Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - imfinzi

Document Subject

Generated Narrative: MedicinalProductDefinition mpa8ab0a50af543bb09893d6d85fe7a719

identifier: http://ema.europa.eu/identifier/EU/1/18/1322/002 120 mg vial

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: IMFINZI 50 mg/ml concentrate for solution for infusion.

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-a8ab0a50af543bb09893d6d85fe7a719

identifier: http://ema.europa.eu/identifier/EU/1/18/1322/002 120 mg vial

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - imfinzi

Attesters

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

IMFINZI contains the active substance durvalumab which is a monoclonal antibody, a type of protein designed to recognise a specific target substance in the body. IMFINZI works by helping your immune system fight your cancer. IMFINZI is used to treat a type of lung cancer called non-small cell lung cancer (NSCLC) in adults. It is used alone when your NSCLC:

has spread within your lung and cannot be removed by surgery, and

has responded or stabilised after initial treatment with chemotherapy and radiotherapy. It is used in combination with tremelimumab and chemotherapy when your NSCLC:

has spread within both your lungs (and/or to other parts of the body), cannot be removed by surgery and

has shown no changes (mutations) in genes called EGFR (epidermal growth factor receptor) or ALK (anaplastic lymphoma kinase). IMFINZI in combination with chemotherapy is used to treat a type of lung cancer called extensive- stage small cell lung cancer (ES-SCLC) in adults. It is used when your SCLC:

has spread within your lungs (or to other parts of the body) and

has not previously been treated. IMFINZI in combination with chemotherapy is used in adults to treat a type of cancer of the bile ducts (cholangiocarcinoma) and gallbladder that are collectively referred to as biliary tract cancers (BTC). It is used when your BTC:

has spread within your bile ducts and gallbladder (or to other parts of the body). IMFINZI in combination with tremelimumab is used to treat a type of liver cancer called advanced or unresectable hepatocellular carcinoma (HCC) 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. If you have any questions about how IMFINZI works or why this medicine has been prescribed for you, ask your doctor or pharmacist. When IMFINZI is given in combination with other anti-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.

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, hole in the bowel;

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, abdominal pain, nausea and vomiting;

type 1 diabetes: symptoms may include high blood sugar, feeling more hungry or thirsty than usual, passing urine more often than usual, fast and deep breathing, confusion, or a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat;

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;

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 and constipation;

infusion-related reactions: symptoms may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness or fever;

inflammation of the brain (encephalitis) or inflammation of the membrane around the spinal cord and brain (meningitis): symptoms may include seizures, neck stiffness, headache, fever, chills, vomiting, eye sensitivity to light, confusion and sleepiness;

inflammation of the nerves: symptoms may include pain, weakness, and paralysis in the extremities (Guillain-Barr syndrome);

low number of platelets: symptoms may include bleeding (nose or gum bleeding) and/or bruising. 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 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. This includes herbal medicines and medicines obtained without a prescription. Pregnancy

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 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.

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

The recommended dose of IMFINZI is 10 mg per kg of your body weight every 2 weeks or 1 500 mg every 3 or 4 weeks.

Your doctor will give you IMFINZI through an infusion (drip) into your vein for about 1 hour.

Your doctor will decide how many treatments you need.

Depending on your type of cancer, IMFINZI may be given in combination with other anti- cancer medicines.

When IMFINZI is given in combination with tremelimumab and chemotherapy for your lung cancer, you will first be given tremelimumab followed by IMFINZI and then chemotherapy.

When IMFINZI is given in combination with chemotherapy for your lung cancer, you will first be given IMFINZI followed by chemotherapy.

When IMFINZI is given in combination with tremelimumab for your liver cancer, you will first be given tremelimumab followed by IMFINZI.

Please refer to the package leaflet of the other anti-cancer medicines in order to understand the use of these other medicines. If you have questions about these medicines, ask your doctor. 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. If you have any further questions about your treatment, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them. When you get IMFINZI, you can have some serious side effects (see section 2). Talk to your doctor straight away if you get any of the following side effects, that have been reported in clinical studies with patients receiving IMFINZI alone: Very common (may affect more than 1 in 10 people) infections of the upper respiratory tract underactive thyroid gland that can cause tiredness or weight gain cough diarrhoea stomach pain skin rash or itchiness fever joint pain (arthralgia) Common (may affect up to 1 in 10 people) serious lung infections (pneumonia) fungal infection in the mouth tooth and mouth soft tissue infections flu-like illness overactive thyroid gland that can cause fast heart rate or weight loss inflammation of the lungs (pneumonitis) hoarse voice (dysphonia) abnormal liver tests (aspartate aminotransferase increased; alanine aminotransferase increased) night sweats muscle pain (myalgia) abnormal kidney function tests (blood creatinine increased) painful urination (dysuria) swelling of the legs (oedema peripheral) reaction to the infusion of the medicine that can cause fever or flushing Uncommon (may affect up to 1 in 100 people) inflammation of thyroid gland (thyroiditis) decreased secretion of hormones produced by the adrenal glands that can cause tiredness scarring of lung tissue inflammation of the liver that can cause nausea or feeling less hungry (hepatitis) blistering of the skin inflammation of the gut or intestine (colitis) inflammation of the muscle (myositis) inflammation of the kidneys (nephritis) that can decrease the amount of your urine inflammation of the pancreas (pancreatitis) red, itchy, dry, scaly patches of thickened skin (psoriasis) Rare (may affect up to 1 in 1 000 people) a condition leading to high blood sugar levels (type 1 diabetes mellitus) underactive function of pituitary gland (hypopituitarism including diabetes insipidus) that can cause tiredness, an increase in the amount of your urine inflammation of the heart (myocarditis) a condition in which the muscles become weak and there is a rapid fatigue of the muscles (myasthenia gravis) inflammation of the membrane around the spinal cord and brain (meningitis) low number of platelets caused by an immune reaction (immune thrombocytopenia) Inflammation of the bladder (cystitis). Signs and symptoms may include frequent and/or painful urination, urge to pass urine, blood in urine, pain or pressure in lower abdomen. The following side effects have been reported in clinical studies in patients taking IMFINZI in combination with chemotherapy (the frequency and severity of side effects may vary depending on chemotherapeutic agents received): Very common (may affect more than 1 in 10 people) low number of white blood cells low number of red blood cells low number of platelets nausea; vomiting; constipation, stomach pain, diarrhoea abnormal liver tests (aspartate aminotransferase increased; alanine aminotransferase increased) hair loss rash, red raised rash, dry or itchy skin; inflammation of the skin fever feeling less hungry feeling tired or weak cough Common (may affect up to 1 in 10 people) low number of white blood cells with signs of fever underactive thyroid gland; overactive thyroid gland; inflammation of thyroid gland lack of energy; general feeling of discomfort or illness inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs (neuropathy peripheral) shortness of breath serious lung infections (pneumonia) tooth and mouth soft tissue infections swelling (oedema) swelling of legs (oedema peripheral) inflammation of the mouth or lips muscle pain (myalgia) inflammation of the lungs (pneumonitis) blood clot in the lung (pulmonary embolism) infection of the upper respiratory tract low number of red blood cells, white blood cells, and platelets (pancytopenia) decreased secretion of hormones produced by the adrenal glands that can cause tiredness inflammation of the liver that can cause nausea or feeling less hungry (hepatitis) abnormal kidney function tests (blood creatinine increased) painful urination (dysuria) reaction to the infusion of the medicine that can cause fever or flushing fungal infection in the mouth joint pain (arthralgia) Uncommon (may affect up to 1 in 100 people) flu-like illness type 1 diabetes mellitus hoarse voice (dysphonia) scarring of lung tissue inflammation of the gut or intestine (colitis) night sweats red, itchy, dry, scaly patches of thickened skin (psoriasis) inflammation of the pancreas (pancreatitis) blistering of the skin The following side effects have been reported in clinical studies in patients taking IMFINZI in combination with tremelimumab and platinum-based chemotherapy (the frequency and severity of side effects may vary depending on chemotherapeutic agents received): Very common (may affect more than 1 in 10 people) infection of the upper respiratory tract lung infection (pneumonia) low number of red blood cells low number of white blood cells low number of platelets underactive thyroid gland that can cause tiredness or weight gain decrease in appetite cough nausea diarrhoea constipation vomiting abnormal liver tests (aspartate aminotransferase increased; alanine aminotransferase increased) hair loss skin rash itchiness joint pain (arthralgia) feeling tired or weak fever Common (may affect up to 1 in 10 people) flu-like illness fungal infection in the mouth low number of white blood cells with signs of fever low number of red blood cells, white blood cells, and platelets (pancytopenia) overactive thyroid gland that can cause fast heart rate or weight loss decreased levels of hormones produced by the adrenal glands that can cause tiredness underactive pituitary gland; inflammation of pituitary gland inflammation of thyroid gland (thyroiditis) inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs (neuropathy peripheral) inflammation of the lungs (pneumonitis) hoarse voice (dysphonia) inflammation of the mouth or lips abnormal pancreas function tests stomach pain inflammation of the gut or intestine (colitis) inflammation of the pancreas (pancreatitis) inflammation of the liver that can cause nausea or feeling less hungry (hepatitis) muscle pain (myalgia) abnormal kidney function tests (blood creatinine increased) painful urination (dysuria) swelling of legs (oedema peripheral) reaction to the infusion of the medicine that can cause fever or flushing Uncommon (may affect up to 1 in 100 people) tooth and mouth soft tissue infections low number of platelets 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 night sweats inflammation of the skin inflammation of the muscles (myositis) inflammation of the muscles and vessels inflammation of the kidneys (nephritis) that can decrease the amount of your urine inflammation of the bladder (cystitis). Signs and symptoms may include frequent and/or painful urination, urge to pass urine, blood in urine, pain or pressure in lower abdomen. Other side effects that have been reported with frequency not known (cannot be estimated from the available data) a condition in which the muscles become weak and there is a rapid fatigue of the muscles (myasthenia gravis) inflammation of the nerves (Guillain-Barr syndrome) inflammation of the membrane around the spinal cord and brain (meningitis) hole in the bowel (intestinal perforation) The following side effects have been reported in clinical studies in patients taking IMFINZI in combination with tremelimumab: Very common (may affect more than 1 in 10 people) underactive thyroid gland that can cause tiredness or weight gain cough diarrhoea stomach pain abnormal liver tests (aspartate aminotransferase increased; alanine aminotransferase increased) skin rash itchiness fever swelling of legs (oedema peripheral) Common (may affect up to 1 in 10 people) infection of the upper respiratory tract lung infection (pneumonia) flu-like illness tooth and mouth soft tissue infections overactive thyroid gland that can cause fast heart rate or weight loss inflammation of the thyroid gland (thyroiditis) decreased secretion of hormones produced by the adrenal glands that can cause tiredness inflammation of the lungs (pneumonitis) abnormal pancreas function tests inflammation of the gut or intestine (colitis) inflammation of the pancreas (pancreatitis) inflammation of the liver (hepatitis) inflammation of the skin night sweats muscle pain (myalgia) abnormal kidney function test (blood creatinine increased) painful urination (dysuria) reaction to the infusion of the medicine that can cause fever or flushing Uncommon (may affect up to 1 in 100 people) fungal infection in the mouth underactive pituitary gland; inflammation of pituitary gland a condition in which the muscles become weak and there is a rapid fatigue of the muscles (myasthenia gravis) inflammation of the membrane around the spinal cord and brain (meningitis) inflammation of the heart (myocarditis) hoarse voice (dysphonia) scarring of lung tissue blistering of the skin inflammation of the muscles (myositis) inflammation of the muscles and vessels inflammation of the kidneys (nephritis) that can decrease the amount of your urine Other side effects that have been reported with frequency not known (cannot be estimated from the available data) low number of platelets with signs of excessive bleeding and bruising (immune thrombocytopenia) diabetes insipidus type 1 diabetes mellitus inflammation of the nerves: (Guillain-Barr syndrome) inflammation of the brain (encephalitis) hole in the bowel (intestinal perforation) inflammation of the bladder (cystitis). Signs and symptoms may include frequent and/or painful urination, urge to pass urine, blood in urine, pain or pressure in lower abdomen. Talk to your doctor straight away if you get any of the side effects listed above. 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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

IMFINZI will be given to you in a hospital or clinic and the healthcare professional will be responsible for its storage. The storage details 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 and vial label after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 C to 8 C). Do not freeze. Store in the original package in order to protect from light. Do not use if this medicine is cloudy, discoloured or contains visible particles. Do not store any unused portion of the infusion solution for re-use. Any unused medicine or waste material should be disposed of in accordance with local requirements.

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 (sterile concentrate) is a 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. Marketing Authorisation Holder AstraZeneca AB SE-151 85 S dert lje Sweden Manufacturer AstraZeneca AB G rtunav gen SE-152 57 S dert lje Sweden For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660

.: +359 24455Luxembourg/Luxemburg AstraZeneca S.A./N.V. T l/Tel: +32 2 370 48 esk republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 Magyarorsz g AstraZeneca Kft. Tel.: +36 1 883 6Danmark AstraZeneca A/S Tlf: +45 43 66 64 Malta Associated Drug Co. Ltd Tel: +356 2277 8Deutschland AstraZeneca GmbH Tel: +49 40 809034Nederland AstraZeneca BV Tel: +31 79 363 2Eesti AstraZeneca Tel: +372 6549 Norge AstraZeneca AS Tlf: +47 21 00 64
AstraZeneca A.E. : +30 210 6871 sterreich AstraZeneca sterreich GmbH Tel: +43 1 711 31 0 Espa a AstraZeneca Farmac utica Spain, S.A. Tel: +34 91 301 91 Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 France AstraZeneca T l: +33 1 41 29 40 Portugal AstraZeneca Produtos Farmac uticos, Lda. Tel: +351 21 434 61 Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 Rom nia AstraZeneca Pharma SRL Tel: +40 21 317 60 Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 sland Vistor hf. S mi: +354 535 7Slovensk republika AstraZeneca AB, o.z. Tel: +421 2 5737 7Italia AstraZeneca S.p.A. Tel: +39 02 00704Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23

: +357 22490Sverige AstraZeneca AB Tel: +46 8 553 26 Latvija SIA AstraZeneca Latvija Tel: +371 67377United Kingdom (Northern Ireland) AstraZeneca UK Ltd Tel: +44 1582 836 This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: