Patient leaflet - Tyenne 162 mg solution for injection in Pre-filled pen
1. What Tyenne is and what it is used for
Tyenne contains the active substance tocilizumab, which is a protein made from specific immune cells (monoclonal antibody), that blocks the action of a specific protein (cytokine) called interleukin-6. This protein is involved in inflammatory processes of the body, and blocking it can reduce the inflammation in your body. Tyenne is used to treat:
- adults with moderate to severe active rheumatoid arthritis (RA), an autoimmune disease, if previous therapies did not work well enough.
adults with severe, active and progressive rheumatoid arthritis (RA), who have not had previous treatment with methotrexate.
Tyenne helps to reduce RA symptoms such as pain and swelling in your joints, and can also improve your performance of daily tasks. Tyenne has been shown to slow the damage to the cartilage and bone of the joints caused by the disease and to improve your ability to do normal daily activities.
Tyenne is usually given in combination with another medicine for RA called methotrexate. However, Tyenne can be given alone if your doctor determines that methotrexate is inappropriate.
adults with a disease of the arteries called giant cell arteritis (GCA), caused by inflammation of the body’s largest arteries, especially those that supply blood to the head and neck. Symptoms include headache, fatigue (tiredness) and jaw pain. Effects can include strokes and blindness.
Tyenne can reduce pain and swelling in the arteries and veins in your head, neck and arms.
GCA is often treated with medicines called steroids. They are usually effective, but can have side effects if used at high doses for a long time. Reducing the steroid dose can also lead to a flare-up of the GCA. Adding Tyenne to the treatment means that steroids can be used for a shorter time, while still controlling the disease.
children and adolescents, aged 12 years and over, with active systemic juvenile idiopathic arthritis (sJIA), an inflammatory disease that causes pain and
swelling in one or more joints as well as fever and rash.
Tyenne is used to improve the symptoms of sJIA. It can be given in combination with methotrexate or alone.
- children and adolescents, aged 12 years and over, with active polyarticular juvenile idiopathic arthritis (pJIA). This is an inflammatory disease that causes pain and swelling in one or more joints. Tyenne is used to improve the symptoms of pJIA. It can be given in combination with methotrexate or alone.
2. What you need to know before you use Tyenne
Do not use Tyenne
- if you or a child patient you look after are allergic to tocilizumab or any of the other ingredients of this medicine (listed in section 6).
- if you or a child patient you look after have an active, severe infection.
If either of these applies to you, tell a doctor. Do not use Tyenne.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Tyenne.
If you experience allergic reactions such as chest tightness, wheezing, severe dizziness or lightheadedness, swelling of the lips, tongue, face or skin itching, hives or rash during or after the injection, then tell your doctor immediately. • Do not take the next dose until you have informed
your doctor AND your doctor has told you to take the next dose if you have experienced any allergic reaction symptoms after Tyenne administration. • If you have any kind of infection, short- or long-term, or if you often get infections. Tell your doctor immediately if you feel unwell. Tyenne can reduce your body’s ability to respond to infections and may
make an existing infection worse or increase the chance of getting a new infection.
If you have had tuberculosis, tell your doctor. Your doctor will check for signs and symptoms of tuberculosis before starting Tyenne. If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever) or any other infection appear
during or after therapy tell your doctor immediately. • If you have had intestinal ulcers or diverticulitis, tell your doctor. Symptoms would include abdominal pain and unexplained changes in bowel habits with a fever.
If you have liver disease, tell your doctor. Before you use Tyenne, your doctor may do a blood test to
measure your liver function.
- If any patient has recently been vaccinated, or is planning a vaccination, tell your doctor. All patients should be up-to-date with all their vaccinations before they start treatment with Tyenne. Certain types of vaccines should not be given while receiving Tyenne.
- If you have cancer, tell your doctor. Your doctor will have to decide if you can still be given Tyenne. • If you have risk factors for heart disease such as raised blood pressure and raised cholesterol levels, tell your doctor. These factors need to be monitored while receiving Tyenne.
- If you have moderate to severe kidney function problems, your doctor will monitor you. • If you have persistent headaches.
Your doctor will perform a blood test before you receive Tyenne, to determine if you have a low white blood cell count, low platelet count or high liver enzymes.
Children and adolescents
Tyenne pre-filled pen is not recommended for use in children under 12 years of age.
Tyenne must not be given to children with sJIA (systemic juvenile idiopathic arthritis) weighing less than 10 kg.
If a child has a history of macrophage activation syndrome (activation and uncontrolled proliferation of specific blood cells), tell your doctor. Your doctor will have to decide if they can still be given Tyenne.
Other medicines and Tyenne
Tell your doctor if you are taking any other medicines, or have recently taken any. Tyenne can affect the way some medicines work, and the dose of these may require adjustment. If you are using medicines containing any of the following active substances, tell your doctor:
- methylprednisolone, dexamethasone, used to reduce inflammation
- simvastatin or atorvastatin, used to reduce cholesterol levels
- calcium channel blockers (such as amlodipine), used to treat high blood pressure
- theophylline, used to treat asthma
warfarin or phenprocoumon, used as a blood thinning
agents
- phenytoin, used to treat convulsions
- ciclosporin, used to suppress your immune system during organ transplants
- benzodiazepines (such as temazepam), used to relieve anxiety
Regarding vaccinations, please see the section on warnings above.
Due to lack of clinical experience, Tyenne is not recommended for use with other biological medicines for the treatment of RA, sJIA, pJIA or GCA.
Pregnancy and breast-feeding
Tyenne is not to be used in pregnancy unless clearly necessary. Talk to your doctor if you are pregnant, may be pregnant, or intend to become pregnant. Women of childbearing potential must use effective contraception during and up to 3 months after treatment.
Stop breast-feeding if you are to be given Tyenne, and talk to your doctor. Leave a gap of at least 3 months
after your last treatment before you start breast-feeding. It is not known whether Tyenne passes into breast milk.
Driving and using machines
This medicine can cause dizziness. If you feel dizzy, do not drive or use machines.
Tyenne contains sodium
This medicinal product contains less than 1 mmol of sodium (23 mg) per 0.9 mL dose, that is to say essentially ‘sodium-free’.
Tyenne contains polysorbate 80
This medicinal producte contains 0.18 mg of polysorbate 80 in each 162 mg/0.9 mL syringe, which
is equivalent to 0.2 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have or your child has any known allergies.
3. How to use Tyenne
Always use this medicine exactly as your doctor, pharmacist or nurse has told you. You should check
with your doctor, pharmacist or nurse if you are not sure.
The treatment will be prescribed and started by healthcare professionals experienced in the diagnosis and treatment of RA, sJIA, pJIA or GCA.
Adults with RA or GCA
The recommended dose for RA (rheumatoid arthritis)
or GCA (giant cell arteritis) for adults is 162 mg (the content of 1 pre-filled pen) given once a week.
Adolescents with sJIA (aged 12 years and over)
The usual dose of Tyenne depends on the patient’s weight.
If the patient weighs less than 30 kg: the dose is
162 mg (the content of 1 pre-filled pen) once every 2 weeks
If the patient weighs 30 kg or more: the dose is 162 mg (the content of 1 pre-filled pen) once every week
Adolescents with pJIA (aged 12 years and over)
The usual dose of Tyenne depends on the patient’s weight.
If the patient weighs less than 30 kg: the dose is 162 mg (the content of 1 pre-filled pen), once every
3 weeks
- If the patient weighs 30 kg or more: the dose is 162 mg (the content of 1 pre-filled pen), once every 2 weeks.
Tyenne is given by injection under the skin (subcutaneously). At the start, your doctor or nurse may inject Tyenne. However, your doctor may decide
that you may inject Tyenne yourself. In this case you will get training on how to inject Tyenne yourself. Parents and carers will get training on how to inject Tyenne for patients who cannot inject themselves. Talk to your doctor if you have any questions about giving yourself or an adolescent patient you look after an injection. You will find detailed “Instructions for
administration” at the end of this leaflet.
If you use more Tyenne than you should
Because Tyenne is given in one pre-filled pen, it is unlikely that you will receive too much.
However, if you are worried, talk to your doctor, pharmacist or nurse.
If an adult with RA or GCA or an adolescent with sJIA misses or forgets a dose
It is very important to use Tyenne exactly as prescribed by your doctor. Keep track of your next
dose.
- If you miss your weekly dose within 7 days, take your dose on the next scheduled day.
- If you miss your once every other week dose within 7 days, inject a dose as soon as you remember and take your next dose at your regular scheduled time. • If you miss your weekly or once every other week dose by more than 7 days, or you are not sure when to inject Tyenne, call your doctor or pharmacist.
If an adolescent with pJIA misses or forgets a dose
It is very important to use Tyenne exactly as prescribed by the doctor. Keep track of the next dose. • If a dose is missed within 7 days, inject a dose as soon as you remember and give the next dose at the regular scheduled time.
If a dose is missed by more than 7 days, or you are
not sure when to inject Tyenne, call the doctor or pharmacist.
If you stop using Tyenne
You should not stop using Tyenne without discussing with your doctor first.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, Tyenne can cause side effects, although not everybody gets them. Side effects could occur 3 months or more after your last dose of Tyenne.
Possible serious side effects: tell a doctor straight away.
These are common: they may affect up to 1 in 10 people
Allergic reactions during or after injection: • difficulty with breathing, chest tightness or light-headedness
- rash, itching, hives, swelling of the lips, tongue or face
If you notice any of these, tell your doctor immediately.
Signs of serious infections:
- fever and chills
- mouth or skin blisters
- stomach ache
Signs and symptoms of liver toxicity
These may affect up to 1 in 1 000 people • tiredness,
- abdominal pain,
jaundice (yellow discoloration of skin or eyes)
If you notice any of these, tell your doctor as soon as possible.
Very common side effects:
These may affect 1 in 10 people or more
upper respiratory tract infections with typical
symptoms such as cough, blocked nose, runny nose, sore throat and headache,
- high blood fat (cholesterol) levels
- injection site reactions.
Common side effects:
These may affect up to 1 in 10 people
- lung infection (pneumonia)
- shingles (herpes zoster)
- cold sores (oral herpes simplex), blisters • skin infection (cellulitis) sometimes with fever and chills • rash and itching, hives
- allergic (hypersensitivity) reactions
- eye infection (conjunctivitis)
- headache, dizziness, high blood pressure • mouth ulceration, stomach pain
- fluid retention (oedema) in the lower legs, weight increase
- cough, shortness of breath
- low white blood cell counts shown by blood tests (neutropenia, leucopenia)
- abnormal liver function tests (increased transaminases)
increased bilirubin shown by blood tests • low fibrinogen levels in the blood (a protein involved
in blood clotting).
Uncommon side effects:
These may affect up to 1 in 100 people
- diverticulitis (fever, nausea, diarrhoea, constipation, stomach pain)
- red swollen areas in the mouth
- high blood fat (triglycerides) • stomach ulcer
- kidney stones
- underactive thyroid.
Rare side effects:
These may affect up to 1 in 1 000 people
- Stevens-Johnson syndrome (skin rash, which may lead to severe blistering and peeling of the skin) • fatal allergic reactions (anaphylaxis [fatal]) • inflammation of the liver (hepatitis), jaundice
Very rare side effects:
These may affect up to 1 in 10 000 people
- low counts for white blood cells, red blood cells and platelets in blood tests.
- liver failure
Additional side effects in children and adolescents with sJIA or pJIA
Side effects in children and adolescents with sJIA or pJIA are generally similar to those in adults. Some side effects are seen more often in children and adolescents: inflamed nose and throat, headache, feeling sick (nausea) and lower white blood cell counts.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: 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.
5. How to store Tyenne
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 pre-filled pen label and carton (EXP). The expiry date refers to the last day of that month. Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the pre-filled pens in the outer carton in order to protect from light.
Pre-filled pens may be stored at room temperature (up to 30°C) for a single period of up to 14 days. The pre-filled pens must be protected from light, and discarded if not used within the 14 day period at room temperature (up to 30°C) or by the original expiry date, whichever is earlier.
Do not use if the medicine is cloudy or contains particles, is any colour besides colourless to pale yellow, or any part of the pre-filled pen appears to be damaged.
The pen should not be shaken. After removing the cap the injection must be started right away to prevent the medicine from drying out and blocking the needle. If the pre-filled pen is not used right away after cap removal, you must dispose of it in a puncture resistant container and use a new pre-filled pen.
If following pressing the activation button the orange plunger rod does not move, you must dispose of the pre-filled pen in a puncture resistant container. Do not try to re-use the pre-filled pen. Do not repeat the injection with another pre-filled pen. Call your healthcare provider for help.
6. Contents of the pack and other information
What Tyenne contains
- The active substance is tocilizumab. Each pre-filled pen contains 162 mg tocilizumab in 0.9 mL. • The other ingredients are L-arginine, L-histidine, L-lactic acid, sodium chloride, polysorbate 80 (E 433), hydrochloric acid (E 507) and/or sodium hydroxide (E 524), water for injections. Regarding sodium and polysorbate 80, please see section 2 “Tyenne contains sodium” and “Tyenne contains polysorbate 80” above.
What Tyenne looks like and contents of the pack
Tyenne is a solution for injection. The solution is clear and colourless to pale yellow.
Tyenne is supplied as a 0.9 mL pre-filled pen containing 162 mg tocilizumab solution for injection.
Each pack contains 1 or 4 pre-filled pens with multipacks containing 12 (3 packs of 4) pre-filled pens. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Fresenius Kabi Limited
Cestrian Court
Eastgate Way, Manor Park
Runcorn, Cheshire, WA7 1NT
United Kingdom
Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstrasse 36 8055 Graz Austria
This leaflet was last revised in October 2025.
M092978/X2 UK Package Leaflet: Information for the user
Solution for injection in pre-filled pen tocilizumab