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Imfinzi Dosage

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

Medically reviewed on February 16, 2018.

Recommended Dosage for Urothelial Carcinoma

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 Recommended Dosage for NSCLC

The recommended dose of IMFINZI is 10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression, unacceptable toxicity, or a maximum of 12 months.

Dosage Modifications for Adverse Reactions

No dose reductions are recommended. Withhold or discontinue IMFINZI to manage adverse reactions as described in Table 1.

Table 1. Recommended Dosage Modifications for Adverse Reactions
*
National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03. ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal.

Adverse Reaction

Severity*

Dosage Modification

Pneumonitis [see Warnings and Precautions (5.1)]

Grade 2

Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).

Grade 3 or 4

Permanently discontinue

Hepatitis [see Warnings and Precautions (5.2)]

For ALT or AST greater than 3 but less than or equal to 8 times the ULN

or

Total bilirubin greater than 1.5 but less than or equal to 5 times the ULN

Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).

ALT or AST greater than 8 times the ULN or total bilirubin greater than 5 times the ULN

or

Concurrent ALT or AST greater than 3 times the ULN and total bilirubin greater than 2 times the ULN with no other cause

Permanently discontinue

Colitis or diarrhea [see Warnings and Precautions (5.3)]

Grade 2

Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).

Grade 3 or 4

Permanently discontinue

Hyperthyroidism [see Warnings and Precautions (5.4)]

Grade 2-4

Withhold dose until clinically stable

Adrenal insufficiency or Hypophysitis/Hypopituitarism [see Warnings and Precautions (5.4)]

Grade 2-4

Withhold dose until clinically stable

Type 1 Diabetes

Mellitus [see Warnings and Precautions (5.4)]

Grade 2-4

Withhold dose until clinically stable

Nephritis [see Warnings and Precautions (5.5)]

For Creatinine greater than 1.5 to 3 times the ULN

Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).

For Creatinine greater than 3 times the ULN

Permanently discontinue

Rash or dermatitis [see Warnings and Precautions (5.6)]

Grade 2 for longer than 1 week or Grade 3

Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).

Grade 4

Permanently discontinue

Infection [see Warnings and Precautions (5.8)]

Grade 3 or 4

Withhold dose until clinically stable

Infusion-related reactions [see Warnings and Precautions (5.9)]

Grade 1 or 2

Interrupt or slow the rate of infusion

Grade 3 or 4

Permanently discontinue

Other immune-mediated adverse reactions [see Warnings and Precautions (5.7)]

Grade 3

Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).

Grade 4

Permanently discontinue

Persistent Grade 2 or 3 adverse reaction (excluding endocrinopathies)

Grade 2 or 3 adverse reaction that does not recover to Grade 0 or 1 within 12 weeks after last IMFINZI dose

Permanently discontinue

Inability to taper corticosteroid

Inability to reduce to less than or equal to prednisone 10 mg per day (or equivalent) within 12 weeks after the last IMFINZI dose

Permanently discontinue

Recurrent Grade 3 or 4 adverse reaction

Recurrent Grade 3 or 4 (severe or life-threatening) adverse reaction

Permanently discontinue

Preparation and Administration

Preparation

Visually inspect drug product for particulate matter and discoloration prior to administration, whenever solution and container permit. 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:
o
24 hours in a refrigerator at 2°C to 8°C (36°F to 46°F)
o
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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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