Sevabertinib (By mouth)

Sevabertinib (se-vah-BER-ti-nib)

Treats non-squamous non-small cell lung cancer (NSCLC).

Brand Name(s):

Hyrnuo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk.
• Swallow the tablet whole with water. Do not cut, crush, or chew it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose:
  • Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
  • If you vomit after taking a dose, do not take an extra dose. Take the next dose at the regular time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how sevabertinib works. Tell your doctor if you are using carbamazepine, dabigatran, itraconazole, midazolam, rosuvastatin, or St. John's wort.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment and for 1 week after your final dose. Males with female partners who are able to become pregnant should use an effective form of birth control during treatment and for 1 week after the last dose.
• Do not breastfeed during treatment with this medicine and for 1 week after the last dose.
• Tell your doctor if you have liver disease, pancreas problems, eye or vision problems, or other lung or breathing problems.
• This medicine may cause the following problems:
  • Liver problems
  • Lung or breathing problems, including interstitial lung disease (ILD), pneumonitis
  • Eye or vision problems
  • Pancreas problems
• This medicine can cause diarrhea. Call your doctor if the diarrhea becomes severe, does not stop, or is bloody. Do not take any medicine to stop diarrhea until you have talked to your doctor. Diarrhea can occur 2 months or more after you stop taking this medicine.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, loss of vision
• Chest pain, cough, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Severe diarrhea
• Weight loss

If you notice these less serious side effects, talk with your doctor:

• Dry skin
• Loosening of the fingernails, redness or soreness around fingernails
• Sores or white patches on your lips, mouth, or throat
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 1/4/2026