Zongertinib

Brand Name(s): Hernexeos®

Why is this medicine prescribed?

Zongertinib is used to treat certain types of non-small cell lung cancer (NSCLC). Zongertinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

Are there other uses for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Zongertinib comes as a tablet to take by mouth. Take with or without food once a day with water. Take zongertinib at around the same time every day. Your doctor will tell you how long to take zongertinib.

Take zongertinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

If a dose is vomited, do not take another dose. Resume normal dosing schedule.

What special precautions should I follow?

Before taking zongertinib,

  • tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
  • some medications should not be taken with zongertinib. Other medications may cause dosing changes or extra monitoring when taken with zongertinib. Make sure you have discussed any medications you are currently taking or plan to take before starting zongertinib with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking zongertinib, please get the advice of your doctor or pharmacist.
  • the following nonprescription or herbal products may interact with zongertinib: St. John's Wort, cimetidine. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking zongertinib. Do not start any of these medications while taking zongertinib without discussing with your healthcare provider.
  • tell your doctor if you have or have ever had liver disease, heart failure or heart disease, or lung disease including lung cancer, asthma, chronic obstructive pulmonary disease (COPD), emphysema.
  • tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are taking zongertinib. You may be required to have a pregnancy test before you start treatment. You should use birth control to prevent pregnancy during your treatment and for 2 weeks after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while taking zongertinib, call your doctor immediately.
  • tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while taking zongertinib and for 2 weeks after your final dose.
  • this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking zongertinib.

What special dietary instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

What should I do if I forget to take a dose?

Take the missed dose as soon as you remember it. However, if more than 12 hours have passed since the scheduled dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What should I do in case of overdose?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

  • nausea
  • vomiting

What side effects can this medicine cause?

Zongertinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • diarrhea, nausea, vomiting
  • rash
  • changes in nail color or thickness
  • tiredness
  • muscle or joints aches or pains

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

  • yellowing of the skin or whites of the eyes, dark urine, lower abdominal pain, clay-colored stools, loss of appetite, bruising easily
  • feeling of racing or abnormal or missing beats, dizziness, tiredness, lightheadedness, shortness of breath, loss of consciousness, coughing, swelling of legs, ankles, or feet
  • trouble breathing, shortness of breath, coughing, or fever

Zongertinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone ( 1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccants in the bottle. Discard any unused tablets 3 months after the bottle was opened.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to zongertinib.

Your doctor will order echocardiogram (ultrasound of the heart) before you start zongertinib and periodically during treatment. It is important to keep these appointments.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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