HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use IMFINZI safely and effectively. See full prescribing information for IMFINZI.
IMFINZI™ (durvalumab) injection, for intravenous use
Initial U.S. Approval: 2017
INDICATIONS AND USAGE
IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with:

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Locally advanced or metastatic urothelial carcinoma who:
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have disease progression during or following platinum-containing chemotherapy. ( 1)
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have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. ( 1)
This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. (1)
DOSAGE AND ADMINISTRATION
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Administer 10 mg/kg as an intravenous infusion over 60 minutes every 2 weeks. ( 2.1)
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Dilute prior to intravenous infusion. ( 2.3)
DOSAGE FORMS AND STRENGTHS
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Injection: 500 mg/10mL (50 mg/mL) solution in a single-dose vial. ( 3)
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Injection: 120 mg/2.4mL (50 mg/mL) solution in a single-dose vial. ( 3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
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Immune-Mediated Pneumonitis: Withhold for moderate and permanently discontinue for severe or life-threatening pneumonitis. ( 2.2, 5.1)
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Immune-Mediated Hepatitis: Monitor for changes in liver function. Withhold for moderate and permanently discontinue for severe or life-threatening transaminase or total bilirubin elevation. ( 2.2, 5.2)
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Immune-Mediated Colitis: Withhold for moderate and permanently discontinue for severe or life-threatening colitis. ( 2.2, 5.3)
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Immune-Mediated Endocrinopathies:
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Adrenal Insufficiency, Hypophysitis, or Type 1 Diabetes Mellitus: Withhold for moderate, severe or life-threatening. ( 2.2, 5.4)
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Immune-Mediated Nephritis: Monitor for changes in renal function. Withhold for moderate and permanently discontinue for severe or life-threatening nephritis. ( 2.2, 5.5)
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Infection: Withhold for severe or life-threatening infection. ( 2.2, 5.6)
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Infusion-Related Reactions: Interrupt infusion or slow the rate of infusion for mild or moderate and permanently discontinue for severe or life-threatening infusion-related reactions. ( 2.2, 5.7)
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Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception. ( 5.8, 8.1, 8.3)
ADVERSE REACTIONS
Most common adverse events (reported in ≥15% of patients) were fatigue, musculoskeletal pain, constipation, decreased appetite, nausea, peripheral edema, and urinary tract infection. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 5/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
2.2 Dose Modificatio