Columvi 2,5 mg/2,5 ml Solution

What COLUMVI isCOLUMVI is a cancer medicine that contains the active substance glofitamab

What COLUMVI is used for
COLUMVI is used to treat adults with a cancer called “diffuse large B-cell lymphoma” (DLBCL). It is used when:
• the cancer has come back (relapsed) or
• the cancer did not respond to previous treatments

Diffuse large B-cell lymphoma is a cancer of a part of your immune system (the body’s defences).
• It affects a type of white blood cell called ‘B-cells’.
• In DLBCL, B cells multiply in an uncontrolled manner and build up in your tissues.

How COLUMVI works
COLUMVI binds to the surface of these cancerous B cells and also to the surface of T cells (another type of white blood cell). This binding on two targets activates T cells which causes them to multiply and causes the rapid breakdown of the cancerous B cells.

You must not be given COLUMVI
• if you are allergic (hypersensitive) to glofitamab or any of the other ingredients of COLUMVI (see Section 5 What COLUMVI Contains and What COLUMVI Looks Like for a complete list of ingredients in COLUMVI. If you are not sure, talk to your doctor or nurse before you are given COLUMVI.

Talk to your doctor before you are given COLUMVI if:
• you have an infection
• you have had a long-lasting infection (chronic) or an infection which keeps coming back (recurring)
• you have or had any kidney, liver, or heart problems

What you should tell your doctor or pharmacist during the course of your treatment with COLUMVI
Pay attention to the following serious side effects. These can sometimes be life-threatening and may happen any time during COLUMVI treatment.

Tell your doctor immediately if you experience any of the following side effects while receiving COLUMVI:
• if you experience fever, fast heartbeat, feeling dizzy or lightheaded, chills, or shortness of breath. These may be symptoms of a condition known as cytokine release syndrome, a serious condition.
• if you develop fever, chills, difficulty breathing, or burning sensation while passing urine. These may be signs of an infection. Some infections may be life-threatening or fatal.
• if you experience kidney problems (weakness, shortness of breath, fatigue, and confusion), heart problems (fluttering of the heart or a faster or slower heartbeat), vomiting or diarrhoea, and tingling in the mouth, hands, or feet. These may be signs of a condition called tumour lysis syndrome.
• your cancer appears to become worse and you develop tender swollen lymph nodes, chest pain, cough, inability to breathe easily, or pain at the site of the tumour. These may be symptoms of tumour flare. If you have any of the above symptoms tell your doctor straight away. Your doctor may:
• give you other medicines to reduce symptoms and prevent complications
• stop your treatment for a short time, or
• stop your treatment completely

Pregnancy and contraception
• Tell your doctor if you are pregnant, think you might be pregnant, or are planning to become pregnant.
• You should not be given COLUMVI if you are pregnant. This is because it is possible that COLUMVI could harm your unborn baby.
• If you could become pregnant, you must use effective contraception while you are being treated with COLUMVI and for 2 months after the last dose.
• If you become pregnant while you are being treated with COLUMVI tell your doctor immediately.

Breastfeeding
Do not breast-feed while receiving COLUMVI and for at least 2 months after the last dose. This is because it is not known if this medicine can pass into breast milk and harm your baby.

Children and adolescents (< 18 years)
COLUMVI should not be used in children or adolescents under 18 years of age. This is because COLUMVI has not been studied in this age group.

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

Ability to drive and use machines
COLUMVI is not likely to affect your ability to drive, cycle, or use any tools or machines. However, if you experience symptoms of cytokine release syndrome (such as fever, fast heartbeat, feeling dizzy or lightheaded, chills or shortness of breath) – do not drive, cycle, or use any tools or machines until you feel better.

You will be given COLUMVI under the supervision of a doctor experienced in cancer treatment, in a hospital or clinic.

Medicines given before COLUMVI treatment
• Seven days before starting COLUMVI treatment, you will be given another medicine, obinutuzumab, to deplete the B cells in your blood in order to prevent cytokine release syndrome.
• During the 30 to 60 minutes before you are given COLUMVI, you may be given other medicines (pre-medication) to help reduce reactions associated with cytokine release syndrome. These medicines may include:
– A corticosteroid such as dexamethasone
– A fever-reducing medicine such as paracetamol
– An antihistamine such as diphenhydramine

How much and how often you will receive COLUMVI
You will be given 12 treatment cycles of COLUMVI.
• Each cycle lasts 21 days.
Your doctor will begin COLUMVI treatment with a low-dose and will gradually increase it to the full dose. A typical schedule is shown below.
Cycle 1: This will include a pre-treatment and 2 low doses of COLUMVI during the 21 days:
• Day 1 – Pre-treatment with obinutuzumab
• Day 8 – starting low COLUMVI dose of 2.5 mg
• Day 15 – the second low COLUMVI dose of 10 mg
Cycle 2 to Cycle 12: This will be just one dose in the 21 days:
• Day 1 – full COLUMVI dose of 30 mg

How COLUMVI is given and monitoring
COLUMVI is given as a drip into a vein (an intravenous infusion). Your doctor will adjust the time required for infusion depending on how you respond to treatment.
• Your first infusion will be given over 4 hours. Your doctor will monitor you carefully during the first infusion and for 10 hours after completion of infusion. This is to watch for any signs or symptoms of cytokine release syndrome.
• For following infusions, your doctor may require to monitor you after completion of infusion. This will be necessary if you have had moderate or severe CRS with your previous dose.
• If you do not have any cytokine release syndrome after 3 doses, your doctor may give the following infusions over 2 hours.

If you miss a dose of COLUMVI
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 COLUMVI treatment
Speak with your doctor before stopping treatment. 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. The following side effects have been reported with this medicine:

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; symptoms include fever, fast heartbeat, feeling dizzy or lightheaded, chills, and shortness of breath
• Infection; symptoms include fever, chills, difficulty breathing, and burning pain when passing urine
• Tumour flare; symptoms include tender swollen lymph nodes, chest pain, inability to breathe easily, and pain at the site of the tumour
• Tumour lysis syndrome; symptoms include weakness, shortness of breath, feeling confused, irregular heartbeat, and muscle cramps

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)
• Reduced levels in blood tests of:
– neutrophils (a type of white blood cell), which may cause fever or any symptoms of an infection
– red blood cells (anaemia), which may cause tiredness, feeling unwell, and pale skin
– platelets (a type of blood cell), which may cause unusual bruising or bleeding
• fever
• Low levels in blood tests of:
– phosphate, magnesium, calcium, or potassium
• rash
• constipation

Common (may affect up to 1 in 10 people)
• diarrhoea
• feeling sick (nausea)
• headache
• low sodium levels in blood tests, which may cause tiredness, muscle twitching, or cramps
• increased levels in blood tests of liver enzymes and bilirubin (yellow substance in blood) which may cause yellowing of skin or eyes and dark urine
• viral infections, such as lung infection and shingles
• bacterial infections, such as urinary tract infection and infection in or around the stomach
• respiratory tract infections, such as runny nose, sore throat, sinus infections, and chest colds
• infection in blood (sepsis), which may cause fever, chills, and confusion
• fever with low levels of neutrophils (a type of white blood cell)
• lung infection (pneumonia) which may cause fever, cough, and difficulty breathing
• vomiting
• bleeding in the stomach or gut (gastrointestinal haemorrhage), which may cause black stools or blood in vomit
• confusion
• trembling
• sleepiness

Uncommon (may affect less than 1 in 100 people)
• fungal infection
• swelling of the spinal cord (myelitis), which may cause muscle weakness or numbness

Reporting of side effects
If you get side effects, talk to your doctor, or pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of COLUMVI.

COLUMVI 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 label after EXP. The expiry date refers to the last day of that month.
• Store in a refrigerator (2 °C to 8 °C).
• Do not freeze.
• Keep the vial in the outer carton in order to protect from light.
• Do not use this medicine if it appears cloudy, discoloured, or contains particles. 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.
COLUMVI is for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.