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This website is intended for UK Healthcare professionals only. Other UK residents please visit astrazeneca.co.uk
For up to 8 cycles*
Until disease progression and unacceptable toxicity*
For patients with a body weight of >36kg.
IMFINZI is for intravenous use. It is to be administered as an intravenous infusion solution over 1 hour. IMFINZI is administered prior to chemotherapy on the same day.1
Prior to prescribing, please read the IMFINZI SmPC for full prescribing information, including important safety information on monitoring and management of imAEs. Dose escalation or reduction is not recommended. Dose withholding or discontinuation may be required based on individual safety and tolerability.
*In the TOPAZ-1 trial, IMFINZI 1500mg or placebo was administered on Day 1 + gemcitabine 1000 mg/m2 and cisplatin 25 mg/m2 (each administered on Days 1 and 8) every 3 weeks (21 days) for up to 8 cycles, followed by IMFINZI 1500 mg or placebo every 4 weeks until clinical or imaging disease progression (per RECIST v1.1) or until unacceptable toxicity, withdrawal of consent, or any other discontinuation criteria were met.1,2
No dose adjustment is required for elderly patients (≥ 65 years).1
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.1
Data from patients with 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.1
Currently, there is no standardised fluid hydration schedule for cisplatin administration, leading to significant variation in schedules across UK clinical practice, prolonged infusion times and the need for inpatient administration.3,4
Low-dose cisplatin regimens (such as that used in TOPAZ-1), offer shorter hydration protocols.5 These shorter protocols can permit outpatient administration and avoid inpatient stays, which may improve the quality of life, whilst offering cost-saving benefits to the healthcare system.4
Below, you will find suggested hydration schedules tailored to help optimise patient outcomes and potentially mitigate the risk of nephrotoxicity, a dose-limiting side effect of cisplatin.3
Suggested hydration schedules*
| Cisplatin dose (mg/m2) | Pre-hydration | Cisplatin | Post-hydration | Total fluid volume |
| ≥80 | 1000 mL sodium chloride 0.9% with 20 mmol potassium and 10 mmol magnesium IV over 2 hours | Cisplatin in 1000 mL sodium chloride 0.9% IV over 2 hours | 1000 mL sodium chloride 0.9% with 20 mmol potassium and 10 mmol magnesium IV over 2 hours | 3000 mL |
| 61–79 | 1000 mL sodium chloride 0.9% with 20 mmol potassium IV over 1 hour | Cisplatin in 1000 mL sodium chloride 0.9% IV over 2 hours | 1000 mL sodium chloride 0.9% with 20 mmol potassium and 10 mmol magnesium IV over 2 hours | 3000 mL |
| 41–60 | 500 mL sodium chloride
0.9% IV over 30 minutes | Cisplatin in 1000 mL sodium chloride 0.9% IV over 2 hours | 1000 mL sodium chloride 0.9% with 20 mmol potassium and 10 mmol magnesium IV over 2 hours | 2500 mL |
| ≤40† | 500 mL sodium chloride
0.9% IV over 30 minutes | Cisplatin in 1000 mL 0.9% sodium chloride IV over 1 hour | Patient required to drink 500 mL before discharge | 2000 mL |
As part of the TOPAZ-1 dosing schedule, IMFINZI 1500 mg was administered on Day 1 of each cycle in combination with gemcitabine 1000 mg/m2 and cisplatin 25 mg/m2 on Days 1 and 8 of each 21-day cycle for up to 8 cycles, followed by IMFINZI 1500 mg every 4 weeks until disease progression or unacceptable toxicity.1
*Based on the available evidence and standard practice in other cancer centres across the UK.3-5
†This regimen does not supplement magnesium. Monitor and manage as guided by local policy.3
BTC, biliary tract cancer; Gem-Cis, gemcitabine-cisplatin; IV, intravenous; mmol, millimole; MHRA, Medicines and Healthcare products Regulatory Agency; NHS, National Health Service; Q3W, once every 3 weeks; Q4W, once every 4 weeks; SmPC, summary product characteristics.
GB-65193 | April 2025
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to AstraZeneca by visiting https://contactazmedical.astrazeneca.com/ or by calling 0800 783 0033.
This website was created for UK HCPs and has been designed to provide information to educate, empower and enable them in the great work they are doing for patients across a range of therapy areas. This website is intended for doctors, nurses, and pharmacists in the UK. Other UK residents please visit astrazeneca.co.uk.
GB-74216| DOP : February 2026
