Hyrnuo

Hyrnuo (sevabertinib) is a prescription medicine used to treat adults with non-squamous non-small cell lung cancer (NSCLC) that has spread within the chest (locally advanced) or to other parts of the body (metastatic), and whose tumors have a certain abnormal HER2 (ERBB2) gene.

Hyrnuo tablets are taken twice daily with food. Swallow the tablets whole; do not cut, crush, or chew them.

Hyrnuo is a kinase inhibitor. It works mainly by blocking human epidermal growth factor receptor 2 (HER2), a protein that signals cancer cells to grow and divide. It also blocks epidermal growth factor receptor (EGFR). In laboratory studies, sevabertinib stopped HER2 from being switched on and slowed the growth of cancer cells that carry HER2 alterations.

Your healthcare provider will use an FDA-authorized test to confirm that your cancer has the HER2 (ERBB2) mutation that Hyrnuo targets.

It is not known if Hyrnuo is safe and effective in children.

Hyrnuo is FDA-approved for adults with non-squamous non-small cell lung cancer (NSCLC) whose tumors meet both of the following criteria:

• HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test
• Locally advanced or metastatic disease.

Hyrnuo can now be used whether or not you have already had other treatment for your lung cancer. When Hyrnuo was first approved on November 19, 2025, it could only be used after previous systemic therapy. The FDA removed that requirement when it updated the label on September 9, 2026.

Hyrnuo received FDA accelerated approval. Continued approval may depend on additional studies confirming the treatment's clinical benefit.

In SOHO-01 (NCT05099172), an open-label, single-arm study, 75% of 69 previously untreated patients responded to Hyrnuo, with responses lasting from 1.5 to more than 21.6 months, and 73% lasting 6 months or longer.

Among 70 previously treated patients not given HER2-targeted therapy before, 71% responded, with a median response of 9.2 months. Of 52 patients previously treated with a HER2-targeted antibody drug conjugate, 38% responded, with a median response of 7 months.

• Take Hyrnuo tablets exactly as prescribed.
• Take doses with food, twice per day. Swallow tablets whole, do not cut, crush or chew.
• Drink plenty of liquids while you are taking this medicine.
• If you vomit shortly after taking Hyrnuo, do not take another dose. Take your next dose as scheduled.
• Have an anti-diarrhea medicine available before you start treatment, and start treatment for diarrhea as soon as possible at the first sign of loose stools or more frequent bowel movements.
• You will need blood tests to check your liver function before treatment, every 2 weeks for the first month, and then monthly, and blood tests to check your pancreas function during treatment.
• Your healthcare provider will check how well your heart is pumping before you start Hyrnuo and at regular intervals during treatment.
• Do not change your dose or stop taking Hyrnuo unless your healthcare provider instructs you to.
• If a dose is missed, take it as soon as you remember, before the next scheduled dose. Do not take 2 doses at the same time to make up for the missed dose.

Before starting treatment, tell your healthcare provider about all of your medical conditions, especially if you:

• have liver problems
• have lung or breathing problems other than lung cancer
• have heart problems
• have vision or eye problems

Pregnancy & Birth Control

Hyrnuo can harm an unborn baby.

For females who can become pregnant:

• A pregnancy test will be done before treatment begins.
• Use effective birth control during treatment and for 1 week after the last dose.
• Notify your healthcare provider right away if you become pregnant.

For males with partners who can become pregnant:

• Use effective contraception during treatment and for 1 week after the final dose.

Breastfeeding

It is unknown whether Hyrnuo passes into breast milk. Do not breastfeed while taking Hyrnuo or for 1 week after your final dose.

Common Hyrnuo side effects include diarrhea, rash, nail problems, including infection and inflammation, mouth sores, nausea, vomiting, and changes in certain blood tests.

Serious side effects

Hyrnuo may cause serious side effects. Call your doctor at once if you have:

• severe or ongoing diarrhea;
• dehydration - dizziness, confusion, feeling very thirsty, less urination;
• signs of an electrolyte imbalance - increased thirst or urination, constipation, muscle weakness, leg cramps, numbness or tingling, feeling jittery, fluttering in your chest;
• new or worsening eye symptoms, including blurred vision or loss of vision, which may be temporary;
• heart problems - shortness of breath, swelling of your legs, ankles, or feet, tiredness, coughing, irregular heartbeat, feeling dizzy or lightheaded, loss of consciousness;
• signs of liver or pancreas problems - loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, dark urine, pale stools, jaundice (yellowing of the skin or eyes); or
• sudden chest pain, wheezing, dry cough, fever, or feeling short of breath.

Your cancer treatments may be changed, delayed, or permanently discontinued if you have certain side effects. This is not a full list of possible side effects. For medical advice, consult your doctor. Side effects can be reported to the FDA at 1-800-FDA-1088.

• Recommended dose: 20 mg taken orally twice daily with food.
• Continue treatment until disease progression or unacceptable side effects occur.
• Swallow tablets whole with a glass of water; do not cut, crush, or chew tablets.
• Tablets are red-brown, round, film-coated, and contain 10 mg of sevabertinib.
• If side effects occur, the dose may be reduced first to 10 mg twice daily, then to 10 mg once daily. Hyrnuo is stopped permanently in people who cannot tolerate 10 mg once daily.
• If a strong CYP3A inhibitor cannot be avoided, the dose is reduced by one level, and people already taking 10 mg once daily stop Hyrnuo until the inhibitor is finished.

Hyrnuo interacts with several types of medications. Some interactions can increase side effects or reduce effectiveness. Always inform your healthcare provider about all medications you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.

CYP3A Interactions

• Strong CYP3A inhibitors: Avoid using strong CYP3A inhibitors with Hyrnuo. If unavoidable, your healthcare provider may reduce your Hyrnuo dose.
• Moderate CYP3A inhibitors:If taking moderate CYP3A inhibitors with this medicine, your healthcare provider will monitor you closely for increased Hyrnuo-related side effects.
• Strong or moderate CYP3A inducers: Avoid using Hyrnuo with strong or moderate CYP3A inducers.

CYP3A Substrates

Avoid combining Hyrnuo with CYP3A substrate drugs where small increases in drug levels could cause serious side effects, unless otherwise recommended in the Prescribing Information of the CYP3A substrate.

CYP1A1 substrates

Sevabertinib blocks CYP1A1 in laboratory studies and may raise levels of medicines that are broken down by this enzyme. Check the prescribing information for any CYP1A1 substrate you take.

P-gp Substrates

For medications that rely on P-glycoprotein (P-gp) transport:

• Refer to their prescribing information if even small increases in concentration could lead to serious side effects.

Not all possible drug interactions are listed here.

Grapefruit may interact with Hyrnuo and cause side effects. Avoid consuming grapefruit products.

Avoid taking an herbal supplement containing St. John's wort.

• Store tablets at 68°F to 77°F (20°C to 25°C). Brief excursions between 59°F and 86°F (15°C to 30°C) are permitted.
• Hyrnuo is supplied in a bottle of 120 tablets with a child-resistant screw cap. Keep it in its original container and out of reach of children.

Active ingredient: Sevabertinib

Inactive ingredients: Microcrystalline cellulose, crospovidone, lactose monohydrate, magnesium stearate

Tablet film coating: Ferric oxide red, hypromellose 5 cP, macrogol 3350.

Manufactured for: Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981 USA Information line: 1-888-842-2937