Hernexeos
Pronunciation: her-nex-ee-ose
Generic name: zongertinib
Dosage form: tablet (60mg)
What is Hernexeos?
Hernexeos tablets are a targeted therapy for non-small-cell lung cancer (NSCLC) that has HER2 (ERBB2) mutations. Mutations in the HER2 (ERBB2) gene can promote tumor growth and spread. Hernexeos is a tyrosine kinase inhibitor (TKI) that works by selectively blocking HER2 (ERBB2), to help control tumor growth and improve survival time for patients.
Hernexeos tablets are taken once daily with or without food.
Hernexeos FDA approval (accelerated) was granted on August 8, 2025, after positive results from Phase Ib Beamion-LUNG 1 trial (NCT04886804). Hernexeos patients had a:
- objective response rate of 75%
- a complete response of 6% had
- a partial response 69%
- duration of response of ≥6 months in 58% of patients.
Hernexeos contains the active ingredient zongertinib.
Who can use Hernexeos?
Hernexeos is indicated to treat adults with non-squamous non-small cell lung cancer (NSCLC) that:
- HER2 (ERBB2) mutations that have been detected by an FDA-approved test.
- who have previously received systemic therapy.
- Cancer can not be removed by surgery (unresectable) or has spread to other parts of your body (metastatic).
Hernexeos side effects
The most common Hernexeos side effects are:
- Diarrhea, which may be severe diarrhea, tell your healthcare provider right away if you have diarrhea.
- Liver problems
- Rash
- Feeling tired (fatigue)
- Nausea
Hernexeos may also cause severe changes in blood test results, including decreased white blood cell count, increased liver function tests, and decreased potassium levels.
Serious side effects
Hernexeos may cause serious side effects, including:
Liver problems can be severe and life-threatening. You will do blood tests to check your liver function before you start taking this medicine and during your treatment. Tell your healthcare provider right away if you develop any signs and symptoms of liver problems, including:
- yellowing of your skin or the white part of your eyes (jaundice)
- dark or brown (tea colored) urine
- bleeding or bruising more easily than normal
- feeling very tired
- loss of appetite
- pain on the upper right side of your stomach area (abdomen)
- nausea or vomiting
Heart problems that may affect your heart’s ability to pump blood. Your healthcare provider will do tests to check your heart function before you start taking this medicine and during your treatment. Tell your healthcare provider right away if you have any new or worsening symptoms of heart problems, including:
- Feeling like your heart is pounding or racing
- Dizziness
- Tiredness
- Feeling lightheaded
- Shortness of breath
- Loss of consciousness
- Coughing
- Swelling of your legs, ankles, or feet
Lung problems may be severe or life-threatening. Tell your healthcare provider immediately if you have any new or worsening symptoms of lung problems, including trouble breathing, shortness of breath, cough, or fever.
Your healthcare provider may temporarily stop, decrease your dose, or permanently stop treatment with Hernexeos
if you have serious side effects your healthcare provider may temporarily stop, decrease your dose, or permanently stop treatment with Hernexeos
Hernexeos may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.
These are not all of the possible side effects of Hernexeos.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
Related/similar drugs
Before taking this medicine.
Before taking this medicine, tell your healthcare provider about all of your medical conditions, including if you have:
- liver problems
- heart problems
- have lung or breathing problems other than lung cancer.
Pregnancy
Tell your healthcare professional if you are pregnant or plan to become pregnant as Hernexeos can harm your unborn baby.
Females who are able to become pregnant: Your healthcare provider will do a pregnancy test before you start treatment with this medicine to ensure you are not pregnant. You must use an effective form of birth control (contraception) during treatment with Hernexeos and for 2 weeks after your last dose. Discuss with your healthcare provider about birth control methods that might be right for you during this time. Tell your healthcare provider immediately if you become pregnant or think you are pregnant during treatment withthis medicine.
Breastfeeding
Tell your healthcare professional if you are breastfeeding or plan to breastfeed as it is not known if Hernexeos passes into your breastmilk. Do not breastfeed during treatment and for 2 weeks after your last dose of Hernexeos.
Fertility
Hernexeos may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.
How should I take Hernexeos?
Take Hernexeos one time a day, with or without food. Tablets should be swallowed whole with water. Do not split, crush, or chew tablets.
Take tablets exactly as your healthcare provider tells you to take them. Your healthcare professional may change your dose if needed. Do not change your dose or stop taking this medicine unless your healthcare provider tells you to.
If you vomit after taking Hernexeos, do not take an extra dose. Take your next dose at your next scheduled time.
What happens if I miss a dose?
If you miss a dose, take it as soon as you remember within 12 hours. If you missed your dose by more than 12 hours, skip the missed dose and take your next dose at your next scheduled time.
What happens if I overdose?
If you take too much of this medicine, call your healthcare provider or go to the nearest hospital emergency room right away.
Interactions
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Hernexeos may affect the way other medicines work, and other medicines may affect how Hernexeos works. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.
Storage
- Store at room temperature between 68°F to 77°F (20°C to 25°C).
- Store tablets in the original bottle, keeping the bottle tightly closed when not in used.
- The bottle contains two desiccants to help keep your tablets dry (protect from moisture). Do not remove the desiccants from the container after opening. Do not eat or swallow the desiccants.
- Hernexeos tablets must be used within 3 months of first opening the bottle. Throw away (discard) any unused tablets 3 months after opening the bottle
Ingredients
Active ingredient: zongertinib
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The film-coating contains ferric oxide (yellow), glycerol mono and dicaprylocaprate, polyvinyl alcohol, sodium lauryl sulfate, talc, and titanium dioxide.
Company
Hernexeos Boehringer Ingelheim
References
More about Hernexeos (zongertinib)
Professional resources
Related treatment guides
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
