Imfinzi Dosage

Medically reviewed by Drugs.com. Last updated on Feb 19, 2021.

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

Recommended Dosage

The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with chemotherapy are presented in Table 1 [see Clinical Studies (14)].

IMFINZI is administered as an intravenous infusion over 60 minutes.

Table 1. Recommended Dosages of IMFINZI
* Administer IMFINZI prior to chemotherapy on the same day. When IMFINZI is administered in combination with chemotherapy, refer to the Prescribing Information for etoposide and carboplatin or cisplatin for dosing information.
Indication	Recommended IMFINZI dosage	Duration of Therapy
Unresectable stage III NSCLC	Patients with a body weight of 30 kg and more: 10 mg/kg every 2 weeks or 1500 mg every 4 weeks Patients with a body weight of less than 30 kg: 10 mg/kg every 2 weeks	Until disease progression, unacceptable toxicity, or a maximum of 12 months
ES-SCLC	Patients with a body weight of 30 kg and more: 1500 mg in combination with chemotherapy* every 3 weeks (21 days) for 4 cycles, followed by 1500 mg every 4 weeks as a single agent Patients with a body weight of less than 30 kg: 20 mg/kg in combination with chemotherapy* every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent	Until disease progression or unacceptable toxicity

Dosage Modifications for Adverse Reactions

No dose reduction for IMFINZI is recommended. In general, withhold IMFINZI for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue IMFINZI for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating corticosteroids.

Dosage modifications for IMFINZI for adverse reactions that require management different from these general guidelines are summarized in Table 2.

Table 2. Recommended Dosage Modifications for Adverse Reactions
Adverse Reaction	Severity*	Dosage Modification
* Based on National Cancer Institute Common Terminology Criteria for Adverse Events, 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 steroids or inability to reduce prednisone 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids. ‡ 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.
Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1)]
Pneumonitis	Grade 2	Withhold†
Pneumonitis	Grade 3 or 4	Permanently discontinue
Colitis	Grade 2 or 3	Withhold†
Colitis	Grade 4	Permanently discontinue
Hepatitis with no tumor involvement of the liver	ALT or AST increases to more than 3 and up to 8 times the ULN or total bilirubin increases to more than 1.5 and up to 3 times ULN	Withhold†
Hepatitis with no tumor involvement of the liver	ALT or AST increases to more than 8 times ULN or total bilirubin increases to more than 3 times the ULN	Permanently discontinue
Hepatitis with tumor involvement of the liver‡	AST or ALT is more than 1 and up to 3 times ULN at baseline and increases to more than 5 and up to 10 times ULN or AST or ALT is more than 3 and up to 5 times ULN at baseline and increases to more than 8 and up to 10 times ULN	Withhold†
Hepatitis with tumor involvement of the liver‡	AST or ALT increases to more than 10 times ULN or Total bilirubin increases to more than 3 times ULN	Permanently discontinue
Endocrinopathies	Grade 3 or 4	Withhold until clinically stable or permanently discontinue depending on severity
Nephritis with Renal Dysfunction	Grade 2 or 3 increased blood creatinine	Withhold†
Nephritis with Renal Dysfunction	Grade 4 increased blood creatinine	Permanently discontinue
Exfoliative Dermatologic Conditions	Suspected SJS, TEN, or DRESS	Withhold†
Exfoliative Dermatologic Conditions	Confirmed SJS, TEN, or DRESS	Permanently discontinue
Myocarditis	Grade 2, 3, or 4	Permanently discontinue
Neurological Toxicities	Grade 2	Withhold†
Neurological Toxicities	Grade 3 or 4	Permanently discontinue
Other Adverse Reactions
Infusion-related reactions [see Warnings and Precautions (5.2)]	Grade 1 or 2	Interrupt or slow the rate of infusion
	Grade 3 or 4	Permanently discontinue
ALT = alanine aminotransferase, AST = aspartate aminotransferase, DRESS = Drug Rash with Eosinophilia and Systemic Symptoms, SJS = Stevens Johnson Syndrome, TEN = toxic epidermal necrolysis, ULN = upper limit normal

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:

∘: 24 hours in a refrigerator at 2°C to 8°C (36°F to 46°F)
∘: 8 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.