DOSING

Recommended Dosage in LS-SCLC

IMFINZI offers Q4W fixed dosing1

IMFINZI is administered as a 60-minute IV infusion with no premedication required1

IMFINZI fixed 1500-mg dose1

Patients with a body weight of ≥30 kg

Q4W

until disease progression, unacceptable toxicity, or up to 24 months*

until disease progression,
unacceptable toxicity,
or up to 24 months*

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Patients with a body weight <30 kg must receive weight-based dosing, equivalent to IMFINZI
20 mg/kg every 4 weeks1

Patients with a body weight <30 kg must receive weight-based dosing, equivalent to IMFINZI 20 mg/kg every 4 weeks1

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IMFINZI is supplied as single-use vials that contain either 120 mg/2.4 mL or 500 mg/10 mL1

*Refer to Prescribing Information for information on dosage modifications.

IV=intravenous; LS-SCLC=limited-stage small cell lung cancer; Q4W=every 4 weeks.

Dosage Modifications in LS-SCLC

Treatment modifications for IMFINZI: General guidance1

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No dose reduction of IMFINZI is recommended

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Withhold IMFINZI for severe (Grade 3) imARs

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Permanently discontinue IMFINZI for life-threatening (Grade 4) imARs

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Permanently discontinue IMFINZI for recurrent severe (Grade 3) imARs that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to ≤10 mg of prednisone or equivalent per day within 12 weeks of initiating corticosteroids

Dosage reduction of IMFINZI is not recommended1

No dose reduction of IMFINZI is recommended. Withholding or permanently discontinuing IMFINZI due to adverse reactions may be required1

TREATMENT MODIFICATIONS FOR IMFINZI1

TREATMENT MODIFICATIONS FOR IMFINZI
Overall survival data by subgroup in the Phase III HIMALAYA study Overall survival data by subgroup in the Phase III HIMALAYA study
 

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Prescribing Information has additional information for dosage modification and management specific to adverse reactions.

*Based on NCI CTCAE, version 4.03.

†Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating corticosteroids or an inability to reduce corticosteroid dose to 10 mg of prednisone or less per day (or equivalent) within 12 weeks of initiating corticosteroids.

‡Permanently discontinue IMFINZI for Grade 3 colitis when administered as part of tremelimumab-actl containing regimen.

§If AST and ALT are less than or equal to ULN at baseline in patients with liver involvement, withhold or permanently discontinue IMFINZI based on recommendations for hepatitis with no liver involvement.

ALT=alanine aminotransferase; AST=aspartate aminotransferase; DRESS=Drug Rash with Eosinophilia and Systemic Symptoms; imARs=immune-mediated adverse reactions; LS-SCLC=limited-stage small cell lung cancer; NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events; SJS=Stevens-Johnson Syndrome; TEN=toxic epidermal necrolysis; ULN=upper limit of normal.

Preparation, Storage, and Administration

Preparation1

Visually Inspect Drug Product before Administration
  • 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 During Preparation
  • Do not shake the vial
Preparing Diluted Solution
  • Withdraw the required volume from the vial(s) of IMFINZI and transfer into an IV 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
Throw away Partially Used or Empty Vials of IMFINZI
  • Discard partially used or empty vials of IMFINZI

Storage of infusion solution1

  • 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 time from preparation until completion of the infusion should not exceed:
Storage of Infusion Solution for 28 Days at 2° C to 8° C
  • 28 days in a refrigerator at 2° C to
    8° C (36° F to 46° F)
Storage of Infusion Solution for 8 Hours at Room Temperature up to 25° C
  • 8 hours at room temperature up to 25° C (77° F)

Additionally

Do not Freeze the Solution
  • Do not freeze
Do not Shake the Solution
  • Do not shake

Administration1

Administration of Infusion Solution over 60 minutes
  • Administer infusion solution intravenously over 60 minutes through an IV line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter
Do not Co-Administer Other IV Doses Through the Same Infusion Line
  • Do not co-administer other drugs through the same infusion line

Dosage forms and strengths1

uHCC IMFINZI Dosage Forms and Strengths
  • Injection: 120 mg/2.4 mL (50 mg/mL) and 500 mg/10 mL (50 mg/mL) clear to opalescent, colorless to slightly yellow solution in a single-dose vial
IV=intravenous; USP=United States Pharmacopeia.
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