Imfinzi Dosage/Direction for Use

IMFINZI is for single use in one patient only. Discard any residue.
Posology: The recommended dose for IMFINZI monotherapy and IMFINZI combination therapy is presented in Table 6. IMFINZI is administered as an intravenous infusion over 1 hour. (See Table 6.)


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Dose escalation or reduction is not recommended. Treatment withholding, or discontinuation may be required based on individual safety and tolerability, see Table 7.
Guidelines for management of adverse reactions are described in Table 7. When used in combination with tremelimumab refer also to the SmPc for tremelimumab. (See Table 7.)


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For suspected immune-mediated adverse reactions, adequate evaluation should be performed to confirm aetiology or exclude alternate aetiologies. Based on the severity of the adverse reaction, IMFINZI and/or tremelimumab should be withheld and corticosteroids administered. Consider increasing dose of corticosteroids and/or using additional systemic immunosuppressants if there is worsening or no improvement. Upon improvement to ≤ Grade 1, corticosteroid taper should be initiated and continued over at least 1 month. After withhold, IMFINZI and/or tremelimumab can be resumed within 12 weeks if the adverse reactions improved to ≤ Grade 1 and the corticosteroid dose has been reduced to ≤10 mg prednisone or equivalent per day. IMFINZI and tremelimumab should be permanently discontinued for recurrent Grade 3 (severe) immune-mediated adverse reactions and for any Grade 4 (life-threatening) immune-mediated adverse reactions, except for endocrinopathies that are controlled with replacement hormones.
Special patient populations: Renal impairment: No dose adjustment of IMFINZI is recommended for patients with mild or moderate renal impairment (see Pharmacology: Pharmacokinetics under Actions). Durvalumab has not been studied in subjects with severe renal impairment.
Hepatic impairment: No dose adjustment of IMFINZI is recommended for patients with mild or moderate hepatic impairment. Data from patients with moderate and severe hepatic impairment are too limited to draw conclusions on this population (see Pharmacology: Pharmacokinetics under Actions).
Use in paediatric patients: The safety and efficacy of durvalumab have not been established in patients younger than 18 years of age.
Use in the elderly: No dose adjustment is required for elderly patients (≥65 years of age) (see Pharmacology: Pharmacodynamics: Clinical trials and Pharmacokinetics under Actions).
Method of administration: IMFINZI is for intravenous use. It is to be administered as an intravenous infusion solution over 1 hour.
IMFINZI in combination with chemotherapy: When IMFINZI is administered in combination with chemotherapy, administer IMFINZI prior to chemotherapy on the same day.
IMFINZI in combination with tremelimumab and platinum-based chemotherapy: When IMFINZI is administered in combination with tremelimumab and platinum-based chemotherapy, tremelimumab is given first, followed by IMFINZI and then platinum-based chemotherapy on the same day of dosing.
When IMFINZI is administered in combination with a fifth dose of tremelimumab and pemetrexed maintenance therapy at week 16, tremelimumab is given first, followed by IMFINZI and then pemetrexed maintenance therapy on the same day of dosing.
IMFINZI, tremelimumab, and platinum-based chemotherapy are administered as separate intravenous infusions. IMFINZI and tremelimumab are each given over 1 hour. For platinum-based chemotherapy, refer to the SmPC for administration information. For pemetrexed maintenance therapy, refer to the SmPC for administration information. Separate infusion bags and filters for each infusion should be used.
During cycle 1, tremelimumab is to be followed by IMFINZI starting approximately 1 hour (maximum 2 hours) after the end of the tremelimumab infusion. Platinum-based chemotherapy infusion should start approximately 1 hour (maximum 2 hours) after the end of the IMFINZI infusion. If there are no clinically significant concerns during cycle 1, then at the physician's discretion, subsequent cycles of IMFINZI can be given immediately after tremelimumab and the time period between the end of the IMFINZI infusion and the start of chemotherapy can be reduced to 30 minutes.
IMFINZI in combination with tremelimumab: When IMFINZI is administered in combination with tremelimumab, administer tremelimumab prior to IMFINZI on the same day. IMFINZI and tremelimumab are administered as separate intravenous infusions. Refer to the summary of product characteristics (SmPC) for tremelimumab dosing information.
Preparation of solution: IMFINZI is supplied as single-dose vials and does not contain any preservatives. Aseptic technique must be observed.
Visually inspect drug product for particulate matter and discolouration. IMFINZI is a clear to opalescent, colourless to slightly yellow solution. Discard the vial if the solution is cloudy, discoloured 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 (IV) bag containing 0.9% Sodium Chloride Injection, or 5% Dextrose Injection. Mix diluted solution by gentle inversion. The final concentration of the diluted solution should be between 1 mg/mL and 15 mg/mL. Do not freeze or shake the solution.
Care must be taken to ensure the sterility of prepared solutions.
Do not re-enter the vial after withdrawal of drug; only withdraw one dose per vial.
Discard any unused portion left in the vial.
No incompatibilities between IMFINZI and 9 g/L (0.9%) sodium chloride or 50 g/L (5%) dextrose in polyvinylchloride or polyolefin IV bags have been observed.
After preparation of infusion solution: IMFINZI does not contain a preservative.
Chemical and physical in-use stability has been demonstrated for up to 30 days at 2ºC to 8ºC and for up to 24 hours at room temperature (up to 25ºC) from the time of preparation.
From a microbiological point of view, the prepared solution for infusion should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2ºC to 8ºC or 12 hours at room temperature (up to 25ºC), unless dilution has taken place in controlled and validated aseptic conditions.
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.