Tecentriq

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PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Tecentriq Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Atezolizumab 60mg/mL; soln for IV infusion after dilution; preservative-free.

    Pharmacological Class

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

    How Supplied

    Single-dose vial (14mL, 20mL)—1

    Manufacturer

    Genentech, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Atezolizumab binds to PD-L1 and blocks its interactions with both PD-1 and B7.1 receptors. This releases the PD-L1/PD-1 mediated inhibition of the immune response, including activation of the anti-tumor immune response without inducing antibody-dependent cellular cytotoxicity.

    Tecentriq Indications

    Indications

    Alveolar soft part sarcoma (ASPS).

    Tecentriq Dosage and Administration

    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

    <2yrs: not established. Give as IV infusion over 60mins; may give subsequent infusions over 30mins if first infusion tolerated. ≥2yrs: 15mg/kg (up to max 1200mg) every 3 weeks until disease progression or unacceptable toxicity. Dose modifications: see full labeling. Administer corticosteroids for most Grade ≥2 related immune-mediated reactions.

    Tecentriq Contraindications

    Not Applicable

    Tecentriq Boxed Warnings

    Not Applicable

    Tecentriq Warnings/Precautions

    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 Pharmacokinetics

    Distribution

    Volume of distribution at steady state: 6.9 L.

    Elimination

    Half-life: 27 days.

    Tecentriq Interactions

    Not Applicable

    Tecentriq Adverse Reactions

    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.

    Tecentriq Clinical Trials

    See Literature

    Tecentriq Note

    Not Applicable

    Tecentriq Patient Counseling

    See Literature

    Tecentriq Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Atezolizumab 60mg/mL; soln for IV infusion after dilution; preservative-free.

    Pharmacological Class

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

    How Supplied

    Single-dose vial (14mL, 20mL)—1

    Manufacturer

    Genentech, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Atezolizumab binds to PD-L1 and blocks its interactions with both PD-1 and B7.1 receptors. This releases the PD-L1/PD-1 mediated inhibition of the immune response, including activation of the anti-tumor immune response without inducing antibody-dependent cellular cytotoxicity.

    Tecentriq Indications

    Indications

    In combination with bevacizumab for the treatment of adults with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

    Tecentriq Dosage and Administration

    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 followed by bevacizumab 15mg/kg on same day, every 3 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.

    Tecentriq Contraindications

    Not Applicable

    Tecentriq Boxed Warnings

    Not Applicable

    Tecentriq Warnings/Precautions

    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 Pharmacokinetics

    Distribution

    Volume of distribution at steady state: 6.9 L.

    Elimination

    Half-life: 27 days.

    Tecentriq Interactions

    Not Applicable

    Tecentriq Adverse Reactions

    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.

    Tecentriq Clinical Trials

    See Literature

    Tecentriq Note

    Not Applicable

    Tecentriq Patient Counseling

    See Literature

    Tecentriq Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Atezolizumab 60mg/mL; soln for IV infusion after dilution; preservative-free.

    Pharmacological Class

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

    How Supplied

    Single-dose vial (14mL, 20mL)—1

    Manufacturer

    Genentech, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Atezolizumab binds to PD-L1 and blocks its interactions with both PD-1 and B7.1 receptors. This releases the PD-L1/PD-1 mediated inhibition of the immune response, including activation of the anti-tumor immune response without inducing antibody-dependent cellular cytotoxicity.

    Tecentriq Indications

    Indications

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

    Tecentriq Dosage and Administration

    Adult

    Confirm presence of a BRAF V600 mutation. 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, or 1200mg every 3 weeks, or 1680mg every 4 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

    Not established.

    Tecentriq Contraindications

    Not Applicable

    Tecentriq Boxed Warnings

    Not Applicable

    Tecentriq Warnings/Precautions

    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 Pharmacokinetics

    Distribution

    Volume of distribution at steady state: 6.9 L.

    Elimination

    Half-life: 27 days.

    Tecentriq Interactions

    Not Applicable

    Tecentriq Adverse Reactions

    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.

    Tecentriq Clinical Trials

    See Literature

    Tecentriq Note

    Not Applicable

    Tecentriq Patient Counseling

    See Literature

    Tecentriq Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Atezolizumab 60mg/mL; soln for IV infusion after dilution; preservative-free.

    Pharmacological Class

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

    How Supplied

    Single-dose vial (14mL, 20mL)—1

    Manufacturer

    Genentech, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Atezolizumab binds to PD-L1 and blocks its interactions with both PD-1 and B7.1 receptors. This releases the PD-L1/PD-1 mediated inhibition of the immune response, including activation of the anti-tumor immune response without inducing antibody-dependent cellular cytotoxicity.

    Tecentriq Indications

    Indications

    As adjuvant treatment following resection and platinum-based chemotherapy for adults with Stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥1% of tumor cells, as determined by an FDA-approved test. First-line treatment of metastatic 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.

    Tecentriq Dosage and Administration

    Adult

    Give as IV infusion over 60mins; may give subsequent infusions over 30mins if first infusion tolerated. Adjuvant treatment of NSCLC: continue up to 1yr unless disease recurrence or unacceptable toxicity occurs. Metastatic NSCLC or SCLC: continue until disease progression or unacceptable toxicity. NSCLC (as single agent or in combination with other therapeutic agents): 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: 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.

    Tecentriq Contraindications

    Not Applicable

    Tecentriq Boxed Warnings

    Not Applicable

    Tecentriq Warnings/Precautions

    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 Pharmacokinetics

    Distribution

    Volume of distribution at steady state: 6.9 L.

    Elimination

    Half-life: 27 days.

    Tecentriq Interactions

    Not Applicable

    Tecentriq Adverse Reactions

    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.

    Tecentriq Clinical Trials

    See Literature

    Tecentriq Note

    Not Applicable

    Tecentriq Patient Counseling

    See Literature

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