IMJUDO 20 mg/ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the Patient

IMJUDO 20mg/ml concentrate for solution for infusiontremelimumab

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start using 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.

Contents of the pack

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

1. What is IMJUDO and what is it used for

IMJUDO is a cancer medicine. It contains the active substance tremelimumab, which is a type of medicine called a monoclonal antibody. This medicine has been designed to recognize a specific target in the body. IMJUDO helps your immune system fight cancer.

IMJUDO in combination with durvalumab is used to treat a type of liver cancer called advanced or unresectable hepatocellular carcinoma (HCC). It is used when your HCC:

• cannot be removed by surgery (unresectable), and
• may have spread within your liver or to other parts of your body.

IMJUDO is used to treat a type of lung cancer called advanced non-small cell lung cancer in adults. It will be used in combination with other cancer medicines (durvalumab and chemotherapy).

Since IMJUDO will be given in combination with other cancer medicines, it is important that you also read the package leaflet for these other medicines. If you have any questions about these medicines, ask your doctor.

2. What you need to know before you use IMJUDO

You should not receive IMJUDO

• if you are allergic to tremelimumab or any of the other ingredients of this medicine (listed in section 6). Check with your doctor if you are unsure.

Warnings and precautions

Tell your doctor before you start using IMJUDO if:

• you have an autoimmune disease (a disease in which the body's immune system attacks its own cells);
• you have received an organ transplant;
• you have lung or breathing problems;
• you have liver problems.

Tell your doctorbefore you are given IMJUDO if you are in any of these situations.

When you are given IMJUDO, you may get some serious side effects.

Your doctor may give you other medicines to prevent more serious complications and help reduce symptoms. Your doctor may delay the next dose of IMJUDO or stop your treatment with IMJUDO. Tell your doctor immediatelyif you get any of the following side effects:

• new or worsening cough; difficulty breathing; chest pain (may be signs of pulmonaryinflammation)
• nausea or vomiting; loss of appetite; pain in the right side of the stomach; yellowing of the skin or the whites of the eyes; sleepiness; dark urine or bleeding or bruising that appears more easily than normal (may be signs of liverinflammation)
• diarrhea or more bowel movements than usual; black, tarry, or sticky stools or blood or mucus in stools; severe or sensitive stomach pain (may be signs of intestinalinflammation or a hole in the intestine)
• fast heart rate; extreme tiredness; weight gain or loss; dizziness or fainting; hair loss; feeling cold; constipation; headaches that do not go away or unusual headaches (may be signs of inflammation of glands, especially the thyroid, adrenal, pituitary, or pancreas)
• feeling more hungry or thirsty than usual; urinating more often than usual; high blood sugar levels; rapid and deep breathing; confusion; sweet breath odor; sweet or metallic taste in the mouth or different odor of urine or sweat (may be signs of diabetes)
• decreased amount of urine (may be a sign of kidneyinflammation)
• skin rash; itching; blisters on the skin or ulcers in the mouth or on other moist surfaces (may be signs of inflammation of the skin)
• chest pain; shortness of breath; irregular heartbeat (may be signs of inflammation of the heart muscle)
• pain, stiffness, or weakness in the muscles or rapid muscle fatigue (may be signs of inflammation or other problems of the muscles)
• chills or shaking, itching or rash, flushing, difficulty breathing or wheezing, dizziness or fever (may be signs of infusion-related reactions)
• seizures; stiff neck; headache; fever, chills; vomiting; sensitivity to light; confusion and sleepiness (may be signs of inflammation of the brainor the membrane covering the brain and spinal cord)
• inflammation of the spinal cord(transverse myelitis): symptoms may include pain, numbness, tingling, or weakness in the arms or legs; bladder or bowel problems, such as needing to urinate more often, urinary incontinence, difficulty urinating, and constipation
• pain; weakness and paralysis in the hands, feet, or arms (may be signs of inflammation of the nerves, Guillain-Barré syndrome)
• pain, swelling, and/or stiffness of the joints (may be signs of inflammation of the joints, immune-mediated arthritis)
• redness of the eyes, eye pain, sensitivity to light, 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 platelet count in the blood).

Tell your doctor immediatelyif you get any of the symptoms listed above.

Children and adolescents

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

Other medicines and IMJUDO

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 and fertility

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 can become pregnant, you must use an effective method of birth control while you are being treated with IMJUDO and for at least 3 months after receiving the last dose.

Breast-feeding

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

Driving and using machines

IMJUDO is unlikely to affect your ability to drive or use machines. However, if you have side effects that affect your ability to concentrate and react, you should be careful when driving or using machines.

IMJUDO has a low sodium content

IMJUDO contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

IMJUDO contains polysorbate

This medicine contains 0.3 mg of polysorbate 80 in each 1.25 ml vial, or 3 mg of polysorbate 80 in each 15 ml vial, equivalent to 0.2 mg/ml. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

3. How to use IMJUDO

IMJUDO will be given to you in a hospital or clinic under the supervision of an experienced doctor. Your doctor will give you IMJUDO as a drip into a vein (infusion) over about one hour.

It is given in combination with durvalumab for liver cancer.

Recommended dose:

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

If you are given IMJUDO in combination with durvalumab for liver cancer, you will be given IMJUDO first, followed by durvalumab.

It is given in combination with durvalumab and chemotherapy for lung cancer.

Recommended dose:

• If you weigh 34 kg or more, the dose is 75 mg every 3 weeks.
• If you weigh less than 34 kg, the dose will be 1 mg per kg of body weight every 3 weeks.

Normally, you will receive a total of 5 doses of IMJUDO. The first 4 doses are given in weeks 1, 4, 7, and 10. The fifth dose is usually given 6 weeks later, in week 16. Your doctor will decide exactly how many treatments you need.

If you are given IMJUDO in combination with durvalumab and chemotherapy, you will be given IMJUDO first, followed by durvalumab and then chemotherapy.

If you miss a scheduled dose of IMJUDO

It is very important that you do not miss any dose of this medicine. If you miss a scheduled dose, call your doctor immediatelyto schedule a new appointment.

If you have any other questions about your treatment, ask your doctor.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

When you receive IMJUDO, you may have some serious adverse effects. You can consult a detailed list in section2.

Consult your doctor immediatelyif you experience any of the following adverse effects that have been reported in a clinical trial with patients treated with IMJUDO in combination with durvalumab.

The following adverse effects have been reported in clinical trials in patients who used IMJUDO in combination with durvalumab:

Very Common (may affect more than 1 in 10 people)

• Underactive thyroid gland, which can cause fatigue or weight gain
• Cough
• Diarrhea
• Stomach pain
• Liver test abnormalities (elevated aspartate aminotransferase; elevated alanine aminotransferase)
• Skin rash
• Itching
• Fever
• Swelling of legs (peripheral edema)

Common (may affect up to 1 in 10 people)

• Upper respiratory tract infections
• Lung infection (pneumonia)
• Flu-like illness
• Infections of the teeth and soft tissues of the mouth
• Overactive thyroid gland that can cause rapid heartbeat or weight loss
• Inflammation of the thyroid gland (thyroiditis)
• Decreased levels of hormones produced by the adrenal glands, which can cause fatigue
• Inflammation of the lungs (pneumonitis)
• Abnormalities in pancreatic function tests
• Inflammation of the intestine (colitis)
• Inflammation of the pancreas (pancreatitis)
• Inflammation of the liver (hepatitis)
• Inflammation of the skin
• Nocturnal sweats
• Muscle pain (myalgia)
• Abnormalities in renal function tests (elevated blood creatinine)
• Painful urination (dysuria)
• Infusion reaction of the medicine that can cause fever or redness

Uncommon (may affect up to 1 in 100 people)

• Fungal infection in the mouth
• Low platelet count with signs of excessive bleeding and bruising (immune thrombocytopenia)
• Underactive pituitary gland; inflammation of the pituitary gland
• Type 1 diabetes mellitus
• A disease in which the muscles weaken and rapid muscle fatigue occurs (myasthenia gravis)
• Inflammation of the membrane covering the spinal cord and brain (meningitis)
• Inflammation of the heart (myocarditis)
• Hoarseness (dysphonia)
• Scarring of lung tissue
• Blistering of the skin
• Inflammation of the muscles (myositis)
• Inflammation of the muscles and blood vessels
• Inflammation of the kidneys (nephritis) that can decrease urine output
• Inflammation of the joints (immune-mediated arthritis)
• Inflammation of the muscles that causes pain or stiffness (polymyalgia rheumatica)

Rare (may affect up to 1 in 1,000 people)

• Diabetes insipidus
• Inflammation of the eye (uveitis)
• Inflammation of the brain (encephalitis)
• Inflammation of the nerves (Guillain-Barré syndrome)
• Hole in the intestine (intestinal perforation)

• Celiac disease (characterized by symptoms such as stomach pain, diarrhea, and bloating after consuming foods containing gluten)
• Inflammation of the bladder (cystitis). Signs and symptoms may include frequent and/or painful urination, urgent need to urinate, blood in the urine, pain or pressure in the lower abdomen

Other adverse effects that have been reported with an unknown frequency (cannot be estimated from the available data)

• Inflammation of part of the spinal cord (transverse myelitis)
• Absence or reduction of digestive enzymes produced by the pancreas (exocrine pancreatic insufficiency)

The following adverse effects have been reported in clinical trials in patients who used IMJUDO in combination with durvalumab and platinum-based chemotherapy:

Very Common (may affect more than 1 in 10 people)

• Upper respiratory tract infections
• Lung infection (pneumonia)
• Low red blood cell count
• Low white blood cell count
• Low platelet count
• Underactive thyroid gland, which can cause fatigue or weight gain
• Decreased appetite
• Cough
• Nausea
• Diarrhea
• Vomiting
• Constipation
• Liver test abnormalities (elevated aspartate aminotransferase; elevated alanine aminotransferase)
• Hair loss
• Skin rash
• Itching
• Joint pain (arthralgia)
• Feeling of fatigue or weakness
• Fever

Common (may affect up to 1 in 10 people)

• Flu-like illness
• Fungal infection in the mouth
• Low white blood cell count with signs of fever
• Low red blood cell count, white blood cell count, and platelet count (pancytopenia)
• Overactive thyroid gland that can cause rapid heartbeat or weight loss
• Decreased levels of hormones produced by the adrenal glands, which can cause fatigue
• Underactive pituitary gland; inflammation of the pituitary gland
• Inflammation of the thyroid gland (thyroiditis)
• Inflammation of the nerves that causes numbness, weakness, tingling, or burning pain in arms and legs (peripheral neuropathy)
• Inflammation of the lungs (pneumonitis)
• Hoarseness (dysphonia)
• Inflammation of the mouth or lips
• Abnormalities in pancreatic function tests
• Stomach pain
• Inflammation of the intestine (colitis)
• Inflammation of the pancreas (pancreatitis)
• Inflammation of the liver that can cause nausea or loss of appetite (hepatitis)
• Muscle pain (myalgia)
• Abnormalities in renal function tests (elevated blood creatinine)
• Painful urination (dysuria)
• Swelling of legs (peripheral edema)
• Infusion reaction of the medicine that can cause fever or redness

Uncommon (may affect up to 1 in 100 people)

• Infections of the teeth and soft tissues of the mouth
• Low platelet count with signs of excessive bleeding and bruising (immune thrombocytopenia)
• Diabetes insipidus
• Type 1 diabetes mellitus
• Inflammation of the brain (encephalitis)
• Inflammation of the heart (myocarditis)
• Scarring of lung tissue
• Blistering of the skin
• Nocturnal sweats
• Inflammation of the skin
• Inflammation of the muscles (myositis)
• Inflammation of the muscles and blood vessels
• Inflammation of the kidneys (nephritis) that can decrease urine output
• Inflammation of the bladder (cystitis). Signs and symptoms may include frequent and/or painful urination, urgent need to urinate, blood in the urine, pain or pressure in the lower abdomen
• Inflammation of the eye (uveitis)
• Inflammation of the joints (immune-mediated arthritis)

Rare (may affect up to 1 in 1,000 people)

• A disease in which the muscles weaken and rapid muscle fatigue occurs (myasthenia gravis)
• Inflammation of the nerves (Guillain-Barré syndrome)
• Inflammation of the membrane covering the spinal cord and brain (meningitis)
• Hole in the intestine (intestinal perforation)
• Celiac disease (characterized by symptoms such as stomach pain, diarrhea, and bloating after consuming foods containing gluten)

Other adverse effects that have been reported with an unknown frequency (cannot be estimated from the available data)

• Inflammation of part of the spinal cord (transverse myelitis)
• Absence or reduction of digestive enzymes produced by the pancreas (exocrine pancreatic insufficiency)
• Inflammation of the muscles that causes pain or stiffness (polymyalgia rheumatica)

Report to your doctor immediatelyif you experience any of the adverse effects mentioned above.

Adverse Effect Reporting

If you experience any type of adverse effect, consult your doctor, even if it is an adverse effect that does not appear in this prospectus. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of IMJUDO

IMJUDO will be administered to you in a hospital or clinic, and the healthcare professional will be responsible for its storage.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and on the label of the vial after CAD. The expiration date is the last day of the month indicated.

Store in a refrigerator (between 2 °C and 8 °C).

Do not freeze.

Store in the original packaging to protect it from light.

Do not use this medicine if it is cloudy, has changed color, or contains visible particles.

Do not store the unused part of the infusion solution for reuse. The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.

6. Package Contents and Additional Information

Composition of IMJUDO

The active ingredient is tremelimumab.

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

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

The other components are: histidine, histidine hydrochloride monohydrate, trehalose dihydrate, disodium edetate dihydrate (see section 2 "IMJUDO has a low sodium content"), polysorbate 80, water for injectable preparations.

Appearance of the Product and Package Contents

IMJUDO concentrate for solution for infusion (sterile concentrate) is a sterile, preservative-free solution that is clear to slightly opalescent, colorless to slightly yellow, and free of visible particles.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of the last revision of this prospectus:

Other sources of information

Detailed information about this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu

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This information is intended only for healthcare professionals:

Preparation and administration of the infusion:

• Parenteral medicines must be visually inspected for the presence of particles and color changes before administration. The concentrate is a clear to opalescent solution, colorless to slightly yellow, free of visible particles. Discard the vial if the solution is cloudy, has changed color, or visible particles are observed.
• Do not shake the vial.
• Withdraw the necessary volume of concentrate from the vial or vials and transfer it to an intravenous bag containing sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) injectable solution to prepare a diluted solution with a final concentration between 0.1 and 10 mg/ml. Mix the diluted solution by gently inverting the bag.
• Use the medicine immediately after dilution. The diluted solution must not be frozen. If not used immediately, the total time from vial puncture to the start of administration must not exceed 24 hours between 2 °C and 8 °C or 12 hours at room temperature (up to 25 °C). If refrigerated, the intravenous bags must reach room temperature before use. Administer the infusion solution intravenously over 1 hour using a sterile 0.2 or 0.22 micron filter with low protein binding.
• Do not administer other medicines through the same infusion line.
• IMJUDO is a single dose. Discard the unused portion remaining in the vial.

The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.