Sunvozertinib (sun-voe-ZER-ti-nib)

Treats non-small cell lung cancer (NSCLC).

Brand Name(s):

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. Take the medicine at the same time each day.
• It is best to take this medicine with food or milk.
• Swallow the tablet whole. Do not split, crush, chew, or dissolve it.
• Your doctor will ask you to take medicines or drink fluids to treat your stomach or bowel problems.
• Use alcohol-free (including isopropanol-free, ethanol-free) moisturizing cream during treatment with this medicine. Do not use skin products that has retinol, retinoic acid, and benzoyl peroxide.
• Do not use contact lenses until your eye problems are checked and for at least 1 week after your symptoms have been treated.
• 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.

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 sunvozertinib works. Tell your doctor if you are using carbamazepine, digoxin, efavirenz, itraconazole, midazolam, rosuvastatin, or birth control pills.

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. Male patients who have female partners should use effective birth control during treatment and for 2 weeks after the 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, eye or vision problems, or other lung or breathing problems.
• This medicine may cause the following problems:
  • Lung or breathing problems, including interstitial lung disease (ILD), pneumonitis
  • Stomach or bowel problems
  • Serious skin reactions
  • Eye or vision problems
• 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.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• 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
• Blurred vision, dry eye, or eye redness, irritation, or pain
• Change in how much or how often you urinate, bloody or cloudy urine, lower back or side pain
• Constipation, diarrhea, nausea, vomiting, stomach pain, decreased appetite or weight
• Dry skin, loosening of the fingernails, redness or soreness around fingernails
• Fever, cough, chest pain, trouble breathing

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

• Muscle or joint pain
• Sores or white patches on your lips, mouth, or throat
• Tiredness

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