• First-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose tumors have high PD-L1 expression (PD-L1 stained ≥50% of tumor cells or PD-L1 stained tumor-infiltrating immune cells covering ≥ 10% of the tumor area) and have no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations (as monotherapy).
• Metastatic NSCLC in patients who have disease progression during or following platinum-containing chemotherapy (as monotherapy). Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving atezolizumab.
• Stage II to IIIA NSCLC as adjuvant treatment following resection and platinum-based chemotherapy in patients whose tumors have PD-L1 expression on ≥ 1% of tumor cells (as monotherapy).
• Metastatic non-squamous, NSCLC as first-line therapy in patients whose tumors have no EGFR or ALK genomic tumor aberrations (in combination with bevacizumab, paclitaxel, and carboplatin).
• Metastatic non-squamous NSCLC as first-line therapy in patients whose tumors have no EGFR or ALK genomic tumor aberrations (in combination with paclitaxel protein bound and carboplatin).
• Extensive-stage small cell lung cancer as first-line therapy (in combination with carboplatin and etoposide).
• Unresectable or metastatic hepatocellular carcinoma in patients who have not previously received systemic therapy (in combination with bevacizumab).
• BRAF V600 mutation-positive unresectable or metastatic melanoma (in combination with cobimetinib and vemurafenib).
• Unresectable or metastatic alveolar soft part sarcoma (as monotherapy).

Contraindicated in:

• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Allogeneic hematopoietic stem cell transplant recipients (↑ risk of transplantation complications)
• Rep: Women of reproductive potential
• Pedi: Children <2 yr (alveolar soft part sarcoma) or <18 yr (all other indications) (safety and effectiveness not established).

CV: peripheral edema, myocarditis, pericarditis.

Derm: pruritus, rash, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN).

Endo: hypothyroidism, ADRENAL INSUFFICIENCY, hyperglycemia, hyperthyroidism, hypophysitis, type 1 diabetes mellitus.

F and E: hyponatremia, dehydration.

GI: ↓ appetite, colitis/diarrhea, constipation, hepatotoxicity, nausea, vomiting, ↑ liver enzymes, abdominal pain, PANCREATITIS.

GU: hematuria, ↓ fertility (females), ↑ serum creatinine, acute kidney injury, nephritis, urinary obstruction.

Hemat: lymphopenia, anemia.

Metab: hypoalbuminemia.

MS: arthralgia.

Neuro: Guillain-Barre syndrome, ENCEPHALITIS, MENINGITIS, MYASTHENIA GRAVIS, myelitis, nerve paresis.

Resp: cough, dyspnea, INTERSTITIAL LUNG DISEASE.

Misc: fatigue, fever, infections (including herpes encephalitis and tuberculosis), INFUSION-RELATED REACTIONS.

Drug-Drug:

• None reported.

• Solution for injection: 60 mg/mL;

Non-Small Cell Lung Cancer

• IV (Adults): As monotherapy (metastatic NSCLC): 840 mg every 2 wk until disease progression or unacceptable toxicity or1200 mg every 3 wk until disease progression or unacceptable toxicity or1680 mg every 4 wk until disease progression or unacceptable toxicity. As monotherapy (adjuvant treatment): 840 mg every 2 wk for up to 1 yr unless there is disease recurrence or unacceptable toxicity or1200 mg every 3 wk for up to 1 yr unless there is disease recurrence or unacceptable toxicity or1680 mg every 4 wk for up to 1 yr unless there is disease recurrence or unacceptable toxicity. Combination therapy: 840 mg every 2 wk until disease progression or unacceptable toxicity or1200 mg every 3 wk until disease progression or unacceptable toxicity or1680 mg every 4 wk until disease progression or unacceptable toxicity. Administer prior to bevacizumab and chemotherapy when given on same day.

Small Cell Lung Cancer

• IV (Adults): 840 mg every 2 wk until disease progression or unacceptable toxicity or1200 mg every 3 wk until disease progression or unacceptable toxicity or1680 mg every 4 wk until disease progression or unacceptable toxicity. Administer prior to carboplatin and etoposide when given on same day.

Hepatocellular Carcinoma

• IV (Adults): 840 mg every 2 wk until disease progression or unacceptable toxicity or1200 mg every 3 wk until disease progression or unacceptable toxicity or1680 mg every 4 wk until disease progression or unacceptable toxicity. Administer prior to bevacizumab when given on same day.

Melanoma

• IV (Adults): 840 mg every 2 wk until disease progression or unacceptable toxicity or1200 mg every 3 wk until disease progression or unacceptable toxicity or1680 mg every 4 wk until disease progression or unacceptable toxicity. A 28–day treatment cycle of cobimetinib and vemurafenib should be administered prior to starting atezolizumab therapy.

Alveolar Soft Part Sarcoma

• IV (Adults): 840 mg every 2 wk until disease progression or unacceptable toxicity or1200 mg every 3 wk until disease progression or unacceptable toxicity or1680 mg every 4 wk until disease progression or unacceptable toxicity.
• IV (Children ≥2 yr): 15 mg/kg (max dose = 1200 mg) every 3 wk until disease progression or unacceptable toxicity.

Tecentriq

• Binds to (PD-L1 to prevent its interaction with the programmed cell death-1 (PD-1) and B7.1 (or CD80) receptors, which activates the anti-tumor immune response.

• Decreased spread of NSCLC, small cell lung cancer, hepatocellular carcinoma, and melanoma with increased survival.
• Decreased spread of alveolar soft part sarcoma.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: monoclonal antibodies

Absorption: IV administration results in complete bioavailability.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Unknown.

Half-life: 27 days.

(plasma concentrations)

• Explain purpose of atezolizumab to patient. Advise patient to read the Medication Guide before starting and periodically during therapy in case of changes.
• Advise patient to notify health care professional immediately if symptoms of pneumonitis, hepatitis, colitis, endocrine problems, meningitis, nervous system problems, ocular inflammatory toxicity (blurry or double vision, eye pain or redness), pancreatitis, infection, infusion-related reactions, or rash occur.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception and to avoid breastfeeding during and for at least 5 mo after last dose. Inform females that atezolizumab may impair fertility during therapy.

a-te-zoe-LIZ-ue-mab

NDC Code^*

• 50242- Genentech, Inc.
  • 50242-917- TECENTRIQ
    • 50242-917-01- 1 VIAL, SINGLE-USE in 1 CARTON (50242-917-01) > 20 mL in 1 VIAL, SINGLE-USE

• 50242- Genentech, Inc.
  • 50242-917- TECENTRIQ
    • 50242-917-86- 1 VIAL, SINGLE-USE in 1 CARTON (50242-917-86) > 20 mL in 1 VIAL, SINGLE-USE

• 50242- Genentech, Inc.
  • 50242-918- TECENTRIQ
    • 50242-918-01- 1 VIAL, SINGLE-USE in 1 CARTON (50242-918-01) > 14 mL in 1 VIAL, SINGLE-USE

• 50242- Genentech, Inc.
  • 50242-918- TECENTRIQ
    • 50242-918-86- 1 VIAL, SINGLE-USE in 1 CARTON (50242-918-86) > 14 mL in 1 VIAL, SINGLE-USE