Select therapeutic use:

Bladder, kidney, and other urologic cancers:

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; may give subsequent infusions over 30mins if first infusion tolerated. 840mg every 2 weeks, or 1200mg every 3 weeks, or 1680mg every 4 weeks until disease progression or unacceptable toxicity. 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/ALT >8×ULN (non-HCC) or AST/ALT >10×ULN (HCC) 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/ALT >3–8×ULN or total bilirubin >1.5–3×ULN (non-HCC; see full labeling for HCC), 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. Advise females of reproductive potential to use effective contraception during and for ≥5 months after final dose. Pregnancy; exclude status before initiation. Nursing mothers: not recommended (during and for ≥5 months after final dose).

Pharmacologic Class:

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

Adverse Reactions:

Fatigue, asthenia, nausea, cough, dyspnea, decreased appetite; immune-mediated reactions. Combination therapy: also alopecia, constipation, diarrhea, peripheral neuropathy, anemia, headache, neutropenia, vomiting, hypertension, proteinuria.

Generic Availability:

NO

How Supplied:

Single-dose vial (14mL, 20mL)—1

Breast cancer:

Indications for TECENTRIQ:

Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in patients whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥1% of tumor area) as determined by an FDA-approved test, in combination with paclitaxel protein-bound.

Adult:

Give as IV infusion over 60mins; may give subsequent infusions over 30mins if first infusion tolerated. 840mg on Days 1 and 15, followed by paclitaxel protein-bound 100mg/m2 on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity. 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/ALT >8×ULN (non-HCC) or AST/ALT >10×ULN (HCC) 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/ALT >3–8×ULN or total bilirubin >1.5–3×ULN (non-HCC; see full labeling for HCC), 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. Advise females of reproductive potential to use effective contraception during and for ≥5 months after final dose. Pregnancy; exclude status before initiation. Nursing mothers: not recommended (during and for ≥5 months after final dose).

Pharmacologic Class:

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

Adverse Reactions:

Fatigue, asthenia, nausea, cough, dyspnea, decreased appetite; immune-mediated reactions. Combination therapy: also alopecia, constipation, diarrhea, peripheral neuropathy, anemia, headache, neutropenia, vomiting, hypertension, proteinuria.

Generic Availability:

NO

How Supplied:

Single-dose vial (14mL, 20mL)—1

Colorectal and other GI cancers:

Indications for TECENTRIQ:

Unresectable or metastatic hepatocellular carcinoma (HCC) in patients who have not received prior systemic therapy, in combination with bevacizumab.

Adult:

Give as IV infusion over 60mins; may give subsequent infusions over 30mins if first infusion tolerated. 1200mg, followed by bevacizumab 15mg/kg on same day, every 3 weeks until disease progression or unacceptable toxicity; if bevacizumab discontinued, give 840mg every 2 weeks, or 1200mg every 3 weeks, or 1680mg every 4 weeks. 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/ALT >8×ULN (non-HCC) or AST/ALT >10×ULN (HCC) 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/ALT >3–8×ULN or total bilirubin >1.5–3×ULN (non-HCC; see full labeling for HCC), 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. Advise females of reproductive potential to use effective contraception during and for ≥5 months after final dose. Pregnancy; exclude status before initiation. Nursing mothers: not recommended (during and for ≥5 months after final dose).

Pharmacologic Class:

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

Adverse Reactions:

Fatigue, asthenia, nausea, cough, dyspnea, decreased appetite; immune-mediated reactions. Combination therapy: also alopecia, constipation, diarrhea, peripheral neuropathy, anemia, headache, neutropenia, vomiting, hypertension, proteinuria.

Generic Availability:

NO

How Supplied:

Single-dose vial (14mL, 20mL)—1

Respiratory and thoracic cancers:

Indications for TECENTRIQ:

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), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. First-line treatment of metastatic non-squamous NSCLC in patients with no EGFR or ALK genomic tumor aberrations, in combination with bevacizumab, paclitaxel, and carboplatin, or with paclitaxel protein-bound and carboplatin. Metastatic 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. First-line treatment of extensive-stage small cell lung cancer (ES-SCLC), in combination with carboplatin and etoposide.

Adult:

Give as IV infusion over 60mins; may give subsequent infusions over 30mins if first infusion tolerated. Continue until disease progression or unacceptable toxicity. NSCLC (as single agent): 840mg every 2 weeks, or 1200mg every 3 weeks, or 1680mg every 4 weeks; (in combination with platinum-based chemotherapy): 1200mg every 3 weeks; after 4–6 cycles of chemotherapy completed, and if bevacizumab discontinued, give 840mg every 2 weeks, or 1200mg every 3 weeks, or 1680mg every 4 weeks. In combination therapy: administer atezolizumab prior to chemotherapy and bevacizumab when given on the same day (see full labeling). SCLC: 1200mg every 3 weeks with carboplatin and etoposide; after 4 cycles of carboplatin/etoposide completed, give 840mg every 2 weeks, or 1200mg every 3 weeks, or 1680mg every 4 weeks. Administer atezolizumab prior to chemotherapy when given on the same day (see full labeling). 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/ALT >8×ULN (non-HCC) or AST/ALT >10×ULN (HCC) 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/ALT >3–8×ULN or total bilirubin >1.5–3×ULN (non-HCC; see full labeling for HCC), 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. Advise females of reproductive potential to use effective contraception during and for ≥5 months after final dose. Pregnancy; exclude status before initiation. Nursing mothers: not recommended (during and for ≥5 months after final dose).

Pharmacologic Class:

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

Adverse Reactions:

Fatigue, asthenia, nausea, cough, dyspnea, decreased appetite; immune-mediated reactions. Combination therapy: also alopecia, constipation, diarrhea, peripheral neuropathy, anemia, headache, neutropenia, vomiting, hypertension, proteinuria.

Generic Availability:

NO

How Supplied:

Single-dose vial (14mL, 20mL)—1