weeks or 1,200 mg once every 3 weeks or 1,680 mg once every 4 weeks until disease progression or unacceptable toxicity.

Previously-treated NSCLC: 840 mg once every 2 weeks or 1,200 mg once every 3 weeks (Fehrenbacher 2016; Rittmeyer 2017) or 1,680 mg once every 4 weeks; continue until disease progression or unacceptable toxicity.

Small cell lung cancer (extensive-stage), first-line treatment: IV: Induction: 1,200 mg on day 1 every 3 weeks in combination with carboplatin and etoposide for 4 cycles (Horn 2018), followed by maintenance therapy of single-agent atezolizumab at 840 mg once every 2 weeks or 1,200 mg once every 3 weeks (Horn 2018) or 1,680 mg once every 4 weeks; continue until disease progression or unacceptable toxicity.

Urothelial carcinoma, locally advanced or metastatic: IV: 840 mg once every 2 weeks or 1,200 mg once every 3 weeks (Balar 2017; Rosenberg 2016) or 1,680 mg once every 4 weeks; continue until disease progression or unacceptable toxicity. Note: Select previously untreated, cisplatin-ineligible patients for atezolizumab therapy based on the PD-L1 expression on tumor-infiltrating immune cells.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Adjustment for Toxicity

Dosage reductions are not recommended for toxicities. Treatment is withheld or permanently discontinued. If therapy is withheld, depending on the toxicity grade, may resume if toxicity recovers to grade 0 or 1. Permanently discontinue for recurrent grade 3 or 4 toxicity. Concomitant chemotherapy may require therapy interruption, dosage reduction, or discontinuation based on toxicity severity.

Cardiovascular toxicity: Myocarditis, pericarditis, arrhythmias, impaired ventricular function with HF, and vasculitis (ASCO guidelines for the Management of Immune-Related Adverse Events in Patients Treated with Immune Checkpoint Inhibitor Therapy [Brahmer 2018]): Withhold therapy for all grades and obtain cardiology consultation for work-up and intervention (due to potential for cardiac compromise). For grade 2 or higher myocarditis, consider high-dose corticosteroids (prednisone 1 to 2 mg/kg daily or equivalent), management per cardiology consultation, and permanent discontinuation. The appropriateness of resuming immune checkpoint inhibitor therapy following resolution of myocarditis is unknown.

Endocrinopathies:

Adrenal insufficiency, ≥ grade 2: Withhold treatment. Administer high-dose systemic corticosteroids (prednisone 1 to 2 mg/kg daily or equivalent) followed by a corticosteroid taper and administer hormone replacement as clinically indicated. May resume atezolizumab when ≤ grade 1 and clinically stable on hormone replacement therapy.

Diabetes mellitus type 1/hyperglycemia, ≥ grade 2: Withhold treatment. May require insulin treatment. May resume atezolizumab when ≤ grade 1 and clinically stable.

Hyperthyroidism, ≥ grade 2: Withhold treatment. May require additional treatment for symptomatic hyperthyroidism. May resume atezolizumab when ≤ grade 1 and clinically stable.

Hypophysitis, ≥ grade 2: Withhold treatment. Administer high-dose systemic corticosteroids (prednisone 1 to 2 mg/kg daily or equivalent) followed by a corticosteroid taper and administer hormone replacement as clinically indicated. May resume atezolizumab when ≤ grade 1 and clinically stable on hormone replacement therapy.

Hypothyroidism: Continue atezolizumab and initiate hormone replacement therapy.

Gastrointestinal toxicity:

Diarrhea or colitis, grade 2 or 3: Withhold treatment. If symptoms persist for >5 days or recur, administer high-dose systemic corticosteroids (prednisone 1 to 2 mg/kg daily or equivalent) followed by a corticosteroid taper. May resume when ≤ grade 1 and prednisone dose is ≤10 mg/day (or equivalent).

Diarrhea or colitis, grade 4: Discontinue permanently. Administer high-dose systemic corticosteroids (prednisone 1 to 2 mg/kg daily or equivalent) followed by a corticosteroid taper.

Infection, ≥ grade 3: Withhold treatment until ≤ grade 1 or resolved.

Infusion-related reactions:

Grade 1 or 2: Interrupt or slow the infusion rate; consider premedication with subsequent doses.

Grade 3 or 4: Permanently discontinue.

Ophthalmic disorders: Uveitis in combination with other immune-mediated adverse reactions may require systemic corticosteroids to reduce the risk of permanent vision loss.

Pulmonary toxicities:

Pneumonitis, grade 2: Withhold treatment. Administer high-dose systemic corticosteroids (prednisone 1 to 2 mg/kg daily or equivalent) followed by a corticosteroid taper. May resume when ≤ grade 1 and prednisone dose is ≤10 mg/day (or equivalent).

Pneumonitis, grade 3 or 4: Discontinue permanently. Administer high-dose systemic corticosteroids (prednisone 1 to 2 mg/kg daily or equivalent) followed by a corticosteroid taper.

Other toxicities:

Grade 2 (immune-mediated): Exclude other causes and initiate corticosteroids as clinically indicated.

Grade 3 (immune-mediated; involving a major organ): Withhold treatment. Administer high-dose systemic corticosteroids (prednisone 1 to 2 mg/kg daily or equivalent) followed by a corticosteroid taper. May resume when ≤ grade 1 and prednisone dose is ≤10 mg/day (or equivalent).

Grade 4 (immune-mediated; involving a major organ): Discontinue permanently. Administer high-dose systemic corticosteroids (prednisone 1 to 2 mg/kg daily or equivalent) followed by a corticosteroid taper.

Persistent/resistant/recurrent toxicities:

Persistent grade 2 or 3 toxicity (excluding endocrinopathies) that does not recover to ≤ grade 1 within 12 weeks after last atezolizumab dose: Discontinue permanently.

Inability to taper corticosteroid to prednisone ≤10 mg/day (or equivalent) within 12 weeks after last atezolizumab dose: Discontinue permanently.

Recurrent grade 3 or 4 (severe or life-threatening) toxicity: Discontinue permanently.

Reconstitution

Withdraw dose from vial and dilute into a 250 mL NS infusion bag made of polyvinyl chloride (PVC), polyethylene (PE), or polyolefin (PO). Dilute only with NS. Mix by gently inverting; do not shake.

Administration

IV: Infuse the initial dose over 60 minutes, if tolerated, may infuse subsequent doses over 30 minutes. May be infused with or without a 0.2- to 0.22-micron sterile, non-pyrogenic, low-protein binding in-line filter. Do not administer as an IV push or bolus. Do not administer other medications at the same time through the same IV line. Monitor for infusion reactions.

When administering in combination with other chemotherapy agents on the same day, administer atezolizumab first, followed by chemotherapy.

Storage

Store intact vials at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not shake. Store in original carton to protect from light. Solutions diluted in NS for infusion should be used immediately after preparation; if not used immediately, may be stored for up to 6 hours (including administration time) at room temperature or 24 hours refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

>10%:

Cardiovascular: Peripheral edema (urothelial carcinoma: 17% to 18%)

Central nervous system: Fatigue (≤52%), pain (NSCLC: ≤20%)

Dermatologic: Pruritus (urothelial carcinoma: 13% to 18%), skin rash (12% to 17%)

Endocrine & metabolic: Hypoalbuminemia (NSCLC: 48%; urothelial carcinoma, grades 3/4: 1%), hyponatremia (NSCLC: 42%; urothelial carcinoma, grades 3/4: 10% to 15%), hypophosphatemia (NSCLC: 27%; urothelial carcinoma, grades 3/4: 4%), hypomagnesemia (NSCLC: 26%)

Gastrointestinal: Decreased appetite (23% to 26%), nausea (18% to 25%), diarrhea (≤24%), constipation (15% to 21%), colitis (≤20%; includes immune-mediated), vomiting (urothelial carcinoma: 16% to 17%), abdominal pain (urothelial carcinoma: 15% to 17%)

Genitourinary: Urinary tract infection (urothelial carcinoma: 17% to 22%), hematuria (urothelial carcinoma: 14%)

Hematologic & oncologic: Anemia (NSCLC: 67%; urothelial carcinoma and NSCLC, grades 3/4: 3% to 8%), lymphocytopenia (NSCLC: 49%; urothelial carcinoma and NSCLC, grades 3/4: 9% to 14%)

Hepatic: Increased serum alkaline phosphatase (NSCLC: 39%; urothelial carcinoma, grades 3/4: 4% to 7%), increased serum aspartate aminotransferase (NSCLC: 31%; urothelial carcinoma, grades 3/4: 2% to 4%), increased serum alanine aminotransferase (NSCLC: 27%; urothelial carcinoma, grades 3/4: 2% to 4%)

Immunologic: Antibody development (urothelial carcinoma: 42%; NSCLC: 30%)

Infection: Infection (42%)

Neuromuscular & skeletal: Asthenia (NSCLC: ≤44%), myalgia (NSCLC: ≤20%), back pain (≤18%), neck pain (urothelial carcinoma: ≤18%), arthralgia (12% to 14%)

Renal: Increased serum creatinine (NSCLC: 23%; urothelial carcinoma, grades 3/4: 3% to 5%)

Respiratory: Cough (NSCLC: 26%; urothelial carcinoma: 14%), dyspnea (12% to 22%)

Miscellaneous: Fever (14% to 21%)

1% to 10%:

Endocrine & metabolic: Hyperglycemia (urothelial carcinoma; grades 3/4: 5% to 10%), hypothyroidism (5%; may be immune-mediated), hyperkalemia (urothelial carcinoma, grades 3/4: 3%), hypermagnesemia (urothelial carcinoma, grades 3/4: 3%), hyperthyroidism (2%; may be immune-mediated)

Hepatic: Hepatitis (9%; includes immune-mediated), hyperbilirubinemia (urothelial carcinoma, grades 3/4: 3%)

Respiratory: Pneumonia (NSCLC, grades ≥4%; also occurred with urothelial carcinoma), pneumonitis (3%; includes immune-mediated)

Miscellaneous: Infusion related reaction (1%)

Frequency not defined:

Cardiovascular: Ischemic heart disease (NSCLC), pulmonary embolism (NSCLC), septic shock (NSCLC), venous thromboembolism (urothelial carcinoma)

Central nervous system: Confusion (urothelial carcinoma)

Endocrine & metabolic: Dehydration (urothelial carcinoma)

Gastrointestinal: Intestinal obstruction (urothelial carcinoma)

Genitourinary: Urinary tract obstruction (urothelial carcinoma)

Hematologic & oncologic: Pulmonary hemorrhage (NSCLC)

Hepatic: Abnormal hepatic function tests

Infection: Sepsis

Renal: Acute renal failure

Respiratory: Pleural effusion (NSCLC), respiratory tract infection

<1%, postmarketing, and/or case reports: Adrenocortical insufficiency, aseptic meningitis, autoimmune hemolytic anemia, bullous dermatitis, demyelinating disease, encephalitis, erythema multiforme, facial paresis, Guillain-Barre syndrome, hypophysitis, immune thrombocytopenia, increased serum amylase, increased serum lipase, iritis, Lambert-Eaton syndrome, lymphadenitis (histiocytic necrotizing), meningoencephalitis, myasthenia gravis, myocarditis, myositis, nephritis, nephrotic syndrome, neuropathy (autoimmune), pancreatitis, paresis (abducens nerve), pemphigoid, pituitary insufficiency, polymyalgia rheumatica, rhabdomyolysis, Stevens-Johnson syndrome, systemic inflammatory response syndrome, thyroiditis, toxic epidermal necrolysis, type 1 diabetes mellitus (with ketoacidosis), uveitis, vasculitis, Vogt-Koyanagi-Harada syndrome

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal insufficiency: Adrenal insufficiency has been reported with atezolizumab (as a single agent and in combination with other antineoplastic agents), including grade 3 events. The median time to onset was 5.7 months (range: 3 days to 19 months), and resolved in approximately one-quarter of patients. Withhold atezolizumab for grade 2 or higher adrenal insufficiency and administer systemic corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) followed by a taper and administer hormone replacement as clinically indicated.
• Cardiovascular toxicity: Myocarditis has been reported with atezolizumab (case reports); may be related to the mechanism of action and/or may be immune-mediated. May require treatment interruption, discontinuation, systemic corticosteroids, and/or other immunosuppressive therapy (ASCO [Brahmer 2018]; Perez 2017). Monitor for signs and symptoms of myocarditis.
• Diabetes mellitus: Type 1 diabetes mellitus has been observed with atezolizumab (as a single agent and in combination with other antineoplastic agents). For type 1 diabetes, initiate insulin treatment as clinically indicated. Monitor for hyperglycemia and other signs/symptoms of diabetes; withhold therapy for grade 2 or higher hyperglycemia.
• Gastrointestinal toxicity: Immune-mediated colitis or diarrhea (defined as requiring systemic corticosteroids) has occurred in patients receiving atezolizumab (as a single agent and in combination with other antineoplastic agents), some events included grade 3 and grade 4 events. The median time to onset was 1.5 months (range: 1 day to 41 months). Monitor for signs/symptoms of colitis and diarrhea. Withhold treatment for grade 2 or 3 diarrhea or colitis. For grade 2 or higher diarrhea or colitis, if symptoms persist for >5 days or recur, administer systemic corticosteroids (1 to 2 mg/kg/day prednisone equivalent). Discontinue permanently for grade 4 diarrhea or colitis. When required, high-dose systemic corticosteroids were administered for a median duration of 3 to 4 days (range: 1 to 170 days) and then tapered. Diarrhea and colitis resolved in most patients receiving atezolizumab as a single agent.
• Hepatotoxicity: Immune-mediated hepatitis (defined as requiring systemic corticosteroids) and liver test abnormalities, including grades 3 and 4 and fatal cases, have occurred with atezolizumab (as a single agent and in combination with other antineoplastic agents). Liver test abnormalities have been reported, including grade 3 or higher events. The median time to onset was 1.4 months (range: 1 day to 25.8 months) and the median duration of hepatitis was 24 days (range: 1 day to 13 months). Monitor for signs/symptoms of hepatitis (during and after treatment) including monitoring liver function tests (AST, ALT, and bilirubin). Administer systemic corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) followed by a taper for grade 2 or higher transaminase and/or bilirubin elevations. For grade 2 toxicity, withhold treatment until grade 1 or resolved or corticosteroid dose is ≤10 mg/day prednisone (or equivalent); permanently discontinue for grade 3 or 4 immune-mediated hepatitis. When required, high-dose systemic corticosteroids were administered for a median duration of 3 to 6 days (range: 1 to 144 days) and then tapered. Hepatitis resolved in over two-thirds of patients receiving atezolizumab as a single agent.
• Hypophysitis: Hypophysitis has occurred (rarely) in patients receiving atezolizumab (as a single agent and in combination with other antineoplastic agents). Monitor for signs/symptoms of hypophysitis. Withhold treatment for grade 2 or higher hypophysitis and administer systemic corticosteroid (1 to 2 mg/kg/day prednisone or equivalent) followed by a taper and administer hormone replacement therapy as clinically indicated.
• Infection: Infections have commonly occurred in patients receiving atezolizumab (as a single agent and in combination with other antineoplastic agents). Grade 3 and higher infections have occurred (including fatal cases), with urinary tract infection and pneumonia being the most common causes of grade 3 or higher infection in patients with urothelial carcinoma and non-small cell lung cancer, respectively. Monitor for signs/symptoms of infection. Withhold treatment for grade 3 or higher infections; may resume once clinically stable.
• Infusion-related reactions: Severe or life-threatening infusion reactions have been reported with atezolizumab. The frequency and severity of infusion reactions was similar whether atezolizumab was administered as a single agent or in combination with other antineoplastic agents, and was similar across the various approved dose ranges (840 mg every 2 weeks, 1,200 mg every 3 weeks, or 1,680 mg every 4 weeks). Monitor for signs/symptoms of infusion reactions. Interrupt or slow the infusion rate in patients with grade 1 or 2 infusion reactions; consider premedication with subsequent doses. Permanently discontinue for grade 3 or 4 infusion reactions.
• Ocular toxicity: Uveitis and iritis have been reported. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, which has been observed in patients receiving other medications in this drug class and may require systemic corticosteroids to reduce the risk of permanent vision loss.
• Pulmonary toxicity: Immune-mediated pneumonitis and interstitial lung disease (defined as requiring systemic corticosteroids), including grades 3 and 4 and fatal cases, have been reported in patients receiving atezolizumab (as a single agent and in combination with other antineoplastic agents). The median time to onset was 3.6 months (range: 3 days to 20.5 months) and the median duration was 1.4 months (range: 1 day to 15.1 months). Monitor for signs (with radiographic imaging) and symptoms of pneumonitis. Administer systemic corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) followed by a taper for grade 2 or higher pneumonitis. For grade 2 toxicity, withhold treatment until grade 1 or resolved or corticosteroid dose is ≤10 mg/day prednisone (or equivalent); permanently discontinue for grade 3 or 4 pneumonitis. Pneumonitis resolved in two-thirds of patients. When required, high-dose systemic corticosteroids were administered for a median duration of 4 to 5 days (range: 1 to 98 days) and then tapered.
• Thyroid disorders: Hypothyroidism, hyperthyroidism, and acute thyroiditis (rare) have occurred with atezolizumab (as a single agent and in combination with other antineoplastic agents). Monitor thyroid function prior to and periodically during treatment. For hypothyroidism, continue atezolizumab treatment and initiate thyroid replacement therapy as needed. For grade 2 or higher hyperthyroidism, withhold atezolizumab and (if clinically indicated) initiate antithyroid medications.
• Other immune-mediated toxicities: Other immune-mediated adverse events have occurred (as a single agent and in combination with other antineoplastic agents), including bullous dermatitis, pemphigoid, erythema multiforme, Stevens Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), pancreatitis (including elevations in serum amylase and lipase), systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis, autoimmune hemolytic anemia, immune thrombocytopenia (formerly known as immune thrombocytopenic purpura), myositis, rhabdomyolysis, demyelination, immune-related meningoencephalitis, myasthenia syndrome/myasthenia gravis, Guillain-Barre syndrome, aseptic meningitis, encephalitis, facial and abducens nerve paresis, polymyalgia rheumatic, autoimmune neuropathy, nephrotic syndrome, nephritis, and vasculitis. Immune-mediated reactions may involve any organ system; while they usually develop during atezolizumab treatment, immune-mediated reactions may also occur after therapy discontinuation. For suspected grade 2 immune-mediated toxicities, exclude other causes and initiate systemic corticosteroids as clinically indicated. Administer systemic corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) followed by a taper for grade 3 or 4 adverse reactions. For grade 3 toxicity, withhold treatment until grade 1 or resolved or corticosteroid dose is ≤10 mg/day prednisone (or equivalent); permanently discontinue for grade 4 toxicity.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Appropriate use: For locally advanced or metastatic urothelial cancer (previously untreated) or locally advanced or metastatic triple-negative breast cancer, select patients for atezolizumab therapy based on the PD-L1 expression on tumor-infiltrating immune cells. Information on tests approved to determine PD-L1 expression is available at http://www.fda.gov/companiondiagnostics.

Monitoring Parameters

PD-L1 expression status (in patients with cisplatin-ineligible locally advanced or metastatic urothelial cancer or locally advanced or metastatic triple-negative breast cancer). Monitor liver function tests (AST, ALT, and bilirubin; at baseline and periodically during treatment), thyroid function (prior to and periodically during treatment), serum glucose. Pregnancy test (prior to treatment initiation in females of reproductive potential). Monitor for signs/symptoms of colitis, diarrhea, endocrinopathies, hepatitis, hypophysitis, infection, infusion reactions, cardiovascular toxicity (myocarditis, pericarditis, arrhythmias, impaired ventricular function with HF, and vasculitis), pneumonitis, and ocular toxicity.

Pregnancy

Pregnancy Considerations

Based on the mechanism of action, atezolizumab is expected to cause fetal harm if used during pregnancy.

Verify pregnancy status prior to treatment initiation in females of reproductive potential. Females of reproductive potential should use effective contraception during therapy and for at least 5 months after the last atezolizumab dose.

Patient Education

What is this drug used for?

• It is used to treat cancer.

Frequently reported side effects of this drug

• Lack of appetite
• Nausea
• Vomiting
• Constipation
• Bone pain
• Neck pain
• Muscle pain
• Joint pain

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Infusion reaction
• Bowel problems like black, tarry, or bloody stools; fever; mucus in stools; vomiting; vomiting blood; severe abdominal pain; constipation; or diarrhea
• Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin
• Urinary tract infection like blood in the urine, burning or painful urination, passing a lot of urine, fever, lower abdominal pain, or pelvic pain
• Severe pulmonary disorder like lung or breathing problems like trouble breathing, shortness of breath, or a cough that is new or worse
• Kidney problems like unable to pass urine, blood in the urine, change in amount of urine passed, or weight gain
• Stevens-Johnson syndrome/toxic epidermal necrolysis like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in mouth, throat, nose, or eyes
• Thyroid, pituitary, or adrenal gland problems like mood changes, behavioral changes, weight changes, constipation, deeper voice, dizziness, passing out, cold sensation, severe fatigue, hair loss, persistent headache, or decreased sex drive
• Pancreatitis like severe abdominal pain, severe back pain, severe nausea, or vomiting
• Nervous system problems like mood changes, behavioral changes, confusion, fever, numbness or tingling in hands or feet, neck rigidity, sensitivity to light, or severe muscle weakness
• Electrolyte problems like mood changes, confusion, muscle pain or weakness, abnormal heartbeat, seizures, lack of appetite, or severe nausea or vomiting
• Severe cerebrovascular disease like change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or vision changes
• Infection
• Chest pain
• Coughing up blood
• Confusion
• Severe back pain
• Severe abdominal pain
• Severe headache
• Fast heartbeat
• Abnormal heartbeat
• Shortness of breath
• Swelling of arms or legs
• Severe loss of strength and energy
• Bruising
• Bleeding
• Vision changes
• Eye pain
• Severe eye irritation
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.