Lunsumio 1 mg Solution

What Lunsumio isLunsumio is a cancer medicine that contains the active substance mosunetuzumab

What Lunsumio is used for
Lunsumio is used to treat follicular lymphoma (FL). It is used when:
• the cancer did not respond to two or more previous treatments for FL or
• the cancer has come back after two or more previous treatments
‘B cells’ are a type of white blood cell that help your body fight infection. In FL, some B cells become cancerous and they multiply quickly. This means that they replace normal cells in the lymph nodes and bone marrow (where blood cells are made).
How Lunsumio works
‘T cells’ are another type of white blood cell - Lunsumio attaches to the B cells, including cancerous B cells, and T cells.
• This means it acts as a bridge between the two cells.
• This allows the T cells to kill the B cells.

You must not be given Lunsumio
● if you are allergic to mosunetuzumab or any of the other ingredients of Lunsumio (see Section 6 What Lunsumio Contains and What Lunsumio Looks Like for a complete list of ingredients in Lunsumio. If you are not sure, talk to your doctor or nurse before you are given Lunsumio.

Warnings and precautions

Talk to your doctor before you are given Lunsumio if:
• you have ever had heart, lung or kidneys 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.
Look out for serious side effects
Lunsumio can cause some serious side effects. These include:
• Cytokine release syndrome – collection of symptoms that can develop as a side effect of certain types of therapy, especially those which involve T - cells. Signs and symptoms vary in different people
• Tell your doctor or nurse straight away if you get any symptoms of this syndrome – these are listed in section 4.
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.
• Tell your doctor or nurse straight away if you get any symptoms of this syndrome – these are listed in section 4.

You will be given Lunsumio under the supervision of a doctor experienced in cancer treatment, in a hospital or clinic.
It is given into a vein, as a drip.
• It is given over 4 hours during the first cycle
• If well tolerated, it is given over 2 hours during the following cycles.
Medicines given before Lunsumio treatment
• During the 30 to 60 minutes before you are given Lunsumio, you may be given other medicines (pre - medication) to help reduce reactions and fever. These medicines may include:
– Corticosteroid such as dexamethasone or methylprednisolone
– Paracetamol
– An antihistamine such as diphenhydramine
How much and how often you will receive Lunsumio
You will be given 8 treatment cycles and possibly more – up to a maximum of 17 cycles
Each cycle lasts 21 days - this is a typical schedule:
Cycle 1 – this will include 3 doses of [Tradename] in the 21 days:
• Day 1 – 1 mg
• Day 8 – 2 mg
• Day 15 – 60 mg
Cycle 2 – just one dose:
• Day 1 – 60 mg
Cycles 3 to 17 – 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.
Before stopping Lunsumio treatment
Do not stop treatment with Lunsumio unless you have discussed with your doctor. This is because stopping treatment may make your condition worse. Ask your doctor if you have any further questions on the use of this medicine.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Tell your doctor immediately if you get any of the serious side effects listed below – you may need urgent medical treatment.
Cytokine release syndrome
• 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 or blurred vision
• headache.
• fits (seizures)
• uneven heartbeat
• dark or cloudy urine
• unusual tiredness
• muscle or joint pain
Shown in tests
• increase in potassium, phosphate or uric acid – which can cause kidney problems (part of tumour lysis syndrome)
Tumour flare
• tender swollen lymph nodes
• chest pain
• cough or unable to breathe easily
• pain at the site of the tumour.
Infections
• 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 [Tradename], tell your doctor straight away. You may need medical treatment.
Other side effects
Tell your doctor or nurse if you notice any of the following side effects or if they get worse:
Very common (may affect more than 1 in 10 people)
• Rash or itchy skin or dry skin
• Diarrhoea
• Headache
• Fever
Shown in 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
Common: may affect up to 1 in 10 people
• Lung infection
• Infection of upper airways (infection of nose, pharynx, larynx, sinuses)
• Urinary tract infection
• Fever due to low levels of neutrophils (a type of white blood cell)
Shown in tests
• Increased levels of liver enzymes
Reporting of side effects
If you get side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of LUNSUMIO.

Lunsumio will be stored by your doctor at the hospital or clinic. 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 the vial after EXP. The expiry date refers to the last Day of that month.
• Store in a refrigerator at 2°C – 8°C.
• Do not freeze.
• Do not shake.
• 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
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
Lunsumio is for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.