Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - besponsa

Document Subject

Generated Narrative: MedicinalProductDefinition mp74d9353bd9b4c9e405e398e02bc5f8ef

identifier: http://ema.europa.eu/identifier/EU/1/17/1200/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: BESPONSA 1 mg powder for 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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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-74d9353bd9b4c9e405e398e02bc5f8ef

identifier: http://ema.europa.eu/identifier/EU/1/17/1200/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - besponsa

Attesters

What is in this leaflet

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

The active substance in BESPONSA is inotuzumab ozogamicin. This belongs to a group of medicines that target cancer cells. These medicines are called antineoplastic agents. BESPONSA is used to treat adults with acute lymphoblastic leukaemia. Acute lymphoblastic leukaemia is a cancer of blood where you have too many white blood cells. BESPONSA is intended for the treatment of acute lymphoblastic leukaemia for adult patients who have previously tried other treatments and for whom those treatments have failed. BESPONSA acts by attaching to cells with a protein called CD22. Lymphoblastic leukaemia cells have this protein. Once attached to the lymphoblastic leukaemia cells, the medicine delivers a substance into the cells that interferes with the cells DNA and eventually kills them.

Do not use BESPONSA if you

are allergic to inotuzumab ozogamicin or any of the other ingredients of this medicine (listed in section 6).

have previously had severe venoocclusive disease (a condition in which the blood vessels in the liver become damaged and blocked by blood clots) which was confirmed or have ongoing venoocclusive disease.

have serious ongoing liver disease, e.g., cirrhosis (a condition in which the liver does not function properly due to long-term damage), nodular regenerative hyperplasia (a condition with signs and symptoms of portal hypertension that can be caused by chronic use of medicines), active hepatitis (a disease characterised by inflammation of the liver). Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given BESPONSA if you:

have a history of liver problems or liver diseases or if you have signs and symptoms of a serious condition called hepatic venoocclusive disease, a condition in which the blood vessels in the liver become damaged and blocked by blood clots. Venoocclusive disease may be fatal and is associated with rapid weight gain, pain in the upper right side of your abdomen (belly), increase in the size of the liver, build-up of fluid causing abdominal swelling, and blood tests showing increases in bilirubin and/or liver enzymes (that may result in yellowing of the skin or eyes). This condition may occur during treatment with BESPONSA or after subsequent treatment with a stem cell transplant. A stem cell transplant is a procedure to transplant another person s stem cells (cells which develop into new blood cells) into your bloodstream. This procedure may take place if your disease responds completely to treatment.

have signs or symptoms of a low number of blood cells known as neutrophils (sometimes accompanied with fever), red blood cells, white blood cells, lymphocytes, or a low number of blood components known as platelets; these signs and symptoms include developing an infection or fever or bruising easily or getting frequent nose bleeds.

have signs and symptoms of an infusion related reaction, such as fever and chills or breathing problems during or shortly after the BESPONSA infusion.

have signs and symptoms of tumour lysis syndrome, which may be associated with symptoms in the stomach and intestines (for example, nausea, vomiting, diarrhoea), heart (for example, changes in the rhythm), kidney (for example, decreased urine, blood in urine), and nerves and muscles (for example, muscular spasms, weakness, cramps), during or shortly after the BESPONSA infusion.

have a history of, or tendency to have, QT interval prolongation (a change in electrical activity of the heart that can cause serious irregular heart rhythms), are taking medicines that are known to prolong QT interval, and/or have abnormal electrolyte (e.g., calcium, magnesium, potassium) levels.

have elevations in amylase or lipase enzymes that may be a sign of problems with your pancreas or liver and gallbladder or bile ducts. Tell your doctor, pharmacist or nurse immediately if you became pregnant during the period of treatment with BESPONSA and for up to 8 months after finishing treatment. Your doctor will take regular blood tests to monitor your blood counts during treatment with BESPONSA. See also section 4. During treatment, especially in the first few days after starting treatment, your white blood cell count may be severely lowered (neutropenia), which may be accompanied by fever (febrile neutropenia). During treatment, especially in the first few days after starting treatment, you may have raised liver enzymes. Your doctor will take regular blood tests to monitor your liver enzymes during treatment with BESPONSA. Treatment with BESPONSA may prolong QT interval (a change in electrical activity of the heart that can cause serious irregular heart rhythms). Your doctor will take an electrocardiogram (ECG) and blood tests to measure electrolytes (e.g., calcium, magnesium, potassium) before the first dose of BESPONSA and repeat these tests during treatment. See also section 4. Your doctor will also monitor for signs and symptoms of tumour lysis syndrome after you receive BESPONSA. See also section 4. Children and adolescents BESPONSA should not to be used in children and adolescents under 18 years of age because limited data are available in this population. Other medicines and BESPONSA Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine. Contraception You must avoid becoming pregnant or fathering a child. Women must use effective contraception during treatment and for at least 8 months after the final dose of treatment. Men must use effective contraception during treatment and for at least 5 months after the final dose of treatment. Pregnancy The effects of BESPONSA in pregnant women are not known, but based on its mechanism of action BESPONSA may harm your unborn baby. You should not use BESPONSA during pregnancy, unless your doctor thinks that it is the best medicine for you. Contact your doctor immediately if you or your partner becomes pregnant during the period of treatment with this medicine. Fertility Men and women should seek advice regarding fertility preservation before treatment. Breast-feeding If you need treatment with BESPONSA, you must stop breast-feeding during treatment and for at least 2 months after treatment. Talk to your doctor. Driving and using machines If you feel unusually tired (this is a very common side effect of BESPONSA), you should not drive or use machines. BESPONSA contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 1 mg inotuzumab ozogamicin, that is to say essentially sodium-free.

Always use this medicine exactly as your doctor, pharmacist, or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure. How BESPONSA is given

Your doctor will decide on the correct dose.

A doctor or nurse will give you BESPONSA through a drip in your vein (intravenous infusion) which will run for 1 hour.

Each dose is given weekly and each treatment cycle is 3 doses.

If the medicine works well and you are going to receive a stem cell transplant (see section 2), you may receive 2 cycles or a maximum of 3 cycles of treatment.

If the medicine works well, but you are not going to receive a stem cell transplant (see section 2), you may receive up to a maximum of 6 cycles of treatment.

If you do not respond to the medicine within 3 cycles, your treatment will be stopped.

Your doctor may change your dose, interrupt, or completely stop treatment with BESPONSA if you have certain side effects.

Your doctor may lower your dose based on your response to treatment.

Your doctor will do blood tests during the treatment to check for side effects and for response to treatment. If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse. Medicines given before treatment with BESPONSA Before your treatment with BESPONSA, you will be given other medicines (pre-medications) to help reduce infusion reactions and other possible side effects. These may include corticosteroids (e.g., dexamethasone), antipyretics (medicines to reduce fever), and antihistamines (medicines to reduce allergic reactions). Before your treatment with BESPONSA, you may be given medicines and be hydrated to prevent tumour lysis syndrome from occurring. Tumour lysis syndrome is associated with a variety of symptoms in the stomach and intestines (for example, nausea, vomiting, diarrhoea), heart (for example, changes in the rhythm), kidney (for example, decreased urine, blood in urine), and nerves and muscles (for example, muscular spasms, weakness, cramps).

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these side effects may be serious. Tell your doctor immediately if you have signs and symptoms of any of the following serious side effects:

infusion related reaction (see section 2); signs and symptoms include fever and chills or breathing problems during or shortly after the BESPONSA infusion.

venoocclusive liver disease (see section 2); signs and symptoms include rapid weight gain, pain in the upper right side of your abdomen, increase in the size of the liver, accumulation of fluid causing abdominal swelling, and increases in bilirubin and/or liver enzymes (that may result in yellowing of the skin or eyes).

low number of blood cells known as neutrophils, (sometimes accompanied with fever), red blood cells, white blood cells, lymphocytes, or low number of blood components known as platelets (see section 2); signs and symptoms include developing an infection or fever or bruising easily or getting nose bleeds on a regular basis.

tumour lysis syndrome (see section 2); this may be associated with a variety of symptoms in the stomach and intestines (for example, nausea, vomiting, diarrhoea), heart (for example, changes in the rhythm), kidney (for example, decreased urine, blood in urine), and nerves and muscles (for example, muscular spasms, weakness, cramps).

QT interval prolongation (see section 2); signs and symptoms include a change in electrical activity of the heart that can cause serious irregular heart rhythms. Tell your doctor if you have symptoms, such as dizziness, lightheadedness or fainting. Other side effects may include: Very common: may affect more than 1 in 10 people

Infections

Reduced number of white blood cells which may result in general weakness and a tendency to develop infections

Reduced number of lymphocytes (a type of white blood cells) which may result in a tendency to develop infections

Reduced number of red blood cells which may result in fatigue and shortness of breath

Decreased appetite

Headache

Bleeding

Pain in the abdomen

Vomiting

Diarrhoea

Nausea

Mouth inflammation

Constipation

Raised bilirubin level which may result in a yellowish colour in the skin, eyes, and other tissues

Fever

Chills

Fatigue

High levels of liver enzymes (which can be indicators of liver injury) in the blood Common: may affect up to 1 in 10 people

Reduction in the number of various types of blood cells

Excess of uric acid in the blood

Excessive accumulation of fluid in the abdomen

Swelling of the abdomen

Changes in heart rhythm (may show on electrocardiogram)

Abnormally high levels of amylase (an enzyme needed for digestion and conversion of starch into sugars) in the blood

Abnormally high levels of lipase (an enzyme needed to process dietary fat) in the blood

Hypersensitivity Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

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 vial label and carton after EXP. The expiry date refers to the last day of that month. Unopened vial

Store in a refrigerator (2 C-8 C).

Store in the original carton in order to protect from light.

Do not freeze. Reconstituted solution

Use immediately or store in a refrigerator (2 C-8 C) for up to 4 hours.

Protect from light.

Do not freeze. Diluted solution

Use immediately or store at room temperature (20 C-25 C) or in a refrigerator (2 C-8 C). The maximum time from reconstitution through the end of administration should be 8 hours, with 4 hours between reconstitution and dilution.

Protect from light.

Do not freeze. This medicine should be inspected visually for particulate matter and discolouration prior to administration. If particles or discolouration are observed, do not use. Do not throw away any medicines via wastewater or household waste. Ask your doctor how to throw away medicines you no longer use. These measures will help protect the environment.

What BESPONSA contains

The active substance is inotuzumab ozogamicin. Each vial contains 1 mg inotuzumab ozogamicin. After reconstitution, 1 mL of solution contains 0.25 mg inotuzumab ozogamicin.

The other ingredients are sucrose, polysorbate 80, sodium chloride, and tromethamine (see section 2). What BESPONSA looks like and contents of the pack BESPONSA is a powder for concentrate for solution for infusion (powder for concentrate). Each pack of BESPONSA contains:

1 glass vial containing a white to off-white lyophilised cake or powder. Marketing Authorisation Holder Pfizer Europe MA EEIG Boulevard de la Plaine 1050 Bruxelles Belgium Manufacturer Pfizer Service Company BV Hoge Wei B-1930, Zaventem Belgium For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgique/Belgi /Belgien Luxembourg/Luxemburg Pfizer NV/SA T l/Tel: +32 (0)2 554 62 Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel: + 370 52 51 4 ,

.: +359 2 970 4Magyarorsz g Pfizer Kft. Tel: +36-1-488-37- esk republika Pfizer, spol. s r.o. Tel: +420 283 004 Malta Vivian Corporation Ltd. Tel: +356 21344Danmark Pfizer ApS Tlf: +45 44 20 11 Nederland Pfizer bv Tel: +31 (0)800 63 34 Deutschland Pfizer Pharma GmbH Tel: +49 (0)30 550055 51Norge Pfizer AS Tlf: +47 67 52 61 Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7 sterreich Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15-0

Pfizer A.E. : +30 210 6785 Polska Pfizer Polska Sp. z o.o. Tel: +48 22 335 61 Espa a Pfizer, S.L. Tel: +34 91 490 99 Portugal Laborat rios Pfizer, Lda. Tel: +351 21 423 5France Pfizer Tel: +33 (0)1 58 07 34 Rom nia Pfizer Romania S.R.L. Tel: +40 (0) 21 207 28 Hrvatska Pfizer Croatia d.o.o. Tel: + 385 1 3908 Slovenija Pfizer Luxembourg SARL Pfizer, podru nica za svetovanje s podro ja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0)1 52 11 Ireland Pfizer Healthcare Ireland Tel: 1800 633 363 (toll free) +44 (0)1304 616Slovensk republika Pfizer Luxembourg SARL, organiza n zlo ka Tel: + 421 2 3355 5 sland Icepharma hf. S mi: +354 540 8Suomi/Finland Pfizer Oy Puh/Tel: +358 (0)9 43 00 Italia Pfizer S.r.l. Tel: +39 06 33 18 Sverige Pfizer AB Tel: +46 (0)8 550-520
Pfizer . . (Cyprus Branch) : +357 22 817United Kingdom (Northern Ireland) Pfizer Limited Tel: +44 (0) 1304 616Latvija Pfizer Luxembourg SARL fili le Latvij Tel: + 371 670 35 This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: