Kisunla 350 mg concentrate for solution for infusion

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

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

• If you are allergic to donanemab or any of the other ingredients of this medicine (listed in section 6).
• If you previously had bleeding in the brain.
• If you are receiving medicines (called anticoagulants) to prevent blood clots.

Talk to your doctor, pharmacist or nurse before using Kisunla.

Amyloid Related Imaging Abnormalities (ARIA)

Kisunla can potentially cause serious side effects, including ARIA. ARIA is a side effect that usually occurs early in treatment and does not usually cause any symptoms. However, serious symptoms can occur; uncommonly ARIA can be fatal. ARIA is most commonly seen as temporary swelling in areas of the brain that usually resolves over time. Some people may also have small spots of bleeding in or on the surface of the brain, and infrequently, larger areas of bleeding in the brain can occur. This may lead to treatment being stopped. Most people with this type of swelling in the brain do not get symptoms, however some people may have symptoms, such as:

• Headache
• Trembling
• Confusion
• Vision changes
• Being sick (vomiting)
• Speech disturbances
• Loss of balance
• Light-headedness and loss of consciousness
• Dizziness
• Fits

Talk to your doctor, pharmacist or nurse before you are given Kisunla if any of the following apply to you:

• You have a bleeding disorder.
• You have Down’s syndrome.

Your doctor will do magnetic resonance imaging (MRI) scans before and during your treatment with Kisunla to check you for ARIA.

Infusion-related reactions

You may experience infusion-related reactions during the infusion or immediately after the infusion. Inform your healthcare professional immediately if you experience symptoms associated with Kisunla infusion. For symptoms, see section 4 “Possible side effects”.

Kisunla should not be used in children and adolescents under 18 years of age because Alzheimer’s disease does not occur in this age group.

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

In particular, tell your doctor or pharmacist before you are given Kisunla if you are taking any other medicine such as medicines to reduce blood clots from forming (antithrombotic medicines, including acetylsalicylic acid).

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The effects of Kisunla in pregnant women are not known.

Kisunla has no effect on the ability to drive and use machines.

This medicine contains 46 mg sodium (main component of cooking/table salt) in each 1400 mg dose. This is equivalent to 2 % of the recommended maximum daily dietary intake of sodium for an adult. Before Kisunla is given to you, it is mixed with a solution that might contain sodium. Talk to your doctor if you are on a low salt diet.

This medicine will be given by a healthcare professional. If you think that you have been accidentally given too much Kisunla, please inform your doctor.

If you forget or miss an appointment to receive Kisunla, make another appointment as soon as possible.

The signs may include:

• Flushing
• Chills
• Headache
• Chest tightness
• Difficulty breathing
• Muscle aches
• Changes in blood pressure

If any of these symptoms occur during infusion, the infusion should be stopped immediately.

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

• Swelling in areas of the brain, with or without small spots of bleeding in or on the surface of the brain (ARIA)
• Headache

Common (may affect up to 1 in 10 people)

• Nausea
• Vomiting
• Infusion-related allergic reactions

Uncommon (may affect up to 1 in 100 people)

• Sudden, severe allergic reaction with breathing difficulty, swelling, light-headedness, fast heartbeat, sweating, and loss of consciousness

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 the 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.

• The active substance is donanemab.
• Each vial contains 350 mg donanemab in 20 ml (17.5 mg/ml)
• The other ingredients are citric acid, anhydrous; polysorbate 80; sodium citrate, dihydrate; sucrose; water for injection.

Kisunla is a concentrate for solution for infusion in a clear glass vial. Its colour may vary from colourless to slightly yellow to slightly brown. Pack size of 1 vial.

Marketing Authorisation Holder:

Manufacturer: