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Posology: The recommended dose for IMFINZI monotherapy and IMFINZI in combination with chemotherapy is presented in Table 3. IMFINZI is administered as an intravenous infusion over 1 hour. (See Table 3.)
Click on icon to see table/diagram/imageIt is recommended to continue treatment for clinically stable patients with initial evidence of disease progression until disease progression is confirmed.
Dose escalation or reduction is not recommended. Dose withholding, or discontinuation may be required based on individual safety and tolerability.
Guidelines for management of adverse reactions are described in Table 4.
Refer to Precautions for further monitoring and evaluation information. (See Table 4.)
Click on icon to see table/diagram/imageFor 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 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 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 should be permanently discontinued for recurrent Grade 3 or 4 (severe or life-threatening) immune-mediated adverse reactions and for any Grade 4 (life-threatening) immune-mediated adverse reactions, except for endocrinopathies that are controlled with replacement hormones.
For non-immune-mediated adverse reactions, withhold IMFINZI for Grade 2 and 3 adverse reactions until ≤Grade 1 or baseline. IMFINZI should be discontinued for Grade 4 adverse reactions (with the exception of Grade 4 laboratory abnormalities, about which the decision to discontinue should be based on accompanying clinical signs/symptoms and clinical judgment).
Special patient populations: Renal impairment: No dose adjustment 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 is recommended for patients with hepatic impairment. Data from patients with moderate and severe hepatic impairment are limited, however, due to minor involvement of hepatic processes in the clearance of durvalumab, no difference in exposure is expected for these patients (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: 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.
