Sevabertinib

Sevabertinib is used in adults to treat a specific type of lung cancer known as non-small cell lung cancer (NSCLC).

Sevabertinib is used when the cancer has spread within your chest or to other areas of the body (metastatic), or when other cancer treatments did not work or have stopped working.

Your doctor will confirm that you have the right tumor type to be treated with sevabertinib.

Sevabertinib may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Your doctor will perform tests to make sure sevabertinib is the right treatment for you.

Sevabertinib is usually taken twice per day with food. Follow your doctor's instructions.

Swallow the tablet whole with a glass of water and do not crush, chew, or break it.

Drink plenty of liquids while you are taking sevabertinib.

If you vomit shortly after taking sevabertinib, do not take another dose. Take your next dose as scheduled.

You may need frequent medical tests including blood tests to check your liver and pancreas function before and during treatment with sevabertinib.

Do not change your dose or stop taking sevabertinib unless your healthcare provider tells you to.

You may be given other medications to help prevent serious side effects or allergic reactions. Keep taking these medicines for as long as your doctor has prescribed.

Store at room temperature away from moisture and heat.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

Tell your doctor if you have or have ever had:

• lung or breathing problems (other than lung cancer); or
• liver disease.

Sevabertinib can harm an unborn baby if either the mother or the father is using sevabertinib.

• If you are a woman, you may need a pregnancy test to confirm that you are not pregnant. Use birth control while taking this medicine and for at least 1 week after your last dose.
• If you are a man, use birth control if your sex partner can become pregnant. Continue using birth control for at least 1 week after your last dose.

Tell your healthcare provider right away if you become pregnant or think you may be pregnant during your treatment with sevabertinib.

Do not breastfeed while taking this medicine, and for at least 1 week after your last dose.

Get emergency medical help if you notice signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Sevabertinib may lead to serious side effects. Contact your doctor immediately if you experience:

• severe or ongoing diarrhea;
• dehydration—dizziness, confusion, extreme thirst, reduced urination;
• signs of an electrolyte imbalance—increased thirst or urination, constipation, muscle weakness, leg cramps, numbness or tingling, feeling jittery, fluttering in your chest;
• severe vision issues, including vision loss;
• signs of liver or pancreas problems—loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, rapid heart rate, dark urine, jaundice (yellowing of the skin or eyes); or
• sudden chest pain, wheezing, dry cough, or shortness of breath.

Your cancer treatments might be adjusted, delayed, or stopped entirely if you experience certain side effects.

Common side effects of sevabertinib may include:

• diarrhea, nausea;
• skin rash;
• nail problems including infection or inflammation;
• mouth sores; or
• abnormal blood tests.

This is not a complete list of side effects, and others may happen. Contact your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Non-Small Cell Lung Cancer:

20 mg orally twice a day with food, until disease progression or unacceptable toxicity Use: For the treatment locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy

Take the medicine as soon as you remember, and then return to your regular schedule. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

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

Sometimes it is not safe to use certain medicines at the same time. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

Other drugs may affect sevabertinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.