Tyenne 20 mg/mL concentrate for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

In addition to this leaflet, you will be given a Patient Alert Card, which contains important safety information that you need to be aware of before and during treatment with Tyenne.

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

• if you are allergic to tocilizumab or any of the other ingredients of this medicine (listed in section 6).
• if you have an active, severe infection.

If any of these applies to you, tell the doctor or nurse giving you the infusion.

Talk to your doctor or nurse before you are given Tyenne.

• If you experience allergic reactions such as chest tightness, wheezing, severe dizziness or light-headedness, swelling of the lips or skin rash during or after the infusion, then tell your doctor immediately.
• 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 (either adult or child), or is planning a vaccination, tell your doctor. All patients, especially children, should be up-to-date with all their vaccinations before they start treatment with Tyenne, unless urgent treatment initiation is required Certain types of vaccines should not be used 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 blood tests before you are given Tyenne, and during your treatment, to determine if you have a low white blood cell count, low platelet count or high liver enzymes.

Tyenne is not recommended for use in children under 2 years of age.

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.

Tell your doctor if you are taking any other medicines (or your child is, if they are the patient), or have recently taken any. This includes medicines obtained without a prescription. 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 or pJIA.

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.

The data available so far does not suggest any effect on fertility from this treatment.

This medicine can cause dizziness. If you feel dizzy, do not drive or use machines.

This medicine contains 34.8 mg sodium per maximum dose of 1200 mg. Take this into account if you are on a low-sodium diet. However, doses below 800 mg of this medicine contain less than 23 mg sodium, so they are essentially sodium free.

Since Tyenne is given by a doctor or nurse, it is unlikely that you will be given too much.

However, if you are worried, talk to your doctor.

Since Tyenne is given by a doctor or nurse, it is unlikely that you will miss a dose. However, if you are worried, talk to your doctor or nurse.

You should not stop receiving Tyenne without discussing with your doctor first.

These are common: they may affect up to 1 in 10 people

Allergic reactions during or after infusion:

• 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 1000 people

• tiredness,
• abdominal pain,
• jaundice (yellow discolouration of skin or eyes)

If you notice any of these, tell your doctor as soon as possible.

Very common side effects:

These may affect more than 1 in 10 people

• upper respiratory tract infections with typical symptoms such as cough, blocked nose, runny nose, sore throat and headache
• high blood fat (cholesterol) levels.

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 ulcers, 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 1000 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 10000 people

• low counts for white blood cells, red blood cells and platelets in blood tests
• liver failure

In general, side effects in sJIA patients were of a similar type to those in adults with RA. Some side effects were seen more often: inflamed nose and throat, diarrhoea, lower white blood cell counts and higher liver enzymes.

In general, side effects in pJIA patients were of a similar type to those in adults with RA. Some side effects were seen more often: inflamed nose and throat, headache, feeling sick (nausea) and lower white blood cell counts.

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

Ireland

UK

or search for MHRA Yellow Card in the Google Play or Apple App Store

• The active substance is tocilizumab.
  Each 4 mL vial contains 80 mg tocilizumab (20 mg/mL).
  Each 10 mL vial contains 200 mg tocilizumab (20 mg/mL).
  Each 20 mL vial contains 400 mg tocilizumab (20 mg/mL).
• The other ingredients are L-arginine, L-histidine, L-lactic acid, sodium chloride, polysorbate 80, hydrochloric acid (E507) and/or sodium hydroxide (E524), water for injections.

Regarding sodium, please see section 2 “Tyenne contains sodium” above.

Tyenne is a concentrate for solution for infusion. The concentrate is a clear and colourless to pale yellow liquid. Tyenne is supplied as vials containing 4 mL, 10 mL and 20 mL concentrate for solution for infusion. Each pack contains 1 vial and multipacks contain 4 (4 packs of 1) vials.

Not all pack sizes may be marketed.

For EU:

For GB: