Patient Medication Information: uses, side effects, how to take - Zynlonta
What ZYNLONTA is used for:
For the following indication ZYNLONTA has been approved with conditions (NOC/c). This means it has passed Health Canada’s review and can be bought and sold in Canada, but the manufacturer has agreed to complete more studies to make sure the drug works the way it should. For more information, talk to your healthcare professional.
ZYNLONTA is used to treat adults with a certain type of cancer called diffuse large B-cell lymphoma who have already received CAR-T cell treatment or who are unable to receive CAR-T cell treatment. It is used when:
- the cancer has come back (relapsed), or
- the cancer did not respond to previous treatment (refractory).
Large B-cell lymphoma is a cancer that develops from a type of white blood cell called B-lymphocytes (also called B-cells). In large B-cell lymphoma, B-cells multiply in an uncontrolled manner and build up in your body.
What is a Notice of Compliance with Conditions (NOC/c)?
A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug in Canada.
Health Canada only gives an NOC/c to a drug that treats, prevents, or helps identify a serious or life-threatening illness. The drug must show promising proof that it works well, is of high quality, and is reasonably safe. Also, the drug must either respond to a serious medical need in Canada, or be much safer than existing treatments.
Drug makers must agree in writing to clearly state on the label that the drug was given an NOC/c, to complete more testing to make sure the drug works the way it should, to actively monitor the drug’s performance after it has been sold, and to report their findings to Health Canada.
How ZYNLONTA works:
ZYNLONTA consist of 2 parts; an antibody (a type of protein designed to recognize and attach to a specific target) and a cytotoxic agent (a medicine able to kill cells, including cancer cells). The antibody in this medicine is designed to attach to a protein, called CD19, that is found on the surface of B cells. When the antibody binds to these cells, including the cancer cells, the medicine enters the cells and kills them.
The ingredients in ZYNLONTA are:
Medicinal ingredient: loncastuximab tesirine
Non-medicinal ingredients: histidine monohydrochloride, L-histidine, polysorbate 20, sucrose
ZYNLONTA comes in the following dosage form:
ZYNLONTA is available as powder for concentrate for solution for infusion in a single-use vial containing 10 mg.
Do not use ZYNLONTA if:
- if you are allergic to loncastuximab tesirine or any of the other ingredients of this medicine (listed in “The ingredients in ZYNLONTA are:”). Talk to your healthcare professional if you are not sure.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ZYNLONTA. Talk about any health conditions or problems you may have, including if you:
- have an active infection or have had one recently
- have liver problems; symptoms may include skin and eyes appearing yellowish (jaundice). Your doctor will monitor you for side effects during treatment.
- are pregnant or plan to become pregnant. ZYNLONTA can harm your unborn baby. You should avoid getting pregnant if you are taking this medicine. Tell your doctor immediately if you become pregnant or think that you are pregnant during treatment with ZYNLONTA.
Other warnings you should know about:
Tell your doctor or nurse straight away if you have any of the following serious side effects.
Infections
Serious infections, including infections that can cause death, have occurred in people treated with ZYNLONTA. Tell your healthcare professional immediately if you have new or worsening signs or symptoms of infection, such as:
- fever
- chills or shivering
- flu-like symptoms (cough, tiredness or feeling weak, and body aches)
- severe headache
- cuts or scrapes that are red, warm, swollen, or painful
Fluid retention
Your body may hold too much fluid during treatment with ZYNLONTA. This can be serious. You can get swelling in various parts of your body including your hands, feet and abdomen, or around internal organs such as your heart and lungs. Tell your healthcare professional immediately if you notice any of the following signs and symptoms:
- chest pain
- difficulty breathing
- dizziness
- sudden and rapid increase in body weight
- swelling and pain in the abdomen, bloating
- swelling in your face or in any part of your body
Your doctor will give appropriate treatment for the fluid retention. If you have serious swelling your doctor may stop treatment until the swelling goes down.
Tell your healthcare professional immediately if you suddenly gain weight during treatment with ZYNLONTA, have new or worsening swelling in your face, limbs or joints (edema) or dizziness (a symptom of low blood pressure). These could be symptoms of a condition called capillary leak syndrome which causes blood to leak from the small blood vessels into your body.
Low levels of certain blood cells (low blood cell counts) can be serious or severe. Your doctor or nurse will monitor your blood cell counts during treatment with ZYNLONTA. Tell your healthcare professional immediately if you have any signs and symptoms of infection. Low blood cell counts could be responsible for your infection.
Liver tests
ZYNLONTA can sometimes cause high levels of liver enzymes. Liver enzymes are proteins released into the blood when liver cells are stressed or damaged. Elevated levels are early indicators of liver inflammation or injury, often before symptoms appear. Your doctor will monitor your liver with routine blood tests during treatment. If your liver enzyme levels become too high, your doctor may temporarily stop your treatment until your liver recovers or discontinue the treatment with ZYNLONTA.
Skin reactions and exposure to sunlight
Serious skin reactions have occurred in people treated with ZYNLONTA. Exposure to sunlight (including through glass or car windows) may cause severe sunburn. It is important to wear sunscreen and appropriate clothing to ensure you do not burn. Tell your healthcare professional immediately if you get new or worsening severe skin reactions, including:
- sensitivity to sunlight including sunburn-like reactions such as skin peeling and irritation following exposure to light
- itchy rash
- blistering of skin
- darker skin patches
- irritation, swelling, pain, and/or skin damage at the injection site
Children and adolescents
This medicine should not be given to children or young people under the age of 18. This is because ZYNLONTA has not been studied in this subgroup.
Contraception (men and women)
- Women of child-bearing potential must use effective contraception during treatment with ZYNLONTA, and for 10 months after the last dose.
- Men with partners of child-bearing potential must use effective contraception during treatment with ZYNLONTA, and for 7 months after the last dose.
- Talk to your healthcare professional about effective contraception.
Pregnancy
ZYNLONTA may harm your unborn baby. You should avoid getting pregnant if you are taking this medicine. Tell your healthcare professional immediately if you become pregnant or think that you are pregnant during treatment with ZYNLONTA. Your doctor may do a pregnancy test before starting treatment with ZYNLONTA.
Male patients with female partners of reproductive potential, should use effective contraception during treatment with ZYNLONTA and for 7 months after the last dose.
Breastfeeding
Do not breastfeed during treatment, and for 3 months after the last dose. It is not known if ZYNLONTA passes into breast milk.
Fertility
ZYNLONTA may cause fertility problems in men, which may affect their ability to father children. You can seek advice on how to preserve sperm before starting treatment. Talk to your doctor for more information.
Driving and using machines
If you get infusion-related reactions or if you feel tired, weak or dizzy do not drive, cycle or use tools or machines until you feel better.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions between ZYNLONTA and other drugs, vitamins, minerals, natural supplements or alternative medicines have not been established.
How to take ZYNLONTA:
- ZYNLONTA will be given to you by a healthcare professional experienced in cancer treatment, in a hospital or clinic. ZYNLONTA is given as a drip into a vein (intravenous infusion) over a period of 30 minutes.
- ZYNLONTA is usually given every 3 weeks (on day 1 of a 21-day cycle).
- Your healthcare professional may give you medicine before each infusion to decrease your chance of side effects.
- Your healthcare professional may stop your treatment, delay your treatment, or change your dose of ZYNLONTA if you have severe side effects.
- Your healthcare professional should do blood tests regularly to check for side effects of ZYNLONTA.
- Your healthcare professional will decide how many treatments you need.
Usual dose:
The dose of this medicine depends on your body weight. The usual starting dose is 0.15 mg for each kilogram (kg) of body weight.
The table below shows the recommended dose in each treatment cycle.
| Recommended Dose | Cycle |
|---|---|
| 0.15 mg per kg every 3 weeks | 1st Cycle |
| 0.15 mg per kg every 3 weeks | 2nd Cycle |
| 0.075 mg per kg every 3 weeks | 3rd Cycle onwards |
Your healthcare professional may lower your dose if you experience any serious side effects.
Taking dexamethasone with ZYNLONTA
During your treatment with ZYNLONTA you will also be given another medicine called dexamethasone to help reduce side effects as a result of treatment.
You will be given 4 mg of dexamethasone either by mouth or into your vein twice a day for three days, beginning the day before you receive ZYNLONTA treatment. If you do not receive dexamethasone the day before your treatment, then it must be given at least 2 hours before you are given ZYNLONTA.
Overdose:
If you think you, or a person you are caring for, have taken too much ZYNLONTA, 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.
Missed dose:
If you miss an appointment to have ZYNLONTA administered, make another one straight away. For treatment to be fully effective, it is very important not to miss a dose. If you have any further questions on the use of this medicine, ask your healthcare professional.
Possible side effects from using ZYNLONTA:
These are not all the possible side effects you may have when taking ZYNLONTA. If you experience any side effects not listed here, tell your healthcare professional.
Very common (may affect more than 1 in 10 people):
- Loss of appetite
- Feeling sick or vomiting
- Cough
- Fever
- Diarrhea
- Stomach pain
- Constipation
- Reddening of the skin
- Rash
- Itching
Common (may affect up to 1 in 10 people):
- Nose and throat infection
- Rash characterized by a flat, red area on the skin that is covered with small, raised bumps
- Muscle pain
- Joint pain
- Back and neck pain
- Pain in the arms and legs
- Lack of energy
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Very common | |||
| Neutropenia (low white blood cells called neutrophils): fever or infection, chills, fatigue, aches and pains, flu-like symptoms. | X | ||
| Anemia (low red blood cells): being short of breath, feeling very tired or cold, having pale skin, fast heartbeat, loss of energy, dizziness or weakness. | X | ||
| Thrombocytopenia (low blood platelets): bruising or bleeding for longer than usual if you hurt yourself, small purple dots (tiny bleeds) on your skin, fatigue, and weakness. | X | ||
| Increased liver enzyme levels (liver problems): symptoms may include skin and eyes appearing yellowish (jaundice), pain or discomfort in the upper right part of the abdomen, loss of appetite. | X | ||
| Skin reactions: sensitivity to sunlight, sunburn-like reactions such as skin peeling, redness or irritation following exposure to light, itchy rash, blistering of skin, darker skin patches, irritation, swelling, pain and/or skin damage at the injection site. | X | ||
| Common | |||
| Infections: fever, chills, flu-like symptoms (cough, tiredness or weakness, and body aches), severe headache; additional symptoms of lung infections including chest pain, shortness of breath, cough; additional symptoms of sepsis/septic shock including low blood pressure, cool, pale arms and legs, restlessness, agitation, lethargy or confusion. | X | ||
| Fluid retention (effusion, edema): swelling in various parts of body including face, hands, feet, abdomen, limbs, joints, or internal organs such as heart, lungs or abdomen, causing chest pain, difficulty breathing, dizziness, abdominal pain or discomfort. | X | ||
| Pneumonitis (inflammation of the lung tissue not caused by infection): shortness of breath, a dry cough that usually doesn’t bring up any mucus. Symptoms may include extreme tiredness, loss of appetite, and fever. | X | ||
| Uncommon | |||
| Pericarditis (inflammation around the heart): chest pain which may become worse when taking a deep breath, lie down, or swallow. Chest pain can be sharp or dull and may spread to shoulder and the upper back. Fever and dry cough may develop. | X | ||
| Unknown | |||
| Cutaneous collagenous vasculopathy (increase in the size of blood vessels under the skin and thickening of the blood vessel walls): small red or purple spots on the skin, often starting on the legs that may spread to other parts of the body with usually no pain, itching or swelling. | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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:
ZYNLONTA will be stored by the healthcare professional at the hospital or clinic where you are treated. The following information is intended for healthcare professionals.
Keep this medicine out of reach and sight of children.
Store in a refrigerator (2°C to 8°C). Do not freeze.
Keep the vial in the original carton in order to protect from light. Both the reconstituted solution and the diluted solution for infusion should not be frozen or exposed to direct sunlight.
ZYNLONTA is a cytotoxic medicine. Applicable special handling and disposal procedures must be followed.
Your healthcare professional is responsible for disposing of any unused ZYNLONTA correctly. These measures will help protect the environment.
If you want more information about ZYNLONTA:
- 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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (https://www.sobi.com/canada/en); or by calling 1-289-291-3852.
ZYNLONTA® is a registered trademark of ADC Therapeutics SA.
©2026 Swedish Orphan Biovitrum AB (publ) – All rights reserved.
Date of Authorization: 2026-05-07