IMFINZI (durvalumab) Minimum Product Information 120mg/2.4mL or 500mg/10mL, Concentrated Solution for Infusion in a Single-Dose Vial INDICATIONS: Small cell lung cancer (SCLC): LS-SCLC: IMFINZI as monotherapy is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT). DOSAGE AND ADMINISTRATION: LS-SCLC: 1500 mg every 4 weeks until disease progression or unacceptable toxicity or for a maximum of 24 months. Patients with a body weight of 30 kg or less must receive weight-based dosing, equivalent to IMFINZI 20 mg/kg every 4 weeks as monotherapy until weight increases to greater than 30 kg. Administer IMFINZI prior to chemotherapy when given on the same day. Refer to other relevant Product Information when IMFINZI is administered in combination with chemotherapy. IMFINZI is administered as an IV infusion over 60 minutes. IMFINZI should be diluted prior to infusion, see full PI for compatible diluents. No dose reduction or escalation for IMFINZI is recommended. In general, withhold IMFINZI for Grade 2 or 3 adverse reactions. Permanently discontinue IMFINZI for life-threatening (Grade 4) 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. For Grade 4 laboratory abnormalities, discontinuation of IMFINZI should be based on clinical signs/symptoms and clinical judgement. See full PI for recommended treatment modifications and specific management foradverse reactions. IMFINZI has not been studied in patients with severe renal or hepatic impairment. CONTRAINDICATIONS: Hypersensitivity to the active substance or to any of the excipients. SPECIAL WARNINGS AND PRECAUTIONS FOR USE: Immune-mediated adverse reactions (imARs): Immune checkpoint inhibitors, including durvalumab, can cause severe and fatal imARs, which may involve any organ system. Patients should be monitored for signs and symptoms associated with imARs including: immune-mediated pneumonitis/interstitial lung disease, radiation pneumonitis, hepatitis, colitis, immune-mediated endocrinopathies including hypothyroidism/hyperthyroidism/thyroiditis, adrenal insufficiency, type 1 diabetes mellitus, hypophysitis/hypopituitarism, nephritis, dermatological adverse reactions, myocarditis, neurological adverse reactions (meningitis, encephalitis, Guillain-Barre syndrome, transverse myelitis, myasthenia gravis) and other imARs. See full PI for further information on monitoring and management recommendations for imARs. Infusion-related reactions: Monitor patients for signs and symptoms, severe reactions have been reported. Patients with pre-existing auto-immune disease (AID): increased risk of imARs compared with the risk in patients without pre-existing AID. In addition, flares of the underlying AID were frequent, but the majority were mild and manageable. Efficacy in patients with PDL1 expression <1%: efficacy may be different, see full PI. Paediatric use: safety and efficacy not established in patients less than 18 years. Use in pregnancy: Category D. Durvalumab has the potential to impact maintenance of pregnancy and may cause foetal harm. Not recommended during pregnancy; women of childbearing potential should use effective contraception during treatment and for at least 3 months after the last dose. Use in lactation: lactating women should be advised not to breastfeed during treatment and for at least 3 months after the last dose. ADVERSE REACTIONS: LS-SCLC (ADRIATIC study): Very common (≥10%, any grade): pneumonitis or radiation pneumonitis, cough/productive cough, dyspnoea, fatigue, rash, pruritus, hypothyroidism, hyperthyroidism, decreased appetite, dizziness, pneumonia, nausea, diarrhoea, constipation.