Ekterly 300 mg film-coated tablet

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

Hereditary angioedema is a condition that often runs in families. In hereditary angioedema your blood does not have enough of a protein called C1 inhibitor, or the protein does not work properly. This leads to too much of the enzyme ‘plasma kallikrein’, which in turn increases the levels of ‘bradykinin’ in your bloodstream. Too much bradykinin leads to attacks of swelling and pain in different parts of your body.

Ekterly works by blocking the activity of plasma kallikrein and helps reduce the levels of bradykinin. When taken at the start, or during an attack, this will stop further progression of the attack and the symptoms of swelling and pain.

• if you are allergic to sebetralstat or any of the other ingredients of this medicine (listed in section 6).

After taking Ekterly for a laryngeal attack it is important to seek immediate medical attention.

If you have severely reduced liver function talk to your doctor before taking Ekterly as this medicine may not be suitable for you.

Ekterly is not recommended in children under 12 years. This is because it has not been studied in this age group.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because some other medicines can affect the way Ekterly works.

In particular, tell your doctor or pharmacist if you are taking the following:

• antibiotic medicines (e.g. rifampicin, clarithromycin)
• some medicines for fungal infections (e.g. itraconazole, ketoconazole)
• antiviral medicines (e.g. efavirenz, ritonavir, saquinavir)
• some medicines used for epilepsy (e.g. carbamazepine, phenytoin, phenobarbital)
• some medicines for high blood sugars (e.g. metformin).

If you are not sure, talk to your doctor or pharmacist before taking Ekterly.

This medicine can be taken with or without food (see Section 3).

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.

Do not drive or use machines if you feel tired as a result of your HAE attack or after using Ekterly.

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

Tell your doctor immediately if you have taken too many Ekterly tablets.

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 sebetralstat.
• The other ingredients are:
  Tablet core: microcrystalline cellulose; croscarmellose sodium; povidone K30; magnesium stearate.
  Film-coatings: Macrogol poly(vinyl alcohol) grafted copolymer; talc; titanium dioxide (E171); glycerol monocaprylocaprate (Type 1); poly(vinyl alcohol); iron oxide yellow (E172); iron oxide black (E172); maltodextrin; guar galactomannan; hypromellose; triglycerides, medium chain.

Ekterly 300 mg tablets are yellow, oval, biconvex tablets debossed with KalVista logo “K” on one side and “300” on the other side. The tablets are packed in a blister encased in a child-resistant cardboard wallet. The wallets are contained in a cardboard box. The pack contains 4 or 6 tablets. Not all pack sizes may be marketed.

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