Hyrnuo 10 mg film-coated tablets

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

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

Hyrnuo belongs to a group of cancer medicines called protein kinase inhibitors.

It contains the active substance sevabertinib.

Hyrnuo is used to treat adults with non-small cell lung cancer (NSCLC).

It is prescribed when the cancer has certain changes (activating mutations) in a gene named 'HER2' (human epidermal growth factor receptor 2), and

• the cancer has spread to other parts of the body or cannot be removed by surgery and
• the patient has already received another treatment for the cancer.

Before you are given Hyrnuo, a test must have been done to check if your cancer has a change in the HER2 gene to make sure that Hyrnuo is right for you.

The HER2 protein is found on the surface of some cells in the body. It helps control how normal cells grow and divide.

A change in the HER2 gene can make the body produce an abnormal HER2 protein. This can cause cells to grow without control and lead to cancer.

Hyrnuo stops the abnormal protein from working and may slow down or stop the growth of the cancer. It may also help to shrink the cancer.

If you have any questions about how this medicine works or why this medicine has been prescribed for you, ask your doctor.

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

Talk to your doctor, pharmacist or nurse immediately while taking Hyrnuo:

• if you develop diarrhoea (having unformed stools). Immediate treatment of diarrhoea is important (see also section 4 ‘Possible side effects’).
• if you develop sudden difficulty in breathing, cough, or fever. Hyrnuo may cause inflammation of the lungs during treatment. Your doctor will monitor you for potential symptoms (see also section 4 ‘Possible side effects’).
• if you develop eye problems. Hyrnuo can cause problems with your eyes that could lead to temporary loss of vision. Your doctor may send you to see an eye specialist (ophthalmologist) if you develop new or worsening eye problems during treatment with Hyrnuo (see also section 4 ‘Possible side effects’).

Monitoring of liver and pancreatic function

Your doctor will carry out blood tests to check how well your liver and pancreas are working.

This medicine is not recommended in children or adolescents below 18 years of age because the safety and efficacy of Hyrnuo have not been established in this age group.

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained with or without a prescription, or over-the-counter medicines such as vitamins, dietary supplements or herbal medicines.

Some medicines may influence the effect of Hyrnuo, or Hyrnuo may influence the effect of other medicines.

In particular, tell your doctor if you are taking any of the following medicines (medicines or active substance), typically used to treat:

• fungal and bacterial infections: clarithromycin, itraconazole, ketoconazole, rifampicin, rifabutin
• HIV infection/AIDS: cobicistat, lopinavir/ritonavir, saquinavir/ritonavir
• epilepsy (seizures): carbamazepine, phenytoin
• slightly low mood and mild anxiety: St. John’s Wort (a herbal medicine)
• pain relief: alfentanil, fentanyl
• prevent organ rejection after transplantation: cyclosporine, sirolimus, tacrolimus
• migraine: dihydroergotamine, ergotamine
• an antipsychotic drug used to control motor or verbal tics: pimozide
• abnormal heart rhythms: quinidine
• heart problems: digoxin
• severe joint inflammation, severe cases of skin disease psoriasis, cancers: methotrexate
• high cholesterol: atorvastatin
• pulmonary hypertension: riociguat
• prevention of nausea and vomiting: ranisetron
• diabetes: metformin
• certain types of cancer: cisplatin

Ask your doctor, pharmacist or nurse for advice before taking any medicine.

Do not eat grapefruit or drink grapefruit juice while you are taking Hyrnuo. This is because it may increase your chance of getting side effects by increasing the amount of Hyrnuo in your body.

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.

Pregnancy

• Avoid becoming pregnant while taking Hyrnuo because this medicine could harm the unborn child.
• Your doctor will perform a pregnancy test before you start taking Hyrnuo if you could become pregnant.
• Tell your doctor straight away if you become pregnant while taking this medicine. Your doctor will decide with you whether treatment should be continued or not.

Contraception – female patients

If you could become pregnant, you must use a highly effective method of contraception to avoid becoming pregnant

• while you are taking Hyrnuo and
• for 1 week after you stop taking it.

Contraception – male patients

If you are a man with a partner who could become pregnant, you must use a highly effective method of contraception to avoid pregnancy

• while you are taking Hyrnuo and
• for 1 week after you stop taking it.

If you are a man and you have sex with a woman who is pregnant: use a condom while you are taking Hyrnuo and for 1 week after you stop taking it. This is important because the semen fluid containing Hyrnuo may negatively affect the development of the unborn child.

Talk to your doctor about the right methods of contraception for you and your partner.

Breast-feeding

You should not breast-feed during treatment with this medicine and for 1 week after you stop taking it. Hyrnuo could harm your breast-fed child. Tell your doctor if you are breast-feeding or planning to breast-feed before taking this medicine.

This medicine is unlikely to affect your ability to drive and use machines.

If you have been told by a doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.

Adults (from 18 years)

The recommended dose is 2 tablets two times a day. This is a total of 4 tablets per day.

Do not take more than the recommended daily dose.

Recommended dose of Hyrnuo

Morning: 2 x 10 mg tablets with food

Evening: 2 x 10 mg tablets with food

Your doctor may change your dose or may recommend to pause or stop taking Hyrnuo if necessary. Take the dose of Hyrnuo that your doctor prescribes for you.

• Take the tablets with food.
• Swallow the tablets whole with a glass of water.
• Do not chew, break or crush the tablets.

If you have taken too much Hyrnuo, or if someone else accidentally takes your medicine, contact a doctor or go to a hospital straight away. Take the medicine pack and this leaflet with you. Medical treatment may be necessary.

Do not take an additional dose. Take your next dose at your next scheduled time.

Take your missed dose as soon as you remember. However, if it is less than 30 minutes until your next dose, skip the missed dose and take your next dose at the scheduled time. Do not take a double dose at your next scheduled time to make up for a forgotten tablet.

Do not stop taking Hyrnuo unless your doctor tells you to. It is important to take Hyrnuo for as long as your doctor prescribes it for you.

Very common: may affect more than 1 in 10 people

• blood tests showing a lower number of white blood cells (including lymphocytes) which may decrease your ability to fight infection
• changes in blood tests for kidney function (higher levels of creatinine)
• changes in blood tests for minerals (lower levels of potassium, magnesium, calcium and sodium)
• changes in blood sugar tests (higher levels of sugar in the blood)
• changes in blood fat tests (higher levels of blood triglycerides, a type of fat)
• blood tests showing lower levels of albumin

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 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 sevabertinib. Each film-coated tablet contains 10 mg of sevabertinib
• The other ingredient(s) are:
  • Tablet core: cellulose microcrystalline, crospovidone (E 1202), lactose monohydrate, magnesium stearate (E 470b).
  • Film coat: ferric oxide red (E 172), hypromellose 5 cP (E 464), macrogol 3350 (E 1521).

Hyrnuo 10 mg film-coated tablets are red brown, round and biconvex, approximately 6 mm diameter. They are debossed with “SE” on one side and “10” on the other side.

Hyrnuo is available in cartons with foil blisters containing:

• 112 (28x4) film-coated tablets.

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