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Imfinzi Dosage

Generic name: DURVALUMAB 120mg in 2.4mL
Dosage form: injection, solution

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

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.

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)]

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.

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.

Administer infusion solution immediately once prepared. If infusion solution is not administered immediately and needs to be stored, the total time from vial puncture to the start of the administration should not exceed:

24 hours in a refrigerator at 2°C to 8°C (36°F to 46°F)
4 hours at room temperature up to 25°C (77°F)
Do not freeze.
Do not shake.

Administration

Administer infusion solution intravenously over 60 minutes through an intravenous line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
Do not co-administer other drugs through the same infusion line.
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