Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - lunsumio

Document Subject

Generated Narrative: MedicinalProductDefinition mp8921696d13cf74e5c9697718160f9f03

identifier: http://ema.europa.eu/identifier/EU/1/22/1649/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Lunsumio 1 mg concentrate for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

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-8921696d13cf74e5c9697718160f9f03

identifier: http://ema.europa.eu/identifier/EU/1/22/1649/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - lunsumio

Attesters

What is in this leaflet

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

Lunsumio contains the active substance mosunetuzumab, which is a type of antibody. This is a cancer medicine. It is used to treat adults who have a blood cancer called follicular lymphoma (FL).

In FL, a type of white blood cells called B cells become cancerous. The abnormal B cells do not work properly and grow too quickly, crowding out the normal B cells in the bone marrow and lymph nodes that help protect you from infection.

Lunsumio is given to patients who have tried at least two previous treatments for FL, when either the cancer has not responded to them, or it has come back again.

How Lunsumio works

The active substance in Lunsumio, mosunetuzumab, is a monoclonal antibody, a type of protein that attaches to specific targets in the body. In this case, mosunetuzumab attaches to a target substance found on B cells, including the cancerous B cells, and another target found on T cells , a different type of white blood cell. T cells are another part of the body s defences that can destroy invading cells. By attaching the two cells together like a bridge, Lunsumio encourages the T cells to destroy the cancerous B cells. This helps control the FL and prevent its spread.

You must not be given Lunsumio

• if you are allergic to mosunetuzumab or any of the other ingredients of this medicine (listed in section 6).

If you are not sure, talk to your doctor or nurse before you are given Lunsumio.

Warnings and precautions

Talk to your doctor or nurse before you are given Lunsumio if any of the following apply to you (or you are not sure):

• you have ever had heart, lung or kidney problems
• you have an infection, or have had an infection in the past which lasted a long time or keeps coming back
• you are due to have a vaccine or you know you may need to have one in the near future.

If any of the above apply to you (or you are not sure), talk to your doctor or nurse before having this medicine.

Tell your doctor straight away if you get symptoms of any of the side effects listed below during or after treatment with Lunsumio. You may need additional medical treatment. The symptoms of each side effect are listed in section 4. * Cytokine release syndrome a condition associated with medicines that stimulate T cells.

Before each infusion, you may be given medicines, which help reduce possible side effects of cytokine release syndrome.

• Tumour lysis syndrome some people may get unusual levels of some salts in the blood caused by the fast breakdown of cancer cells during treatment.

Your doctor or nurse will do blood tests to check for this condition. Before each infusion, you should be well-hydrated and may be given medicines that can help reduce high levels of uric acid. These may help reduce possible side effects of tumour lysis syndrome.

• Tumour flare as your cancer is destroyed, it may react and appear to get worse this is called tumour flare reaction .
• Infections you may get signs of infection, which can vary depending on where in the body the infection is.

Children and adolescents

This medicine should not be used in children or adolescents under the age of 18. This is because there is no information about use in this age group.

Other medicines and Lunsumio

Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.

Pregnancy and breast-feeding

It is important to tell your doctor before and during treatment if you are pregnant, think you may be pregnant, or are planning to get pregnant. This is because Lunsumio may affect your unborn baby.

• Do not use Lunsumio during pregnancy, unless after discussion with your doctor, it is agreed that the benefits of treatment outweigh any risk to the unborn baby.

Contraception

Women who could become pregnant must use effective contraception during treatment and for 3 months after the last dose of Lunsumio.

• Talk to your doctor or nurse about suitable methods of contraception. Breast-feeding

You must not breast-feed during and for at least 3 months after your last treatment. This is because it is not known whether any Lunsumio passes into breast milk and could therefore affect the baby.

Driving and using machines

Lunsumio has minor influence on your ability to drive, cycle or use any tools or machines. If you feel any symptoms that may affect your ability to drive, do not drive, cycle or use tools or machines until the reaction stops. See section 4 for more information about side effects.

Lunsumio is given under the supervision of a doctor experienced in giving such treatments. Follow the treatment schedule explained to you by your doctor. Check with your doctor if you are not sure.

How Lunsumio is given

It is given into a vein, as a drip (infusion).

• It is given over 4 hours during the first cycle. Each cycle is 21 days and in the first cycle, you will be given the 4 hour infusion on day 1, day 8 and day 15. * If side effects are not too severe, the dose may be given over 2 hours during the following cycles.

Medicines given before Lunsumio treatment

You may be given other medicines 30 to 60 minutes before you are given Lunsumio. This is to help prevent infusion reactions and fever. These other medicines may include:

• Corticosteroids such as dexamethasone or methylprednisolone
• Paracetamol
• An antihistamine - such as diphenhydramine

How much Lunsumio is given

Lunsumio is normally given in cycles of 21 days. The recommended treatment duration is at least 8 treatment cycles. However, depending on side effects and how the disease responds to treatment, you may be given up to 17 cycles.

In cycle 1, you will be given 3 doses of Lunsumio in the 21 days:

• Day 1: 1 mg
• Day 8: 2 mg
• Day 15: 60 mg

In cycle 2, you will be given just one dose:

• Day 1: 60 mg

In cycles 3 to 17, you will be given just one dose:

• Day 1: 30 mg

If you miss a dose of Lunsumio

If you miss an appointment, make another one straight away. For the treatment to be fully effective, it is very important not to miss a dose.

If you stop receiving Lunsumio

Do not stop treatment with Lunsumio unless you have discussed this with your doctor. This is because stopping treatment may make your condition worse.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Tell your doctor straight away if you notice any of the symptoms of the following serious side effects. You may only get one or some of these symptoms.

Cytokine release syndrome

Symptoms can include:

• fever (38 C or higher)
• chills or shaking chills
• cold or pale clammy skin
• difficulty breathing
• feeling dizzy or lightheaded
• fast or uneven heartbeat
• confusion
• feeling very tired or weak
• fainting
• blurred vision
• headache.

Tumour lysis syndrome

Symptoms can include:

• fever
• chills
• feeling or being sick (nausea and vomiting)
• confusion
• being short of breath
• fits (seizures)
• uneven heartbeat
• dark or cloudy urine
• unusual tiredness
• muscle or joint pain.

Shown in blood tests

• increase in potassium, phosphate or uric acid which can cause kidney problems (part of tumour lysis syndrome)

Tumour flare

Symptoms can include:

• tender swollen lymph nodes
• chest pain
• cough or difficulty breathing easily
• pain at the site of the tumour.

Infections

Symptoms can include:

• fever
• cough
• chest pain
• tiredness
• shortness of breath
• painful rash
• sore throat
• burning pain when passing urine
• feeling weak or generally unwell.

If you have any of these symptoms after treatment with Lunsumio, tell your doctor straight away. You may need medical treatment.

Other side effects

Very common: may affect more than 1 in 10 people

• Rash
• Itchy skin
• Dry skin
• Diarrhoea
• Headache
• Fever
• Chills
• Cytokine release syndrome Shown in blood tests
• Low levels of some white blood cells (neutropenia)
• Low number of red blood cells, which can cause tiredness and shortness of breath
• Low platelet count, which may make you more likely to bruise or bleed (thrombocytopenia)
• Low level of phosphate, potassium or magnesium
• High level of alanine aminotransferase in the blood

Common: may affect up to 1 in 10 people

• Lung infection
• Infection of upper airways (infection of nose, throat, sinuses)
• Urinary tract infection
• Fever due to low levels of neutrophils (a type of white blood cell)
• Tumour flare Shown in blood tests
• Increased levels of liver enzymes, which may be a sign of liver problems

Uncommon: may affect up to 1 in 100 people

• A rapid breakdown of tumour cells resulting in chemical changes in the blood and damage to organs, including the kidneys, heart, and liver (tumour lysis syndrome)

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.

Lunsumio will be stored by the healthcare professionals at the hospital or clinic. The storage details that they must take account of 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 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.

• The diluted solution should not be kept more than 24 hours at 2 C 8 C and 24 hours at ambient temperature (9 C 30 C).

• Keep the container in the outer carton in order to protect from light.

Your healthcare professional will dispose of any unneeded medicine appropriately. These measures will help protect the environment.

What Lunsumio contains

• The active substance is mosunetuzumab.
• Lunsumio 1 mg: Each vial contains 1 milligram (mg) mosunetuzumab in 1 mL at a concentration of 1 mg/mL.
• Lunsumio 30 mg: Each vial contains 30 milligrams (mg) mosunetuzumab in 30 mL at a concentration of 1 mg/mL.
• The other ingredients are: L-histidine, L-methionine, acetic acid, sucrose, polysorbate (E432), water for injections.

What Lunsumio looks like and contents of the pack

Lunsumio is a concentrate for solution for infusion (sterile concentrate). It is a clear, colourless liquid provided in a glass vial.

Each pack of Lunsumio contains one vial.

Marketing Authorisation Holder

Roche Registration GmbH
Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany

Manufacturer

Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany

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

Belgi /Belgique/Belgien N.V. Roche S.A. T l/Tel: +32 (0) 2 525 82 Lietuva UAB Roche Lietuva
Tel: +370 5 2546

: +359 2 474 54 Luxembourg/Luxemburg (Voir/siehe Belgique/Belgien)

esk republika Roche s. r. O. Tel: +420 - 2 20382Magyarorsz g Roche (Magyarorsz g) Kft. Tel: +36 1 279 4Danmark Roche Pharmaceuticals A/S Tlf: +45 - 36 39 99 Malta Irreferi g all-Irlanda
Deutschland Roche Pharma AG Tel: +49 (0) 7624 Nederland Roche Nederland B.V. Tel: +31 (0) 348 438Eesti Roche Eesti O
Tel: + 372 - 6 177 Norge Roche Norge AS Tlf: +47 - 22 78 90
Roche (Hellas) A.E. : +30 210 61 66 sterreich Roche Austria GmbH Tel: +43 (0) 1 27Espa a Roche Farma S.A. Tel: +34 - 91 324 81 Polska Roche Polska Sp.z o.o. Tel: +48 - 22 345 18 France Roche T l: +33 (0) 1 47 61 40 Portugal Roche Farmac utica Qu mica, Lda Tel: +351 - 21 425 70 Hrvatska Roche d.o.o. Tel: +385 1 4722 Rom nia Roche Rom nia S.R.L. Tel: +40 21 206 47 Ireland Roche Products (Ireland) Ltd. Tel: +353 (0) 1 469 0Slovenija Roche farmacevtska dru ba d.o.o. Tel: +386 - 1 360 26 sland Roche Pharmaceuticals A/S c/o Icepharma hf S mi: +354 540 8Slovensk republika Roche Slovensko, s.r.o. Tel: +421 - 2 52638Italia Roche S.p.A. Tel: +39 - 039 2Suomi/Finland Roche Oy Puh/Tel: +358 (0) 10 554
. . & . : +357 - 22 76 62 Sverige Roche AB Tel: +46 (0) 8 726 1Latvija Roche Latvija SIA Tel: +371 - 6 7039United Kingdom (Northern Ireland) Roche Products (Ireland) Ltd. Tel: +44 (0) 1707 366This leaflet was last revised in

This medicine has been given conditional approval . This means that there is more evidence to come about this medicine.

The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: