IMJUDO 20 mg/ml concentrate for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

1. What IMJUDO is and what it is used for
2. What you need to know before you are given IMJUDO
3. How you are given IMJUDO
4. Possible side effects
5. How to store IMJUDO
6. Contents of the pack and other information

if you are allergic to tremelimumab or any of the other ingredients of this medicine (listed in section 6). Talk to your doctor if you are not sure.

Talk to your doctor before you are given IMJUDO if:

• you have an autoimmune disease (an illness where the body’s immune system attacks its own cells)
• you have had an organ transplant
• you have lung or breathing problems
• you have liver problems.

Talk to your doctor before you are given IMJUDO if any of these could apply to you.

When you are given IMJUDO, you can have some serious side effects.

Your doctor may give you other medicines that prevent more severe complications and to help reduce your symptoms. Your doctor may delay the next dose of IMJUDO or stop your treatment with IMJUDO. Talk to your doctor straight away if you get any of the following side effects:

• new or worsening cough; shortness of breath; chest pain (may be signs of lung inflammation)
• feeling sick (nausea) or vomiting; feeling less hungry; pain on the right side of your stomach; yellowing of skin or whites of eyes; drowsiness; dark urine or bleeding or bruising more easily than normal may be signs of liver inflammation)
• diarrhoea or more bowel movements than usual; stools that are black, tarry or sticky with blood or mucus; severe stomach pain or tenderness (may be signs of bowel inflammation, or a hole in the bowel)
• fast heart rate; extreme tiredness; weight gain or weight loss; dizziness or fainting; hair loss; feeling cold; constipation; headaches that will not go away or unusual headaches (may be signs of glands being inflamed, especially the thyroid, adrenal, pituitary or pancreas)
• feeling more hungry or thirsty than usual; passing urine more often than usual; high blood sugar; fast and deep breathing; confusion; a sweet smell to your breath; a sweet or metallic taste in your mouth or a different odour to your urine or sweat (may be signs of diabetes)
• decrease in the amount of urine you pass (may be sign of kidney inflammation)
• rash; itching; skin blistering or ulcers in the mouth or on other moist surfaces (may be signs of skin inflammation)
• chest pain; shortness of breath; irregular heartbeat (may be signs of heart muscle inflammation)
• muscle pain or weakness or rapid tiring of the muscles (may be signs of inflammation or other problems of the muscles)
• chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness or fever (may be signs of infusion-related reactions)
• seizures; neck stiffness; headache; fever, chills; vomiting; eye sensitivity to light; confusion and sleepiness (may be signs of inflammation of the brain or the membrane around the brain and spinal cord)
• pain; weakness and paralysis in the hands, feet or arms (may be signs of inflammation of the nerves, Guillain-Barré syndrome)
• joint pain, swelling, and/or stiffness (may be signs of inflammation of the joints, immune-mediated arthritis)
• eye redness, eye pain, light sensitivity, and/or changes in vision (may be signs and symptoms of inflammation of the eye, uveitis)
• bleeding (from the nose or gums) and/or bruising (may be signs of low blood platelets).

Talk to your doctor straight away if you have any of the symptoms listed above.

IMJUDO should not be given to children and adolescents below 18 years of age as it has not been studied in these patients.

Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes herbal medicines and medicines obtained without a prescription.

This medicine is not recommended during pregnancy. Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. If you are a woman who could become pregnant, you must use effective contraception while you are being treated with IMJUDO and for at least 3 months after your last dose.

Tell your doctor if you are breast-feeding. It is not known if IMJUDO passes into human breast milk. You may be advised to not breast-feed during treatment and for at least 3 months after your last dose.

IMJUDO is not likely to affect your driving or use of machines. However, if you have side effects that affect your ability to concentrate and react, be careful when driving or operating machines.

IMJUDO contains less than 1 mmol sodium (23 mg) in each dose, that is to say essentially sodium-free.

• If you weigh 40 kg or more, the dose is 300 mg as a one-time single dose.
• If you weigh less than 40 kg, the dose will be 4 mg per kg of your body weight.

When IMJUDO is given in combination with durvalumab for your liver cancer, you will be given IMJUDO first, then durvalumab.

It is very important that you do not miss a dose of this medicine. If you miss an appointment, call your doctor straight away to reschedule your appointment.

If you get any side effects, talk to your doctor.

This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is tremelimumab.

Each ml of concentrate for solution for infusion contains 20 mg of tremelimumab.

One vial contains either 300 mg of tremelimumab in 15 ml of concentrate or 25 mg of tremelimumab in 1.25 ml of concentrate.

The other ingredients are: histidine, histidine hydrochloride monohydrate, trehalose dihydrate, disodium edetate dihydrate (see section 2 “IMJUDO has a low sodium content”), polysorbate 80 and water for injections.

IMJUDO concentrate for solution for infusion (sterile concentrate) is a preservative-free, clear to slightly opalescent, colourless to slightly yellow solution, free from visible particles.

It is available in packs containing either 1 glass vial of 1.25 ml of concentrate or 1 glass vial of 15 ml of concentrate.

Not all pack sizes may be marketed.