Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - tevimbra

Document Subject

Generated Narrative: MedicinalProductDefinition mpb118a8011d0099eb4bb6c4b864ba44c0

identifier: http://ema.europa.eu/identifier/EU/1/23/1758/001-002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Tevimbra 100 mg concentrate for solution for infusion

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-b118a8011d0099eb4bb6c4b864ba44c0

identifier: http://ema.europa.eu/identifier/EU/1/23/1758/001-002

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - tevimbra

Attesters

What is in this leaflet

1. What Tevimbra is and what it is used for
2. What you need to know before you are given Tevimbra
3. How Tevimbra is given
4. Possible side effects
5. How to store Tevimbra
6. Contents of the pack and other information

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 oesophageal cancer called oesophageal squamous cell carcinoma that has spread to other parts of the body, has already been treated by anti-cancer therapy and cannot be removed by surgery.

If you have any questions about how Tevimbra works or why this medicine has been prescribed for you, 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 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 have 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: 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 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 membrane around the heart (pericarditis)
• inflammation of the nerves: symptoms may include pain, weakness and paralysis in the extremities (Guillain-Barr syndrome)

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. This is equivalent to 1.6% of the recommended maximum daily dietary intake of sodium for an adult.

Tevimbra will be given to you in a hospital or clinic under the supervision of an experienced doctor.

• The usual dose of Tevimbra is 200 mg, which is given as an intravenous infusion (drip into a vein) every 3 weeks.
• The first dose of Tevimbra will be given by an infusion over a period of 60 minutes. If you tolerate the first dose well, then the next infusion may be given over a period of 30 minutes.
• 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 alone:

Very common (may affect more than 1 in 10 people)

• Underactive thyroid gland, which can cause tiredness, weight gain, skin and hair changes (hypothyroidism)
• Cough
• Rash
• Itching (pruritus)
• Tiredness (fatigue)
• Decreased appetite
• Weakness, spontaneous bleeding or bruising and frequent infections, fever, chills and sore throat (anaemia)
• High 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 the liver enzyme aspartate aminotransferase
• Increased blood level of the liver enzyme alanine aminotransferase

Common (may affect up to 1 in every 10 people)

• Pneumonia
• Diarrhoea
• Nausea
• Spontaneous bleeding or bruising (thrombocytopenia)
• Frequent infections, fever, chills, sore throat or mouth ulcers due to infections (neutropenia or lymphopenia)
• 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)
• Shortness of breath, cough or chest pain - possible symptoms of lung problems (pneumonitis)
• 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)
• Overactive thyroid gland, which can cause hyperactivity, sweating, weight loss and thirst (hyperthyroidism)
• Difficulty breathing (dyspnoea)
• Increased blood pressure (hypertension)
• Mouth sores or ulcers with inflammation of the gums (stomatitis)
• Increased blood level of the liver enzyme alkaline phosphatase
• High blood level of the enzyme creatine kinase
• High blood level of creatinine

Uncommon (may affect up to 1 in every 100 people)

• Changes in the amount or colour of the urine, pain while urinating, pain in kidney area
  possible symptoms of kidney problems (nephritis)
• 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)
• Severe upper stomach pain, nausea, vomiting, fever, tender abdomen possible symptoms of pancreas problems (pancreatitis)
• High blood sugar, feeling more hungry or thirsty than normal, passing urine more often than normal - possible symptoms of diabetes mellitus
• Muscle pain, stiffness, weakness, chest pain or severe tiredness possible symptoms of muscle problems (myositis)
• Chest pain, rapid or abnormal heartbeat, shortness of breath at rest or during activity, fluid build-up with swelling of the legs, ankles and feet, tiredness - possible symptoms of heart muscle problems (myocarditis)
• Joint pain, stiffness, swelling or redness, decreased range of motion in the joints possible symptoms of joint problems (arthritis)
• Eye redness, eye pain and swelling - possible symptoms of problems affecting the uvea, the layer beneath the white of the eyeball (uveitis)
• Adrenal insufficiency (disorder in which the adrenal glands do not make enough of certain hormones)
• Inflammation of the nerves: symptoms may include pain, weakness and paralysis in the extremities (Guillain-Barr syndrome)
• 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 leukocytes
• High blood levels of haemoglobin, potassium and sodium
• Low blood level of albumin

Rare (may affect up to 1 in every 1 000 people)

• Chest pain, fever, cough, palpitations - possible symptoms of problems affecting the membrane around the heart (pericarditis)
• 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)
• Itching or peeling skin, skin sores - possible symptoms of severe skin reactions

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 national reporting system listed in Appendix V. 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. Store in the original carton in order to protect from light.

Tevimbra does not contain a preservative. Chemical and physical in-use stability has been demonstrated for 24 hours at 2 C to 8 C. The 24 hours include storage of the diluted solution under refrigeration (2 C to 8 C) for no more than 20 hours, 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, unless the method of dilution precludes the risk of microbial contamination, 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 Beigene Ireland Limited
10 Earlsfort Terrace Dublin 2 D02 TIreland Tel. +353 1 566 7E-mail: bg.ireland@beigene.com

Manufacturer Novartis Farmac utica, S.A. Gran Via de les Corts Catalanes, 08013 Barcelona Spain

Novartis Pharma GmbH Roonstrasse 90429 Nuremberg Germany

This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: