Patient leaflet - Tyenne 162 mg solution for injection in Pre-filled syringe
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 1 year 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 2 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 syringe is not recommended for use in children under 1 year 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 breas passes into breast milk.
Driving and using mach
This medicine can cause use machines.
Tyenne contains sodium
This medicinal product c per 0.9 mL dose, that is
Tyenne contains polyso
This medicinal producte 162 mg/0.9 mL syringe, w may cause allergic reacti has any known allergies.
t-feeding. It is not known whether Tyenne
ines
dizziness. If you feel dizzy, do not drive or
ontains less than 1 mmol of sodium (23 mg) to say essentially ‘sodium-free’.
rbate 80
contains 0.18 mg of polysorbate 80 in each hich is equivalent to 0.2 mg/mL. Polysorbates ons. Tell your doctor if you have or your child
3. How to use Tyenne
Always use this medicin has told you. You should if you are not sure. The treatment will be pre experienced in the diagno
Adults with RA or GCA The recommended dose
cell arteritis) for adults given once a week.
Children and adolescen
The usual dose of Tyen
e exactly as your doctor, pharmacist or nurse check with your doctor, pharmacist or nurse
scribed and started by healthcare professionals sis and treatment of RA, sJIA, pJIA or GCA.
for RA (rheumatoid arthritis) and GCA (giant is 162 mg (the content of 1 pre-filled syringe)
ts with sJIA (aged 1 year and over)
ne depends on the patient’s weight.
- If the patient weighs content of 1 pre-filled s • If the patient weighs 3 of 1 pre-filled syringe)
Children and adolescen
The usual dose of Tyen
If the patient weighs content of 1 pre-filled s • If the patient weighs 3 of 1 pre-filled syringe), Tyenne is given by injec start, your doctor or nu may decide that you ma
less than 30 kg: the dose is 162 mg (the yringe) once every 2 weeks
0 kg or more: the dose is 162 mg (the content once every week
ts with pJIA (aged 2 and over)
ne depends on the patient’s weight. less than 30 kg: the dose is 162 mg (the yringe), once every 3 weeks
0 kg or more: the dose is 162 mg (the content once every 2 weeks.
tion under the skin (subcutaneously). At the rse may inject Tyenne. However, your doctor y inject Tyenne yourself. In this case you will
get training on how to in get training on how to i themselves, such as chil Talk to your doctor if yo or a child patient you l “Instructions for adminis
If you use more Tyenne
Because Tyenne is given will receive too much. Ho pharmacist or nurse. If an adult with RA or misses or forgets a dos
as prescribed by your do • If you miss your weekl
ject Tyenne yourself. Parents and carers will nject Tyenne for patients who cannot inject dren.
u have any questions about giving yourself ook after an injection. You will find detailed tration” at the end of this leaflet.
than you should
in one pre-filled syringe, it is unlikely that you wever, if you are worried, talk to your doctor,
GCA or a child or adolescent with sJIA e, it is very important to use Tyenne exactly ctor. Keep track of your next dose. y dose within 7 days, take your dose on the
next scheduled day.
- If you miss your once every 2 weeks 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 dose by more than 7 days, or you are not sure when to inject Tyenne, call your doctor or pharmacist.
If a child or 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 ef
fects, although not
everybody gets them. Side effects could occur 3 m
onths or more after
your last dose of Tyenne.
Possible serious side effects: tell a doctor stra
ight away.
These are common: they may affect up to 1 in 10 p
eople
Allergic reactions during or after injection: • difficulty with breathing, chest tightness or ligh
t-headedness
rash, itching, hives, swelling of the lips, tongue
or face
If you notice any of these, tell your doctor immed
iately.
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 discolouration of skin or eyes) If you notice any of these, tell your doctor as soo
n 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 a
nd 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 a
nd 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, weig
ht increase
- cough, shortness of breath
low white blood cell counts shown by blood
tests (neutropenia,
leucopenia)
abnormal liver function tests (increased transa
minases)
increased bilirubin shown by blood tests • low fibrinogen levels in the blood (a protei
n involved in blood
clotting).
Uncommon side effects:
These may affect up to 1 in 100 people • diverticulitis (fever, nausea, diarrhoea, constipa
tion, 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 syringe 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 syringes in the outer carton in order to protect from light.
Pre-filled syringes may be stored at room temperature (up to 30°C) for a single period of up to 14 days. The pre-filled syringes 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 syringe appears to be damaged.
The syringe 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 syringe is not used right away after cap removal, you must dispose of it in a puncture resistant container and use a new pre-filled syringe. If following insertion of the needle, you cannot depress the plunger, you must dispose of the pre-filled syringe in a puncture resistant container and use a new pre-filled syringe.
6. Contents of the pack and other information
What Tyenne contains
The active substance is tocilizumab
- Each pre-filled syringe 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 syringe containing 162 mg tocilizumab solution for injection.
Each pack contains 1, 4 or 12 pre-filled syringes. 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.
Package leaflet: Information for the user
Solution for injection in pre-filled syringe tocilizumab
Subcutaneous use
162 mg
M0FOxxxx/X2 UK