Hyrnuo: Uses, Side Effects and Dosage

What HYRNUO is used for:

For the following indication HYRNUO has been approved with conditions (NOC/c). This means it has passed Health Canada’s review and can be bought and sold in Canada, but the manufacturer has agreed to complete more studies to make sure the drug works the way it should. For more information, talk to your healthcare professional.

• HYRNUO is used to treat adults with a type of lung cancer called “non-small cell lung cancer” (NSCLC) when:

  • the cancer has a mutation (a change) in a gene named “HER2” (human epidermal growth factor)
  • the cancer has spread to other parts of your body
  • the cancer cannot be removed through surgery
  • you have tried another treatment for your cancer

Your healthcare professional will do a test to make sure that HYRNUO is the right treatment for you.

What is a Notice of Compliance with Conditions (NOC/c)?

A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug in Canada.

Health Canada only gives an NOC/c to a drug that treats, prevents, or helps identify a serious or life-threatening illness. The drug must show promising proof that it works well, is of high quality, and is reasonably safe. Also, the drug must either respond to a serious medical need in Canada, or be much safer than existing treatments.

Drug makers must agree in writing to clearly state on the label that the drug was given an NOC/c, to complete more testing to make sure the drug works the way it should, to actively monitor the drug’s performance after it has been sold, and to report their findings to Health Canada.

How HYRNUO works:

HYRNUO belongs to a group of cancer medicines called “protein kinase inhibitors.”

The HER2 protein is a protein kinase and is found on the surface of some cells in the body. It is made in the body by the HER2 gene which 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.

The ingredients in HYRNUO are:

Medicinal ingredient(s): sevabertinib

Non-medicinal ingredients: cellulose microcrystalline, crospovidone, ferric oxide red, hypromellose 5 cP, lactose monohydrate, macrogol 3350, and magnesium stearate

HYRNUO comes in the following dosage form(s):

Tablet: 10 mg

Do not use HYRNUO if:

• you are allergic to sevabertinib, any of the other ingredients of this medicine or any parts of the container (see The ingredients in HYRNUO are).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take HYRNUO. Talk about health conditions or problems you may have including if you:

• have recurring diarrhea.
• have liver problems.
• have lung or breathing problems other than lung cancer.
• are pregnant, planning to become pregnant, or planning to have a child with your partner.
• are breastfeeding or plan to breastfeed.

Other warnings you should know about:

Diarrhea

HYRNUO can cause diarrhea during treatment. Diarrhea is when you have loose stools which can cause your body to lose water, important minerals and become dehydrated.

Talk to your healthcare professional before you take this medicine. You should have medicine available to treat diarrhea before you start taking HYRNUO.

If you get diarrhea while taking HYRNUO, tell your healthcare professional immediately. Drink fluids and take the medicine to treat your diarrhea as soon as possible. It is important the diarrhea is treated quickly.

Your healthcare professional may decide to lower the dose, pause or stop treatment with HYRNUO.

Eye problems

HYRNUO can cause problems with your eyes that could lead to temporary loss of vision.

If you have eye problems while taking HYRNUO, tell your healthcare professional immediately.

Pregnancy

• Talk to your healthcare professional before taking this medicine if you are pregnant, think you may be pregnant or are planning to have a baby.
• You should not take HYRNUO if you are pregnant. HYRNUO may harm your unborn child.

• If you are able to become pregnant:

  • Your healthcare professional will do a pregnancy test before you start taking HYRNUO.
  • Avoid becoming pregnant while taking HYRNUO because this medicine could harm the unborn child.
  • Tell your healthcare professional immediately if you become pregnant or think you are pregnant while taking HYRNUO. Your healthcare professional will decide with you whether treatment with HYRNUO should be continued or not.

Breastfeeding

• Tell your healthcare professional if you are breastfeeding or planning to breastfeed before taking this medicine.
• HYRNUO could harm your breastfed child. It is not known if HYRNUO passes into breast milk.
• You should not breastfeed during treatment with HYRNUO and for 1 week after you stop taking it.

Contraception

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

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

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

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

If you are male and your partner becomes pregnant or might already be pregnant, while you are taking HYRNUO, tell your healthcare professional as soon as possible.

If you are a male and you have sex with a partner 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 harm the unborn child.

Talk to your healthcare professional about the right methods of birth control for you and your partner.

Liver problems

HYRNUO can cause increases in liver function blood test values which may be severe. Your healthcare professional will do blood tests to check your liver function before and during treatment with HYRNUO.

Tell your healthcare professional right away if you get any symptoms of liver problems such as:

• yellowing of the skin or white part of your eyes (jaundice)
• dark urine
• pale stools
• feel tired or weak
• nausea
• vomiting
• pain on the upper right side of your stomach

Pancreas problems

HYRNUO may cause increases in certain pancreatic lab test values (amylase and lipase). Your healthcare professional will do blood tests to check your pancreatic function before and during treatment with HYRNUO.

Tell your healthcare professional right away if you get any symptoms of pancreas problems such as:

• pain in the upper area of your stomach. This pain may spread to your back or get worse when you eat.
• weight loss
• nausea
• vomiting

Lung problems

HYRNUO may cause severe lung problems.

Tell your healthcare professional right away if you get any symptoms of lung problems during treatment with HYRNUO such as:

• cough
• fever
• shortness of breath or trouble breathing

Check-ups and testing:

HYRNUO can cause changes in blood test results. Your healthcare professional will tell you if any changes in your tests might need treatment.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with HYRNUO:

• medicines used to treat fungal and bacterial infections such as clarithromycin, itraconazole, ketoconazole, erythromycin, rifampicin and rifabutin
• medicines used to treat HIV infections and AIDS such as cobicistat, lopinavir/ritonavir and saquinavir/ritonavir
• medicines used to treat seizures such as carbamazepine, phenytoin and midazolam
• St. John’s Wort (used to treat slightly low mood and mild anxiety)
• medicines used to treat pain such as alfentanil and fentanyl
• medicines used after organ transplants such as cyclosporine, sirolimus and tacrolimus
• medicines used to treat migraines such as dihydroergotamine and ergotamine
• pimozide (used to control motor or verbal tics)
• quinidine (used to treat abnormal heart rhythms)
• digoxin (used to treat heart problems)
• methotrexate (used to treat inflammation of the joints, a skin diseased called “psoriasis,” and certain kinds of cancers)
• medicines used to treat high cholesterol such as atorvastatin and rosuvastatin
• riociguat (used to treat high blood pressure in the lungs)
• granisetron (used to prevent nausea and vomiting)
• metformin (used to treat diabetes)
• cisplatin (used to treat certain kinds of cancer)
• dabigatran (used to treat blood clots)
• grapefruit and grapefruit juice

How to take HYRNUO:

• Take HYRNUO exactly as your healthcare professional tells you.

• Take the tablets with food.

• Swallow the tablets whole with a glass of water. Do not chew, break or crush tablets.
• If you vomit after taking a dose of HYRNUO, do not take an extra dose. Take your next dose at your regular time.
• Your healthcare professional may change your dose, pause or stop treatment with HYRNUO, if necessary.
• Do not change your dose or stop taking HYRNUO unless your healthcare professional tells you to. It is important to take HYRNUO for as long as your healthcare professional tells you.

Usual dose:

Take two 10 mg tablets, twice a day. This is a total of 4 tablets each day.

Do not take more than 4 tablets per day.

Overdose:

If you think you, or a person you are caring for, have taken too much HYRNUO, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you missed a dose of HYRNUO, take it as soon as you remember before your next regular dose.

Do not take two doses at the same time to make up for a missed dose.

Possible side effects from using HYRNUO:

These are not all the possible side effects you may have when taking HYRNUO. If you experience any side effects not listed here, tell your healthcare professional.

• nausea with or without vomiting
• mouth sores, inflammation, or ulcer
• stomach pain
• redness, irritation, or bumps on the skin

• nail problems including:

  • in growing nails
  • nails separating from the nail bed
  • nail infection
  • nail splitting
  • color change
• itching
• dry skin
• loss of appetite
• weight loss

• low number of red blood cells (anemia) which may make you:

  • feel tired
  • look pale
  • feel your heart pumping
• feeling tired (fatigue)
• hair loss
• pain, redness, swelling or peeling of the skin of your hands and feet

Serious side effects and what to do about them:

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store HYRNUO between 15°C to 30°C.

Keep out of reach and sight of children.

Do not use this medicine after the expiry date.

If you want more information about HYRNUO:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.bayer.ca; or by calling Bayer Medical Information at 1-800-265-7382 or emailing canada.medinfo@bayer.com.

  Bayer Inc.

  2920 Matheson Blvd East

  Mississauga, Ontario

  L4W 5R6

  Canada

Date of Authorization: 2026-01-29

© 2025, Bayer Inc.

® TM see www.bayer.ca/tm-mc