Selpercatinib

Selpercatinib is used in adults to treat a specific type of non-small cell lung cancer.

Selpercatinib is also used in adults and children who are at least 2 years old to treat certain types of thyroid cancer.

Selpercatinib is used when the cancer has worsened, has spread to other parts of the body (metastatic), or after other treatments did not work or stopped working.

Your doctor will ensure you have the right tumor type to be treated with selpercatinib.

Selpercatinib may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. Use the medicine exactly as directed.

Selpercatinib is usually taken twice daily with or without food.

Take selpercatinib with food if you are also taking a stomach acid medicine such as dexlansoprazole, esomeprazole, lansoprazole, omeprazole, rabeprazole, and others.

Swallow the medicine whole and do not crush, chew, break, or open it.

Drink plenty of liquids while you are taking selpercatinib.

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

Doses are based on body surface area (height and weight) in children. Your child's dose may change if they gain or lose weight or if they are still growing.

Doses are based on weight in adults. Your dose may change if you gain or lose weight.

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.

Your blood pressure will need to be checked often.

You will need frequent medical tests, and your dose or medication schedule may be changed based on the results.

If you need surgery, tell the surgeon ahead of time that you are using selpercatinib. You may need to stop using the medicine for a short time.

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 ever had:

• bleeding problems;
• lung or breathing problems other than lung cancer;
• high blood pressure;
• recent or planned surgery;
• thyroid problems other than thyroid cancer;
• heart problems including long QT syndrome (in you or a family member); or
• liver disease.

Selpercatinib can harm an unborn baby if the mother or the father is using selpercatinib.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 1 week after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 1 week after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

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

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

You may feel faint while taking selpercatinib. Call your doctor right away if you have fast or pounding heartbeats, shortness of breath, and sudden dizziness.

Selpercatinib may cause serious side effects. Call your doctor immediately if you have:

• unusual bleeding or signs of bleeding inside your body--bruising, nosebleeds, bleeding gums, abnormal vaginal bleeding, any bleeding that does not stop, weakness, dizziness, pink or brown urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• any wound that does not heal;
• pain in your knees or hips, walking with a limp;
• severe headache, blurred vision, pounding in your neck or ears;
• signs of tumor cell breakdown--tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth;
• underactive thyroid--tiredness, depressed mood, dry skin, thinning hair, decreased sweating, weight gain, puffiness in your face, feeling more sensitive to cold temperatures;
• sudden chest pain, wheezing, new or worsening cough, feeling short of breath or trouble breathing; or
• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed or permanently stopped if you have certain side effects.

Common side effects of selpercatinib may include:

• abnormal blood tests;
• high blood pressure;
• fever, tiredness, headache;
• bleeding;
• dry mouth;
• bone, muscle, or stomach pain;
• nausea, vomiting, constipation, or diarrhea;
• swelling;
• coronavirus infection; or
• rash.

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

Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 6 hours. Do not take two doses at one time.

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

• Ask your doctor before taking any medicine to reduce stomach acid.
• Take only the type your doctor recommends.

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

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

Selpercatinib can cause a serious heart problem. Your risk may be higher if you also take certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Some medicines can make selpercatinib much less effective when taken at the same time. If you take any of the following medicines, take them separately from your dose of selpercatinib:

• an antacid that contains aluminum, magnesium, calcium, simethicone, or buffered medicine--take selpercatinib 2 hours before or 2 hours after taking the antacid; or
• stomach acid medicines (such as cimetidine, famotidine, nizatidine, and others)--take selpercatinib 2 hours before or 10 hours after you take the other medicine.

Many drugs can affect selpercatinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.