Prospect: information for the patient

Lunsumio 1 mg concentrate for infusion solution

Lunsumio 30 mg concentrate for infusion solution

mosunetuzumab

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospectus carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus. See section 4.

Lunsumio contains the active ingredient mosunetuzumab, which is a class of antibody. This is an oncological medication. It is used to treat adults with a blood cancer called follicular lymphoma (FL).

In FL, a type of white blood cells called ‘B cells’ become cancerous. Abnormal B cells do not function properly and grow very quickly, displacing normal B cells in the bone marrow and lymph nodes that help protect you from infections.

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

How Lunsumio works

The active ingredient of Lunsumio, mosunetuzumab, is a monoclonal antibody, a type of protein that binds to specific targets in the body. In this case, mosunetuzumab binds to a target found in B cells, including cancerous B cells, and another target found in ‘T cells’, a different type of white blood cell. T cells are another part of the body's defenses that can destroy by invading cells, binding the two cells together as a bridge. Lunsumio encourages T cells to destroy cancerous B cells. This helps control FL and prevent its progression.

You should not be given Lunsumio

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

If you are unsure, speak with your doctor or nurse before using Lunsumio.

Warnings and precautions

Consult your doctor or nurse before Lunsumio is administered if you have any of the following (or are unsure):

• any history of heart, lung, or kidney problems
• you have an infection, or have had an infection in the past that lasted a long time or persists
• you need to get a vaccine or know that you will need one in the near future

If you have any of the above (or are unsure), contact your doctor or nurse before Lunsumio is administered.

Contact your doctor immediately if you experience symptoms of any of the following adverse effects listed below during or after treatment with Lunsumio. You may need additional medical treatment. The symptoms of each adverse effect are listed in section 4.

• Cytokine Release Syndrome (CRS)– is a condition associated with medications that stimulate T cells.

• Before each infusion, you should be given medications to help reduce the possible adverse effects of cytokine release syndrome.
• Lymphohistiocytosis is a condition where the immune system produces too many cells that fight infections, called histiocytes and lymphocytes. The signs and symptoms can overlap with CRS, your doctor will check if you have this condition if your CRS does not respond to treatment or lasts longer than expected.

• Immune Effector Cell-Associated Neurotoxicity (ICANS)– is a condition associated with reactions in the nervous system. Symptoms include feeling confused, memory problems, language or judgment problems, disorientation, and confusion, often accompanied by hallucinations (seeing, hearing, or feeling things that are not there), and being unable to concentrate.
• Tumor Lysis Syndrome– some people may experience unusual levels of certain salts in the blood– caused by the rapid depletion 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 given medications that may help reduce high levels of uric acid. These may help reduce the possible adverse effects of tumor lysis syndrome.

• Tumor flare– since your cancer is being destroyed, you may react and appear to have a worsening tumor– this is called “tumor flare reaction”
• Infections– you may have signs of infection, which vary depending on where the infection is in the body.

Children and adolescents

This medication should not be given to children or adolescents under 18 years old. This is because there is no information on its use in this age group.

Other medications and Lunsumio

Inform your doctor if you are taking, have taken recently, or may need to take any other medication. This includes medications obtained without a prescription and herbal remedies.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. This is because Lunsumio may affect your unborn fetus.

• Do not use Lunsumio during pregnancy, unless after speaking with your doctor you agree that the benefits of treatment outweigh any risk to the unborn child.

Contraception

Women who may become pregnant should use effective contraceptive methods during treatment–and for 3 months after the last dose of Lunsumio.

• Speak with your doctor or nurse about suitable contraceptive methods.

Breastfeeding

You should not breastfeed during and for 3 months after your last treatment. This is because it is not known if anything of Lunsumio is excreted in breast milk and may therefore affect the baby.

Driving and operating machinery

The influence of Lunsumio on the ability to drive and operate machinery is important. Due to the possible symptoms of ICANS, you should be careful while driving, cycling, or operating heavy or potentially hazardous machinery. If you currently experience such symptoms, avoid these activities and contact your doctor, nurse, or pharmacist. See section 4 for more information on adverse effects.

Lunsumio is administered under the supervision of an experienced doctor who has given these treatments. Follow the treatment schedule that your doctor has explained to you. In case of doubt, consult your doctor again.

How Lunsumio is Administered

It is administered through a vein, as an infusion.

• It is administered for 4 hours in the first cycle. Each cycle lasts 21 days, and in the first cycle, the infusion will be administered for 4 hours on day 1, day 8, and day 15.
• If the side effects are not too severe, the dose may be administered for 2 hours in the following cycles.

Medicines Administered Before Treatment with Lunsumio

You must be administered other medicines 30 to 60 minutes before receiving Lunsumio. This is to help prevent reactions with the infusion and fever. These other medicines may include:

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

How Much Lunsumio is Administered

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

In Cycle 1, you will be administered 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 administered only one dose:

• Day 1: 60 mg

In Cycles 3 to 17, you will be administered only one dose:

• Day 1: 30 mg

If You Miss a Dose of Lunsumio

If you miss an appointment, ask for another one as soon as possible. To make the treatment completely effective, it is very important not to miss any dose.

If You Interrupt Treatment with Lunsumio

Do not interrupt treatment with Lunsumio unless you have talked to your doctor. This is because interrupting treatment may make your condition worse.

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

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

Severe side effects

Talk to your doctor immediately if you notice any of the following severe side effects. You may only have one or some of these symptoms.

Cytokine release syndrome

The symptoms may include:

• fever (38°C or higher)
• chills or shaking with chills
• cool or pale and moist skin
• difficulty breathing
• sensation of dizziness
• rapid or irregular heartbeat
• confusion
• sensation of fatigue or weakness
• syncope
• blurred vision
• headache

Hemophagocytic lymphohistiocytosis

The symptoms may include:

• fever
• enlarged liver and/or spleen
• skin rash
• enlarged lymph nodes
• easiness to bruise
• renal abnormalities
• breathing problems
• cardiac problems

Tumor lysis syndrome

The symptoms may include:

• fever
• chills
• sensation of nausea and vomiting
• confusion
• sensation of shortness of breath
• seizures
• irregular heartbeat
• dark or turbid urine
• unusual fatigue
• muscle or joint pain

Shown in blood tests

• increased levels of potassium, phosphate, or uric acid – which may cause kidney problems (part of tumor lysis syndrome)

Tumor flare

The symptoms may include:

• swollen and soft lymph nodes
• chest pain
• cough or difficulty breathing easily
• pain in the tumor site

Infections

The symptoms may include:

• fever
• cough
• chest pain
• fatigue
• shortness of breath
• painful rash
• sore throat
• burning sensation when urinating
• sensation of weakness or generalized malaise.

Immune effector cell-associated neurotoxicity syndrome (ICANS)

The symptoms may occur days or weeks after receiving the infusion and may initially be subtle. The symptoms may include:

• confusion/disorientation
• fatigue
• altered mental state
• diminished mental state
• memory deterioration

If you experience any of these symptoms after treatment with Lunsumio, contact your doctor immediately. You may need medical treatment.

Other side effects

Very common:may affect more than 1 in 10 people

• rash
• itching on the skin
• dry skin
• diarrhea
• headache
• fever
• chills
• cytokine release syndrome

Shown in blood tests

• low levels of some white blood cells (neutropenia)
• low red blood cell count, which may cause fatigue and shortness of breath
• low platelet count, which may make you more prone to bruising or bleeding (thrombocytopenia)
• low levels of phosphate, potassium, or magnesium
• high levels of alanine aminotransferase in the blood

Common:may affect up to 1 in 10 people

• pulmonary infection
• upper respiratory tract infection (infection of the nose, throat, sinuses)
• urinary tract infection
• fever due to low neutrophil levels (a type of white blood cell)
• tumor flare
• a severe immune reaction that affects the nervous system (immune effector cell-associated neurotoxicity syndrome)

Shown in blood tests

• increased levels of liver enzymes, which may be a sign of liver problems

Rare:may affect 1 in 100 peoplepeople

• rapid destruction of tumor cells that results in changes in the blood and damage to organs, including the kidneys, heart, and liver (tumor lysis syndrome)
• a condition where the immune system produces too many cells responsible for fighting infections called histiocytes and lymphocytes (hemophagocytic lymphohistiocytosis).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational reporting system included in theAppendix V*. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Lunsumio will be stored by healthcare professionals in the hospital or clinic. The details to be taken into account for storage 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 after CAD. The expiration date is the last day of the month indicated.
• Store in the refrigerator (2 °C – 8 °C)
• Do not freeze
• The diluted solution should not be kept for more than 24 hours at 2 °C – 8 °C or 24 hours at room temperature (9 °C – 30 °C)
• Store the container in the outer packaging to protect it from light

Your healthcare professional will dispose of unused medications properly. This will help protect the environment.

Composition of Lunsumio

• The active ingredient is mosunetuzumab.
• Lunsumio 1 mg: each vial contains 1 mg of mosunetuzumab in 1 ml at a concentration of 1 mg/ml.
• Lunsumio 30 mg: each vial contains 30 mg of mosunetuzumab in 30 ml at a concentration of 1 mg/ml.
• The other components are: L-histidine, L-methionine, acetic acid, sucrose, polisorbate 20 (E432), water for injection.

Appearance of Lunsumio and contents of the pack

Lunsumio is a concentrate for solution for infusion (sterile concentrate). It is a clear, transparent liquid contained 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 responsible

Roche Pharma AG

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

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

Last update of this leaflet:

This medicinal product has been authorised under a conditional approval. This type of approval means that more information is expected to be obtained about this medicinal product.

The European Medicines Agency will review the new information about this medicinal product at least once a year and this leaflet will be updated as necessary.

Other sources of information

Further information about 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 for healthcare professionals only:

Procedures for proper handling and disposal of oncology medicines should be considered.

Instructions for dilution

1. Remove and discard a volume of sodium chloride 9 mg/ml (0.9%) injection or sodium chloride 4.5 mg/ml (0.45%) injection equal to the volume of Lunsumio required for the patient's dose from the infusion bag according to the table below.
2. Remove the required volume of Lunsumio from the vial using a sterile syringe and dilute it within the infusion bag. Discard any unused remainder left in the vial.

Table 1: Dilution of Lunsumio

1. Mix the infusion bag gently by inverting it slowly. Do not shake.
2. Inspect the infusion bag to discard any particles and discard if present.
3. Attach the detachable label from the leaflet to the infusion bag.

Diluted solution

The product should be used immediately. If not used immediately, the storage and handling conditions for use are the responsibility of the user and may not be more than 24 hours at 2°C to 8°C, unless the dilution has taken place in controlled and validated aseptic conditions.

Detachable label

Detach and attach this label to the infusion bag.