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 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. Advise females of reproductive potential to use effective contraception during and for ≥5 months after final dose. 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.

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 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. Advise females of reproductive potential to use effective contraception during and for ≥5 months after final dose. 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.

Generic Availability:

NO

How Supplied:

Single-dose vial (14mL, 20mL)—1

Respiratory and thoracic cancers:

Indications for TECENTRIQ:

First-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in patients with no EGFR or ALK genomic tumor aberrations, in combination with bevacizumab, paclitaxel, 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 bevacizumab, paclitaxel, and carboplatin): 1200mg every 3 weeks; after 4–6 cycles of paclitaxel/carboplatin completed, and if bevacizumab discontinued, give 840mg every 2 weeks, or 1200mg every 3 weeks, or 1680mg every 4 weeks. 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. In combination with chemotherapy or other antineoplastic drugs: give prior to chemotherapy or other antineoplastic drugs 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 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. Advise females of reproductive potential to use effective contraception during and for ≥5 months after final dose. 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.

Generic Availability:

NO

How Supplied:

Single-dose vial (14mL, 20mL)—1