Imfinzi 500mg Injection contains durvalumab, a human monoclonal antibody that blocks programmed death-ligand 1 (PD-L1). It is an anticancer medicine used for certain types of lung cancer, biliary tract cancer and hepatocellular carcinoma, depending on the approved indication and treatment regimen.

Imfinzi may be used alone or in combination with other anticancer medicines, depending on the type and stage of cancer being treated.

Imfinzi 500mg Injection may be used for:

• Non-small cell lung cancer (NSCLC): Certain adults with locally advanced or metastatic NSCLC, as well as selected patients with resectable NSCLC, depending on tumour characteristics and the treatment regimen.

• Small cell lung cancer (SCLC): Certain adults with extensive-stage or limited-stage SCLC, depending on the approved treatment setting.

• Biliary tract cancer (BTC): In combination with gemcitabine and cisplatin for adults with unresectable or metastatic biliary tract cancer.

• Hepatocellular carcinoma (HCC): Certain adults with unresectable or advanced liver cancer, depending on the treatment regimen and approved indication.

The exact indication, combination medicines and treatment schedule depend on the type and stage of cancer and the applicable regulatory approval.

Imfinzi contains durvalumab, a programmed death-ligand 1 (PD-L1) blocking antibody.

Some cancer cells and immune cells can produce PD-L1, which can bind to PD-1 and related receptors on T cells and reduce their ability to attack cancer cells. Durvalumab binds to PD-L1 and blocks this interaction.

This helps restore T-cell activity against cancer cells and allows the immune system to recognise and attack the tumour.

Tell your doctor about all prescription medicines, over-the-counter medicines, vitamins and herbal supplements you take.

• Other anticancer medicines: Imfinzi is frequently used with chemotherapy or other anticancer medicines for certain indications. Your oncologist will determine which combination is appropriate.

• Medicines that affect the immune system: Tell your doctor if you are taking medicines that suppress the immune system, including corticosteroids or other immunosuppressive medicines. These may affect the immune response to treatment.

• Other medicines: There are no major conventional medicine interactions that routinely require dose adjustment with durvalumab. However, your doctor should know about all medicines you use before treatment.

Do not start, stop or change any medicine without discussing it with your oncology team.

• Store Imfinzi 500mg Injection in a refrigerator at 2°C to 8°C.

• Do not freeze.

• Keep the vial in the original package to protect it from light.

• Do not shake the vial.

• Imfinzi is supplied as a single-dose vial.

• The diluted infusion solution should be prepared, stored and used according to the product instructions and hospital protocols.

Imfinzi 500mg Injection is administered by intravenous infusion after dilution. It must be given by a healthcare professional in a clinical setting.

The dose and frequency depend on the type of cancer being treated, the patient's body weight and whether Imfinzi is being used alone or with other anticancer medicines.

For adults weighing 30kg or more, many approved regimens use 1,500mg of durvalumab at specified intervals. The 500mg vial is therefore used as part of the prescribed dose and is not necessarily the complete dose for one treatment session. Some regimens use weight-based dosing.

Imfinzi is generally infused over approximately 60 minutes. Patients are monitored for infusion-related reactions during and after administration.

Do not self-administer Imfinzi or change the treatment schedule without medical advice.

Common side effects may include:

• Cough

• Feeling tired or weak

• Shortness of breath

• Diarrhoea

• Nausea

• Reduced appetite

• Rash or itching

• Fever

• Constipation

• Muscle or joint pain

• Upper respiratory tract infections

The side effects can also depend on whether Imfinzi is being used alone or together with chemotherapy or other anticancer medicines.

Serious side effects

Durvalumab can cause immune-mediated adverse reactions when the immune system attacks healthy organs. These may include:

• Pneumonitis: New or worsening cough, chest pain or difficulty breathing

• Colitis: Persistent diarrhoea, abdominal pain or blood in the stool

• Hepatitis: Yellowing of the skin or eyes, dark urine or abnormal liver tests

• Endocrine disorders: Changes in thyroid, adrenal or pituitary function, which may cause unusual tiredness, weight changes, dizziness or changes in heart rate

• Nephritis: Changes in kidney function or reduced urine output

• Skin reactions: Severe rash, blistering or peeling skin

• Pancreatitis: Severe or persistent abdominal pain

• Infusion-related reactions: Fever, chills, flushing, dizziness or breathing difficulty during or shortly after the infusion

Seek medical attention promptly if you develop new or worsening symptoms during treatment. Immune-mediated reactions can be serious or life-threatening and may occur during treatment or after treatment has ended.

• Imfinzi is an immunotherapy and should be given only under the supervision of an oncologist or appropriately trained healthcare professional.

• Attend all scheduled blood tests and follow-up appointments. Your doctor may monitor liver enzymes, kidney function, thyroid function, blood glucose and other parameters during treatment.

• Report new or worsening cough, breathing difficulty, persistent diarrhoea, severe abdominal pain, yellowing of the skin or eyes, changes in urination or unusual fatigue promptly.

• Tell your doctor if you have previously received an organ transplant or have an autoimmune condition.

• Inform your doctor about all medicines and supplements you take before starting treatment.

• Do not stop corticosteroids or other medicines prescribed to manage immune-related side effects unless your doctor tells you to do so.

• Tell your doctor before receiving any new anticancer treatment or immunosuppressive medicine.

• Imfinzi may cause immune-mediated side effects even after treatment has been completed. Report new symptoms to your doctor even if your last infusion was some time ago.