Patient Medication Information: uses, side effects, how to take - Columvi
Serious warnings and precautions box
What COLUMVI is used for:
COLUMVI is used to treat adults with a cancer called “diffuse large B-cell lymphoma” (DLBCL) who cannot take CAR-T cell treatment or who have already used CAR-T cell treatment.
COLUMVI is used with medicines called gemcitabine and oxaliplatin to treat adults with DLBCL, when the cancer has come back (relapsed) or did not respond to previous treatment (refractory) and you cannot receive a stem cell transplant. DLBCL is a cancer of a part of your immune system (the body’s defenses). 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. |
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How COLUMVI works:
COLUMVI is a cancer medicine that contains the active substance glofitamab. 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.
The ingredients in COLUMVI are:
Medicinal ingredient(s): glofitamab
Non-medicinal ingredients: L-histidine; L-histidine hydrochloride, monohydrate; L-methionine; polysorbate 20; D-sucrose; water for injection.
COLUMVI comes in the following dosage form(s):
Concentrate for solution for infusion. Each vial contains either 2.5 mg (in 2.5 mL) or 10 mg (in 10 mL) of glofitamab. Each mL contains 1 mg of glofitamab.
Do not use COLUMVI if:
- you are allergic to glofitamab or any of the other ingredients of COLUMVI
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take COLUMVI. Talk about any health conditions or problems you may have, including if you:
- 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
- have or had any type of neurological disease
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 breastfeed 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.
Other warnings you should know about:
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.
Ability to drive and use machines: COLUMVI may affect your ability to drive, cycle, or use any tools or machines. If you experience any symptoms that might make it difficult to drive (e.g., symptoms of cytokine release syndrome such as fever, fast heartbeat, feeling dizzy or lightheaded, chills or shortness of breath and/or symptoms of neurologic toxicity including immune effector cell-
- associated neurotoxicity syndrome such as confusion, disorientation, sleepiness or change of consciousness level) - do not drive, cycle, or use any tools or machines until your symptoms fully resolve.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
How to take COLUMVI:
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 acetaminophen
- An antihistamine such as diphenhydramine
Usual dose:
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 – 2.5 mg starting dose of COLUMVI
- Day 15 – 10 mg intermediate dose of COLUMVI
Cycle 2 to Cycle 12: During these cycles, you will only be given one dose every 21 days:
- Day 1 – 30 mg full dose of COLUMVI
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 of COLUMVI 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 cytokine release syndrome 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.
Overdose:
| If you think you, or a person you are caring for, have taken too much COLUMVI, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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Missed Dose:
If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
Possible side effects from using COLUMVI:
These are not all the possible side effects you may have when taking COLUMVI. If you experience any side effects not listed here, tell your healthcare professional.
COLUMVI monotherapy
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 (symptoms include: chills, sore throat, shortness of breath, nasal congestion, diarrhoea)
- red blood cells (anemia), 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):
- diarrhea
- 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
- lung infection (pneumonia) which may cause fever, cough, and difficulty breathing
- vomiting
- confusion
- trembling
- sleepiness
Uncommon (may affect less than 1 in 100 people):
- Candida infection (fungus)
COLUMVI in combination with gemcitabine and oxaliplatin
Very common (may affect more than 1 in 10 people)
reduced levels in blood tests of:
- platelets (a type of blood cell), which may cause unusual bruising or bleeding
- neutrophils (a type of white blood cell), which may cause fever or any symptoms of an infection
- red blood cells (anemia), which may cause tiredness, feeling unwell, and pale skin
- lymphocytes (a type of white blood cell), that may affect the body’s ability to fight infection
- feeling sick (nausea)
- numbness, tingling, a burning sensation, pain, discomfort or weakness and/or difficulty walking (peripheral neuropathy)
- diarrhoea
- increased levels in blood tests of liver enzymes
- rash
- fever
- vomiting
- pain in the muscles and bones
- abdominal (belly) pain
- constipation
- low levels in blood tests of potassium (hypokalemia) or sodium (hyponatremia)
- COVID-19 infection caused by a virus called coronavirus (SARS-CoV-2)
- respiratory tract infections, such as runny nose, sore throat, sinus infections, and chest colds
- lung infection (pneumonia) which may cause fever, cough, and difficulty breathing
Common (may affect up to 1 in 10 people)
- headache
- low levels in blood tests of magnesium, calcium, or phosphate
- new or recurring viral infections, such as shingles and cytomegalovirus infection
- bacterial infections, such as urinary tract infection
- infection in blood (sepsis), which may cause fever, chills, and confusion
- Candida infection (fungus)
- increased level of bilirubin in the blood which may cause yellowing of skin or eyes
- fever with low levels of neutrophils (a type of white blood cell)
- inflammation of the large bowel, which may cause abdominal pain, bloody stools and urge to have a bowel movement
- inflammation of the pancreas
- inflammation of the lungs (pneumonitis), which may cause cough and difficulty breathing
Uncommon (may affect less than 1 in 100 people)
- trembling
- elevated liver enzymes (shown in tests), which may be a sign of an inflamed liver
- lung infection (pneumocystis jirovecii pneumonia)
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Very Common | |||
| Cytokine release syndrome: fever, fast heartbeat, feeling dizzy or lightheaded, chills, shortness of breath | ✔ | ||
| Tumour Flare: tender swollen lymph nodes, chest pain, cough, inability to breathe easily, pain at the site of the tumour | ✔ | ||
| Common | |||
| Severe infections: fever, chills, difficulty breathing, burning pain when passing urine, confusion, fatigue, muscle aches, swollen lymph nodes | ✔ | ||
| Tumour Lysis Syndrome: kidney problems (weakness, shortness of breath, fatigue, feeling confused), heart problems (irregular heartbeat or fluttering of the heart or a faster or slower heartbeat), vomiting, diarrhoea, tingling in the mouth, hands or feet, muscle cramps | ✔ | ||
| Gastrointestinal hemorrhage (bleeding in the stomach or gut): black stools or blood in vomit | ✔ | ||
| Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS): confusion, disorientation, sleepiness, and change of consciousness level | ✔ | ||
| Uncommon | |||
| Myelitis (swelling of the spinal cord): muscle weakness or numbness | ✔ | ||
| Colitis (inflammation of the large bowel): abdominal pain, bloody stools and urge to have a bowel movement | ✔ | ||
| Unknown | |||
| Hemophagocytic lymphohistiocytosis / Immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (too many infection-fighting cells, called histiocytes and lymphocytes, are made by the immune system): fever, enlarged liver and/or spleen, changes in urination (dark urine or less urine), lymph node enlargement, easy bruising, and breathing problems | ✔ | ||
| Progressive multifocal leukoencephalopathy (PML) (serious and potentially fatal brain condition): blurry vision, loss of vision or seeing 2 things when there’s only 1 (double vision), trouble speaking, feeling weak or clumsy in an arm or leg, changes in the way you walk or problems with your balance, changes in your personality, thinking, or memory, which may lead to confusion; these symptoms may overlap or be similar to neurologic toxicity symptoms mentioned above. | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
COLUMVI will be stored by your healthcare professionals 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 throw away any medicines via wastewater or household waste. Your healthcare professional will throw away any medicines that are no longer being used. These measures will help to protect the environment.
If you want more information about COLUMVI:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website (www.rochecanada.com); or by calling 1-888-762-4388.
Date of Authorization: 2026-09-28
©Copyright 2026, Hoffmann-La Roche Limited
COLUMVI® is a registered trademark of F. Hoffmann-La Roche AG, used under license.
All other trademarks are the property of their respective owners.
Hoffmann-La Roche Limited
Mississauga, ON L5N 5M8