Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
IMFINZI as monotherapy is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (see section 5.1).
Treatment must be initiated and supervised by a physician experienced in the treatment of cancer.
Patients with locally advanced NSCLC should be evaluated for treatment based on the tumour expression of PD-L1 confirmed by a validated test (section 5.1).
The recommended dose of IMFINZI is 10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks, until disease progression or unacceptable toxicity, or a maximum of 12 months.
It 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 immune-mediated adverse reactions are described in Table 1 (see section 4.4).
Table 1. Recommended treatment modifications for IMFINZI and management recommendations:
For suspected immune-mediated adverse reactions, adequate evaluation should be performed to confirm etiology or exclude alternate etiologies. 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.
For non-immune-mediated adverse reactions, consider withholding 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).
The safety and efficacy of IMFINZI in children and adolescents aged below 18 years of age have not been established. No data are available.
No dose adjustment is required for elderly patients (≥65 years of age) (see section 5.1). Data on patients aged 75 years of age or older are limited.
No dose adjustment of IMFINZI is recommended in patients with mild or moderate renal impairment. Data from patients with severe renal impairment are too limited to draw conclusions on this population (see section 5.2).
Data from patients with moderate and severe hepatic impairment are limited. Due to minor involvement of hepatic processes in the clearance of durvalumab no dose adjustment of IMFINZI is recommended for patients with hepatic impairment as no difference in exposure is expected (see section 5.2).
IMFINZI is for intravenous use. It is to be administered as an intravenous infusion solution over 60 minutes (see section 6.6).
For instructions on dilution of the medicinal product before administration, see section 6.6.
There is no information on overdose with durvalumab. In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted immediately.
Unopened vial: 3 years.
Diluted solution: If not used immediately, chemical and physical in-use stability of IMFINZI has been demonstrated for no more than 24 hours at 2°C to 8°C or 12 hours at room temperature up to 25°C from the time of vial puncture to the start of administration.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Store in the original package in order to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3.
2.4 mL of concentrate in a Type 1 glass vial with an elastomeric stopper and a gray flip-off aluminium seal containing 120 mg durvalumab. Pack size of 1 vial.
10 mL of concentrate in a Type 1 glass vial with an elastomeric stopper and a white flip-off aluminium seal containing 500 mg durvalumab. Pack size of 1 vial.
Not all pack sizes may be marketed.
IMFINZI is supplied as a single-dose vial and does not contain any preservatives, aseptic technique must be observed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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