Patient Information Leaflet

IMFINZI 50mg/ml concentrate for solution for infusion
durvalumab

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor.
• If you experience any side effects, consult your doctor, even if they are not listed in this leaflet.

1.What is IMFINZI and what it is used for

2.What you need to know before starting to use IMFINZI

3.How to use IMFINZI

4.Possible side effects

5.Storage of IMFINZI

6.Contents of the pack and additional information

IMFINZI contains the active ingredient durvalumab, which is a monoclonal antibody, a type of protein designed to recognize a specific target substance in the body. IMFINZI acts by helping the immune system to fight cancer.

IMFINZI is used in adults to treat a type of lung cancer called non-small cell lung cancer (NSCLC). It is used as monotherapy when NSCLC:

• has spread to the lung, cannot be removed by surgery, and
• has responded or stabilized after initial treatment with chemotherapy and radiation therapy.

It is used in combination with tremelimumab and chemotherapy when NSCLC:

• has spread to both lungs (and/or to other parts of the body), cannot be removed by surgery, and
• has not shown changes (mutations) in genes called EGFR (epidermal growth factor receptor) or ALK (anaplastic lymphoma kinase).

IMFINZI in combination with chemotherapy is used in adults to treat a type of lung cancer called small cell lung cancer in extended stage (SCLC-EE). It is used when your SCLC:

• has spread within the lungs (or to other parts of the body) and
• has not been previously treated.

IMFINZI in combination with chemotherapy is used in adults to treat a type of cancer of the bile ducts (cholangiocarcinoma) and the gallbladder, collectively known as bile duct cancers (BDC). It is used when BDC:

• has spread within the bile ducts and the gallbladder (or to other parts of the body).

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

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

IMFINZI is used in women to treat a type of uterine cancer (endometrial cancer) that has spread beyond the original tumor or has recurred.It is used in combination with chemotherapy (carboplatin and paclitaxel), followed by:

• IMFINZI as monotherapy when your tumor is MMR deficient, or
• IMFINZI in combination with olaparib when your tumor is MMR competent.

A test is used to determine the MMR status of your endometrial cancer.

If you have any doubts about how IMFINZI works or why you have been prescribed this medication, consult your doctor or pharmacist.

When IMFINZI is administered in combination with other cancer medications, it is essential that you also read the prospectus of these other medications. If you have any questions about these medications, consult your doctor.

Do not administer IMFINZI

• If you are allergic to durvalumab or any of the other components of this medication (listed in section 6 “Contents of the package and additional information”). If in doubt, consult your doctor.

Warnings and precautions

Consult your doctor before starting to use IMFINZI 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 respiratory or lung problems;
• You have liver problems.

If you are in any of the above circumstances (or are unsure), consult your doctor before using IMFINZI.

When you are administered IMFINZI, you may experience some severe side effects.

If you have any of the following, call or visit your doctor immediately. Your doctor may administer other medications to prevent more serious complications and to help alleviate your symptoms. Your doctor may decide to delay the administration of the next dose of IMFINZI or interrupt your treatment with IMFINZI if you have:

• Lung inflammation: symptoms may include the onset or worsening of cough, difficulty breathing, or chest pain;
• Liver inflammation: symptoms may include nausea or vomiting, loss of appetite, right-sided abdominal pain, yellowing of the skin or the white part of the eyes, drowsiness, dark urine, or the appearance of bruises or ecchymoses more frequently than usual;

• Intestinal inflammation: symptoms may include diarrhea or more frequent bowel movements than usual, or stools that are black, tar-like, or sticky with blood or mucus, severe abdominal pain, or anal fissures;

• Adrenal gland inflammation
• (especially the thyroid gland, adrenal glands, pituitary gland, and pancreas): symptoms may include increased heart rate, extreme fatigue, weight gain or loss, dizziness or fainting, hair loss, feeling cold, constipation, severe headaches that do not subside or unusual headaches, abdominal pain, nausea, and vomiting;

• Type 1 diabetes mellitus: symptoms may include elevated blood sugar levels, increased hunger or thirst, frequent urination, rapid and deep breathing, confusion, or a sweet odor in the breath, a sweet or metallic taste in the mouth, or a different odor in the urine or sweat;

• Kidney inflammation: symptoms may include decreased urine output.
• Skin inflammation: symptoms may include rash, itching, blisters on the skin, or ulcers in the mouth or on other moist surfaces;
• Cardiac muscle inflammation: symptoms may include chest pain, difficulty breathing, or irregular heartbeats;
• Muscle inflammation: symptoms may include pain, stiffness, or weakness in the muscles, or rapid muscle fatigue;
• Spinal cord inflammation(transverse myelitis): symptoms may include pain, numbness, tingling, or weakness in the arms or legs, urinary or intestinal problems, such as frequent urination, urinary incontinence, difficulty urinating, or constipation;
• Reactions associated with infusion: symptoms may include chills or shivering, itching or rash, shortness of breath or wheezing, dizziness, or fever;
• Brain inflammation(encephalitis) or inflammation of the membrane surrounding the spinal cord and brain
• (meningitis): symptoms may include seizures, neck stiffness, headache, fever, chills, vomiting, sensitivity to light, confusion, and drowsiness;

• Nerve inflammation:symptoms may include pain, weakness, and paralysis in the limbs (Guillain-Barré syndrome);
• Joint inflammation:symptoms may include pain, swelling, and/or stiffness in the joints (immune-mediated arthritis);
• Eye inflammation:symptoms may include redness of the eyes, eye pain, sensitivity to light, and/or changes in vision (uveitis);
• Low platelet count:symptoms may include bleeding (nosebleeds or bleeding gums) and/or bruising;
• Low red blood cell count in blood tests: symptoms may include difficulty breathing, fatigue, pale skin, and/or rapid heartbeats. When IMFINZI is used in combination with another cancer medication (olaparib), low red blood cell counts may be a sign of "pure red cell aplasia" (PRA), a condition in which red blood cells are not produced, or "autoimmune hemolytic anemia" (AIHA), excessive destruction of red blood cells.

If you experience any of these symptoms, call or visit your doctor immediately.

IMFINZI acts on your immune system. It may cause inflammation in parts of your body. The risk of you experiencing these side effects may be higher if you already have an autoimmune disease (a condition in which your body attacks its own cells). You may also experience frequent relapses of your autoimmune disease, which in most cases are mild.

Children and adolescents

IMFINZI should not be administered to children or adolescents under 18 years old, as it has not been studied in these patients.

Other medications and IMFINZI

Inform your doctor if you are taking, have taken recently, or may need to take any other medication. This includes herbal medications and over-the-counter medications.

Pregnancy

• This medication is not recommended during pregnancy.
• If you are pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.
• If you are a woman who may become pregnant, you must use an effective contraceptive method while receiving treatment with IMFINZI and for at least 3 months after your last dose.

Breastfeeding

• Inform your doctor if you are breastfeeding.
• Consult your doctor if you can breastfeed during or after treatment with IMFINZI.
• The passage of IMFINZI into breast milk is unknown.

Driving and operating machinery

It is unlikely that IMFINZI will affect your ability to drive and operate machinery.

However, if you experience side effects that affect your ability to concentrate and react, you should exercise caution when driving or operating machinery.

IMFINZI will be administered in a hospital or clinic under the supervision of an experienced doctor.

• The recommended dose of IMFINZI is 10mg per kg of body weight every 2weeks, 1120mg every 3 weeks or 1500mg every 3 or 4weeks.
• Your doctor will administer IMFINZI via intravenous infusion (drip) for approximately 1hour.
• Your doctor will decide how many treatments you need.
• Depending on your type of cancer, IMFINZI may be administered in combination with other cancer medications.
• When IMFINZI is administered in combination with tremelimumab and chemotherapy for lung cancer, tremelimumab will be administered first, followed by IMFINZI and then chemotherapy.
• When IMFINZI is administered in combination with chemotherapy for lung cancer or endometrial cancer, IMFINZI will be administered first, followed by chemotherapy.
• When IMFINZI is administered in combination with tremelimumab for liver cancer, tremelimumab will be administered first, followed by IMFINZI.
• Refer to the package insert for other cancer medications to understand the use of these other medications. If you have questions about these medications, consult your doctor.

If you do not attend an appointment to receive treatment with IMFINZI

• Call your doctor immediately to reschedule your appointment.
• It is very important not to miss any dose of this medication.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

When you receive IMFINZI, you may experience some serious side effects (see section 2).

Seek medical attention immediately if you experience any of the following side effects that have been reported in clinical trials with patients who received IMFINZI in monotherapy:

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

• Upper respiratory tract infections
• Reduced activity of the thyroid gland, which may cause fatigue or weight gain
• Cough
• Diarrhea
• Abdominal pain
• Rash or itching on the skin
• Fever
• Joint pain (arthralgia)

Common (may affect up to 1 in 10 people)

• Severe lung infections (pneumonia)
• Fungal infection of the mouth
• Teeth and soft tissue infections of the mouth
• Illness similar to the flu
• Increased activity of the thyroid gland, which may cause rapid heartbeat or weight loss
• Lung inflammation (pneumonitis)
• Hoarseness (dysphonia)
• Abnormal liver function test results (elevated aspartate aminotransferase; elevated alanine aminotransferase)
• Nocturnal sweating
• Muscle pain (myalgia)
• Abnormal kidney function test results (elevated creatinine in blood)
• Painful urination (dysuria)
• Peripheral edema
• Reaction to the medication infusion, which may cause fever or chills
• Liver inflammation, which may cause nausea or loss of appetite (hepatitis)

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

• Condition that produces high blood sugar levels (type 1 diabetes mellitus)
• Insufficient activity of the pituitary gland (including diabetes insipidus), which may cause fatigue and increased urine production
• Muscle weakness and rapid muscle fatigue (myasthenia gravis)
• Membrane inflammation surrounding the spinal cord and brain (meningitis)
• Celiac disease (characterized by symptoms such as abdominal pain, diarrhea, and bloating after consuming gluten-containing foods)
• Low platelet count caused by an autoimmune reaction (immune thrombocytopenia)
• Bladder inflammation (cystitis). Symptoms may include frequent or painful urination, urgent need to urinate, blood in the urine, abdominal pain or pressure in the lower abdomen
• Eye inflammation (uveitis)
• Joint inflammation (immunemediated arthritis)
• Muscle inflammation causing pain or stiffness (polymyalgia rheumatica)
• Muscle and blood vessel inflammation (polymyositis)

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

• Nerve inflammation (Guillain-Barré syndrome)
• Absence or reduction of pancreatic digestive enzymes (exocrine pancreatic insufficiency)
• Non-infectious brain inflammation (encephalitis)
• Transverse myelitis

The following additional side effects have been reported when receiving IMFINZI in monotherapy in clinical trials in patients who received IMFINZI in combination with chemotherapy:

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

• Low white blood cell count
• Low red blood cell count
• Low platelet count
• Loss of appetite
• Nausea; vomiting; constipation
• Hair loss
• Weight loss
• Feeling tired or weak
• Nerve inflammation causing numbness, weakness, tingling, or burning in arms and legs (peripheral neuropathy)

Common (may affect up to 1 in 10 people)

• Low white blood cell count with fever (febrile neutropenia)
• Low red blood cell count, white blood cell count, and platelet count (pancytopenia)

IMFINZI will be administered in a hospital or clinic and the healthcare professional will be responsible for its conservation. The conservation details are as follows:

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

Do not use this medication after the expiration date that appears on the box and on the vial label 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 medication if it is cloudy, has changed color, or contains visible particles.

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

Composition of IMFINZI

The active ingredient is durvalumab.

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

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

The other components are: histidine, monohydrochloride of histidine, trehalose dihydrate, polisorbate 80 and water for injection.

Appearance of the product and contents of the pack

IMFINZI concentrate for solution for infusion (sterile concentrate) is a preservative-free solution, transparent to opalescent, colorless to slightly yellow, without visible particles.

It is presented in containers with 1 vial of 2.4 ml of concentrate or 1 vial of 10 ml of concentrate.

Marketing Authorization Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Responsible for manufacturing

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:https://www.ema.europa.eu

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This information is intended solely for healthcare professionals:

Preparation and administration of the infusion

• Parenteral medications should be visually inspected for particles and color change before administration. The concentrate is a sterile, transparent to opalescent, colorless to slightly yellow solution, without visible particles. Discard the vial if the solution is turbid, has a color change, or has visible particles.
• Do not agitate the vial.
• Extract the required volume of concentrate from the vial or vials and transfer it to an intravenous infusion bag containing sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection, to prepare a diluted solution with a final concentration between 1 mg/ml and 15 mg/ml. To mix the diluted solution, invert it gently.
• Once diluted, the medication should be used immediately. The diluted solution should not be frozen. Chemical and physical stability has been demonstrated in use for up to 30 days between 2°C and 8°C and for up to 24 hours at room temperature (up to 25°C) from the time of preparation.
• From a microbiological point of view, the prepared infusion solution should be used immediately. If not used immediately, the storage times in use and the conditions prior to use are the responsibility of the user and are generally not to be longer than 24 hours between 2°C and 8°C or 12 hours at room temperature (up to 25°C), unless the dilution has taken place in controlled and validated aseptic conditions.
• If refrigerated, the intravenous infusion bags should be left out until they reach room temperature before use. Administer the infusion solution intravenously over 1 hour using a sterile, in-line filter with a pore size of 0.2 to 0.22 microns and low protein binding.
• Do not administer other medications concomitantly through the same infusion route.
• IMFINZI is a single-dose product. Discard any unused portion remaining in the vial.

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