Names and pronunciation
(a-te-zoe-liz′ue-mab) Tecentriq
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Drug reference
(a-te-zoe-liz′ue-mab) Tecentriq
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Func. class.: Antineoplastic
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Chem. class.: Monoclonal antibody
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ACTION: Binds to PD-1, resulting in an antitumor response
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USES: Treatment of locally advanced or metastatic urothelial carcinoma, including bladder cancer and other uri- nary system cancers, in patients who progress during or following platinum- containing chemotherapy for advanced disease, or within 12 months of neoadju- vant or adjuvant platinum-containing chemotherapy; triple-negative breast cancers (PD-1 expression) in combina- tion; nonsquamous NSCLC with no EGFR or ALK gene aberrations
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CONTRAINDICATIONS: Hyper- sensitivity
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SIDE EFFECTS CV: Peripheral edema, venous thrombo embolism CNS: Confusion, fatigue, fever GI: Nausea, vomiting, abdominal pain, constipation, anorexia, diarrhea, ob- struction, immunomediated colitis, immu- nomediated hepatitis, increased LFTs GU: Hematuria, UTI, obstruction HEMA: Anemia, lymphopenia MS: Back/neck pain, arthralgia, myalgia RESP: Dyspnea, cough, immunomediated pneumonitis, ILD INTEG: Rash, pruritus, Stevens-Johnson syndrome MISC: Infection, infusion-related reac- tions, hypo/hyperthyroidism
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DOSAGE AND ROUTES Breast cancer (triple negative), locally advanced or metastatic • Adult: IV: 840 mg on days 1 and 15 q4wk with protein-bound paclitaxel until disease progression or unacceptable tox- icity Hepatocellular carcinoma, unre- sectable or metastatic • Adult: IV: 1200 mg q3wk with bevaci- zumab on the same day until disease progression or unacceptable toxicity; if bevacizumab is discontinued due to un- acceptable toxicity, may continue atezoli- zumab monotherapy at 840 mg q2wk or 1200 mg q3wk or 1680 mg q4wk until disease progression or unac- ceptable toxicity Melanoma, unresectable or meta- static (BRAF V600 mutation-posi- tive) • Adult: IV: 840 mg q2wk with cobi- metinib and vemurafenib until disease progression or unacceptable toxicity; before starting atezolizumab, patients should receive 28 days of cobimetinib and vemurafenib Non–small-cell lung cancer (NSCLC), metastatic • Adult: IV: First-line treatment NSCLC (single agent): 840 mg q2wk or 1200 mg q3wk or 1680 mg q4wk; continue until disease progression or unacceptable tox- icity; first-line treatment, non-squamous NSCLC: 1200 mg on day 1 q3wk with bevacizumab, paclitaxel, and carboplatin × 4 to 6 cycles, then atezolizumab 1200 mg on day 1, followed by bevacizumab q3wk until disease progression or unac- ceptable toxicity; previously treated NSCLC: 840 mg q2wk or 1200 mg q3wk or 1680 mg q4wk; continue until disease progression or unacceptable toxicity Small cell lung cancer (extensive stage), first-line treatment • Adult: IV: Induction: 1200 mg on day 1 q3wk with carboplatin and etoposide × 4 cycles, then maintenance therapy of monotherapy of atezolizumab at 840 mg q2wk or 1200 mg q3wk or 1680 mg q4wk; continue until disease progression or unacceptable toxicity Urothelial carcinoma, locally advanced or metastatic • Adult: IV: 840 mg q2wk or 1200 mg q3wk or 1680 mg q4wk; continue until disease progression or unacceptable tox- icity AVAILABLE FORMS: Injection 840 mg/14 mL, 1200 mg/20 mL single-dose vials ADMINISTER IV Route • Visually inspect parenteral products for particulate matter and discoloration prior to use, discard if present • Withdraw 20 mL of product and dilute A with 250 mL in a polyvinyl chloride (PVC), polyethylene (PE), or polyolefin (PO) infusion bag containing 0.9% so- dium chloride injection • Mix by gentle inversion; do not shake • Storage after dilution: Store diluted solution at room temperature for no more than 6 hr (including infusion time) or under refrigeration 36°F to 46°F (2°C to 8°C) for no more than 24 hr from the time of preparation • Give atezolizumab prior to chemo- therapy or other antineoplastic agents when given on the same day • Do not infuse through the same IV line with other drugs • Give first dose with or without a sterile, nonpyrogenic, low protein-binding in-line filter (0.2 to 0.22 micron) over 60 min; do not administer atezolizumab as an IV push or bolus. If tolerated, all subsequent infusions may be infused over 30 min • Interrupt or slow administration for grade 2 infusion–related reactions; the infusion may resume when symptoms have resolved to grade 0 or 1, perma- nently discontinue atezolizumab for grade 3 or 4 infusion–related reactions
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Assess: • Adrenal insufficiency: Monitor for ad- renal insufficiency (fatigue, joint/muscle pain, dizziness, nausea) usually within 5.7 mo. Withhold for grade 2 or higher and give systemic corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) fol- lowed by a taper and administer hor- mone replacement as indicated • Cardiovascular toxicity: Monitor for myocarditis. May require treatment inter- ruption, discontinuation, systemic corti- costeroids, and/or other immunosup- pressive therapy (ASCO) • Diabetes mellitus: For type 1 diabetes, initiate insulin treatment as indicated. Mon- itor for hyperglycemia and other signs/ symptoms of diabetes; withhold therapy for grade 2 or higher hyperglycemia • Gastrointestinal toxicity: Immune-medi- ated colitis or diarrhea (defined as requir- ing systemic corticosteroids) has occurred. 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 cor- ticosteroids (1 to 2 mg/kg/day prednisone equivalent). Discontinue permanently for grade 4 diarrhea or colitis • Hepatotoxicity: Immune-mediated hepatitis and liver test abnormalities, in- cluding grades 3 and 4 and fatal cases, have occurred. Monitor for signs/symp- toms of hepatitis (during and after treat- ment), including liver function tests (AST, ALT, and bilirubin). Give systemic corticosteroids (1 to 2 mg/kg/day pred- nisone or equivalent) followed by a taper for grade 2 or higher transaminase and/ or bilirubin elevations. For grade 2 toxic- ity, withhold treatment until grade 1 or resolved or corticosteroid dose is ≤10 mg/day prednisone (or equivalent); per- manently discontinue for grade 3 or 4 immune-mediated hepatitis • Infection: Monitor for signs/symptoms of infection. Withhold treatment for grade 3 or higher infections; may resume once clinically stable • Infusion-related reactions: Monitor for signs/symptoms of infusion reactions. Interrupt or slow the infusion in those with grade 1 or 2 infusion reactions; may premedicate with subsequent doses. Per- manently discontinue for grade 3 or 4 infusion reactions • Ocular toxicity: Uveitis and iritis have been reported. May require systemic cor- ticosteroids to reduce the risk of perma- nent vision loss • Pulmonary toxicity: Immune-medi- ated pneumonitis and interstitial lung disease may occur. Monitor for signs (with radiographic imaging) and symp- toms of pneumonitis. Give systemic corti- costeroids (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 • Thyroid disorders: Hypothyroidism, hyperthyroidism, and acute thyroiditis (rare) have occurred. Monitor thyroid function prior to and periodically during treatment. For hypothyroidism, initiate thyroid replacement. For grade 2 or higher hyperthyroidism, withhold
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To report all severe reactions, as these may require corticosteroids or discon- tinuation (infection, immune-mediated reactions, allergic reactions) • To report of infusion reaction (back pain, neck pain, chills, tremors, dizzi- ness, passing out, fever, flushing, itching, rash, shortness of breath, swelling of the face, or wheezing) • To report bowel problems (black, tarry, or bloody stools; fever; mucus in stools; vomiting; vomiting blood; severe abdominal pain; constipation; or diarrhea) • To report liver problems (dark urine, fatigue, lack of appetite, nausea, abdomi- nal pain, light-colored stools, vomiting, or yellow skin) • To report UTI (blood in the urine, burning or painful urination, passing a lot of urine, fever, lower abdominal pain, or pelvic pain) • To report lung problems (like short- ness of breath or other trouble breath- ing, cough that is new or worse) • To report kidney problems (unable to pass urine, blood in the urine, change in amount of urine passed, or weight gain) • To report Stevens-Johnson syn- drome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) • To report mood changes, behavioral changes, weight changes, constipation, deeper voice, dizziness, passing out, cold sensation, severe fatigue, hair loss, persistent headache, or de- creased sex drive • To report pancreatitis (severe abdom- inal pain, severe back pain, severe nau- sea, or vomiting) • To report signs of an allergic reaction (rash; hives; itching; red, swollen, blis- tered, or peeling skin with or without fe- ver; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat) Evaluate • Therapeutic response: Decreasing progression of cancer
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PHARMACOKINETICS Onset unknown, peak unknown, dura- tion unknown, half-life 27 days Interactions None known
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• Adult: IV: 840 mg on days 1 and 15 q4wk with protein-bound paclitaxel until disease progression or unacceptable tox- icity Hepatocellular carcinoma, unre- sectable or metastatic
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• Adult: IV: 1200 mg q3wk with bevaci- zumab on the same day until disease progression or unacceptable toxicity; if bevacizumab is discontinued due to un- acceptable toxicity, may continue atezoli- zumab monotherapy at 840 mg q2wk or 1200 mg q3wk or 1680 mg q4wk until disease progression or unac- ceptable toxicity Melanoma, unresectable or meta- static (BRAF V600 mutation-posi- tive)
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• Adult: IV: 840 mg q2wk with cobi- metinib and vemurafenib until disease progression or unacceptable toxicity; before starting atezolizumab, patients should receive 28 days of cobimetinib and vemurafenib Non–small-cell lung cancer (NSCLC), metastatic
PDF pages 118, 119
• Adult: IV: First-line treatment NSCLC (single agent): 840 mg q2wk or 1200 mg q3wk or 1680 mg q4wk; continue until disease progression or unacceptable tox- icity; first-line treatment, non-squamous NSCLC: 1200 mg on day 1 q3wk with bevacizumab, paclitaxel, and carboplatin × 4 to 6 cycles, then atezolizumab 1200 mg on day 1, followed by bevacizumab q3wk until disease progression or unac- ceptable toxicity; previously treated NSCLC: 840 mg q2wk or 1200 mg q3wk or 1680 mg q4wk; continue until disease progression or unacceptable toxicity Small cell lung cancer (extensive stage), first-line treatment
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• Adult: IV: Induction: 1200 mg on day 1 q3wk with carboplatin and etoposide × 4 cycles, then maintenance therapy of monotherapy of atezolizumab at 840 mg q2wk or 1200 mg q3wk or 1680 mg q4wk; continue until disease progression or unacceptable toxicity Urothelial carcinoma, locally advanced or metastatic
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• Adult: IV: 840 mg q2wk or 1200 mg q3wk or 1680 mg q4wk; continue until disease progression or unacceptable tox- icity AVAILABLE FORMS: Injection 840 mg/14 mL, 1200 mg/20 mL single-dose vials ADMINISTER IV Route
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