Zongertinib (zon-GER-ti-nib)

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

Brand Name(s):

Hernexeos

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.
• Swallow the tablet whole with water. Do not split, 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: If a dose is missed within 12 hours, take the missed dose. If a dose is missed by more than 12 hours, skip the missed dose. Take the next dose at the regular scheduled time. Do not take extra medicine to make up for the 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. Use the tablets within 3 months of opening the bottle. Throw away unused tablets 3 months after opening.
• Do not remove the desiccants (drying agent) from the container after opening.

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 medicine can affect how zongertinib works. Tell your doctor if you are using carbamazepine or rosuvastatin.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment and for 2 weeks after your last dose.
• Do not breastfeed during treatment and for 2 weeks after the last dose.
• Tell your doctor if you have kidney disease, liver disease, heart disease, or other lung or breathing problems.
• This medicine may cause the following problems:
  • Liver problems
  • Heart problems
  • Lung or breathing problems, including interstitial lung disease (ILD), pneumonitis
  • Severe diarrhea
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• 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
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fast, pounding, or uneven heartbeat
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Lightheadedness, dizziness, fainting
• Severe diarrhea
• Swelling in your hands, ankles, or feet
• Tiredness, trouble breathing, chest pain
• Unusual bleeding, bruising, or weakness

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

• Dry skin, changes in your nails
• Muscle or joint pain
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Sores or white patches on your lips, mouth, or throat

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