Imfinzi

Package leaflet: Information for the patient

IMFINZI 50 mg/mL concentrate for solution for infusion

durvalumab
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

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

Contents of 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 IMFINZI is given
4. Possible side effects
5. How to store IMFINZI
6. Contents of the pack and other information

1. What IMFINZI is and what it is used for

IMFINZI contains the active substance durvalumab, which is a monoclonal antibody, a type of protein
designed to recognize a specific target substance in the body. IMFINZI works by helping the
immune system 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 if the NSCLC:

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

It is used in combination with tremelimumab and chemotherapy if the NSCLC:

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

It is used in combination with platinum-based chemotherapy before surgery (neoadjuvant treatment) and as monotherapy after surgery (adjuvant treatment) if the NSCLC:

• has spread within the lung and can be removed by surgery.

IMFINZI is used in adults to treat a type of lung cancer called limited-stage small cell lung cancer (LS-SCLC). It is used when SCLC:

• has not been removed by surgery, and
• has responded to or stabilized after initial treatment with chemotherapy and radiotherapy.

IMFINZI in combination with chemotherapy is used in adults to treat a type of lung cancer called extensive-stage small cell lung cancer (ES-SCLC). It is used when 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 bile duct cancer (cholangiocarcinoma) and gallbladder cancer, collectively referred to as biliary tract cancers (BTC). It is used when BTC:

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

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

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

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

• IMFINZI alone when the tumour is MMR-deficient, or
• IMFINZI in combination with olaparib when the tumour is MMR-proficient. An MMR test is used to determine the MMR status of endometrial cancer.

IMFINZI is used to treat a type of bladder cancer called muscle-invasive bladder cancer (MIBC), which occurs when the bladder tumour has spread into the muscular layer of the bladder but not to other parts of the body. It is used in combination with chemotherapy (neoadjuvant treatment) before surgical removal of the bladder, followed by IMFINZI alone after surgery (adjuvant treatment).

IMFINZI is used to treat a type of stomach tumour called gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJC) that can be surgically removed. It is used in combination with chemotherapy before and after surgery, followed by IMFINZI alone.

If you have any questions about how IMFINZI works or why this medicine has been prescribed for you, speak with your doctor or pharmacist.

When IMFINZI is administered in combination with other anticancer medicines, it is important to also read the package leaflet of these other medicines. If you have any questions about these medicines, speak with your doctor.

2. What you should know before you are given IMFINZI

You must not be given IMFINZI

• if you are allergic to durvalumab or to any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”). If you are unsure, discuss this with your doctor.

Warnings and precautions
Talk to your doctor before receiving IMFINZI if:

• you have an autoimmune disease (a condition in which 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.

If any of the above conditions apply to you (or if you have any doubts), consult your doctor before you are given IMFINZI.
Serious side effects may occur when you receive IMFINZI.
If you experience any of the following effects, call your doctor or seek immediate medical attention. Your doctor may prescribe other medicines to prevent more serious complications and help relieve symptoms. Your doctor may delay the next dose of IMFINZI or stop treatment with IMFINZI altogether 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, loss of appetite, pain on the right side of the stomach, yellowing of the skin or whites of the eyes, drowsiness, dark-coloured urine, bleeding or bruising more easily than usual;
• inflammation of the intestine: symptoms may include diarrhoea or more frequent bowel movements than usual, black, tarry or sticky stools with blood or mucus, severe abdominal pain or tenderness, or a hole in the intestine;
• inflammation of glands (especially the thyroid, adrenal glands, pituitary gland, and pancreas): symptoms may include fast heartbeat, extreme tiredness, weight gain or weight loss, dizziness or fainting, hair loss, feeling cold, constipation, persistent or unusual headaches, abdominal pain, nausea, and vomiting;
• type 1 diabetes: symptoms may include high blood sugar levels, increased appetite or thirst, need to urinate more often than usual, rapid and deep breathing, confusion, sweet-smelling breath, a sweet or metallic taste in the mouth, or a different smell in the urine or sweat;
• inflammation of the kidneys: symptoms may include decreased amount of urine passed;
• inflammation of the skin: symptoms may include rash, itching, blistering of the skin, or mouth ulcers or ulcers on other moist surfaces;
• inflammation of the heart muscle (myocarditis): symptoms may include chest pain, shortness of breath, or irregular heartbeat;
• inflammation or problems with muscles: symptoms may include muscle pain, stiffness, weakness, or rapid muscle fatigue;
• inflammation of the spinal cord (transverse myelitis): symptoms may include pain, numbness, tingling, or weakness in the arms or legs; bladder or bowel problems, including needing to urinate more frequently, urinary incontinence, difficulty urinating, or constipation;
• infusion-related reactions: symptoms may include chills or shaking, itching or rash, redness, shortness of breath or wheezing, dizziness, or fever;
• inflammation of the brain (encephalitis) or inflammation of the membranes surrounding the brain and spinal cord (meningitis): symptoms may include seizures, neck stiffness, headache, fever, chills, vomiting, sensitivity to light, confusion, and drowsiness;
• inflammation of the nerves: symptoms may include pain, weakness, and paralysis in the limbs (Guillain-Barré syndrome);
• inflammation of the joints: signs and symptoms include joint pain, swelling, and/or stiffness (immune-mediated arthritis);
• inflammation of the eye: signs and symptoms include redness of the eye, eye pain, sensitivity to light, and/or changes in vision (uveitis);
• low number of platelets in the blood: symptoms may include bleeding (such as nosebleeds or bleeding gums) and/or bruising;
• low number of red blood cells in blood tests: symptoms may include shortness of breath, fatigue, paleness, and/or fast heartbeat. When IMFINZI is used in combination with another anticancer medicine (olaparib), a low number of red blood cells could be a sign of “pure red cell aplasia” (PRCA), a condition in which red blood cells are not produced, or of “autoimmune haemolytic anaemia” (AIHA), a condition involving excessive breakdown of red blood cells.

If you experience any of the symptoms listed above, contact or consult your doctor immediately.
IMFINZI acts on the immune system. It may cause inflammation in parts of the body. The risk of developing these side effects may be higher if you already have an autoimmune disease (a condition in which the body attacks its own cells). You may also experience frequent flare-ups of your autoimmune disease, which in most cases are mild.

Children and adolescents
IMFINZI must not be given to children or adolescents under 18 years of age, as it has not been studied in these patients.

Other medicines and IMFINZI
Tell your doctor if you are taking, have recently taken, or might take any other medicines, including herbal medicines and over-the-counter medicines.

Pregnancy

• This medicine is not recommended during pregnancy.
• If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine.
• If you are a woman of childbearing potential, you must use an effective method of contraception during treatment with IMFINZI and for at least 3 months after the last dose.

Breast-feeding

• If you are breast-feeding, inform your doctor.
• Ask your doctor whether you can breast-feed during or after treatment with IMFINZI.
• It is not known whether IMFINZI passes into breast milk.

Driving and using machines
IMFINZI is unlikely to affect your ability to drive or use machines.
However, if you experience side effects that affect your ability to concentrate or react, take great care when driving or using machines.

IMFINZI contains Polysorbate 80
This medicine contains 2 mg of polysorbate 80 in each 10 mL of concentrate, equivalent to 0.2 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How IMFINZI is administered

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

• The recommended dose of IMFINZI is 10 mg per kg of body weight every 2 weeks, 20 mg per kg every 4 weeks, 1 120 mg every 3 weeks, or 1 500 mg every 3 or 4 weeks.
• Your doctor will administer IMFINZI through an intravenous infusion (drip) over approximately 1 hour.
• Your doctor will determine the number of treatments required.
• Depending on the type of cancer, IMFINZI may be given in combination with other anticancer medicines.
• When IMFINZI is given in combination with tremelimumab and chemotherapy for lung cancer, tremelimumab will be administered first, followed by IMFINZI, and then chemotherapy.
• When IMFINZI is given in combination with chemotherapy for lung cancer, endometrial cancer, or stomach cancer (GC/GEJC), IMFINZI will be administered first, followed by chemotherapy.
• When IMFINZI is given in combination with tremelimumab for liver cancer, tremelimumab will be administered first, followed by IMFINZI.
• Please refer to the package leaflet of the other anticancer medicines to understand how these other medicines are used. If you have any questions about these medicines, please consult your doctor.

If you miss an appointment for IMFINZI administration

• Call your doctor immediately to schedule another appointment.
• It is very important not to miss a dose of this medicine. If you have further questions about your treatment, please consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects may occur during treatment with IMFINZI (see section 2).
Inform your doctor immediately if you experience any of the following side effects reported in clinical
studies of patients treated with IMFINZI monotherapy:

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

• upper respiratory tract infections
• reduced thyroid activity, which may cause tiredness or weight gain
• cough
• diarrhoea
• stomach pain
• skin rash or itching
• joint pain (arthralgia)
• fever

Common (may affect up to 1 in 10 people)

• severe lung infections (pneumonia)
• flu-like illness
• fungal infection in the mouth
• dental and soft tissue infections of the mouth
• increased thyroid activity, which may cause rapid heartbeat or weight loss
• inflammation of the lungs (pneumonitis)
• hoarseness (dysphonia)
• liver inflammation, which may cause nausea or loss of appetite (hepatitis)
• abnormal liver function test results (increased aspartate aminotransferase; increased alanine aminotransferase)
• night sweats
• muscle pain (myalgia)
• abnormal kidney function test results (increased blood creatinine)
• painful urination (dysuria)
• swelling of the legs (peripheral oedema)
• infusion-related reaction to the medicine, which may cause fever or redness

Uncommon (may affect up to 1 in 100 people)

• low platelet count due to an immune reaction (immune thrombocytopenia)
• inflammation of the thyroid gland (thyroiditis)
• decreased secretion of hormones produced by the adrenal glands, which may cause tiredness
• reduced pituitary activity, inflammation of the pituitary gland
• a condition causing high blood sugar levels (type 1 diabetes mellitus)
• a condition in which muscles become weak and fatigue easily (myasthenia gravis)
• brain inflammation (encephalitis)
• heart inflammation (myocarditis)
• scarring of lung tissue
• intestinal inflammation (colitis)
• pancreas inflammation (pancreatitis)
• skin inflammation (dermatitis)
• red, itchy, dry, scaly patches of thickened skin (psoriasis)
• blistering skin rash (bullous pemphigoid)
• muscle inflammation (myositis)
• joint inflammation (immune-mediated arthritis)
• kidney inflammation (nephritis), which may reduce urine output
• bladder inflammation (cystitis). Signs and symptoms may include frequent and/or painful urination, urgency to urinate, blood in the urine, pain or pressure in the lower abdomen

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

• diabetes insipidus
• eye inflammation (uveitis)
• inflammation of the membrane surrounding the spinal cord and brain (meningitis)
• coeliac disease (characterised by symptoms such as stomach pain, diarrhoea, and abdominal swelling after consuming foods containing gluten)
• muscle inflammation causing pain or stiffness (polymyalgia rheumatica)
• inflammation of muscles and blood vessels (polymyositis)
• absence or reduction of digestive enzymes produced by the pancreas (pancreatic exocrine insufficiency)

Other side effects reported with unknown frequency (frequency cannot be estimated from the available data)

• nerve inflammation: (Guillain-Barré syndrome)
• inflammation of part of the spinal cord (transverse myelitis)

The following side effects, in addition to those from treatment with IMFINZI monotherapy, have been reported in clinical studies of patients receiving IMFINZI in combination with chemotherapy (the frequency and severity of side effects may vary depending on the chemotherapeutic agent received):

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

• low white blood cell count
• low red blood cell count
• low platelet count
• nausea; vomiting; constipation
• hair loss
• decreased appetite
• feeling tired or weak
• nerve inflammation causing numbness, weakness, tingling, or burning pain in arms and legs (peripheral neuropathy)

Common (may affect up to 1 in 10 people)

• low white blood cell count with signs of fever (febrile neutropenia)
• inflammation of the mouth or lips (stomatitis)

Uncommon (may affect up to 1 in 100 people)

• low red blood cells, white blood cells, and platelets (pancytopenia)
• heart attack (acute myocardial infarction), which may cause chest pain or discomfort (which may radiate to arms, jaw, neck, back), shortness of breath, cold sweat, nausea/vomiting, mental confusion, or fainting
• blood clot in the lungs (pulmonary embolism), which may cause symptoms such as shortness of breath, chest pain, faster breathing than normal, or faster heart rate (when used in combination with chemotherapy in patients with stomach cancer/gastroesophageal junction cancer)

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

• blood clot in a deep vein (deep vein thrombosis), usually in the leg, which may cause symptoms such as redness/heat, pain, or swelling in the legs

The following side effects, in addition to those from treatment with IMFINZI monotherapy, have been reported in clinical studies of patients receiving IMFINZI in combination with tremelimumab and platinum-based chemotherapy (the frequency and severity of side effects may vary depending on the chemotherapeutic agents received):

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

• low red blood cell count
• low white blood cell count
• low platelet count
• decreased appetite
• nausea; vomiting; constipation
• hair loss
• feeling tired or weak

Common (may affect up to 1 in 10 people)

• low white blood cell count with signs of fever (febrile neutropenia)
• low red blood cells, white blood cells, and platelets (pancytopenia)
• nerve inflammation causing numbness, weakness, tingling, or burning pain in arms and legs (peripheral neuropathy)
• inflammation of the mouth or lips (stomatitis)
• abnormal pancreatic function test results

Other side effects reported with unknown frequency (frequency cannot be estimated from the available data)

• hole in the intestine (intestinal perforation)

The following side effects, in addition to those from treatment with IMFINZI monotherapy, have been reported in clinical studies of patients receiving IMFINZI in combination with tremelimumab:

Common (may affect up to 1 in 10 people)

• abnormal pancreatic function test results

Other side effects reported with unknown frequency (frequency cannot be estimated from the available data)

• hole in the intestine (intestinal perforation)

The following side effects, in addition to those from treatment with IMFINZI monotherapy, have been reported in clinical studies of patients receiving IMFINZI in combination with platinum-based chemotherapy followed by IMFINZI with olaparib:

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

• low red blood cell count
• low white blood cell count (neutropenia and leucopenia)
• low platelet count
• decreased appetite
• nerve inflammation causing numbness, weakness, tingling, or burning pain in arms and legs (peripheral neuropathy)
• nausea; vomiting; constipation
• dizziness
• headache
• changes in taste (dysgeusia)
• shortness of breath (dyspnoea)
• inflammation of the mouth or lips (stomatitis)
• hair loss
• feeling tired or weak

Common (may affect up to 1 in 10 people)

• low white blood cell count with fever (febrile neutropenia)
• low levels of lymphocytes, a type of white blood cell
• allergic reactions
• indigestion or heartburn (dyspepsia)
• blood clot in a deep vein, usually in the leg (venous thrombosis), which may cause symptoms such as leg pain or swelling
• failure to produce red blood cells (red cell aplasia), which may cause symptoms such as shortness of breath, tiredness, paleness, or rapid heartbeat

Uncommon (may affect up to 1 in 100 people)

• low red blood cells, white blood cells, and platelets (pancytopenia)

Inform your doctor immediately if you notice any of the side effects listed above.
Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store IMFINZI

IMFINZI is administered in a hospital or clinic, and the healthcare provider is responsible for
the storage of this medicine. The storage instructions are as follows:
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “Exp” and
on the label of the vial after “EXP”.
The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Store in the original packaging to protect the medicine from light.
Do not use this medicine if it is cloudy, shows a change in colour, or contains visible particles.
Do not store any unused portion of the infusion solution for later use. Unused medicine and waste material arising from this medicine should be disposed of in accordance with local regulations.

6. Package contents and other information

What IMFINZI contains
The active substance is durvalumab.
Each mL of concentrate for infusion solution 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 monohydrate of histidine, trehalose dihydrate, polysorbate 80 (E
433), water for injections.

Description of the appearance of IMFINZI and contents of the pack
IMFINZI concentrate for infusion solution (sterile concentrate) is a solution ranging from clear to opalescent, colourless to slightly yellow, without preservatives and free from visible particles.
It is available in packs containing 1 glass vial of 2.4 mL of concentrate or 1 glass vial of 10 mL of concentrate.

Marketing Authorisation Holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden

Manufacturer
AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje
Sweden

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
AstraZeneca S.A./N.V. UAB AstraZeneca Lietuva
Tel: +32 2 370 48 11 Tel: +370 5 2660550

България Luxembourg/Luxemburg
АстраЗенека България ЕООД AstraZeneca S.A./N.V.
Тел.: +359 24455000 Tél/Tel: +32 2 370 48 11

Česká republika Magyarország
AstraZeneca Czech Republic s.r.o. AstraZeneca Kft.
Tel: +420 222 807 111 Tel.: +36 1 883 6500

Danmark Malta
AstraZeneca A/S Associated Drug Co. Ltd
Tlf: +45 43 66 64 62 Tel: +356 2277 8000

Deutschland Nederland
AstraZeneca GmbH AstraZeneca BV
Tel: +49 40 809034100 Tel: +31 85 808 9900

Eesti Norge
AstraZeneca AstraZeneca AS
Tel: +372 6549 600 Tlf: +47 21 00 64 00

Ελλάδα Österreich
AstraZeneca A.E. AstraZeneca Österreich GmbH
Τηλ: +30 210 6871500 Tel: +43 1 711 31 0

España Polska
AstraZeneca Farmacéutica Spain, S.A. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 91 301 91 00 Tel.: +48 22 245 73 00

France Portugal
AstraZeneca AstraZeneca Produtos Farmacêuticos, Lda.
Tél: +33 1 41 29 40 00 Tel: +351 21 434 61 00

Hrvatska România
AstraZeneca d.o.o. AstraZeneca Pharma SRL
Tel: +385 1 4628 000 Tel: +40 21 317 60 41

Ireland Slovenija
AstraZeneca Pharmaceuticals (Ireland) DAC AstraZeneca UK Limited
Tel: +353 1609 7100 Tel: +386 1 51 35 600

Ísland Slovenská republika
Vistor AstraZeneca AB, o.z.
Sími: +354 535 7000 Tel: +421 2 5737 7777

Italia Suomi/Finland
AstraZeneca S.p.A. AstraZeneca Oy
Tel: +39 02 00704500 Puh/Tel: +358 10 23 010

Κύπρος Sverige
Αλέκτωρ Φαρµακευτική Λτδ AstraZeneca AB
Τηλ: +357 22490305 Tel: +46 8 553 26 000

Latvija
SIA AstraZeneca Latvija
Tel: +371 67377100

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu

The following information is intended for healthcare professionals only:

Preparation and administration of the infusion

• Parenteral medications should be inspected visually before administration to confirm the absence of particulate matter and discoloration. The concentrate is a solution ranging from clear to opalescent, colourless to slightly yellow, and free from visible particles. Discard the vial if the solution is cloudy, discoloured, or contains visible particles.
• Do not shake the vial.
• Withdraw the required volume from the vial(s) and transfer it into an intravenous infusion bag containing either 9 mg/mL (0.9%) sodium chloride solution for injection or 50 mg/mL (5%) glucose solution for injection, to prepare a diluted solution with a final concentration between 1 and 15 mg/mL. Mix the diluted solution gently by inverting.
• The solution should be used immediately after dilution. The diluted solution must not be frozen. Chemical and physical in-use stability has been demonstrated for up to 30 days at 2 °C - 8 °C and up to 24 hours at room temperature (up to 25 °C) from the time of preparation.
• From a microbiological standpoint, the prepared infusion solution should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2 °C - 8 °C or 12 hours at room temperature (up to 25 °C), unless dilution has taken place under controlled and validated aseptic conditions.
• If refrigerated, the intravenous infusion bags must be brought to room temperature before use. Administer the infusion solution intravenously over 1 hour using a sterile in-line filter of 0.2 or 0.22 micron with low protein binding.
• Do not co-administer other medicinal products using the same infusion line.
• IMFINZI is for single use. Discard any unused medicinal product remaining in the vial.

Any unused medicine and waste material derived from this medicine must be disposed of in accordance with
local regulations.