Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
TEVIMBRA is a cancer medicine that contains the active substance tislelizumab. It is a monoclonal antibody, a type of protein that is designed to recognise and attach to a specific target in the body called programmed death-1 receptor (PD-1) which is found on the surface of T and B cells (types of white blood cells that form part of the immune system, the body’s natural defences). When PD-1 is activated by cancer cells it can switch off the activity of T cells. By blocking PD-1, TEVIMBRA prevents it from switching off your T cells which helps your immune system fight the cancer.
TEVIMBRA is used in adults to treat:
• a type of lung cancer called non-small cell lung cancer.
• a type of lung cancer called extensive-stage small cell lung cancer.
• a type of stomach cancer called gastric or gastroesophageal junction adenocarcinoma
• a type of oesophageal (gullet) cancer called oesophageal squamous cell carcinoma
• a type of head and neck cancer called nasopharyngeal cancer
People get TEVIMBRA when their cancer has spread or cannot be taken out by surgery.
People get TEVIMBRA before surgery (neoadjuvant therapy) to treat non-small cell lung cancer and then continue getting TEVIMBRA after surgery (adjuvant therapy) to help prevent their cancer from coming back.
If you have any questions about how TEVIMBRA works or why this medicine has been prescribed for you, ask your doctor.
TEVIMBRA may be given in combination with other anti-cancer medicines. It is important that you also read the package leaflet for these other medicines. If you have any questions about these medicines, ask your doctor.
You must not be given TEVIMBRA • if you are allergic to tislelizumab or any of the other ingredients of this medicine (listed in section 6). Talk to your doctor if you are not sure.
Warnings and precautions Talk to your doctor before you are given TEVIMBRA if you have or have had:
• autoimmune disease (a condition where the body’s own defence system attacks normal cells)
• inflammation of the liver (hepatitis) or other liver problems
• inflammation of the kidney (nephritis)
• pneumonia or inflammation of the lungs (pneumonitis)
• inflammation of the large bowel (colitis)
• serious rash
• problems with hormone-producing glands (including the adrenal, pituitary and thyroid glands)
• type 1 diabetes mellitus
• a solid organ transplant
• infusion-related reaction
• A rare condition in which the immune system makes too many of otherwise normal infection fighting cells called histiocytes and lymphocytes. It can lead to enlarged liver and/or spleen, heart problems and kidney abnormalities. Symptoms may include fever, skin rash, swollen lymph glands, breathing problems and easy bruising. Tell your doctor immediately if you experience these symptoms at the same time (haemophagocytic lymphohistiocytosis)
TEVIMBRA acts on your immune system. It may cause inflammation in parts of your body. Your risk of these side effects may be higher if you already have an autoimmune disease (a condition where the body attacks its own cells). You may also experience frequent flares of your autoimmune disease, which in the majority of cases are mild.
If any of the above apply to you, or you are not sure, talk to your doctor before you are given TEVIMBRA.
Look out for serious side effects
TEVIMBRA can cause serious side effects, which can sometimes become life-threatening and can lead to death. Tell your doctor immediately if you get any of these serious side effects during treatment with TEVIMBRA:
• inflammation of the liver (hepatitis) or other liver problems
• inflammation of the kidney (nephritis)
• inflammation of the lungs (pneumonitis)
• inflammation of the large bowel (colitis)
• severe skin reactions(including Stevens-Johnson syndrome (SJS) or Toxic epidermal necrolysis (TEN): symptoms may include fever, flu-like symptoms, rash, itching, skin blistering or ulcers in the mouth or on other moist surfaces
• problems with hormone-producing glands (especially the adrenal, pituitary or thyroid glands): symptoms may include fast heart rate, extreme tiredness, weight gain or weight loss, dizziness or fainting, hair loss, feeling cold, constipation, headaches that will not go away or unusual headaches
• type 1 diabetes mellitus
• infusion-related reaction
• inflammation of the muscles (myositis)
• inflammation of the heart muscle (myocarditis)
• inflammation of the membrane around the heart (pericarditis)
• inflammation of the joints (arthritis)
• inflammatory disorder that causes muscle pain and stiffness, especially in the shoulders and hips (polymyalgia rheumatica): symptoms may include pain in the shoulders, neck, upper arms, buttocks, hips or thighs, stiffness in affected areas, pain or stiffness in the wrists, elbows or knees
• inflammation of the nerves: symptoms may include pain, weakness and paralysis in the extremities (Guillain-Barré syndrome)
• Myocarditis-Myositis-Myasthenia Gravis Overlap Syndrome: an overlap of either two or three conditions including inflammation of the heart muscle (myocarditis) that may cause chest pain, shortness of breath, irregular and/or rapid heartbeat, inflammation of the muscles (myositis) that may cause muscle pain, and a condition in which muscles become weak and tire easily (myasthenia gravis)
• For more information on the symptoms of any of the above, read section 4 (“Possible side effects”). Talk to your doctor if you have any questions or concerns.
Patient Card You will also find key information from this package leaflet in the Patient Card that you have been given by your doctor. It is important that you carry the Patient Card with you at all times and show it to a healthcare professional in case of signs and symptoms that may indicate immune-related adverse reactions (listed above under “Look out for serious side effects”), for a prompt diagnosis and adequate treatment.
Monitoring during your treatment with TEVIMBRA Your doctor will carry out regular tests (liver function tests, kidney function tests, radiographic imaging tests) before and during treatment.
Your doctor will also carry out regular blood tests before and during treatment with TEVIMBRA to monitor the blood sugar and hormone levels in your body. This is because blood sugar and hormone levels can be affected by TEVIMBRA.
Children and adolescents TEVIMBRA should not be used in children and adolescents below 18 years of age.
Other medicines and TEVIMBRA Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes herbal medicines and medicines obtained without a prescription.
In particular, tell your doctor if you are taking any medicines that suppress your immune system, including corticosteroids (such as prednisone), since these medicines may interfere with the effect of TEVIMBRA. However, once you have started treatment with TEVIMBRA, your doctor may give you corticosteroids to reduce any side effects that you may have.
Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
You should not be given TEVIMBRA if you are pregnant unless your doctor 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.
• If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor.
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, tell your doctor. You should not breast-feed during treatment with TEVIMBRA and for at least 4 months after the last dose of TEVIMBRA.
Driving and using machines TEVIMBRA has a minor effect on your ability to drive or use machines.
Feeling tired or weak are possible side effects of TEVIMBRA. Do not drive or use machines after you have been given TEVIMBRA unless you are sure you are feeling well.
TEVIMBRA contains sodium Tell your doctor if you are on a low-sodium (low-salt) diet before you are given TEVIMBRA. This medicine contains 1.6 mg sodium (main component of cooking/table salt) in each ml of concentrate. A single infusion of Tevimbra contains 32 mg sodium in two 10 ml vials before dilution. This is equivalent to 1.6% of the recommended maximum daily dietary intake of sodium for an adult. TEVIMBRA is to be diluted in sodium chloride solution for infusion. This should be taken into consideration for patients on a controlled sodium diet.
TEVIMBRA contains polysorbate This medicine contains 0.2 mg of polysorbate 20 in each ml of concentrate, which is equivalent to 4.0 mg in two 10 ml vials of a single infusion of Tevimbra. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
TEVIMBRA will be given to you in a hospital or clinic under the supervision of an experienced doctor.
• The dose of TEVIMBRA is either 200 mg given every 3 weeks or 400 mg given every 6 weeks as an intravenous infusion (drip into a vein).
• For 200 mg dosage of Tevimbra, the first dose of TEVIMBRA will be given by an infusion over a period of 60 minutes. If you tolerate the first dose well, the next infusion may be given over a period of 30 minutes.
• The infusion of an initial dose of Tevimbra 400 mg should be delivered over 120 minutes (over 90 minutes if it is used as subsequent treatment after the dose of 200 mg). If well tolerated, the second infusion may be administered over 60 minutes. If the second infusion is well tolerated, subsequent infusions may be administered over 30 minutes.
• When TEVIMBRA is given in combination with chemotherapy, you will be given TEVIMBRA first and then the chemotherapy.
• Please refer to the package leaflet of the other anti-cancer medicines in order to understand the use of these medicines. If you have questions, ask your doctor.
• Your doctor will decide how many treatments you need.
If you miss a dose of TEVIMBRA • Call your doctor immediately to reschedule your appointment.
• It is very important that you do not miss a dose of this medicine.
If you stop TEVIMBRA treatment Stopping your treatment may stop the effect of the medicine. Do not stop treatment with TEVIMBRA unless you have discussed this with your doctor.
If you have any further questions about your treatment or the use of this medicine, ask your doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of the side effects of TEVIMBRA may be serious (see the list under “Look out for serious side effects” in section 2 of this leaflet). If you experience any of these serious side effects, tell your doctor immediately.
The following side effects have been reported with TEVIMBRA when TEVIMBRA is given together with other anti-cancer medicines Note that it is important that you also read the package leaflets for the other anti-cancer medicines that you receive as they may also cause side effects.
• 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 – possible symptoms of hyperglycaemia
• High blood sugar, feeling more hungry or thirsty than normal, passing urine more often than normal – possible symptoms of diabetes mellitus
• 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 – possible symptoms of heart muscle problems (myocarditis)
• Severe upper stomach pain, nausea, vomiting, fever, tender abdomen – possible symptoms of pancreas problems (pancreatitis)
• Feeling sick (nausea), vomiting, loss of appetite, pain on the right side of the stomach, yellowing of the skin or the whites of the eyes, drowsiness, dark-coloured urine, bleeding or bruising more easily than normal – possible symptoms of liver problems (hepatitis)
• Disease in which the immune system attacks the glands that make moisture for the body, such as tears and saliva (Sjögren’s syndrome).
• Fatigue, swelling at the base of the neck, pain in front of the throat – possible symptoms of thyroid gland problems (thyroiditis)
• Adrenal insufficiency (disorder in which the adrenal glands do not make enough of certain hormones)
• 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)
• A condition where the immune system makes too many of otherwise normal infection-fighting cells called histiocytes and lymphocytes. Symptoms can include fever, skin rash, swollen lymph glands, breathing problems, easy bruising (haemophagocytic lymphohistiocytosis)
• Inflammation of the brain, which may cause confusion, fever, memory problems or seizures (encephalitis)
• Serious problems of the nerves, which may cause difficulty breathing, sensation of prickling or pins and needles in the fingers, toes, ankles or wrists, weakness in the legs that spreads to the upper body, unsteady walking or inability to walk or climb stairs, difficulty with facial movements including speaking, chewing or swallowing, double vision or inability to move eyes, difficulty with bladder control or bowel function, rapid heart rate and paralysis – possible symptoms of Guillain-Barré syndrome
• Muscle weakness and tiredness (myasthenia gravis)
• Chest pain, fever, cough, palpitations – possible symptoms of problems affecting the membrane around the heart (pericarditis)
• Itching or peeling skin, skin sores – possible symptoms of severe skin reactions
The following side effects have been reported with TEVIMBRA alone: Very common (may affect more than 1 in 10 people)
• Weakness, rapid heart rate, shortness of breath (anaemia)
• Spontaneous bleeding or bruising (thrombocytopenia)
• Underactive thyroid gland, which can cause tiredness, weight gain, skin and hair changes (hypothyroidism)
• Cough
• Nausea
• Diarrhoea
• Rash
• Itching (pruritus)
• Tiredness (fatigue)
• Fever
• Decreased appetite
• Increased blood level of the liver enzyme aspartate aminotransferase
• Increased blood level of the liver enzyme alanine aminotransferase
• Increased blood level of bilirubin, a breakdown product of red blood cells, which can cause yellowing of the skin and eyes, indicating liver problems
Common (may affect up to 1 in every 10 people)
• Pneumonia
• Frequent infections, fever, chills, sore throat or mouth ulcers due to infections (neutropenia or lymphopenia)
• Overactive thyroid gland, which can cause hyperactivity, sweating, weight loss and thirst (hyperthyroidism)
• Fatigue, swelling at the base of the neck, pain in front of the throat – possible symptoms of thyroid gland problems (thyroiditis)
• 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 – possible symptoms of hyperglycaemia
• Tiredness, confusion, muscle twitching, convulsions (hyponatraemia)
• Muscle weakness, muscle spasms, abnormal heart rhythm (hypokalaemia)
• Increased blood pressure (hypertension)
• Difficulty breathing (dyspnoea)
• Shortness of breath, cough or chest pain – possible symptoms of lung problems (pneumonitis)
• Mouth sores or ulcers with inflammation of the gums (stomatitis)
• Feeling sick (nausea), vomiting, loss of appetite, pain on the right side of the stomach, yellowing of the skin or the whites of the eyes, drowsiness, dark-coloured urine, bleeding or bruising more easily than normal – possible symptoms of liver problems (hepatitis)
• Joint pain (arthralgia)
• Muscle pain (myalgia)
• Increased blood level of the liver enzyme alkaline phosphatase
• Increased blood level of creatinine
• 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 reaction
• Low blood level of haemoglobin
• Low blood levels of the following blood cells: lymphocytes, neutrophils and platelets
• High blood levels of the following enzymes: alanine aminotransferase, alkaline aminotransferase, aspartate aminotransferase and creatine kinase
• High blood level of alkaline phosphatase
• High blood level of bilirubin
• High blood level of creatinine
• High blood level of glucose
• Low blood levels of potassium and sodium
Uncommon (may affect up to 1 in every 100 people)
• 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)
• High blood sugar, feeling more hungry or thirsty than normal, passing urine more often than normal – possible symptoms of diabetes mellitus
• Eye redness, eye pain and swelling – possible symptoms of problems affecting the uvea, the layer beneath the white of the eyeball (uveitis)
• 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 – possible symptoms of heart muscle problems (myocarditis)
• Chest pain, fever, cough, palpitations – possible symptoms of problems affecting the membrane around the heart (pericarditis)
• Severe upper stomach pain, nausea, vomiting, fever, tender abdomen – possible symptoms of pancreas problems (pancreatitis)
• Diarrhoea or more bowel movements than normal, black tarry, sticky stools, blood or mucus in stools, severe pain or tenderness in the stomach – possible symptoms of intestinal problems (colitis)
• Skin discolouration (vitiligo)
• Itching or peeling skin, skin sores – possible symptoms of severe skin reactions
• Muscle pain, stiffness, weakness, chest pain or severe tiredness – possible symptoms of muscle problems (myositis)
• Joint pain, stiffness, swelling or redness, decreased range of motion in the joints – possible symptoms of joint problems (arthritis)
• Changes in the amount or colour of the urine, pain while urinating, pain in kidney area – possible symptoms of kidney problems (nephritis)
• High blood levels of haemoglobin
• Low blood level of leukocytes
• High blood level of lymphocytes
• Low blood level of albumin
• Low blood level of glucose
• High blood levels of potassium and sodium
Rare (may affect up to 1 in every 1 000 people)
• Serious problems of the nerves, which may cause difficulty breathing, sensation of prickling or pins and needles in the fingers, toes, ankles or wrists, weakness in the legs that spreads to the upper body, unsteady walking or inability to walk or climb stairs, difficulty with facial movements including speaking, chewing or swallowing, double vision or inability to move eyes, difficulty with bladder control or bowel function, rapid heart rate and paralysis – possible symptoms of Guillain-Barré syndrome
• Coeliac disease (characterised by symptoms such as stomach pain, diarrhoea, and bloating after consuming gluten-containing foods)
• Serious rash and reddening of the skin on upper body and quickly spreading to other body parts, blistering of the lips, eyes or mouth, skin peeling, sometimes with flu-like symptoms such as fever, sore throat, cough, and joint pain (Stevens-Johnson syndrome)
• Inflammation of the bladder. Signs and symptoms may include frequent and/or painful urination, urge to pass urine, blood in urine, pain or pressure in lower abdomen (noninfective cystitis)
Other side effects that have been reported (frequency not known):
• A condition where the immune system makes too many of otherwise normal infection-fighting cells called histiocytes and lymphocytes. Symptoms can include fever, skin rash, swollen lymph glands, breathing problems, easy bruising (haemophagocytic lymphohistiocytosis)
• Lack or reduction of digestive enzymes made by the pancreas (pancreatic exocrine insufficiency)
The following side effects have been reported with TEVIMBRA when TEVIMBRA is given together with other anti-cancer medicines Note that it is important that you also read the package leaflets for the other anti-cancer medicines that you receive as they may also cause side effects.
Very common (may affect more than 1 in 10 people)
• Pneumonia
• Weakness, rapid heart rate, shortness of breath (anaemia)
• Spontaneous bleeding or bruising (thrombocytopenia)
• Frequent infections, fever, chills, sore throat or mouth ulcers due to infections (neutropenia or lymphopenia)
• Underactive thyroid gland which can cause tiredness, weight gain, skin and hair changes (hypothyroidism)
• Muscle weakness, muscle spasms, abnormal heart rhythm (hypokalaemia)
• Cough
• Nausea
• Diarrhoea
• Rash
• Itching (pruritus)
• Joint pain (arthralgia)
• Tiredness (fatigue)
• Fever
• Decreased appetite
• Increased blood level of the liver enzyme aspartate aminotransferase
• Increased blood level of the liver enzyme alanine aminotransferase
• Increased blood level of bilirubin, a breakdown product of red blood cells, which can cause yellowing of the skin and eyes, indicating liver problems
• Increased blood level of creatinine, a substance normally eliminated by the kidneys into the urine. This may mean that your kidneys are not functioning properly.
• Low blood level of haemoglobin
• Low blood levels of the following blood cells: leukocytes, lymphocytes, neutrophils and platelets
• Low blood level of sodium
Common (may affect up to 1 in every 10 people)
• Overactive thyroid gland, which can cause hyperactivity, sweating, weight loss and thirst (hyperthyroidism)
• Increased blood pressure (hypertension)
• Difficulty breathing (dyspnoea)
• Shortness of breath, cough or chest pain – possible symptoms of lung problems (pneumonitis)
• Mouth sores or ulcers with inflammation of the gums (stomatitis)
• Diarrhoea or more bowel movements than normal, black tarry, sticky stools, blood or mucus in stools, severe pain or tenderness in the stomach – possible symptoms of intestine problems (colitis)
• Muscle pain (myalgia)
• Joint pain, stiffness, swelling or redness, decreased range of motion in the joints – possible symptoms of joint problems (arthritis)
• Increased blood level of the liver enzyme alkaline phosphatase
• 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 reaction
• High blood levels of the following enzymes: alanine aminotransferase and aspartate aminotransferase
• High blood level of bilirubin
• High blood levels of creatine kinase and creatinine
• High blood level of glucose
• High blood level of potassium
• Low blood level of potassium
Uncommon (may affect up to 1 in every 100 people)
• Eye redness, eye pain and swelling – possible symptoms of problems affecting the uvea, the layer beneath the white of the eyeball (uveitis)
• Muscle pain, stiffness, weakness, chest pain, or severe tiredness – possible symptoms of muscle problems (myositis)
• Myocarditis-Myositis-Myasthenia Gravis Overlap Syndrome: an overlap of either two or three conditions, including inflammation of the heart muscle (myocarditis), inflammation of the muscles (myositis), and a condition in which muscles become weak and tire easily (myasthenia gravis)
• Skin discolouration (vitiligo)
• High blood level of lymphocytes
• Low blood level of albumin
• High blood level of alkaline phosphatase
• Low blood level of glucose
• High blood level of sodium
Tell your doctor immediately if you experience any of the serious side effects listed above.
Using TEVIMBRA should be stopped and medical attention should be sought immediately if you notice any of the following symptoms:
Frequency not known (cannot be estimated from the available data)
• Reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (TEN)
Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Your doctor, pharmacist or nurse is responsible for storing this medicine and disposing of any unused product correctly. The following information is intended for healthcare professionals.
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 vial 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'
TEVIMBRA does not contain a preservative. Chemical and physical in-use stability has been demonstrated for 10 days ( 240 hours) at 2°C to 8°C. The 10 days (240 hours) include storage of the diluted solution under refrigeration (2°C to 8°C), time required for returning to room temperature (25°C or below) and time to complete the infusion within 4 hours.
From a microbiological point of view, once diluted, the product should be used immediately.
If not used immediately, in-use storage times and conditions are the responsibility of the user. The diluted solution must not be frozen.
Do not store any unused portion of the infusion solution for reuse. Any unused medicine or waste material should be disposed of in accordance with local requirements.
What TEVIMBRA contains • The active substance is tislelizumab. Each ml of concentrate for solution for infusion contains 10 mg of tislelizumab.
• Each vial contains 100 mg of tislelizumab in 10 ml of concentrate.
The other ingredients are sodium citrate dihydrate (see section 2, “TEVIMBRA contains sodium”), citric acid monohydrate, L-histidine hydrochloride monohydrate, L-histidine, trehalose dihydrate, polysorbate 20 and water for injections.
What TEVIMBRA looks like and contents of the pack TEVIMBRA concentrate for solution for infusion (sterile concentrate) is a clear to slightly opalescent, colourless to slightly yellowish solution.
TEVIMBRA is available in packs containing 1 vial and in multipacks containing 2 (2 packs of 1) vials.
Marketing Authorisation Holder BeOne Medicines UK, Ltd.
c/o Regus London Paddington
2 Kingdom Street
London
W2 6BD
Manufacturer BeOne Medicines I GmbH – Dutch Branch
Evert Van De Beekstraat 1/104
Schiphol
1118 CL
Netherlands
For any information about this medicine, please contact the Marketing Authorisation Holder.
United Kingdom
BeOne Medicines UK, Ltd.
Tel.: 0800 917 6799 This leaflet was last revised in July 2026.
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BeOne Medicines UK, Ltd.
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Tevimbra 100 mg/10 ml Infusion comes as infusion containing 100 mg/10. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Tevimbra 100 mg/10 ml Infusion is tislelizumab.
This leaflet reproduces the patient information leaflet approved for Tevimbra 100 mg/10 ml Infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Non-small cell lung cancer (NSCLC)
Tevimbra, in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of adult patients with resectable NSCLC at high risk of recurrence (for selection criteria, see section 5.1).
Tevimbra, in combination with pemetrexed and platinum containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous NSCLC whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations and who have:
• locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or
• metastatic NSCLC.
Tevimbra in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous NSCLC who have:
• locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or
• metastatic NSCLC.
Tevimbra as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.
Small Cell Lung Cancer (SCLC)
Tevimbra, in combination with etoposide and platinum chemotherapy, is indicated for the first-line treatment of adult patients with extensive-stage SCLC.
Gastric or gastroesophageal junction (G/GEJ) adenocarcinoma
Tevimbra, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adult patients with HER-2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumours express PD L1 with a tumour area positivity (TAP) score ≥ 5% (see section 5.1).
Oesophageal squamous cell carcinoma (OSCC)
Tevimbra, in combination with platinum-based chemotherapy, is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic OSCC whose tumours express PD‑L1 with a TAP score ≥ 5% (see section 5.1).
Tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic OSCC after prior platinum-based chemotherapy.
Nasopharyngeal carcinoma (NPC)
Tevimbra, in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of adult patients with recurrent, not amenable to curative surgery or radiotherapy, or metastatic NPC.
Tevimbra treatment must be initiated and supervised by physicians experienced in the treatment of cancer.
PD-L1 testing
If specified in the indication, patient selection for treatment with Tevimbra based on the tumour expression of PD-L1 should be assessed by a CE-marked IVD with the corresponding intended purpose. If the CE-marked IVD is not available, an alternative validated test should be used (see sections 4.1, 4.4, and 5.1).
Posology
Tevimbra monotherapy
The recommended dose of Tevimbra is either 200 mg once every 3 weeks or 400 mg once every 6 weeks administered by intravenous infusion.
For resectable NSCLC, during the adjuvant treatment phase, the recommended dose of Tevimbra is 400 mg administered by intravenous infusion once every 6 weeks.
Tevimbra combination therapy
The recommended dose of Tevimbra is either 200 mg once every 3 weeks or 400 mg once every 6 weeks administered by intravenous infusion, in combination with chemotherapy.
When Tevimbra and chemotherapy are administered on the same day, Tevimbra should be administered before chemotherapy. The Summary of Product Characteristics (SmPC) for the chemotherapy product should be referred to for dosing as well as for recommendations on corticosteroid use as pre-medication for the prevention of chemotherapy-related adverse reactions.
Duration of treatment
Patients should be treated with Tevimbra until disease progression or unacceptable toxicity (see section 5.1).
For the neoadjuvant and adjuvant treatment of resectable NSCLC, patients should be treated with neoadjuvant Tevimbra (200 mg every 3 weeks) in combination with chemotherapy for 3 or 4 cycles or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with Tevimbra (400 mg every 6 weeks) as monotherapy for up to 8 cycles or until disease recurrence, metastasis, or unacceptable toxicity.
Dose delay or discontinuation (see also section 4.4)
Dose reductions of Tevimbra as monotherapy or in combination therapy are not recommended. Tevimbra should be withheld or discontinued based on safety and tolerability as described in Table 1.
Detailed guidelines for the management of immune‑related adverse reactions are described in section 4.4.
Table 1 Recommended treatment modifications for Tevimbra
| Immune‑related adverse reaction | Severity1 | Tevimbra treatment modification |
| Pneumonitis | Grade 2 | Withhold2,3 |
| Recurrent Grade 2; Grade 3 or 4 | Permanently discontinue3 | |
| Hepatitis | ALT or AST >3 to 8 x ULN or total bilirubin >1.5 to 3 x ULN | Withhold2,3 |
| ALT or AST >8 x ULN or total bilirubin >3 x ULN | Permanently discontinue3 | |
| Rash | Grade 3 | Withhold2,3 |
| Grade 4 | Permanently discontinue3 | |
| Severe cutaneous adverse reactions (SCARs) | Suspected SCARs, including SJS or TEN | Withhold2,3 For suspected SJS or TEN, do not resume unless SJS/TEN has been ruled out in consultation with appropriate specialist(s). |
| Confirmed SCARs, including SJS or TEN | Permanently discontinue | |
| Colitis | Grade 2 or 3 | Withold2,3 |
| Recurrent Grade 3; Grade 4 | Permanently discontinue3 | |
| Myositis/rhabdomyolysis | Grade 2 or 3 | Withhold2,3 |
| Recurrent Grade 3; Grade 4 | Permanently discontinue3 | |
| Hypothyroidism | Grade 2, 3 or 4 | Hypothyroidism may be managed with replacement therapy without treatment interruption. |
| Hyperthyroidism | Grade 3 or 4 | Withhold2 For Grade 3 or 4 that has improved to Grade ≤2 and is controlled with anti‑thyroid therapy, if indicated continuation of Tevimbra may be considered after corticosteroid taper. Otherwise, treatment should be discontinued. |
| Adrenal insufficiency | Grade 2 | Consider withholding treatment until controlled by HRT. |
| Grade 3 or 4 | Withhold3 For Grade 3 or 4 that has improved to Grade ≤2 and is controlled with HRT, if indicated continuation of Tevimbra may be considered after corticosteroid taper. Otherwise, treatment should be discontinued.3 | |
| Hypophysitis | Grade 2 | Consider withholding treatment until controlled by HRT. |
| Grade 3 or 4 | Withhold2,3 For Grade 3 or 4 that has improved to Grade ≤2 and is controlled with HRT, if indicated continuation of Tevimbra may be considered after corticosteroid taper. Otherwise, treatment should be discontinued.3 | |
| Type 1 diabetes mellitus | Type 1 diabetes mellitus associated with Grade ≥3 hyperglycaemia (glucose >250 mg/dl or >13.9 mmol/l) or associated with ketoacidosis | Withhold For Grade 3 or 4 that has improved to Grade ≤2 with insulin therapy, if indicated continuation of Tevimbra may be considered once metabolic control is achieved. Otherwise, treatment should be discontinued. |
| Nephritis with renal dysfunction | Grade 2 (creatinine >1.5 to 3 x baseline or >1.5 to 3 x ULN) | Withhold2,3 |
| Grade 3 (creatinine >3 x baseline or >3 to 6 x ULN) or Grade 4 (creatinine >6 x ULN) | Permanently discontinue3 | |
| Myocarditis | Grade 2, 3 or 4 | Permanently discontinue3 |
| Neurological toxicities | Grade 2 | Withhold2,3 |
| Grade 3 or 4 | Permanently discontinue3 | |
| Pancreatitis | Grade 3 pancreatitis or Grade 3 or 4 serum amylase or lipase levels increased (>2 x ULN) | Withhold2,3 |
| Grade 4 | Permanently discontinue3 | |
| Other immune‑related adverse reactions | Grade 3 | Withhold2,3 |
| Recurrent Grade 3; Grade 4 | Permanently discontinue3 | |
| Other adverse drug reactions | ||
| Infusion-related reactions | Grade 1 | Consider pre-medication for prophylaxis of subsequent infusion reactions. Slow the rate of infusion by 50%. |
| Grade 2 | Interrupt infusion. Resume infusion if resolved or decreased to Grade 1, and slow rate of infusion by 50%. | |
| Grade 3 or 4 | Permanently discontinue | |
| Myocarditis-Myositis-Myasthenia Gravis Overlap Syndrome4 | Grade 2 Myocarditis-Myositis- Myasthenia Gravis Overlap Syndrome | Withhold dose(s) until symptoms resolve and management with corticosteroids is complete |
| Grade 3 or 4 Myocarditis- Myositis-Myasthenia Gravis Overlap Syndrome | Permanently discontinue treatment | |
| ALT = alanine aminotransferase, AST = aspartate aminotransferase, HRT= hormone replacement therapy, SJS = Stevens‑Johnson syndrome, TEN = Toxic epidermal necrolysis, ULN = upper limit of normal 1 Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.0). Hypophysitis grade is in accordance with NCI-CTCAE v5.0. 2 Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper over at least 1 month. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating corticosteroids or inability to reduce prednisone to ≤10 mg/day (or equivalent) within 12 weeks of initiating corticosteroids. 3 Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper to ≤10 mg/day (or equivalent) over at least 1 month is recommended, except for pneumonitis, where initial dose of 2 to 4 mg/kg/day is recommended. 4 Presenting as an overlap of either two or all three conditions. The most severe CTCAE grade from the individual events should be considered to assess the recommended treatment modification. | ||
Special populations
Paediatric population
The safety and efficacy of Tevimbra in patients aged below 18 years have not been established. No data are available.
Elderly
No dose adjustment is needed for patients aged ≥65 years (see section 4.8).
Renal impairment
No dose adjustment is needed for patients with mild or moderate renal impairment. Data from patients with severe renal impairment are too limited to make dosing recommendations for this population (see section 5.2).
Hepatic impairment
No dose adjustment is needed for patients with mild or moderate hepatic impairment. Data from patients with severe hepatic impairment are too limited to make dosing recommendations for this population (see section 5.2).
Method of administration
Tevimbra is for intravenous use only. It is to be administered as an infusion and must not be administered as an intravenous push or single bolus injection. For instructions on dilution of the medicinal product before administration, see section 6.6.
The first infusion at 200 mg should be administered over a period of 60 minutes. If this is well tolerated, the subsequent infusions may be administered over a period of 30 minutes. The infusion should be given via an intravenous line containing a sterile, non-pyrogenic, low‑protein‑binding 0.2 or 0.22 micron in-line or add-on filter.
The infusion of an initial dose of Tevimbra 400 mg should be delivered over 120 minutes (over 90 minutes if it is used as subsequent treatment after the dose of 200 mg once every 3 weeks). If well tolerated, the second infusion may be administered over 60 minutes. If the second infusion is well tolerated, subsequent infusions may be administered over 30 minutes.
Other medicinal products must not be mixed or co-administered through the same infusion line.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Tislelizumab is a humanised monoclonal antibody, cleared from the circulation through catabolism. As such, formal pharmacokinetic interaction studies have not been conducted. As monoclonal antibodies are not metabolised by cytochrome P450 (CYP) enzymes or other drug-metabolising enzymes, inhibition or induction of these enzymes by co-administered medicinal products is not anticipated to affect the pharmacokinetics of tislelizumab.
The use of systemic corticosteroids and other immunosuppressants at baseline, before starting tislelizumab, except for low doses of systemic corticosteroid (10 mg/day prednisone or equivalent), should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of tislelizumab. However, systemic corticosteroids and other immunosuppressants can be used after starting tislelizumab to treat immune-related adverse reactions (see section 4.4). Corticosteroids can also be used as pre-medication when tislelizumab is used in combination with chemotherapy, as antiemetic prophylaxis and/or to alleviate chemotherapy-related adverse reactions.
Women of childbearing potential/Contraception
Tislelizumab should not be used in women of childbearing potential not using effective contraception unless the clinical condition of the woman requires treatment with tislelizumab. Women of childbearing potential should use effective contraception (methods that result in less than 1% pregnancy rates) during treatment and for at least 4 months following the last dose of tislelizumab.
Pregnancy
There are no available data on the use of tislelizumab in pregnant women. Based on its mechanism of action, tislelizumab can cause foetal harm when administered to a pregnant woman.
Animal reproduction studies have not been conducted with tislelizumab. However, in murine models of pregnancy, blockade of PD-1/PD-L1 signalling has been shown to disrupt tolerance to the foetus and to result in increased foetal loss.
Human IgG4 (immunoglobulins) are known to cross the placental barrier. Therefore, tislelizumab, being an IgG4 variant, has the potential to be transmitted from the mother to the developing foetus. Women should be advised of the potential risk to a foetus.
Tislelizumab should not be used during pregnancy unless the clinical condition of the woman requires treatment with tislelizumab.
Breast-feeding
It is unknown whether tislelizumab is excreted in human milk. Its effects on breast-fed newborns/infants and on milk production are also unknown.
Because of the potential for serious adverse drug reactions in breast-fed newborns/infants from Tevimbra, women should be advised not to breast-feed during treatment and for at least 4 months after the last dose of Tevimbra.
Fertility
No clinical data are available on the possible effects of tislelizumab on fertility. No reproductive and development toxicity studies have been conducted with tislelizumab. Based on a 3-month repeat-dose toxicity study, there were no notable effects in the male and female reproductive organs in cynomolgus monkeys when tislelizumab was given at doses of 3, 10 or 30 mg/kg every 2 weeks for 13 weeks (7 dose administrations) (see section 5.3).
Tevimbra has minor influence on the ability to drive and use machines. In some patients, fatigue has been reported following administration of tislelizumab (see section 4.8).
There is no information on overdose with tislelizumab. In case of overdose, patients should be closely monitored for signs or symptoms of adverse drug reactions, and appropriate symptomatic treatment should be instituted immediately.
Ask anything about Tevimbra 100 mg/10 ml Infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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