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Overview: Hyrnuo is used to treat certain people with non-small-cell lung cancer (NSCLC). It is a kinase inhibitor that helps slow down how quickly certain cancer cells grow and may help shrink tumors. Common side effects may include a rash, nail problems, mouth sores, nausea, and changes in certain lab tests. Diarrhea is also a common side effect, and it can sometimes be severe. Other serious side effects may include problems with the liver, lungs, eyes, and pancreas. Keep all appointments for blood work to make sure if it is safe for you to keep taking this medicine. Hyrnuo is a tablet that is taken by mouth.

Uses

What is Hyrnuo used for?

Hyrnuo (sevabertinib) is commonly used to treat certain people with non-small-cell lung cancer (NSCLC).

Your health care provider can do a test to see if Hyrnuo is an option to treat your cancer. 

Hyrnuo may also be used for other conditions as determined by your health care provider.

How does Hyrnuo work (mechanism of action)?

Hyrnuo is a type of medicine known as a kinase inhibitor. Hyrnuo mainly blocks the effects of an enzyme in the body called human epidermal growth factor receptor 2 (HER2). In some cancers, HER2 has a mutation that causes cancer cells to grow and spread more quickly. By blocking the effects of HER2, Hyrnuo helps turn off the signals that cause the cells to grow. This slows down how quickly these cancer cells grow and multiply, and may make tumors shrink in size.

How is Hyrnuo supplied (dosage forms)?

Brands and other names

  • Hyrnuo

Dosage forms and strengths

  • 10 mg oral tablets

How should I store Hyrnuo?

Hyrnuo should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Hyrnuo?

The most common side effects of Hyrnuo are listed below. Tell your health care provider if you have any of these side effects that bother you.

There may be other side effects of Hyrnuo that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Hyrnuo?

While less common, the most serious side effects of Hyrnuo are described below, along with what to do if they happen.

Severe Allergic Reactions. Hyrnuo may cause allergic reactions, which can be serious. Stop taking Hyrnuo and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Diarrhea. Diarrhea is common with Hyrnuo, and it can sometimes be severe. In some cases, it can lead to dehydration. Call your health care provider right away at the first sign of diarrhea or if you are pooping more often than usual. If you are given medicine to prevent or treat diarrhea, take it exactly as your health care provider tells you. Also follow any instructions from your health care provider about how to increase your fluids and electrolytes.

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Hyrnuo. Keep all appointments for blood work. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Lung Inflammation. Hyrnuo can cause inflammation in your lungs, also called interstitial lung disease or pneumonitis. This can be serious or even life-threatening. Get emergency help if you have new or worsening trouble breathing. You may also have a cough, fever, or chest pain. 

Eye Problems. Hyrnuo may cause eye problems and temporarily vision loss. Contact your health care provider right away if you have any new or worsening eye symptoms.

High Pancreatic Enzyme Levels. Hyrnuo may increase levels of certain digestive enzymes, such as amylase and lipase. Keep all appointments for blood work. Call your health care provider right away if you have any signs or symptoms of pancreas problems, including nausea or vomiting, weight loss, or severe pain in the upper part of your belly that travels to your back and gets worse after eating.

Warnings & Precautions

Who should not use Hyrnuo?

Allergies to Ingredients. People who are allergic to any of the following should not take Hyrnuo.

  • Hyrnuo 
  • Sevabertinib
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Hyrnuo.

What should I know about Hyrnuo before using it?

Do not take Hyrnuo unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Hyrnuo with other people, even if they have the same condition as you. It may harm them.

Keep Hyrnuo out of the reach of children.

Swallow Hyrnuo whole with a glass of water. Do not chew, cut, or crush Hyrnuo.

Keep all appointments with your health care provider, including for blood work, before and while taking Hyrnuo. This helps make sure it is safe for you to keep taking the medicine.

If you have certain side effects, your health care provider may tell you to lower your dose, pause, or stop Hyrnuo. Follow your health care provider’s instructions about how to take the medicine.

If you can get a partner pregnant, you should use effective birth control while taking Hyrnuo and for 1 week after your last dose of Hyrnuo. See the Pregnancy section for more information.

What should I tell my health care provider before using Hyrnuo?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Hyrnuo is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Liver problems
  • Any other lung or breathing problems besides lung cancer

Other Medicines and Supplements. Hyrnuo may interact with other medicines and supplements. Before taking Hyrnuo, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Hyrnuo can cause harm to an unborn baby. If you can get pregnant, your health care provider will likely do a test to make sure you are not pregnant before starting Hyrnuo. You should also use effective birth control while taking Hyrnuo and for 1 week after your last dose.  Tell your health care provider right away if you are pregnant, think you might be pregnant, or plan to become pregnant.

Breastfeeding. Do not breastfeed while you are taking Hyrnuo and for 1 week after your last dose. It is not known if Hyrnuo passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Hyrnuo?

For more information about Hyrnuo, you can visit the drugmaker’s website at www.hyrnuo-us.com or call them at 888-842-2937.

Interactions

Does Hyrnuo interact with foods or drinks?

Take Hyrnuo with food. 

Do not eat or drink grapefruit or grapefruit juice while you are taking Hyrnuo. Grapefruit may increase levels of Hyrnuo in your body and increase the risk of side effects. 

It is unknown if drinking alcohol will affect Hyrnuo, but heavy drinking can slow your immune response and make it harder for your body to fight cancer.

Does Hyrnuo interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Hyrnuo.

  • Fluconazole (Diflucan), itraconazole (Sporanox, Tolsura), ketoconazole, posaconazole (Noxafil), or voriconazole (Vfend), which is a medicine used for fungal infections
  • Carbamazepine (Carbatrol, Tegretol, and others), which is a medicine commonly used to treat seizures or nerve pain
  • Phenobarbital, phenytoin (Dilantin, Phenytek, and others), or primidone, which is a medicine to treat seizures 
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis   
  • St. John’s wort, which is a supplement that may be used for depression
  • Efavirenz, which is a medicine commonly used to treat HIV

Many other medicines may alter the blood levels of Hyrnuo, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Hyrnuo. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Hyrnuo?

If you or someone else has used too much Hyrnuo, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Hyrnuo?

If you miss a dose, take it as soon as you remember before your next dose. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.

If you throw up (vomit) after taking a dose, do not take another dose. Take your next dose at the regularly scheduled time.