Patient Medication Information: uses, side effects, how to take - Tevimbra
Serious Warnings and Precautions Box:
- TEVIMBRA may cause severe and fatal immune-mediated adverse reactions, in any organ system or tissue including: colitis, endocrinopathies, hepatitis, myocarditis, myositis, nephritis with renal dysfunction, organ transplant rejection, pancreatitis, pneumonitis, and severe cutaneous adverse reactions (SCARS) (see 7. Warnings and Precautions).
- TEVIMBRA can cause severe or life-threatening infusion-related reactions including hypersensitivity and anaphylaxis (see 7. Warnings and Precautions).
- Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody (see 7. Warnings and Precautions).
What is TEVIMBRA used for?
TEVIMBRA in combination with gemcitabine and cisplatin is used to treat patients with a type of head and neck cancer called nasopharyngeal carcinoma that has spread to other parts of the body and/or that has returned after previous therapy.
- as monotherapy is indicated for the treatment of adult patients with unresectable, recurrent, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior chemotherapy.
How does TEVIMBRA work?
TEVIMBRA is a cancer medicine that works by helping your immune system fight your cancer. It can help to slow down or stop the cancer from growing and may shrink the tumor.
If you have any questions about how TEVIMBRA works or why this medicine has been prescribed for you, ask your healthcare professional.
What are the ingredients in TEVIMBRA
Medicinal ingredients: tislelizumab
Non-medicinal ingredients: Citric acid monohydrate, L-histidine, L-histidine hydrochloride monohydrate, polysorbate-20, sodium citrate dihydrate, trehalose dihydrate, and water for injection (WFI).
TEVIMBRA comes in the following dosage form:
TEVIMBRA comes in glass vials that contain 10 mL of tislelizumab at a concentration of 10 mg/mL.
Do not use TEVIMBRA if:
- You are allergic to tislelizumab or any other ingredients in TEVIMBRA. If you are not sure about this, talk to your healthcare professional before taking TEVIMBRA.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TEVIMBRA. Talk about any health conditions or problems you may have or previously had, including:
- autoimmune disease (a condition where the body’s own defence system attacks normal cells) such as Crohn’s disease, ulcerative colitis, or lupus
- inflammation of the liver (hepatitis) or other liver problems
- inflammation of the kidney (nephritis) or other kidney problems
- pneumonia or inflammation of the lungs (pneumonitis) or other lung problems
- inflammation of the large bowel (colitis) or other bowel problems
- inflammation of the heart (myocarditis) or lining of the heart (pericarditis) or other heart problems
- any condition that affects your nervous system such as myasthenia gravis or Guillain-Barre Syndrome
- problems with hormone-producing glands (including the adrenal, pituitary and thyroid glands)
- diabetes mellitus
- a severe rash or skin condition
- a solid organ transplant or a hematopoietic stem cell transplant (HSCT)
- infusion-related reaction
- a chronic viral infection of the liver (hepatitis)
- human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS)
- taking medications that affect the immune system such as a steroids
- taking medicine to treat an infection
- have recently received a live, attenuated vaccine
- muscle pain or stiffness (myositis)
Other warnings you should know about:
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your healthcare professional for advice before you are given this medicine.
You should not be given TEVIMBRA if you are pregnant unless your healthcare professional specifically prescribes it for you. The effects of TEVIMBRA in pregnant women are not known, but it is possible that the active substance, tislelizumab, could harm an unborn baby.
If you are a woman who could become pregnant, you must use effective contraception while you are being treated with TEVIMBRA and for at least 4 months following the last dose of TEVIMBRA.
Breast-Feeding
It is not known whether TEVIMBRA passes into breast milk. A risk to the breast-fed infant cannot be ruled out. If you are breast-feeding or plan to breastfeed, tell your healthcare professional. You should not breast-feed during treatment with TEVIMBRA and for at least 4 months after the last dose of TEVIMBRA.
Children and adolescents
TEVIMBRA is not for use in patients under 18 years of age.
Driving and using machines
Please see how you react to TEVIMBRA before driving or operating heavy machinery because TEVIMBRA has been known to cause dizziness, tiredness, and fatigue.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
How to take TEVIMBRA
TEVIMBRA should be given to you by a healthcare professional who has experience with treating cancer.
- TEVIMBRA is given directly into your bloodstream as an infusion (giving the medicine through a vein).
- The first dose of TEVIMBRA is given over 1-2 hours depending upon the dose, subsequent infusions may be shorter if you tolerate TEVIMBRA well.
- TEVIMBRA is given before your chemotherapy if both are given on the same day
- Your healthcare professional will determine how many doses of TEVIMBRA you will receive
Usual dose:
The recommended dose of TEVIMBRA for the treatment of nasopharyngeal carcinoma (NPC) is 200 mg once every 3 weeks.
The recommended dose of TEVIMBRA for the treatment of esophageal squamous cell carcinoma (ESCC) after prior chemotherapy is 200 mg once every 3 weeks, or 150 mg once every 2 weeks, or 300 mg once every 4 weeks, or 400 mg once every 6 weeks.
Overdose:
If you think you, or a person you are caring for, have taken too much TEVIMBRA, 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:
It is important that you make it to all your appointments to receive TEVIMBRA. If you miss your appointment to receive TEVIMBRA, please contact your healthcare professional to reschedule your visit.
What are possible side effects from using TEVIMBRA?
These are not all the possible side effects you may have when taking TEVIMBRA If you experience any side effects not listed here, tell your healthcare professional.
Very common side effects when TEVIMBRA is used in combination with chemotherapy (may affect more than 1 in 10 people)
- Rash
- Muscle weakness, muscle spasms, abnormal heart rhythm (hypokalemia)
- Underactive thyroid gland with tiredness, weight gain, skin, and hair changes (hypothyroidism)
- Increased blood level of the liver enzymes
- Cough
- Diarrhea
- Itching
- Tiredness
- Fever
Common side effects when TEVIMBRA is used in combination with chemotherapy (may affect up to 1 in 10 people)
- Overactive thyroid gland, which can cause hyperactivity, sweating, weight loss and thirst (hyperthyroidism)
- Increased blood sugar level, thirst, dry mouth, need to pass urine more frequently, tiredness, increased appetite with weight loss, confusion, nausea, vomiting, fruity smelling breath, difficulty breathing and dry or flushed skin (hyperglycemia)
- Mouth sores or ulcers with inflammation of the gums (stomatitis)
- Severe upper stomach pain, nausea, vomiting, fever, tender abdomen – possible symptoms of pancreas problems (pancreatitis)
- Itching or peeling skin, skin sores (erythema multiforme)
- Eye redness, eye pain and swelling – possible symptoms of problems affecting the uvea, the layer beneath the white of the eyeball (uveitis)
- Chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness or fever which may occur during infusion or up to 24 hours after infusion (possible symptoms of infusion-related reactions).
Uncommon side effects (may affect up to 1 in 100 people)
Skin color change in patches (vitiligo)
Disorder in which the adrenal glands do not make enough of certain hormones (adrenal insufficiency)
- Frequent headaches, vision changes (either low vision or double vision), fatigue and/or weakness, confusion, decreased blood pressure, dizziness – possible symptoms of pituitary gland problems (hypophysitis).
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Diarrhea/Colitis (inflammation of the intestines): which can cause increased number of bowel movements, watery, loose or soft stools, stools with blood or mucus stomach pain (abdominal pain) and/or cramps | ✓ | ||
| Hypothyroidism (underactive thyroid gland) tiredness, weight gain, skin and hair changes, constipation, feeling cold | ✓ | ||
| COMMON | |||
| Arthritis (inflammation of the joints): which may cause joint pain, stiffness, swelling or redness, decreased range of motion in the joints | ✓ | ||
| Hepatitis (inflammation of the liver): yellowing of the skin or the whites of the eyes, belly (abdominal) pain, nausea, vomiting, loss of appetite, confusion, fatigue, darkening of the urine | ✓ | ||
Hyperthyroidism (overactive thyroid gland) which may cause hyperactivity, rapid heartbeat, sweating, weight loss and thirst | ✓ | ||
| Infusion-related reaction; chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness or fever which may occur during infusion or up to 24 hours after infusion | ✓ | ||
| Myocarditis (inflammation of the heart muscle): which may cause chest pain, rapid or abnormal heartbeat, shortness of breath at rest or during activity, fluid buildup with swelling of the legs, ankles and feet, tiredness | ✓ | ||
| Pneumonitis (inflammation of the lung) which may cause trouble breathing, dry cough, chest pain | ✓ | ||
Thyroiditis (inflammation of the thyroid): which may cause fatigue, swelling at the base of the neck, pain in front of the throat | ✓ | ||
Diabetes mellitus (Blood sugar problems): which may cause hunger or thirst, a need to urinate more often, or weight loss | ✓ | ||
| UNCOMMON | |||
Adrenal insufficiency (Disorder in which the adrenal glands do not make enough of certain hormones) which may cause possible weakness and/or low blood pressure | ✓ | ||
| Hypophysitis (inflammation of the pituitary gland): which may cause frequent headaches, vision changes (either low vision or double vision), fatigue and/or weakness, confusion, decreased blood pressure, dizziness | ✓ | ||
| Myositis (inflammation of the muscles): which may cause muscle pain, stiffness, weakness, chest pain or severe tiredness | ✓ | ||
| Nephritis (inflammation of the kidney) which may cause changes in the amount or color of the urine (dark tea-colored urine), swelling of extremities(edema) | ✓ | ||
| RARE | |||
| Myasthenia gravis (Muscle weakness and tiredness without atrophy) which may cause drooping eyelids, weakness in the arms, hands legs and neck | ✓ | ||
| Serious Skin Reactions including Stevens-Johnson Syndrome, (SJS, toxic epidermal necrosis (TEN) (Serious rash and reddening of the skin on upper body and quickly spreading to other body parts), which may cause blistering of the lips, eyes or mouth, skin peeling, sometimes with flu-like symptoms such as fever, sore throat, cough, and joint pain | ✓ | ||
| Guillain-Barré syndrome (inflammation of the nerves): which may cause pain, weakness and paralysis in the extremities | ✓ | ||
| Pericarditis (inflammation of the membrane around the heart/pericardium): which may cause chest pain, fever, cough, palpitations | ✓ | ||
| Unknown | |||
| Myocarditis-Myositis-Myasthenia gravis-overlap syndrome (inflammation of the muscles including the heart muscles): may cause chest pain, rapid or abnormal | ✓ | ||
| heartbeat, shortness of breath at rest or during activity, drooping eyelids, weakness in the arms, hands legs and neck, muscle pain and stiffness | |||
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 health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
If you want more information about TEVIMBRA
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (Drug Product Database: Access the database); the manufacturer’s website: www.beonemedicines.ca/en/ or by calling 1-877-828-5598.
Distributed by Innomar Strategies Inc.
Milton, ON, L9T 6W3
Date of Authorization: 2026-04-16