- Bladder, kidney, and other urologic cancers
- Colorectal and other GI cancers
- Respiratory and thoracic cancers
Bladder, kidney, and other urologic cancers:
Colorectal and other GI cancers:
Indications for: IMFINZI
Treatment of locally advanced or metastatic biliary tract cancer (BTC), in combination with gemcitabine and cisplatin.
Adult Dosage:
Give as IV infusion over 60mins. <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. In combination with chemotherapy: give Imfinzi 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, 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; other immune-related reactions (eg, aseptic meningitis, hemolytic anemia), infusion-related reactions, lab abnormalities.
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. 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. 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. 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 Imfinzi 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, 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; other immune-related reactions (eg, aseptic meningitis, hemolytic anemia), infusion-related reactions, lab abnormalities.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial (2.4mL, 10mL)—1
