Tzield 2 mg/2 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.

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

Tzield is a medicine that contains the active substance teplizumab. It belongs to a group of medicines called ‘monoclonal antibodies’.

Tzield is a protein that recognises and sticks to a target. The target is a substance called CD3 that is found on a type of white blood cell – called ‘T lymphocytes’.

Tzield is a medicine used to delay the start of Stage 3 type 1 diabetes. This condition happens when the body cannot make enough insulin on its own and may need insulin injections.

• This medicine is used in adult and children aged 8 years and older – who have Stage 2 type 1 diabetes.

If you have any questions on how Tzield works or about your treatment with Tzield, ask your doctor.

• you have had a severe allergic reaction to teplizumab or any of the other ingredients of this medicine (listed in section 6).

Before and after you are given Tzield, talk to your doctor or nurse about all your medical conditions, including if you:

• have a serious infection – or an infection that does not go away or that keeps coming back.
• are taking medicine that weakens your immune system (immunosuppressive medication).
• have recently had or are planning to have a vaccine. Tzield may affect how well a vaccine works. Tell your doctor or nurse that you are being treated with Tzield before having a vaccine.
• have any of the serious side effects described in section 4.

It is not known if Tzield is safe and effective in children under 8 years of age.

Tell your doctor or nurse about the medicines you take, have recently taken or plan to take, including prescription and non-prescription medicines, vitamins, and other supplements.

• This also includes if you have had or are planning to have a vaccine. Tzield may affect how well a vaccine works. You should tell your doctor or nurse that you are being treated with Tzield before having a vaccine.

Pregnancy

Tell your doctor or nurse if you are pregnant or plan to become pregnant. Tzield may harm your unborn baby.

• Do not have Tzield during pregnancy – and at least 30 days before a planned pregnancy.

Breast-feeding

Tell your doctor or nurse if you are breast-feeding or plan to breast-feed. It is not known if Tzield passes into your breast milk and if it can harm your baby.

• Talk to your doctor about the best way to feed your baby if you have Tzield.
• If you are breast-feeding, it is best to pump and throw away your breast milk during treatment with Tzield – and for 20 days after treatment.

Tzield is not expected to affect your ability to drive and use machines. However, if you feel tired, do not drive or use machines before discussing it with your doctor or nurse.

Sodium

This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.

Polysorbate 80

This medicine contains 0.10 mg of polysorbate 80 in each vial which is equivalent to 0.05 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you or your child have any known allergies.

Tzield is given by your doctor or nurse. They will give it through a needle placed in a vein in your arm.

You will be given Tzield infusion once every day – for 14 days. Each infusion will last at least 30 minutes.

For the first 5 days of treatment, your doctor or nurse will give you medicines by mouth to reduce potential side effects that could be due to your Tzield infusion.

These medicines include:

• ibuprofen or naproxen – or other medicines for fever such as paracetamol
• an anti-histamine
• an anti-sickness (anti-nausea) medicine.

These medicines may help reduce symptoms of Cytokine Release Syndrome (CRS). These symptoms include fever, headache, muscle and joint pain, or feeling sick (nausea). Your doctor or nurse may decide to continue with this treatment for longer, if needed.

Tell your doctor immediately if you think you have been given too much Tzield (an overdose). Your doctor will treat and monitor your side effects.

If you miss a scheduled infusion, your doctor or nurse will continue your treatment on the next scheduled day. You will not get 2 infusions on the same day.

Cytokine Release Syndrome (CRS)

Tell your doctor or nurse right away if you get any signs and symptoms of CRS during treatment with Tzield. The signs and symptoms may start during the first 5 days of treatment and may include:

• fever
• feeling tired
• muscle and joint pain
• feeling sick (nausea)
• headache
• increased liver enzymes in your blood.

Decrease in white blood cells (lymphocytes)

This is common and may affect up to 1 in 10 people.

• This can happen after your first dose.
• This can affect how well your body can fight infections.
• Some people may get longer and more severe decreases in lymphocytes.
• Your white blood cell counts will start to go back to normal after your fifth dose of Tzield.

Your doctor or nurse may pause or stop your treatment if you get liver problems, have a serious infection, or if your blood counts stay too low.

Tell your doctor or nurse if you have any of the following side effects:

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

• Headache
• Feeling sick (nausea)
• Rash
• Fever
• If any of the following are found on your blood tests:
  • Increase in liver enzyme levels
  • Decrease in white blood cell counts (leukopenia)
  • Decrease in number of red blood cells (anaemia)
  • Decrease in number of blood platelets (thrombocytopenia)
  • Decrease in blood bicarbonate and blood calcium levels

Common (may affect up to 1 in 10 people)

• Cytokine Release Syndrome
• Inflamed nose and throat
• Diarrhoea
• Red and itchy raised bumps (hives)
• Chills

Not known (frequency cannot be estimated from the available data)

• Vomiting
• Itchy skin
• Feeling tired
• Pain
• Illness

These are not all of the possible side effects of Tzield. Tell your doctor or nurse of any side effects and ask for medical advice.

If you get any side effects, talk to your doctor or nurse. 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.

• The active substance is teplizumab.
• One vial contains 2 mg of teplizumab.
• The other ingredients (excipients) are dibasic sodium phosphate (E339), monobasic sodium phosphate (E339), polysorbate 80 (E433), sodium chloride, and water for injection.

Tzield is a concentrate for solution for infusion in a vial (2 mg/2 mL). It is a clear, colourless solution. Tzield is supplied in a carton pack containing 1, 10 or 14 vials. Not all pack sizes may be marketed.