Select therapeutic use:

Colorectal and other GI cancers:

Indications for: IMFINZI

Locally advanced or metastatic biliary tract cancer (BTC), in combination with gemcitabine and cisplatin. Unresectable hepatocellular carcinoma (uHCC), in combination with tremelimumab-actl.

Adult Dosage:

Give as IV infusion over 60mins. BTC: (<30kg): 20mg/kg (with chemotherapy) every 3 weeks up to 8 cycles, followed by 20mg/kg every 4 weeks as a single agent; (≥30kg): 1500mg (with chemotherapy) every 3 weeks up to 8 cycles, followed by 1500mg every 4 weeks as a single agent; continue until disease progression or unacceptable toxicity. uHCC: (<30kg): 20mg/kg (with tremelimumab-actl 4mg/kg as a single dose) at Day 1 of Cycle 1, followed by 20mg/kg every 4 weeks as a single agent; (≥30kg): 1500mg (with tremelimumab-actl 300mg as a single dose) at Day 1 of Cycle 1, followed by 1500mg every 4 weeks as a single agent; after Cycle 1 of combination therapy, continue until disease progression or unacceptable toxicity. In combination with chemotherapy: give durvalumab prior to chemotherapy on the same day (see full labeling). In combination with tremelimumab-actl: give tremelimumab-actl prior to durvalumab 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.

IMFINZI Warnings/Precautions:

Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related pneumonitis, colitis, hepatitis, endocrinopathies (adrenal insufficiency, thyroid disorders, hypophysitis/hypopituitarism, diabetes), nephritis/renal dysfunction, dermatologic reactions, pancreatitis, 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 ≥3 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥3 months after the last dose).

IMFINZI Classification:

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

Adverse Reactions:

Cough, pneumonitis/radiation pneumonitis, fatigue/asthenia, nausea, alopecia, upper RTI, dyspnea, rash, diarrhea, pyrexia, abdominal pain, pruritus, musculoskeletal pain; other immune-related reactions (eg, aseptic meningitis, hemolytic anemia), infusion-related reactions, lab abnormalities.

Drug Elimination:

Half-life: ~18 days.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (2.4mL, 10mL)—1

Respiratory and thoracic cancers:

Indications for: IMFINZI

Unresectable, Stage III non-small cell lung cancer (NSCLC) in adults whose disease has not progressed after concurrent platinum-based chemotherapy and radiation. Metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations, in combination with tremelimumab-actl and platinum-based chemotherapy. First-line treatment of extensive-stage small cell lung cancer (ES-SCLC), in combination with etoposide and either carboplatin or cisplatin.

Adult Dosage:

Give as IV infusion over 60mins. Unresectable, Stage III NSCLC (<30kg): 10mg/kg every 2 weeks; (≥30kg): 10mg/kg every 2 weeks or 1500mg every 4 weeks; continue until disease progression, unacceptable toxicity, or max 12 months. Metastatic NSCLC: non-squamous or squamous: (<30kg): 20mg/kg every 3 weeks (with tremelimumab-actl 1mg/kg and platinum-based chemotherapy) for 4 cycles, followed by 20mg/kg every 4 weeks as a single agent (with histology-based pemetrexed therapy) every 4 weeks, and a fifth dose of tremelimumab-actl 1mg/kg (with durvalumab dose 6) at week 16;  (≥30kg): 1500mg every 3 weeks (with tremelimumab-actl 75mg and platinum-based chemotherapy) for 4 cycles, followed by 1500mg every 4 weeks as a single agent (with histology-based pemetrexed maintenance therapy) every 4 weeks, and a fifth dose of tremelimumab-actl 75mg (with durvalumab dose 6) at week 16. Continue durvalumab until disease progression or intolerable toxicity. In combination with tremelimumab-actl and chemotherapy: give tremelimumab-actl first, followed by durvalumab and then platinum-based chemotherapy on the day of dosing (see full labeling). If patients receive fewer than 4 cycles of chemotherapy, give remaining tremelimumab-actl cycles (up to a total of 5) after chemotherapy phase, in combination with durvalumab, every 4 weeks. For patients with non-squamous disease who received pemetrexed and carboplatin/cisplatin: optional pemetrexed therapy from week 12 until disease progression or intolerable toxicity. ES-SCLC (<30kg): 20mg/kg (with chemotherapy) every 3 weeks for 4 cycles, followed by 10mg/kg every 2 weeks as a single agent; (≥30kg): 1500mg (with chemotherapy) every 3 weeks for 4 cycles, followed by 1500mg every 4 weeks as a single agent. Continue until disease progression or unacceptable toxicity. In combination with chemotherapy: give durvalumab prior to chemotherapy 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.

IMFINZI Warnings/Precautions:

Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related pneumonitis, colitis, hepatitis, endocrinopathies (adrenal insufficiency, thyroid disorders, hypophysitis/hypopituitarism, diabetes), nephritis/renal dysfunction, dermatologic reactions, pancreatitis, 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 ≥3 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥3 months after the last dose).

IMFINZI Classification:

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

Adverse Reactions:

Cough, pneumonitis/radiation pneumonitis, fatigue/asthenia, nausea, alopecia, upper RTI, dyspnea, rash, diarrhea, pyrexia, abdominal pain, pruritus, musculoskeletal pain; other immune-related reactions (eg, aseptic meningitis, hemolytic anemia), infusion-related reactions, lab abnormalities.

Drug Elimination:

Half-life: ~18 days.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (2.4mL, 10mL)—1