Lunsumio 1 mg concentrate for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lunsumio 1 mg concentrate for solution for infusion

Lunsumio 30 mg concentrate for solution for infusion

mosunetuzumab

This medicinal product is subject to additional monitoring, which will allow for faster identification of new safety information. You can help by reporting any adverse reactions you may experience. The end of section 4 includes information on how to report these adverse reactions.

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Lunsumio is and what it is used for

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

In FL, a type of white blood cell called “B-cells” becomes cancerous. The 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 against infections.

Lunsumio is given to patients who have received at least two prior treatments for FL, when the cancer has not responded to these treatments, or when it has come back.

How Lunsumio works

The active substance in 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 on B-cells, including cancerous B-cells, and to another target found on “T-cells”, a different type of white blood cell. “T-cells” are another part of the body's defenses that can destroy invading cells, linking the two cells together like a bridge. Lunsumio encourages T-cells to destroy the cancerous B-cells. This helps control FL and prevent its progression.

2. What you need to know before using Lunsumio

Do not use Lunsumio

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

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

Warnings and precautions

Talk to your doctor or nurse before receiving Lunsumio if any of the following apply to you (or if you are unsure):

• you have ever had heart, lung, or kidney problems
• you have an infection, or have had a past infection that lasted a long time or persists
• you are due to receive a vaccine or know you will need one in the near future

If any of the above apply to you (or if you are unsure), contact your doctor or nurse before receiving this medicine.

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 require additional medical treatment. The symptoms of each adverse effect are listed in section 4.

• Cytokine release syndrome (CRS) – a condition associated with medicines that stimulate T cells.

  • Before each infusion, you should be given medications to help reduce the potential adverse effects of cytokine release syndrome.

• Immune effector cell-associated neurotoxicity syndrome (ICANS) – a condition associated with reactions in the nervous system. Symptoms include confusion, memory, language or judgment problems, disorientation and confusion, often accompanied by hallucinations (seeing, hearing or feeling things that are not there), and inability to concentrate.

• Hemophagocytic lymphohistiocytosis (HLH) – a condition in which the immune system produces too many infection-fighting cells called histiocytes and lymphocytes. Signs and symptoms may overlap with CRS; your doctor will check whether you have this condition if your CRS does not respond to treatment or lasts longer than expected.

• Tumor lysis syndrome – some people may develop abnormal levels of certain salts in the blood, caused by the rapid depletion of cancer cells during treatment.

  • Your doctor or nurse will perform blood tests to monitor for this condition. Before each infusion, you should be well hydrated and given medications that may help reduce high levels of uric acid. These measures may help reduce the potential adverse effects of tumor lysis syndrome.

• Tumor flare reaction – as your cancer is destroyed, it may react in a way that makes your tumor appear to worsen – this is called a "tumor flare reaction".

• Infections – you may experience signs of infection, which vary depending on where the infection is located in the body.

Children and adolescents

This medicine must not be given to children or adolescents under 18 years of age. This is because there is no information on use in this age group.

Other medicines and Lunsumio

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine. This is because Lunsumio could affect your unborn fetus.

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

Contraception

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

• Talk to your doctor or nurse about appropriate contraceptive methods.

Breastfeeding

You must not breastfeed during treatment and for 3 months after your last treatment. This is because it is unknown whether any Lunsumio is excreted in breast milk and could therefore affect the baby.

Driving and using machines

The effect of Lunsumio on the ability to drive and operate machinery is significant. Due to the possible symptoms of ICANS, you should be cautious when driving, cycling, or operating heavy or potentially dangerous machinery. If you currently have such symptoms, avoid these activities and contact your doctor, nurse, or pharmacist. See section 4 for more information about adverse effects.

Lunsumio contains polysorbate

This medicine contains the following amount of polysorbate 20, equivalent to 0.6 mg/ml:

• Lunsumio 1 mg: each vial contains 0.6 mg of polysorbate 20
• Lunsumio 30 mg: each vial contains 18 mg of polysorbate 20

Polysorbate 20 may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How Lunsumio is administered

Lunsumio is administered under the supervision of a physician experienced in administering these types of treatments. Follow the treatment schedule explained to you by your doctor. If in doubt, consult your doctor again.

How Lunsumio is administered

It is administered into a vein as an intravenous infusion (drip).

• During the first cycle, it is given over 4 hours. Each cycle lasts 21 days, and in the first cycle, the infusion will be administered over 4 hours on Day 1, Day 8, and Day 15.
• If side effects are not too severe, the dose may be administered over 2 hours in subsequent cycles.

Medications administered before treatment with Lunsumio

Other medications should be given 30 to 60 minutes before receiving Lunsumio. These are intended to help prevent infusion-related reactions and fever. These medications may include:

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

How much Lunsumio is administered

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

In Cycle 1, you will receive 3 doses of Lunsumio over the 21 days:

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

In Cycle 2, you will receive only one dose:

• Day 1: 60 mg

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

• Day 1: 30 mg

If you miss a dose of Lunsumio

If you miss an appointment, reschedule as soon as possible. To ensure the treatment is fully effective, it is very important not to miss any doses.

If you interrupt treatment with Lunsumio

Do not interrupt treatment with Lunsumio unless discussed with your doctor. Interrupting treatment may cause your condition to worsen.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.

Serious adverse effects

Talk to your doctor immediately if you notice any of the symptoms listed under the following serious adverse effects. You may have only one or some of these symptoms.

Cytokine release syndrome

Symptoms may include:

• fever (38 °C or higher)
• chills or shaking with chills
• cold, pale, and clammy skin
• difficulty breathing
• feeling dizzy
• rapid or irregular heartbeat
• confusion
• feeling tired or weak
• fainting
• blurred vision
• headache

Haemophagocytic lymphohistiocytosis

Symptoms may include:

• fever
• enlarged liver and/or spleen
• skin rash
• swollen lymph nodes
• easy bruising
• kidney abnormalities
• breathing problems
• heart problems

Tumour lysis syndrome

Symptoms may include:

• fever
• chills
• feeling unwell (nausea and vomiting)
• confusion
• feeling short of breath
• seizures
• irregular heartbeat
• dark or cloudy urine
• unusual tiredness
• muscle or joint pain

Shown in blood tests

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

Tumour flare

Symptoms may include:

• swollen, soft lymph nodes
• chest pain
• cough or difficulty breathing
• pain at the tumour site

Infections

Symptoms may include:

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

Immune effector cell-associated neurotoxicity syndrome (ICANS)

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

• confusion/disorientation
• tiredness
• altered mental state
• decreased mental status
• impaired memory

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

Other adverse effects

Very common: may affect more than 1 in 10 people

• rash
• itching of the skin
• dry skin
• diarrhoea
• headache
• fever
• chills
• cytokine release syndrome

Shown in blood tests

• low levels of certain white blood cells (neutropenia)
• low number of red blood cells, which may cause tiredness 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

• lung infection
• upper airway infection (infection of the nose, throat, sinuses)
• urinary tract infection
• fever due to low neutrophil levels (a type of white blood cell)
• tumour flare
• a serious immune reaction affecting the nervous system (immune effector cell-associated neurotoxicity syndrome)

Shown in blood tests

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

Uncommon: may affect up to 1 in 100 people

• rapid destruction of tumour cells leading to chemical changes in the blood and organ damage, including to the kidneys, heart, and liver (tumour lysis syndrome)
• a condition in which the immune system produces too many infection-fighting cells called histiocytes and lymphocytes (haemophagocytic lymphohistiocytosis)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V*. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lunsumio

Lunsumio will be stored by healthcare professionals in the hospital or clinic. The following storage instructions must be observed:

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and vial after EXP. The expiry date is the last day of the month indicated.
• Store in a refrigerator (2 °C – 8 °C).
• Do not freeze.
• The diluted solution must not be kept for longer than 24 hours at 2 °C – 8 °C or 24 hours at 9 °C – 30 °C.
• Keep the container in the outer packaging to protect it from light.

Any unused medicines will be properly disposed of by your healthcare professional. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lunsumio

The active substance 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, polysorbate 20 (E432), water for injections (see section 2 “Lunsumio contains polysorbate”).

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 Lunsumio pack contains one vial.

Marketing Authorization Holder

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Manufacturer

Roche Pharma AG

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

More information about this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

This medicinal product has been authorised under a "conditional approval". This type of approval means that further information on this medicinal product is expected.

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

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.

This information is intended for healthcare professionals only:

Procedures for the appropriate handling and disposal of oncological medicinal products should be considered.

Instructions for dilution

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

Table 1: Dilution of Lunsumio

1. Gently mix the infusion bag by slowly inverting it. Do not shake.
2. Inspect the infusion bag for particles and discard if any are present.
3. Attach the detachable label from the package leaflet to the infusion bag.

Diluted solution

The product should be used immediately. If not used immediately, the user is responsible for the storage times and conditions prior to use, which should not exceed 24 hours at 2 °C to 8 °C, unless the dilution was carried out under controlled and validated aseptic conditions.

Detachable label

Detach and affix this label to the infusion bag.