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IMFINZI (durvalumab) UK Prescribing Information
Adverse Event Reporting

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ADRIATIC Dosing and Administration

Logo for IMFINZI (durvalumab) which is coloured red and blue with brand and generic name

Dosing and administration: ADRIATIC Regimen

Explore CASPIAN Data for IMFINZI in ES-SCLC

      

  • Dosing and administration
  • Regimen with concurrent chemoradiotherapy (cCRT) with or without Prophylactic Cranial Irradiation (PCI)
  • Regimen with sequential chemoradiotherapy (sCRT) with or without Prophylactic Cranial Irradiation (PCI)
  • Practicalities of delivering PCI
  • IMFINZI administration

Dosing and administration

IMFINZI offers Q4W fixed dosing1§ and should be initiated within 42 days commencing from the last day of the final cycle of chemoradiation therapy (CRT) or the last day of radiotherapy1,2,6

AEGEAN Study design for resectable NSCLC randomising patients to perioperative durvalumab arm or placebo arm AEGEAN Study design for resectable NSCLC randomising patients to perioperative durvalumab arm or placebo arm

*The ADRIATIC trial investigated durvalumab following cCRT only. However, NICE and SMC recommend durvalumab for use following either sCRT or cCRT for the management of LS-SCLC.2,4,6

§ Infuse IMFINZI for up to 24 months or until disease progression or unacceptable toxicity.1

† 60 to 66 Gy once daily (QD) over 6 weeks or 45 Gy twice daily (BID) over 3 weeks.1

‡ Patients must have achieved CR, PR, or SD, and have not progressed following cCRT.6

¶ Refer to Prescribing Information for information on dosage modifications.

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The NICE recommended and SMC accepted ADRIATIC regimen 
offers a flexible treatment solution tailored to patient needs, as IMFINZI can be initiated following either sCRT or cCRT, with flexibility in radiotherapy dosing and the use of PCI.1,2,4,6

ADRIATIC REGIMEN with cCRT with or without PCI

In the ADRIATIC trial, the 42-day window commenced from the last day of the final cycle of chemotherapy.6
AEGEAN Study design for resectable NSCLC randomising patients to perioperative durvalumab arm or placebo arm AEGEAN Study design for resectable NSCLC randomising patients to perioperative durvalumab arm or placebo arm
AEGEAN Study design for resectable NSCLC randomising patients to perioperative durvalumab arm or placebo arm AEGEAN Study design for resectable NSCLC randomising patients to perioperative durvalumab arm or placebo arm

*Different doses were studied in the ADRIATIC trial of either 60 to 66 Gy over 6 weeks (standard once-daily schedule) or 45 Gy over 3 weeks (hyperfractionated twice-daily schedule).6

 

†In the ADRIATIC trial, 88.3% of patients received 4 cycles of chemotherapy.6

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ADRIATIC REGIMEN with sCRT with or without PCI

When giving sCRT, the 42-day window commences from the last day of radiotherapy.6.7
AEGEAN Study design for resectable NSCLC randomising patients to perioperative durvalumab arm or placebo arm AEGEAN Study design for resectable NSCLC randomising patients to perioperative durvalumab arm or placebo arm
AEGEAN Study design for resectable NSCLC randomising patients to perioperative durvalumab arm or placebo arm AEGEAN Study design for resectable NSCLC randomising patients to perioperative durvalumab arm or placebo arm

*Different doses were studied in the ADRIATIC trial of either 60 to 66 Gy over 6 weeks (standard once-daily schedule) or 45 Gy over 3 weeks (hyperfractionated twice-daily schedule).6


†In the ADRIATIC trial, 88.3% of patients received 4 cycles of chemotherapy.6

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Practicalities of delivering PCI by Dr Huiqi Yang

The NICE recommended and SMC accepted IMFINZI ADRIATIC regimen offers the solution of PCI alongside sCRT or cCRT.2,4,6

Plan early to protect the prescribing window. The ADRIATIC Regimen allows PCI alongside sCRT or CCRT. Early planning helps ensure 
PCI can be delivered within the 42-day window before durvalumab initiation.6,7

Hear Dr Huiqi Yang, Consultant Clinical Oncologist, Cambridge University Hospitals NHS Foundation Trust share her insights on the practicalities of delivering PCI in a real-world setting.

All statements and opinions expressed in this video are those of the individual speaker and are based on their own personal experience.

IMFINZI administration

For detailed instructions on preparation of solution please see below or refer to section 6.6 of the IMFINZI Summary of Product Characteristics.1


Administer the infusion solution intravenously over 1 hour through an intravenous line containing a sterile, low-protein binding 0.2 to 0.22 μm in-line filter.1


Do not co-administer other medicinal products through the same infusion line.1


For treatment modifications for IMFINZI please refer to section 4.2 in the SmPC.1


Any unused medicinal product or waste material should be disposed of in accordance with local requirements.1


When IMFINZI is administered in combination with chemotherapy, administer IMFINZI prior to chemotherapy on the same day.1

 

Special populations

Paediatric population

The safety and efficacy of IMFINZI monotherapy in children and adolescents aged below 18 years of age has not been established regarding NSCLC. No data are available. For more information, please see section 5.1 and 5.2 of the IMFINZI Summary of Product Characteristics.1

Elderly

No dose adjustment is required for elderly patients (≥65 years of age). For more information, please see section 5.1 of the IMFINZI Summary of Product Characteristics.1

Renal impairment

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. For more information, please see section 5.2 of the IMFINZI Summary of Product Characteristics.1

Hepatic impairment

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. For more information, please see section 5.2 of the IMFINZI Summary of Product Characteristics.1


For the full list of special warnings and precautions, please see section 4.4 of the IMFINZI Summary of Product Characteristics.

Patients with pre-existing AID

In patients with pre-existing AID, data from observational studies suggest an increased risk of immune-related adverse reactions following immune-checkpoint inhibitor therapy as compared with patients without pre-existing AID. In addition, flares of the underlying AID were frequent, but the majority were mild and manageable.1

Patients excluded from clinical trials

Patients with the following were excluded from clinical trials: a baseline ECOG performance score ≥2; active or prior documented autoimmune disease within 2 years of initiation of the study; a history of immunodeficiency; a history of severe immune-mediated adverse reactions; medical conditions that required systemic immunosuppression, except physiological dose of systemic corticosteroids (≤10 mg/day prednisone or equivalent), uncontrolled intercurrent illnesses; active tuberculosis or hepatitis B or C or HIV infection or patients receiving live attenuated vaccine within 30 days before or after the start of IMFINZI. In the absence of data, IMFINZI should be used with caution in these populations after careful consideration of the potential benefit/risk on an individual basis.1


For more information on exclusion criteria for each specific study see section 5.1.

 

IMFINZI dosage strengths and forms

IMFINZI is supplied as single-use vials, available in two dosage strengths: either 120 mg/2.4 mL (50 mg/ml) or 500 mg/10 mL (50 mg/mL).1


Inside is a clear-to-opalescent, colourless-to-slightly yellow solution in a type glass 1 vial with an elastomeric stopper and a grey flip-off aluminium seal for 2.4 ml vials or a white flip-off aluminium seal for 10 ml vials.1


The drug product must be visually inspected, and the vial must be discarded if the solution is cloudy, discoloured, or visible particles are observed prior to administration.1

 

IMFINZI storage and preparation

Unopened vial

Shelf life: 3 years.1

Store in refrigerator (2 ˚C – 8 ˚C).1

Do not freeze.1

Store in the original package in order to protect from light.1

Diluted solution

Chemical and physical in-use stability has been demonstrated for up to 30 days at 2 ˚C – 8 ˚C and for up to 24 hours at room temperature (up to 25 ˚C) from the time of preparation.1


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 2 ˚C – 8 ˚C or 12 hours at room temperature (up to 25 ˚C), unless dilution has taken place in controlled and validated aseptic conditions.1

Preparation

IMFINZI is supplied as a single-dose vial and does not contain any preservatives, aseptic technique must be observed.1

 

  • Visually inspect the medicinal 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.1
  • Withdraw the required volume from the vial(s) of IMFINZI and transfer into an IV bag containing sodium chloride 9 mg/mL (0.9%) solution for injection, or glucose 50 mg/mL (5%) solution for 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.1
  • Discard any unused portion left in the vial.1

ADRIATIC indication: IMFINZI as monotherapy is indicated for the treatment of adults with limited-stage small-cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy.1


CASPIAN indication: IMFINZI in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small-cell lung cancer (ES‑SCLC).1


NICE recommends durvalumab can be used, within its marketing authorisation, as an option to treat limited-stage small-cell lung cancer that has not progressed after platinum-based chemoradiotherapy in adults. Durvalumab can only be used if the company provides it according to the commercial arrangement.²


SMC has accepted durvalumab for treating adults with limited-stage small-cell lung cancer (LS-SCLC). It is used in patients whose disease has not got worse after platinum-based chemoradiation therapy (chemotherapy and radiotherapy given at the same time).4


Continue exploring the ADRIATIC regimen

Get to know the ADRIATIC safety profile

Explore safety data

Take a closer look at how IMFINZI works within the ADRIATIC Regimen

Explore MOA

Discover more about the ADRIATIC study design and efficacy outcomes

Explore efficacy data

AID, autoimmune disease, BID, twice a day; CRT, chemoradiation therapy; cCRT, concurrent chemoradiotherapy; CR, complete response; CT, chemotherapy; ES-SCLC, extensive-stage small-cell lung cancer; Gy, gray; IO, immunotherapy; IV, intravenous; LS-SCLC, limited-stage small-cell lung cancer; PCI, prophylactic cranial irradiation; PR, partial response; Q4W, once every 4-weeks; QD, once daily; RT, radiotherapy, sCRT, sequential chemoradiation therapy; SD, stable disease.

  1. IMFINZI (durvalumab) Summary of Product Characteristics. [Accessed September 2026]
  2. NICE. Durvalumab for treating limited-stage small-cell lung cancer after platinum-based chemoradiotherapy -TA1099 (October 2025). Available at https://www.nice.org.uk/guidance/ta1099/resources/durvalumab-for-treating-limitedstage-smallcell-lung-cancer-after-platinumbased-chemoradiotherapy-pdf-2973528765889477. [Accessed September 2026].
  3. NICE. Durvalumab with etoposide and either carboplatin or cisplatin for untreated extensive-stage small-cell lung cancer. https://www.nice.org.uk/guidance/ta1041 [Accessed September 2026].
  4. SMC. IMFINZI (durvalumab) https://scottishmedicines.org.uk/media/8945/durvalumab-imfinzi-abbreviated-final-jan-2025-for-website.pdf [Accessed September 2026].
  5. SMC. IMFINZI (durvalumab) https://scottishmedicines.org.uk/medicines-advice/durvalumab-imfinzi-abb-smc2734/ [Accessed September 2026]
  6. Cheng Y, et al. Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer. N Engl J Med 2024;391(14):1313–1327 (including protocol).
  7. Blueteq form. Available at: https://www.england.nhs.uk/wp-content/uploads/2017/04/national-CDF-list-ver1.358.pdf (Accessed September 2026)


GB-76777 | DOP: September 2026

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