ns
2.3 Preparation and Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Immune-Mediated Pneumonitis
5.2 Immune-Mediated Hepatitis
5.3 Immune-Mediated Colitis
5.4 Immune-Mediated Endocrinopathies
5.5 Other Immune-Mediated Adverse Reactions
5.6 Infection
5.7 Infusion-Related Reactions
5.8 Embryo-Fetal Toxicity
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Urothelial Carcinoma
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
IMFINZI is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
•
have disease progression during or following platinum-containing chemotherapy.
•
have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
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 [see CLINICAL STUDIES (14.1)].
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
The recommended dose of IMFINZI is 10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.
2.2 Dose Modifications
No dose reductions are recommended. Withhold and/or discontinue IMFINZI to manage adverse reactions as described in Table 1.
Table 1. Recommended Treatment Modifications for IMFINZI
Adverse Reactions Severitya IMFINZI Treatment Modification Corticosteroid Treatment Unless Otherwise Specified
Pneumonitis [see WARNINGS AND PRECAUTIONS (5.1)]
Grade 2
Withhold doseb
Initial dose of 1 mg/kg/day to 2 mg/kg/day prednisone or equivalent followed by a taper
Grade 3 or 4
Permanently discontinue
Initial dose of 1 mg/kg/day to 4 mg/kg/day prednisone or equivalent followed by a taper
Hepatitis [see WARNINGS AND PRECAUTIONS (5.2)]
Grade 2 ALT or AST >3‑5xULN or total bilirubin >1.5-3xULN
Withhold doseb
Initial dose of 1 mg/kg/day to 2 mg/kg/day prednisone or equivalent followed by a taper
Grade 3 ALT or AST ≤8xULN or total bilirubin ≤5xULN
Grade 3 ALT or AST >8xULN or total bilirubin >5xULN
Permanently discontinue
Concurrent ALT or AST >3xULN and total bilirubin >2xULN with no other cause
Colitis or diarrhea [see WARNINGS AND PRECAUTIONS (5.3)]
Grade 2
Withhold doseb
Initial dose of 1 mg/kg/day to 2 mg/kg/day prednisone or equivalent followed by a taper
Grade 3 or 4
Permanently discontinue
Hypothyroidism [see WARNINGS AND PRECAUTIONS (5.4)]
