Grade 2-4

Initiate thyroid hormone replacement as clinically indicated

Hyperthyroidism [see WARNINGS AND PRECAUTIONS (5.4)]

Grade 2-4

Withhold dose until clinically stable

Symptomatic management

Adrenal insufficiency, Hypophysitis/Hypopituitarism [see WARNINGS AND PRECAUTIONS (5.4)]

Grade 2-4

Withhold dose until clinically stable

Initiate 1 to 2 mg/kg/day prednisone or equivalent followed by a taper and hormone replacement as clinically indicated

Type 1 Diabetes Mellitus [see WARNINGS AND PRECAUTIONS (5.4)]

Grade 2-4

Withhold dose until clinically stable

Initiate treatment with insulin as clinically indicated

Nephritis [see WARNINGS AND PRECAUTIONS (5.5)]

Grade 2 Creatinine >1.5-3x ULN

Withhold doseb

Initial dose of 1 mg/kg/day to 2 mg/kg/day prednisone or equivalent followed by a taper

Grade 3 Creatinine >3-6x ULN

Permanently discontinue

Grade 4 Creatinine >6x ULN

Rash or dermatitis [see WARNINGS AND PRECAUTIONS (5.5)]

Grade 2 for >1 week

Withhold doseb

Consider initial dose of 1 mg/kg/day to 2 mg/kg/day prednisone or equivalent followed by a taper

Grade 3

Grade 4

Permanently discontinue

Infection [see WARNINGS AND PRECAUTIONS (5.6)]

Grade 3 or 4
Withhold dose

Symptomatic management; treat with anti-infectives for suspected or confirmed infections

Infusion-related reactions [see WARNINGS AND PRECAUTIONS (5.7)]

Grade 1 or 2
Interrupt or slow the rate of infusion
Consider pre-medications with subsequent doses
Grade 3 or 4
Permanently discontinue
Other
Grade 3
Withhold doseb
Symptomatic management
Grade 4
Permanently discontinue
Consider initial dose of 1 mg/kg/day to 4 mg/kg/day prednisone or equivalent followed by taper
a Common Terminology Criteria for Adverse Events, version 4.03. ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal.
b Based on severity of the adverse reactions, IMFINZI should be withheld and corticosteroids administered. Consider increasing dose of corticosteroids and/or other systemic immunosuppressants if there is worsening or no improvement. Corticosteroid taper should be initiated when adverse reaction improves to < Grade 1 and should be continued over at least 1 month. For adverse reactions that do not result in permanent discontinuation, resume treatment when adverse reaction returns to ≤ Grade 1 and the corticosteroid dose has been reduced to <10 mg prednisone or equivalent per day.
2.3 Preparation and Administration
Preparation
•
Visually inspect drug product for particulate matter and discoloration. IMFINZI is clear to opalescent, colorless to slightly yellow solution, free from visible particles. Discard the vial if the solution is cloudy, discolored, or visible particles are observed.
•
Do not shake the vial.
•
Withdraw the required volume from the vial(s) of IMFINZI and transfer into an intravenous bag containing 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Mix diluted solution by gentle inversion. Do not shake the solution. The final concentration of the diluted solution should be between 1 mg/mL and 15 mg/mL.
•
Discard partially used or empty vials of IMFINZI.
Storage of Infusion Solution
IMFINZI does not contain a preservative.