Non-small cell lung cancer (NSCLC) that has spread to neighbouring tissues, cannot be removed surgically, and has not become worse despite being treated with other chemotherapy drugs and radiation therapies is treated with durvalumab alone. It is also used to treat a specific kind of NSCLC that has spread across the lungs and to other regions of the body, along with tremelimumab-actl (Imjudo) and platinum-based chemotherapy. For the treatment of people with extensive-stage small cell lung cancer (ES-SCLC), which has progressed across the lungs and to other regions of the body, durvalumab injection is also used in conjunction with chemotherapy drugs. Adults with biliary tract cancer (BTC; cancer in the organs and ducts that produce and store bile, the liquid generated by the liver) that has progressed to surrounding tissues or to other regions of the body are also treated with it in combination with chemotherapy drugs. When surgery is not an option, durvalumab and tremelimumab-actl are also used to treat hepatocellular carcinoma (HCC), a kind of liver cancer. The drug durvalumab injection belongs to the monoclonal antibody drug class. It functions by assisting your immune system in reducing or halting the spread of cancer cells.

A doctor or nurse must administer the liquid form of the durvalumab injection over the course of 60 minutes in a hospital or other healthcare setting. For as long as your doctor advises you receive treatment, it is often injected once every two weeks, once every three weeks, or once every four weeks. Your body’s reaction to the drug and the type of cancer you have will determine how often you should take it.

During an infusion, durvalumab injection may result in severe or perhaps fatal responses. When you are receiving the infusion and immediately thereafter, a doctor or nurse will keep a close eye on you to make sure you are not having a dangerous response to the medication. Any of the following symptoms, which could appear during or after the infusion: chills or trembling, itching, rash, flushing, breathing problems, wheezing, dizziness, fever, feeling dizzy, back or neck discomfort, or facial swelling, should be reported right away to your doctor or nurse.

Depending on how you respond to the drug and any side effects you have, your doctor may reduce the rate of your infusion, postpone or discontinue your durvalumab injectable treatment, or administer you extra medication. Discuss your feelings regarding your treatment with your doctor.

As you start treatment with durvalumab injection and after each dosage, your doctor or pharmacist will give you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm).

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

Before receiving durvalumab injection,

• If you have an allergy to durvalumab, any other drugs, or any of the chemicals in durvalumab injection, notify your doctor right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
• Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
• Inform your doctor if you have ever undergone a bone marrow or organ transplant as well as any radiation treatment to your chest area. Tell your doctor if you currently have or have ever had an autoimmune disease (condition in which the immune system attacks a healthy part of the body), such as Crohn’s disease (condition in which the immune system attacks the lining of the digestive tract, causing pain, diarrhoea, weight loss, and fever), ulcerative colitis (condition in which the immune system causes swelling and sores in the lining of the colon [large intestine] and rectum), or lupus (condition in which the immune system attacks many tissues and organs including the skin, joints, blood, and kidneys); any condition that has an impact on your nervous system, such as myasthenia gravis (a nervous system disorder that causes muscle weakness) or Guillain-Barré syndrome (weakness, tingling, and potentially paralysis due to sudden nerve damage); any form of lung disease or breathing issues; diabetes; thyroid issues; kidney or liver disease; or any condition that has an impact on your blood sugar levels. Tell your physician if you have or have ever had cytomegalovirus as well (CMV; a viral infection that may cause symptoms in patients with weak immune systems).
• If you are pregnant or plan to become pregnant, let your doctor know. Pregnancy should not occur while a patient is getting a durvalumab injection. Throughout your treatment with durvalumab injection and for at least three months following your last dosage, you should use an effective birth control method to avoid getting pregnant. Discuss effective birth control options with your doctor. Call your doctor right away if you fall pregnant while receiving a durvalumab injection. The foetus could suffer from a durvalumab injection.
• If you are currently breastfeeding or intend to do so, let your doctor know. While receiving durvalumab injection and for three months following your final dosage, you shouldn’t breastfeed.

Keep eating normally unless your doctor instructs you otherwise.

The injection of durvalumab may have adverse effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

• Your arms or legs swelling
• Constipation
• Hair fall
• Difficulty sleeping or staying asleep
• Bone or muscle ache

Some adverse effects may be severe. Call your doctor right away if you notice any of these signs:

• Chest pain or shortness of breath, with a new or worsening cough
• Reduced appetite, dark (tea-colored) urine, pain in the upper right part of the stomach, excessive fatigue, yellowing of the eyes or skin, bleeding or bruising easily, nausea or vomiting
• Gastrointestinal distress, black, tarry, sticky, or bloody faeces, or diarrhoea
• Reduced urination, blood in the urine, ankle edoema, and decreased appetite
• Frequent or painful urination, a fever, a cough, chills, flu-like symptoms, or other symptoms of infection
• Excessive fatigue, weight loss or gain, increased hunger or thirst, feeling dizzy or faint, feeling cold, persistent or uncommon headaches, extreme exhaustion; deepening of voice, constipation, hair loss, modifications in attitude or conduct, such as feeling irritated, confused, or forgetful, increased urination, increased sweating, and stomach discomfort
• Rapid or erratic heartbeat
• Tingling or numbness in the arms or legs
• Chronic aches, weakness, or cramping in the muscles
• Itching, scaling, or blistering skin rashes
• Throat, mouth, nose, or genital sores
• Enlarged glands
• Neck rigidity
• Vision issues such as double vision, sensitivity to light, and eye pain or redness
• Persistent stomach pain that sometimes radiates to the back, along with nausea, vomiting, and appetite loss

Further adverse effects from durvalumab injection are possible. If you have any strange side effects while taking this medicine, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to the durvalumab injection, your doctor will request a few lab tests.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.