Imfinzi 50 mg/mL concentrate for solution for infusion

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• 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.

What is in this leaflet

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

You should not be given IMFINZI

• if you are allergic to durvalumab or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”). Talk to your doctor if you are not sure.

Warnings and precautions

Talk to your doctor before you are given IMFINZI 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 problems or breathing problems;
• you have liver problems.

If any of the above apply to you (or you are not sure), talk to your doctor before you are given IMFINZI.

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

If you have any of the following, call or see your doctor straight away. 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 IMFINZI or stop your treatment with IMFINZI, if you have:

• inflammation of the lungs: symptoms may include new or worsening cough, shortness of breath or chest pain;
• inflammation of the liver: symptoms may include 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;
• inflammation of the intestines: symptoms may include diarrhoea or more bowel movements than usual, or stools that are black, tarry or sticky with blood or mucus, severe stomach pain or tenderness;
• inflammation of glands (especially the thyroid, adrenal, pituitary and pancreas): symptoms may include 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;
• type 1 diabetes: symptoms may include high blood sugar, feeling more hungry or thirsty than usual, passing urine more often than usual;
• inflammation of the kidneys: symptoms may include decrease in the amount of urine you pass;
• inflammation of the skin: symptoms may include rash, itching, skin blistering or ulcers in the mouth or on other moist surfaces;
• inflammation of the heart muscle: symptoms may include chest pain, shortness of breath, or irregular heartbeat;
• inflammation or problems of the muscles: symptoms may include muscle pain, or weakness or rapid fatigue of the muscles;
• Infusion-related reactions: symptoms may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing dizziness, or fever.

If you have any of the symptoms listed above, call or see your doctor straight away.

Children and adolescents

IMFINZI should not be used in children and adolescents below 18 years of age.

Other medicines and IMFINZI

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.

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 birth control while you are being treated with IMFINZI and for at least 3 months after your last dose.

Breast-feeding

• Tell your doctor if you are breast-feeding.
• Ask your doctor if you can breast-feed during or after treatment with IMFINZI.
• It is not known if IMFINZI passes into human breast milk.

Driving and using machines

IMFINZI is not likely to affect you being able to drive and use machines.

However, if you have side effects that affect your ability to concentrate and react, you should be careful when driving or operating machines.

If you miss an appointment to get IMFINZI

• Call your doctor straight away to reschedule your appointment.
• It is very important that you do not miss a dose of this medicine.

Reporting of side effects

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

or search for MHRA Yellow Card in the Google Play or Apple App Store.

What IMFINZI contains

The active substance is durvalumab.

Each mL of concentrate for solution for infusion contains 50 mg of durvalumab.

Each vial contains either 500 mg of durvalumab in 10 mL of concentrate or 120 mg of durvalumab in 2.4 mL of concentrate.

The other ingredients are: histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 80, water for injections.

What IMFINZI looks like and contents of the pack

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

It is available in packs containing either 1 glass vial of 2.4 mL of concentrate or 1 glass vial of 10 mL of concentrate.

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