Imfinzi Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Imfinzi Indications
Indications
Locally advanced or metastatic biliary tract cancer (BTC), in combination with gemcitabine and cisplatin. Unresectable hepatocellular carcinoma (uHCC), in combination with tremelimumab-actl.
Imfinzi Dosage and Administration
Adult
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
Imfinzi Contraindications
Not Applicable
Imfinzi Boxed Warnings
Not Applicable
Imfinzi Warnings/Precautions
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 Pharmacokinetics
Distribution
Geometric mean (% coefficient of variation [CV%]) steady state volume of distribution (Vss): 5.4 (13.1%) L.
Elimination
Half-life: ~21 days.
Imfinzi Interactions
Not Applicable
Imfinzi Adverse Reactions
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.
Imfinzi Clinical Trials
See Literature
Imfinzi Note
Not Applicable
Imfinzi Patient Counseling
See Literature
Imfinzi Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Imfinzi Indications
Indications
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.
Imfinzi Dosage and Administration
Adult
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
Imfinzi Contraindications
Not Applicable
Imfinzi Boxed Warnings
Not Applicable
Imfinzi Warnings/Precautions
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 Pharmacokinetics
Distribution
Geometric mean (% coefficient of variation [CV%]) steady state volume of distribution (Vss): 5.4 (13.1%) L.
Elimination
Half-life: ~21 days.
Imfinzi Interactions
Not Applicable
Imfinzi Adverse Reactions
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.
Imfinzi Clinical Trials
See Literature
Imfinzi Note
Not Applicable
Imfinzi Patient Counseling
See Literature
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