Imfinzi Dosage

Generic name: DURVALUMAB 120mg in 2.4mL
Dosage form: injection, solution
Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)

Medically reviewed by Drugs.com. Last updated on Jun 16, 2023.

Recommended Dosage

The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Tables 1, 2 and 3.

Administer IMFINZI as an intravenous infusion after dilution as recommended [see Dosage and Administration (2.3)].

Table 1. Recommended Dosages of IMFINZI
* Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate. † Administer tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.
Indication	Recommended IMFINZI Dosage	Duration of Therapy
Single Agent
Unresectable stage III NSCLC	Patients with a body weight of ≥ 30 kg: 10 mg/kg every 2 weeks or 1,500 mg every 4 weeks Patients with a body weight of < 30 kg: 10 mg/kg every 2 weeks	Until disease progression, unacceptable toxicity, or a maximum of 12 months
Combination with Other Therapeutic Agents
ES-SCLC	Patients with a body weight of ≥ 30 kg: 1,500 mg in combination with chemotherapy* every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent Patients with a body weight of < 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
BTC	Patients with a body weight of ≥ 30 kg: 1,500 mg in combination with chemotherapy* every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent Patients with a body weight of < 30 kg: 20 mg/kg in combination with chemotherapy* every 3 weeks (21 days) up to 8 cycles followed by 20 mg/kg every 4 weeks as a single agent	Until disease progression or until unacceptable toxicity
uHCC	Patients with a body weight of ≥ 30 kg and more: • IMFINZI 1,500 mg following a single dose of tremelimumab-actl† 300 mg at Day 1 of Cycle 1; • Continue IMFINZI 1,500 mg as a single agent every 4 weeks Patients with a body weight of < 30 kg: • IMFINZI 20 mg/kg following a single dose of tremelimumab-actl† 4 mg/kg at Day 1 of Cycle 1; • Continue IMFINZI 20 mg/kg as a single agent every 4 weeks	After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity

IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic non-small cell lung cancer (NSCLC) are provided in Tables 2 and 3.

Weigh patients prior to each infusion.

Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

Table 2: Recommended Dosage Schedule
	Week*,†
	0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21	22	23	24
Cycle:	1			2			3			4			5				6				7				8
* continue IMFINZI until disease progression or intolerable toxicity. † Note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5. ‡ intravenous infusion over 60 minutes [see Dosage and Administration (2.3)]. § if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks. ¶ optional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.
IMFINZI*,‡	X			X			X			X			X				X				X				X
Tremelimumab-actl‡,§	X			X			X			X							X
Chemotherapy	X			X			X			X			X¶				X¶				X¶				XÞ

Table 3: Recommended Regimen and Dosage
Tumor Histology	Patient Weight	IMFINZI Dosage	Tremelimumab-actl Dosage*	Platinum-based Chemotherapy Regimen*
* Refer to the Prescribing Information for dosing information.
Non-Squamous	≥30kg	1,500 mg	75 mg	• carboplatin & nab-paclitaxel OR • carboplatin or cisplatin & pemetrexed
Non-Squamous	<30kg	20 mg/kg	1 mg/kg
Squamous	≥30kg	1,500 mg	75 mg	• carboplatin & nab-paclitaxel OR • carboplatin or cisplatin & gemcitabine
Squamous	<30kg	20 mg/kg	1 mg/kg

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 or IMFINZI in combination with tremelimumab-actl and platinum-based chemotherapy for adverse reactions that require management different from these general guidelines are summarized in Table 4.

Table 4. 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 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 a 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.
Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1)]
Pneumonitis	Grade 2	Withhold†
Pneumonitis	Grade 3 or 4	Permanently discontinue
Colitis	Grade 2	Withhold†
	Grade 3	Withhold† or permanently discontinue‡
	Grade 4	Permanently discontinue
Intestinal perforation	Any grade	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 the infusion solution is not administered immediately and needs to be stored, the time from preparation until the completion of the infusion should not exceed:

∘: 28 days 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.
•: Use separate infusion bags and filters for each drug product.

IMFINZI in Combination with Other Products

•: Administer all drug products as separate intravenous infusions.
•: Do not co-administer other drugs through the same infusion line.
•: For platinum-based chemotherapy, refer to Prescribing Information for administration information.
•: For pemetrexed therapy, refer to Prescribing Information for administration information.

Combination Regimens: Order of Infusions

IMFINZI in Combination with Tremelimumab-actl

•: Infuse tremelimumab-actl first, followed by IMFINZI on the same day of dosing.

IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

•: Infuse tremelimumab-actl first, followed by IMFINZI and then platinum-based chemotherapy on the day of dosing.

IMFINZI in Combination with Tremelimumab-actl and Pemetrexed Therapy

•: Infuse tremelimumab-actl first, followed by IMFINZI and then pemetrexed therapy on the day of dosing.

Combination Regimens: Infusion Instructions

IMFINZI in Combination with Tremelimumab-actl

•: Administer tremelimumab-actl over 60 minutes followed by a 60 minute observation period. Then administer IMFINZI as a separate intravenous infusion over 60 minutes.

IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy/ Pemetrexed Therapy

Cycle 1

•: Infuse tremelimumab-actl over 1 hour. One to two hours after completion of tremelimumab-actl infusion, infuse IMFINZI over 1 hour. One to two hours after completion of IMFINZI infusion, administer platinum-based chemotherapy.

Subsequent Cycles

•: If there are no infusion reactions during cycle 1, subsequent cycles of IMFINZI can be given immediately after tremelimumab-actl. The time between the end of the IMFINZI infusion and the start of chemotherapy can be reduced to 30 minutes.