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.

Adult Dosage:

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 Dosage:

Not established.

TECENTRIQ Warnings/Precautions:

Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related pneumonitis, hepatitis, colitis, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), nephritis/renal dysfunction, dermatologic reactions, myocarditis, neurological toxicities, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain liver enzymes, creatinine and thyroid function at baseline and periodically during therapy. Monitor for infection. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Interrupt, slow the infusion rate, or permanently discontinue based on severity of infusion-related reactions. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease, hepatic veno-occlusive disease, steroid-requiring febrile syndrome) and manage promptly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥5 months after the last dose. Pregnancy: exclude status before initiation. Nursing mothers: not recommended (during and for ≥5 months after the last dose).

TECENTRIQ Classification:

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

Adverse Reactions:

Fatigue, asthenia, nausea, cough, dyspnea, decreased appetite; infusion-related reactions. Combination w. paclitaxel: also alopecia, constipation, diarrhea, peripheral neuropathy, anemia, headache, neutropenia, vomiting; combination w. bevacizumab: also hypertension, proteinuria; combination w. cobimetinib/vemurafenib: also rash, musculoskeletal pain, hepatotoxicity, pyrexia, pruritus, edema, stomatitis, hypothyroidism, photosensitivity reaction.

Generic Drug 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.

Limitations of Use:

Not for use in combination with paclitaxel for treating adults with unresectable locally advanced or metastatic TNBC.

Adult Dosage:

Do not substitute paclitaxel protein-bound with paclitaxel. 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 Dosage:

Not established.

TECENTRIQ Warnings/Precautions:

Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related pneumonitis, hepatitis, colitis, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), nephritis/renal dysfunction, dermatologic reactions, myocarditis, neurological toxicities, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain liver enzymes, creatinine and thyroid function at baseline and periodically during therapy. Monitor for infection. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Interrupt, slow the infusion rate, or permanently discontinue based on severity of infusion-related reactions. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease, hepatic veno-occlusive disease, steroid-requiring febrile syndrome) and manage promptly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥5 months after the last dose. Pregnancy: exclude status before initiation. Nursing mothers: not recommended (during and for ≥5 months after the last dose).

TECENTRIQ Classification:

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

Adverse Reactions:

Fatigue, asthenia, nausea, cough, dyspnea, decreased appetite; infusion-related reactions. Combination w. paclitaxel: also alopecia, constipation, diarrhea, peripheral neuropathy, anemia, headache, neutropenia, vomiting; combination w. bevacizumab: also hypertension, proteinuria; combination w. cobimetinib/vemurafenib: also rash, musculoskeletal pain, hepatotoxicity, pyrexia, pruritus, edema, stomatitis, hypothyroidism, photosensitivity reaction.

Generic Drug 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 Dosage:

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 Dosage:

Not established.

TECENTRIQ Warnings/Precautions:

Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related pneumonitis, hepatitis, colitis, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), nephritis/renal dysfunction, dermatologic reactions, myocarditis, neurological toxicities, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain liver enzymes, creatinine and thyroid function at baseline and periodically during therapy. Monitor for infection. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Interrupt, slow the infusion rate, or permanently discontinue based on severity of infusion-related reactions. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease, hepatic veno-occlusive disease, steroid-requiring febrile syndrome) and manage promptly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥5 months after the last dose. Pregnancy: exclude status before initiation. Nursing mothers: not recommended (during and for ≥5 months after the last dose).

TECENTRIQ Classification:

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

Adverse Reactions:

Fatigue, asthenia, nausea, cough, dyspnea, decreased appetite; infusion-related reactions. Combination w. paclitaxel: also alopecia, constipation, diarrhea, peripheral neuropathy, anemia, headache, neutropenia, vomiting; combination w. bevacizumab: also hypertension, proteinuria; combination w. cobimetinib/vemurafenib: also rash, musculoskeletal pain, hepatotoxicity, pyrexia, pruritus, edema, stomatitis, hypothyroidism, photosensitivity reaction.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (14mL, 20mL)—1

Melanoma and other skin cancers:

Indications for: TECENTRIQ

In combination with cobimetinib and vemurafenib for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma.

Adult Dosage:

Prior to initiation, administer a 28-day treatment cycle of cobimetinib 60mg orally once daily (21 days on, 7 days off) and vemurafenib 960mg orally twice daily (Days 1–21) and vemurafenib 720mg orally twice daily (Days 22–28). Give atezolizumab as IV infusion over 60mins; may give subsequent infusions over 30mins if first infusion tolerated. 840mg every 2 weeks until disease progression or unacceptable toxicity, in combination with cobimetinib 60mg orally once daily (21 days on, 7 days off) and vemurafenib 720mg orally twice daily. Dose modifications: see full labeling. Administer corticosteroids for most Grade ≥2 related immune-mediated reactions.

Children Dosage:

Not established.

TECENTRIQ Warnings/Precautions:

Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related pneumonitis, hepatitis, colitis, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), nephritis/renal dysfunction, dermatologic reactions, myocarditis, neurological toxicities, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain liver enzymes, creatinine and thyroid function at baseline and periodically during therapy. Monitor for infection. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Interrupt, slow the infusion rate, or permanently discontinue based on severity of infusion-related reactions. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease, hepatic veno-occlusive disease, steroid-requiring febrile syndrome) and manage promptly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥5 months after the last dose. Pregnancy: exclude status before initiation. Nursing mothers: not recommended (during and for ≥5 months after the last dose).

TECENTRIQ Classification:

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

Adverse Reactions:

Fatigue, asthenia, nausea, cough, dyspnea, decreased appetite; infusion-related reactions. Combination w. paclitaxel: also alopecia, constipation, diarrhea, peripheral neuropathy, anemia, headache, neutropenia, vomiting; combination w. bevacizumab: also hypertension, proteinuria; combination w. cobimetinib/vemurafenib: also rash, musculoskeletal pain, hepatotoxicity, pyrexia, pruritus, edema, stomatitis, hypothyroidism, photosensitivity reaction.

Generic Drug 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 Dosage:

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 Dosage:

Not established.

TECENTRIQ Warnings/Precautions:

Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related pneumonitis, hepatitis, colitis, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), nephritis/renal dysfunction, dermatologic reactions, myocarditis, neurological toxicities, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain liver enzymes, creatinine and thyroid function at baseline and periodically during therapy. Monitor for infection. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Interrupt, slow the infusion rate, or permanently discontinue based on severity of infusion-related reactions. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease, hepatic veno-occlusive disease, steroid-requiring febrile syndrome) and manage promptly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥5 months after the last dose. Pregnancy: exclude status before initiation. Nursing mothers: not recommended (during and for ≥5 months after the last dose).

TECENTRIQ Classification:

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

Adverse Reactions:

Fatigue, asthenia, nausea, cough, dyspnea, decreased appetite; infusion-related reactions. Combination w. paclitaxel: also alopecia, constipation, diarrhea, peripheral neuropathy, anemia, headache, neutropenia, vomiting; combination w. bevacizumab: also hypertension, proteinuria; combination w. cobimetinib/vemurafenib: also rash, musculoskeletal pain, hepatotoxicity, pyrexia, pruritus, edema, stomatitis, hypothyroidism, photosensitivity reaction.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (14mL, 20mL)—1