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TECENTRIQ
Bladder, kidney, and other urologic cancers
Respiratory and thoracic cancers
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Drug Name:

TECENTRIQ Rx

Generic Name and Formulations:
Atezolizumab 60mg/mL; soln for IV infusion after dilution; preservative-free.

Company:
Genentech, Inc.

Therapeutic Use:

Indications for TECENTRIQ:

Locally advanced or metastatic urothelial carcinoma in patients who: are ineligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥5% of tumor area), as determined by an FDA-approved test; are ineligible for any platinum-containing chemotherapy regardless of PD-L1 status; or have disease progression during or following any platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant chemotherapy.

Adult:

Give as IV infusion over 60mins. 1200mg every 3 weeks until disease progression or unacceptable toxicity. May give subsequent infusions over 30mins if first infusion tolerated. Dose modifications: see full labeling. Administer corticosteroids for most Grade ≥2 related immune-mediated reactions.

Children:

Not established.

Warnings/Precautions:

Monitor for immune-mediated pneumonitis, hepatitis (monitor LFTs), diarrhea or colitis, endocrinopathies (eg, hypophysitis, thyroid disorders, adrenal insufficiency, diabetes), other immune-mediated reactions (eg, myocarditis, pancreatitis, encephalitis, serious skin reactions). Permanently discontinue for Grade 3 or 4 pneumonitis, AST or ALT >8×ULN or total bilirubin >3×ULN, Grade 4 diarrhea or colitis, Grade 4 other immune-mediated reactions, persistent Grade 2 or 3 reactions (except endocrinopathies) that do not recover to Grade 0–1 within 12wks after last dose, inability to reduce corticosteroid dose to ≤10mg/day of prednisone or equivalent within 12wks after last dose, or recurrent Grade 3 or 4 reactions. Withhold for Grade 2 pneumonitis, AST or ALT >3–8×ULN or total bilirubin >1.5–3×ULN, Grade 2 or 3 diarrhea or colitis, Grade 2–4 endocrinopathies, Grade 3 other immune-mediated reactions; may be resumed when recover to Grade 0–1 and steroid dose ≤10mg/day of prednisone or equivalent. Monitor for signs/symptoms of infection; withhold if Grade 3 or 4 until resolved. Monitor for infusion-related reactions; permanently discontinue if Grade 3 or 4 develops; interrupt or slow the infusion rate if Grade 1 or 2 (consider premedications with subsequent doses). Evaluate for Vogt-Koyanagi-Harada syndrome if uveitis combined with other immune-mediated reactions occur. Embryo-fetal toxicity. Pregnancy; exclude status before initiation. Females of reproductive potential should use effective contraception during and for ≥5 months after final dose. Nursing mothers: not recommended (during and for ≥5 months after final dose).

Pharmacological Class:

Programmed death-ligand 1 (PD-L1) blocking antibody.

Adverse Reactions:

Fatigue, decreased appetite, nausea, constipation, urinary tract infection, diarrhea, pyrexia, dyspnea, cough; immune-mediated reactions, lab abnormalities.

Generic Availability:

NO

How Supplied:

Single-dose vial (20mL)—1

Indications for TECENTRIQ:

Metastatic non-small cell lung cancer (NSCLC) in patients with disease progression during or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Tecentriq.

Adult:

Give as IV infusion over 60mins. 1200mg every 3 weeks until disease progression or unacceptable toxicity. May give subsequent infusions over 30mins if first infusion tolerated. Dose modifications: see full labeling. Administer corticosteroids for most Grade ≥2 related immune-mediated reactions.

Children:

Not established.

Warnings/Precautions:

Monitor for immune-mediated pneumonitis, hepatitis (monitor LFTs), diarrhea or colitis, endocrinopathies (eg, hypophysitis, thyroid disorders, adrenal insufficiency, diabetes), other immune-mediated reactions (eg, myocarditis, pancreatitis, encephalitis, serious skin reactions). Permanently discontinue for Grade 3 or 4 pneumonitis, AST or ALT >8×ULN or total bilirubin >3×ULN, Grade 4 diarrhea or colitis, Grade 4 other immune-mediated reactions, persistent Grade 2 or 3 reactions (except endocrinopathies) that do not recover to Grade 0–1 within 12wks after last dose, inability to reduce corticosteroid dose to ≤10mg/day of prednisone or equivalent within 12wks after last dose, or recurrent Grade 3 or 4 reactions. Withhold for Grade 2 pneumonitis, AST or ALT >3–8×ULN or total bilirubin >1.5–3×ULN, Grade 2 or 3 diarrhea or colitis, Grade 2–4 endocrinopathies, Grade 3 other immune-mediated reactions; may be resumed when recover to Grade 0–1 and steroid dose ≤10mg/day of prednisone or equivalent. Monitor for signs/symptoms of infection; withhold if Grade 3 or 4 until resolved. Monitor for infusion-related reactions; permanently discontinue if Grade 3 or 4 develops; interrupt or slow the infusion rate if Grade 1 or 2 (consider premedications with subsequent doses). Evaluate for Vogt-Koyanagi-Harada syndrome if uveitis combined with other immune-mediated reactions occur. Embryo-fetal toxicity. Pregnancy; exclude status before initiation. Females of reproductive potential should use effective contraception during and for ≥5 months after final dose. Nursing mothers: not recommended (during and for ≥5 months after final dose).

Pharmacological Class:

Programmed death-ligand 1 (PD-L1) blocking antibody.

Adverse Reactions:

Fatigue, decreased appetite, nausea, constipation, urinary tract infection, diarrhea, pyrexia, dyspnea, cough; immune-mediated reactions, lab abnormalities.

Generic Availability:

NO

How Supplied:

Single-dose vial (20mL)—1

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