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Atezolizumab

Class: Antineoplastic Agents
- Programmed Death Ligand-1 Antagonist
- PD-L1 Inhibitor
Chemical Name: Immunoglobulin G1-κ, anti-[Homo sapiens CD274 (programmed death ligand 1, PDL1, PD-L1, B7 homolog 1, B7H1)], humanized monoclonal antibody
Molecular Formula: C6446H9902N1706O1998S42
CAS Number: 1380723-44-3
Brands: Tecentriq

Medically reviewed by Drugs.com. Last updated on May 12, 2020.

Introduction

Antineoplastic agent; humanized anti-programmed-death ligand-1 (anti-PD-L1) monoclonal antibody.1 2 4 10

Uses for Atezolizumab

Urothelial Carcinoma

Used as a single agent for the treatment of locally advanced or metastatic urothelial carcinoma that has progressed during or following platinum-containing therapy for advanced disease or within 12 months of chemotherapy in the neoadjuvant or adjuvant setting.1 2

Used as a single agent for the treatment of locally advanced or metastatic urothelial carcinoma in patients with high PD-L1 expression (defined as PD-L1 staining in tumor-infiltrating immune cells covering ≥5% of tumor area) who are not candidates for cisplatin-containing therapy.1 13 FDA-approved diagnostic test required to confirm presence of PD-L1 expression prior to initiation of therapy.1

Used as a single agent for the treatment of locally advanced or metastatic urothelial carcinoma in patients who are not candidates for platinum-containing chemotherapy regardless of PD-L1 expression.1

Accelerated approval for these indications based on objective response rate and duration of response.1 2 13 Continued approval may be contingent on verification and description of clinical benefit in confirmatory studies.1

Decreased survival reported with atezolizumab monotherapy compared with platinum-based therapy in patients with previously untreated metastatic urothelial carcinoma with low PD-L1 expression; atezolizumab is not indicated in such patients.1 14

Non-small Cell Lung Cancer (NSCLC)

Used in combination with bevacizumab, carboplatin, and paclitaxel for the treatment of previously untreated metastatic nonsquamous NSCLC without epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic aberrations.1 16

Used as a single agent for the treatment of metastatic NSCLC that has progressed during or following platinum-based chemotherapy.1 11 12 Patients with EGFR- or ALK-positive tumors also should have documented disease progression during or following an FDA-labeled anti-EGFR or anti-ALK therapy prior to initiating therapy with atezolizumab.1

Atezolizumab Dosage and Administration

General

Restricted Distribution

  • Obtain atezolizumab through a limited network of specialty distributors.3 5

  • Contact manufacturer at 800-551-22313 or consult the Tecentriq website ([Web]) for specific availability information.5

Administration

IV Administration

For solution compatibility information, see Compatibility under Stability.

Administer by IV infusion.1 Do not administer by rapid IV injection (e.g., IV push or bolus).1

Atezolizumab injection concentrate must be diluted prior to administration.1 Immediate administration recommended.1 (See Storage under Stability.)

Do not infuse simultaneously through the same IV line with other drugs.1

Use of low-protein-binding 0.2- to 0.22-µm inline filter is optional.1

Dilution

Undiluted solution should be colorless to slightly yellow.1 Do not use if it is cloudy or discolored or if particulate matter is present.1

Do not shake vial.1

Withdraw 20 mL of atezolizumab injection concentrate (containing 60 mg/mL) and dilute in a PVC, polyethylene, or polyolefin infusion bag containing 250 mL of 0.9% sodium chloride.1 Do not use any other diluent.1 Mix the diluted solution by gentle inversion; do not shake.1 Discard any partially used vial.1

Rate of Administration

Initial dose: Administer over 60 minutes.1

Subsequent doses: Administer over 30 minutes (if first infusion well tolerated).1

Dosage

Adults

Urothelial Carcinoma
IV

1.2 g every 3 weeks.1 Continue therapy until disease progression or unacceptable toxicity occurs.1

Cisplatin-eligible patients: Selection based on presence of PD-L1 expression.1 (See Urothelial Carcinoma under Uses.)

NSCLC
Combination Therapy for Previously Untreated Metastatic Nonsquamous NSCLC
IV

1.2 g every 3 weeks (use in combination with bevacizumab, carboplatin, and paclitaxel).1 Administer carboplatin and paclitaxel for a maximum of 4–6 cycles; continue atezolizumab and bevacizumab until disease progression or unacceptable toxicity occurs.1

Administer atezolizumab prior to bevacizumab, carboplatin, and paclitaxel.1

Monotherapy for Previously Treated Metastatic NSCLC
IV

1.2 g every 3 weeks.1 Continue therapy until disease progression or unacceptable toxicity occurs.1

Therapy Interruption for Toxicity

Permanently discontinue therapy in patients experiencing persistent grade 2 or 3 immune-mediated adverse effects (except for endocrinopathies) that do not recover to grade 0 or 1 within 12 weeks of the last dose of atezolizumab.1

Permanently discontinue therapy in those unable to reduce corticosteroid dosage to ≤10 mg of prednisone daily (or equivalent) within 12 weeks of the last dose of atezolizumab.1 (See Warnings/Precautions under Cautions.)

Permanently discontinue therapy if any grade 3 or 4 immune-mediated adverse effects recur.1

Immune-mediated Pneumonitis
IV

If grade 2 immune-mediated pneumonitis occurs, interrupt therapy until toxicity resolves to grade 0 or 1 and corticosteroid dosage reduced to ≤10 mg of prednisone daily (or equivalent).1 (See Immune-mediated Pneumonitis under Cautions.)

If grade 3 or 4 immune-mediated pneumonitis occurs, discontinue drug.1

Immune-mediated Hepatic Effects
IV

For grade 2 immune-mediated hepatitis, serum ALT or AST elevations >3 times but ≤8 times the ULN, or total bilirubin concentrations >1.5 times but ≤3 times the ULN, interrupt therapy until toxicity resolves to grade 0 or 1 and corticosteroid dosage reduced to ≤10 mg of prednisone daily (or equivalent).1 (See Immune-mediated Hepatic Effects under Cautions.)

For grade 3 or 4 immune-mediated hepatitis, ALT or AST elevations >8 times the ULN, or total bilirubin concentrations >3 times the ULN, discontinue drug.1

Immune-mediated GI Effects
IV

If grade 2 or 3 immune-mediated colitis or diarrhea occurs, interrupt therapy until toxicity resolves to grade 0 or 1 and corticosteroid dosage reduced to ≤10 mg of prednisone daily (or equivalent).1 (See Immune-mediated GI Effects under Cautions.)

If grade 4 immune-mediated colitis or diarrhea occurs, discontinue drug.1

Immune-mediated Endocrine Effects
IV

If grade 2–4 immune-mediated endocrinopathies (e.g., hypophysitis, adrenal insufficiency, hyperthyroidism, type 1 diabetes mellitus) occur, interrupt therapy until toxicity resolves to grade 0 or 1 and patient is stable on replacement therapy, if needed.1 (See Immune-mediated Endocrine Effects under Cautions.)

Other Immune-mediated Adverse Effects
IV

If any other grade 3 immune-mediated adverse effects involving a major organ occur, interrupt therapy until toxicity resolves to grade 0 or 1 and corticosteroid dosage reduced to ≤10 mg of prednisone daily (or equivalent).1 (See Other Immune-mediated Effects under Cautions.)

If any other grade 4 immune-mediated adverse effects involving a major organ occur, discontinue drug.1

Infusion-related Reactions
IV

If grade 1 or 2 infusion-related reactions occur, interrupt infusion or reduce infusion rate.1 (See Infusion-related Effects under Cautions.)

If grade 3 or 4 infusion-related reactions occur, discontinue drug.1

Infectious Complications
IV

If grade 3 or 4 infection occurs, interrupt therapy until infection resolves to grade 0 or 1.1 (See Infectious Complications under Cautions.)

Special Populations

Hepatic Impairment

No special dosage recommendations at this time.1 (See Special Populations under Pharmacokinetics.)

Renal Impairment

No special dosage recommendations at this time.1 (See Special Populations under Pharmacokinetics.)

Geriatric Patients

No special dosage recommendations at this time.1 (See Geriatric Use under Cautions.)

Cautions for Atezolizumab

Contraindications

  • No known contraindications.1

Warnings/Precautions

Immune-mediated Pneumonitis

Immune-mediated pneumonitis or interstitial lung disease, sometimes fatal, reported.1 2

Monitor patients for manifestations of pneumonitis.1 If pneumonitis is suspected, evaluate patients using radiographic imaging.1

If immune-mediated pneumonitis occurs, temporarily withhold or discontinue atezolizumab.1 (See Immune-mediated Pneumonitis under Dosage and Administration.) If grade 2 or greater pneumonitis occurs, initiate systemic corticosteroid therapy (1–2 mg/kg of prednisone daily [or equivalent]) followed by tapering of the corticosteroid dosage.1

Immune-mediated Hepatic Effects

Immune-mediated hepatitis, sometimes fatal, and liver function test abnormalities reported.1 2 11

Monitor patients for signs and symptoms of hepatitis (e.g., perform liver chemistry tests) during therapy and following discontinuance of drug.1

If immune-mediated hepatitis or liver function test abnormalities occur, temporarily withhold or discontinue atezolizumab.1 (See Immune-mediated Hepatic Effects under Dosage and Administration.) If grade 2 or greater serum ALT, AST, and/or total bilirubin elevations occur, initiate systemic corticosteroid therapy (1–2 mg/kg of prednisone daily [or equivalent]) followed by tapering of the corticosteroid dosage.1

Immune-mediated GI Effects

Immune-mediated colitis or diarrhea reported.1

Monitor patients for signs and symptoms of colitis or diarrhea.1

Depending on severity of immune-mediated colitis or diarrhea, temporarily withhold or discontinue atezolizumab.1 (See Immune-mediated GI Effects under Dosage and Administration.) If grade 2 or 3 colitis or diarrhea occurs, temporarily withhold atezolizumab; if grade 2 colitis or diarrhea recurs or persists for >5 days, initiate systemic corticosteroid therapy (1–2 mg/kg of prednisone daily [or equivalent]) followed by tapering of the corticosteroid dosage.1 If grade 4 immune-mediated colitis or diarrhea occurs, permanently discontinue drug.1

Immune-mediated Endocrine Effects

Immune-mediated endocrinopathies, such as thyroid dysfunction (i.e., hypothyroidism, hyperthyroidism), adrenal insufficiency, hypophysitis/hypopituitarism, and diabetes mellitus (including ketoacidosis), reported.1

Thyroid Dysfunction

Evaluate thyroid function prior to initiation of and periodically during therapy.1

If immune-mediated hypothyroidism occurs, initiate thyroid hormone replacement therapy as clinically indicated.1

Depending on severity of immune-mediated hyperthyroidism, temporary interruption of atezolizumab may be necessary.1 (See Immune-mediated Endocrine Effects under Dosage and Administration.) If immune-mediated hyperthyroidism occurs, initiate appropriate medical therapy as clinically indicated.1

Adrenal Insufficiency

Monitor for signs and symptoms of adrenal insufficiency.1

If grade 2 or greater immune-mediated adrenal insufficiency occurs, temporarily withhold atezolizumab and initiate systemic corticosteroid therapy (1–2 mg/kg of prednisone daily [or equivalent] followed by tapering of corticosteroid dosage) and replacement therapy as clinically indicated.1

Hypophysitis

Monitor for signs and symptoms of hypophysitis.1

If grade 2 or greater immune-mediated hypophysitis occurs, temporarily withhold atezolizumab and initiate systemic corticosteroid therapy (1–2 mg/kg of prednisone daily [or equivalent] followed by tapering of corticosteroid dosage) and hormone replacement therapy as clinically indicated.1 (See Immune-mediated Endocrine Effects under Dosage and Administration.)

Diabetes Mellitus

Monitor for signs and symptoms of diabetes mellitus (e.g., hyperglycemia).1

Depending on severity of immune-mediated type 1 diabetes mellitus, temporary interruption of atezolizumab may be necessary.1 (See Immune-mediated Endocrine Effects under Dosage and Administration.) If immune-mediated type 1 diabetes mellitus occurs, initiate insulin therapy as clinically indicated.1

Other Immune-mediated Effects

Immune-mediated adverse effects (e.g., myocarditis, dermatologic effects [i.e., bullous dermatitis, pemphigoid, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis], pancreatitis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis, autoimmune hemolytic anemia, immune thrombocytopenic purpura, myositis, rhabdomyolysis, Guillain-Barré syndrome, myasthenic syndrome/myasthenia gravis, demyelination, meningoencephalitis, aseptic meningitis, encephalitis, facial and abducens nerve paresis, polymyalgia rheumatica, autoimmune neuropathy, Vogt-Koyanagi-Harada syndrome, uveitis, iritis, nephrotic syndrome, nephritis, vasculitis), sometimes fatal, reported.1 Onset may occur following discontinuance of therapy.1

Depending on severity of immune-mediated adverse effect, temporarily withhold or discontinue atezolizumab.1 (See Other Immune-mediated Adverse Effects under Dosage and Administration.) If a grade 2 immune-mediated adverse effect is suspected, ensure adequate evaluation to exclude other causes and initiate systemic corticosteroid therapy as clinically indicated.1 If severe (grade 3 or 4) immune-mediated adverse effects occur, initiate systemic corticosteroid therapy (1–2 mg/kg of prednisone daily [or equivalent]) followed by tapering of the corticosteroid dosage.1

If uveitis occurs in conjunction with other immune-mediated adverse effects, consider possibility of Vogt-Koyanagi-Harada syndrome (reported in patients receiving other anti-PD-L1 or anti-programmed-death receptor-1 [anti-PD-1] antibodies).1 Systemic corticosteroid therapy may be required to reduce risk of permanent vision loss.1

Infectious Complications

Serious, sometimes fatal, infections reported.1

Monitor patients for signs and symptoms of infection.1 If grade 3 or greater infection occurs, temporarily interrupt atezolizumab until the patient is stable.1 (See Infectious Complications under Dosage and Administration.)

Infusion-related Effects

Severe or life-threatening infusion-related reactions reported.1

Monitor patients for signs and symptoms of infusion-related reactions.1

If infusion-related reactions occur, interrupt infusion, reduce infusion rate, or discontinue atezolizumab.1 (See Infusion-related Reactions under Dosage and Administration.)

If grade 1 or 2 infusion-related reactions occur, consider premedication prior to subsequent infusions.1

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm.1 May disrupt maternal immune tolerance to the fetus and increase risk of fetal loss (abortion, stillbirth); also may increase risk of immune-mediated disorders.1

Avoid pregnancy during therapy.1 Women of childbearing potential should use an effective contraceptive method while receiving atezolizumab and for ≥5 months after the drug is discontinued.1 Apprise women of childbearing potential of potential fetal hazard if used during pregnancy.1

Immunogenicity

Potential for immunogenicity.1 Development of anti-atezolizumab antibodies reported; neutralizing capacity of the antibodies not established.1

Effects on safety of atezolizumab not observed; however, clearance of atezolizumab increased by 18–25% and systemic exposure of the drug decreased in the presence of anti-atezolizumab antibodies.1 Exploratory analysis suggests reduced efficacy (overall survival) of single-agent atezolizumab in patients with locally advanced or metastatic NSCLC who develop anti-atezolizumab antibodies by week 4.1 Exploratory analysis in patients with nonsquamous NSCLC receiving atezolizumab in combination with bevacizumab, carboplatin, and paclitaxel suggests similar efficacy in those with or without development of anti-atezolizumab antibodies by week 4.1

Impairment of Fertility

May impair female fertility.1

Specific Populations

Pregnancy

May cause fetal harm.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Confirm pregnancy status prior to initiating atezolizumab therapy.1

Lactation

Not known whether atezolizumab is distributed into milk.1 Discontinue nursing during therapy and for ≥5 months after drug discontinuance.1

Pediatric Use

Safety and efficacy not established.1

Geriatric Use

In the IMvigor210 study in patients with previously treated locally advanced or metastatic urothelial carcinoma (cohort 2), no overall differences in safety and efficacy of atezolizumab monotherapy in geriatric patients (≥65 years of age) compared with younger adults.1

In the IMvigor210 study in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma (cohort 1), no overall differences in safety and efficacy of atezolizumab monotherapy in geriatric patients (≥65 or ≥75 years of age) compared with younger adults.1

In the OAK study in patients with metastatic NSCLC, no overall differences in safety and efficacy of atezolizumab monotherapy in geriatric patients (≥65 years of age) compared with younger adults.1

In the IMpower150 study in patients with metastatic nonsquamous NSCLC, no overall differences in safety and efficacy of atezolizumab in combination with bevacizumab, carboplatin, and paclitaxel in geriatric patients (≥65 years of age) compared with younger adults.1

Hepatic Impairment

Systemic exposure and clearance not affected by mild hepatic impairment.1 4 Data lacking in patients with moderate or severe hepatic impairment.1 4 (See Special Populations under Pharmacokinetics.)

Renal Impairment

Clearance not affected by mild or moderate renal impairment.1 4 Limited data available in patients with severe renal impairment.1 4 (See Special Populations under Pharmacokinetics.)

Common Adverse Effects

Monotherapy for locally advanced or metastatic urothelial carcinoma (cisplatin-ineligible patients): Fatigue,1 13 diarrhea,1 13 decreased appetite,1 nausea,1 back or neck pain,1 pruritus,1 13 peripheral edema,1 rash,1 urinary tract infection,1 vomiting,1 abdominal pain,1 constipation,1 cough,1 pyrexia,1 arthralgia,1 dyspnea,1 hyponatremia,1 hyperglycemia,1 lymphopenia,1 anemia,1 elevated alkaline phosphatase concentrations,1 elevated Scr.1

Monotherapy for relapsed or refractory locally advanced or metastatic urothelial carcinoma: Fatigue,1 2 loss of appetite,1 2 nausea,1 2 urinary tract infection,1 constipation,1 pyrexia,1 diarrhea,1 peripheral edema,1 abdominal pain,1 vomiting,1 dyspnea,1 back/neck pain,1 rash,1 arthralgia,1 cough,1 hematuria,1 pruritus,1 2 lymphopenia,1 hyponatremia,1 anemia,1 hyperglycemia.1

Combination therapy (with bevacizumab, carboplatin, and paclitaxel) for previously untreated metastatic nonsquamous NSCLC: Neuropathy,1 16 fatigue/asthenia,1 16 alopecia,1 16 myalgia/pain,1 nausea,1 16 diarrhea, 1 16 constipation,1 16 decreased appetite,1 16 arthralgia,1 hypertension,1 16 rash,1 16 cough,1 pyrexia,1 vomiting,1 epistaxis,1 headache,1 proteinuria,1 anemia,1 16 hyperglycemia,1 increased BUN,1 neutropenia,1 lymphopenia,1 hypomagnesemia,1 hypoalbuminemia,1 elevated alkaline phosphatase concentrations,1 elevated ALT/AST concentrations,1 hyponatremia,1 increased thyrotropin (thyroid-stimulating hormone, TSH) concentration,1 hyperkalemia,1 elevated Scr,1 hypocalcemia,1 hypophosphatemia,1 hypokalemia,1 hyperphosphatemia.1

Monotherapy for previously treated metastatic NSCLC: Fatigue,1 cough,1 decreased appetite,1 dyspnea,1 musculoskeletal pain,1 constipation,1 nausea,1 pyrexia,1 diarrhea,1 arthralgia,1 rash,1 anemia,1 lymphocytopenia,1 hypoalbuminemia,1 hyponatremia,1 elevated alkaline phosphatase concentrations,1 elevated ALT/AST concentrations,1 hypophosphatemia,1 hypomagnesemia,1 elevated Scr.1

Interactions for Atezolizumab

No formal drug interaction studies to date.1

Atezolizumab Pharmacokinetics

Absorption

Bioavailability

Steady-state concentrations achieved within 6–9 weeks.1 4 10

Systemic exposure is dose proportional over the dose range of 1–20 mg/kg, including fixed dosage of 1.2 g every 3 weeks; systemic accumulation is 1.9-fold when administered every 3 weeks.1 4 10

Distribution

Extent

Not known whether atezolizumab is distributed into milk.1

Elimination

Half-life

27 days.1 4 10

Clearance decreases over time by approximately 17% from baseline values; difference not clinically important.1

Special Populations

Mild hepatic impairment (total bilirubin concentration not exceeding the ULN with AST concentration exceeding the ULN, or total bilirubin concentration between 1–1.5 times the ULN with any AST concentration) does not affect clearance and systemic exposure.1 4 Effect of moderate or severe hepatic impairment on atezolizumab pharmacokinetics not established.1 4

Mild or moderate renal impairment (estimated GFR 30–89 mL/minute per 1.73 m2) does not affect clearance.1 4 Limited data available for severe renal impairment.1 4

Age (range of 21–89 years), body weight, sex, serum albumin concentration, tumor burden, geographic region, race, PD-L1 expression, and performance status do not have meaningful effects on systemic exposure of atezolizumab.1 4

Stability

Storage

Parenteral

Injection

2–8°C.1 Do not freeze; protect from light.1

Diluted solution: Room temperature for ≤6 hours from time of preparation (including infusion time) or 2–8°C for ≤24 hours from time of preparation.1 Do not freeze.1

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility1

Compatible

Sodium chloride 0.9%

Actions

  • An IgG1 kappa immunoglobulin that is selective for PD-L1.1 2 4

  • Overexpression of PD-1 ligands on surface of tumor cells results in activation of PD-1 and B7.1 and suppression of cytotoxic T-cell activity, T-cell proliferation, and cytokine production.1 8 9 10

  • Blocks interaction between PD-L1 and the receptors PD-1 and B7.1, resulting in activation of antitumor immune response without inducing antibody-dependent cell-mediated cytotoxicity (ADCC).1 10

Advice to Patients

  • Importance of advising patients to read the manufacturer's medication guide.1

  • Risk of immune-mediated pneumonitis.1 Importance of informing clinician immediately if new or worsening cough, chest pain, or shortness of breath occurs.1

  • Risk of immune-mediated hepatitis.1 Importance of informing clinician immediately if signs and symptoms of liver damage (e.g., jaundice, severe nausea or vomiting, abdominal pain [particularly in right upper quadrant], lethargy, easy bruising or bleeding, lack of appetite, dark urine, drowsiness) occur.1

  • Risk of immune-mediated colitis.1 Importance of informing clinician immediately if diarrhea or severe abdominal pain occurs or if mucus or blood is present in stool.1

  • Risk of immune-mediated endocrine effects.1 Importance of informing clinician immediately if manifestations of hypophysitis, hyperthyroidism, hypothyroidism, adrenal insufficiency, or diabetes mellitus (including ketoacidosis) occur.1

  • Risk of other immune-mediated adverse effects.1 Importance of informing clinician immediately if manifestations of other potential immune-mediated adverse effects occur.1

  • Risk of infections.1 Importance of informing clinician if fever, flu-like symptoms, cough, or painful or frequent urination occurs.1

  • Risk of infusion-related reactions.1 Importance of informing clinician if signs and symptoms of such reactions, including dizziness, chills, fever, breathing difficulty (i.e., shortness of breath, wheezing), pruritus, flushing, feeling of faintness, back or neck pain, or angioedema, occur.1

  • Risk of fetal harm.1 Necessity of advising women of childbearing potential that they should use an effective method of contraception while receiving atezolizumab and for ≥5 months after discontinuance of therapy.1 Importance of women informing clinicians if they are or plan to become pregnant.1 If pregnancy occurs, advise pregnant women of potential risk to the fetus.1

  • Importance of advising women to avoid breast-feeding while receiving atezolizumab and for ≥5 months after discontinuance of therapy.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Distribution of atezolizumab is restricted.3 5 (See Restricted Distribution under Dosage and Administration.)

Atezolizumab

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Concentrate, for injection, for IV infusion

60 mg/mL (1.2 g)

Tecentriq

Genentech

AHFS DI Essentials™. © Copyright 2020, Selected Revisions May 22, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

1. Genentech. Tecentriq (atezolizumab) injection for intravenous infusion prescribing information. South San Francisco, CA; 2018 Dec.

2. Rosenberg JE, Hoffman-Censits J, Powles T et al. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. Lancet. 2016; 387:1909-20. http://www.ncbi.nlm.nih.gov/pubmed/26952546?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=5480242&blobtype=pdf

3. Genentech. Genentech Tecentriq distribution quick reference guide. From Genentech for Healthcare Professionals website. Accessed 2016 Sep 13. https://www.tecentriq.com/content/dam/gene/tecentriq/Tecentriq-Distribution-Quick-Reference-Guides.pdf

4. Food and Drug Administration. Center for Drug Evaluation and Research. Application number 761034Orig1s000: Clinical pharmacology and biopharmaceutics review(s). From FDA website. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761034Orig1s000ClinPharmR.pdf

5. Genentech. Tecentriq distribution. 2016 Sept. From Genentech for Healthcare Professionals website. Accessed 2016 Sep 13. https://www.genentech-access.com/hcp/brands/tecentriq/learn-about-our-services/product-distribution.html

6. Robert C, Ribas A, Wolchok JD et al. Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial. Lancet. 2014; 384:1109-17. http://www.ncbi.nlm.nih.gov/pubmed/25034862?dopt=AbstractPlus

7. Hamid O, Robert C, Daud A et al. Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma. N Engl J Med. 2013; 369:134-44. http://www.ncbi.nlm.nih.gov/pubmed/23724846?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=4126516&blobtype=pdf

8. Poole RM. Pembrolizumab: first global approval. Drugs. 2014; 74:1973-81. http://www.ncbi.nlm.nih.gov/pubmed/25331768?dopt=AbstractPlus

9. Gentzler R, Hall R, Kunk PR et al. Beyond melanoma: inhibiting the PD-1/PD-L1 pathway in solid tumors. Immunotherapy. 2016; 8:583-600. http://www.ncbi.nlm.nih.gov/pubmed/27140411?dopt=AbstractPlus

10. Markham A. Atezolizumab: First Global Approval. Drugs. 2016; 76:1227-32. http://www.ncbi.nlm.nih.gov/pubmed/27412122?dopt=AbstractPlus

11. Fehrenbacher L, Spira A, Ballinger M et al. Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trial. Lancet. 2016; 387:1837-46. http://www.ncbi.nlm.nih.gov/pubmed/26970723?dopt=AbstractPlus

12. Rittmeyer A, Barlesi F, Waterkamp D et al. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017; 389:255–65.

13. Balar AV, Galsky MD, Rosenberg JE et al. Atezolizumab as first-line therapy in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Lancet. 2017; 389:67–76.

14. Food and Drug Administration. FDA alerts health care professionals and oncology clinical investigators about an efficacy issue identified in clinical trials for some patients taking Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as monotherapy to treat urothelial cancer with low expression of PD-L1. Silver Spring, MD; 2018 Jun 20. From the FDA website. https://www.fda.gov/Drugs/DrugSafety/ucm608075.htm

15. Genentech. Tecentriq (atezolizumab) injection for intravenous infusion prescribing information. South San Francisco, CA; 2016 Oct.

16. Socinski MA, Jotte RM, Cappuzzo F et al. Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC. N Engl J Med. 2018; 378:2288-2301. http://www.ncbi.nlm.nih.gov/pubmed/29863955?dopt=AbstractPlus

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