Imfinzi Dosage
Generic name: DURVALUMAB 120mg in 2.4mL
Dosage form: injection, solution
Drug class: Anti-PD-1 monoclonal antibodies
Medically reviewed by Drugs.com. Last updated on May 11, 2022.
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.
|
||
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.
Adverse Reaction | Severity* | Dosage Modification |
---|---|---|
|
||
|
||
|
Grade 2 |
Withhold† |
Grade 3 or 4 |
Permanently discontinue |
|
|
Grade 2 or 3 |
Withhold† |
Grade 4 |
Permanently discontinue |
|
|
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† |
ALT or AST increases to more than 8 times ULN or total bilirubin increases to more than 3 times the ULN |
Permanently discontinue |
|
|
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† |
AST or ALT increases to more than 10 times ULN or Total bilirubin increases to more than 3 times ULN |
Permanently discontinue |
|
|
Grade 3 or 4 |
Withhold until clinically stable or permanently discontinue depending on severity |
|
Grade 2 or 3 increased blood creatinine |
Withhold† |
Grade 4 increased blood creatinine |
Permanently discontinue |
|
|
Suspected SJS, TEN, or DRESS |
Withhold† |
Confirmed SJS, TEN, or DRESS |
Permanently discontinue |
|
|
Grade 2, 3, or 4 |
Permanently discontinue |
|
Grade 2 |
Withhold† |
Grade 3 or 4 |
Permanently discontinue |
|
Other Adverse Reactions |
||
|
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 time from preparation 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.
- •
- Do not co-administer other drugs through the same infusion line.
Frequently asked questions
More about Imfinzi (durvalumab)
- Side effects
- Drug interactions
- During pregnancy or Breastfeeding
- Drug images
- Pricing & coupons
- En español
- Drug class: anti-PD-1 monoclonal antibodies
- FDA approval history
Patient resources
Professional resources
Related treatment guides
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.