selpercatinib

What is the most important information I should know about selpercatinib?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What is selpercatinib?

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

Selpercatinib is also used to treat certain types of thyroid cancer in adults and children at least 12 years old.

This medicine is used when the cancer has spread to other parts of the body (metastatic).

Selpercatinib is used only if your cancer has a specific genetic marker (an abnormal "RET" gene). Your doctor will test you for this gene.

Selpercatinib was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to this medicine, but further studies are needed.

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

What should I discuss with my healthcare provider before taking selpercatinib?

Tell your doctor if you have ever had:

• liver disease; or
• long QT syndrome (in you or a family member).

Tell your doctor right away if a pregnancy occurs while either the mother or the father is using selpercatinib.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because selpercatinib can harm an unborn baby.

How should I take selpercatinib?

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

Selpercatinib is usually taken every 12 hours.

Take selpercatinib with food if you also use a "proton pump inhibitor" stomach acid medicine such as esomeprazole, lansoprazole, omeprazole, Prevacid, Prilosec, Nexium, and others.

Follow your doctor's dosing instructions very carefully.

If you vomit shortly after taking selpercatinib, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Selpercatinib doses are based on weight (especially in children and teenagers). Your dose needs may change if you gain or lose weight.

Your blood pressure will need to be checked often.

If you need surgery, tell your surgeon you currently use selpercatinib. You may need to stop for at least 7 days before a planned surgery.

What happens if I miss a dose?

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.

What happens if I overdose?

What should I avoid while taking selpercatinib?

Ask your doctor before using any medicine to reduce stomach acid, including an antacid.

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

What are the possible side effects of selpercatinib?

• easy bruising or bleeding (nosebleeds, bleeding gums);
• coughing up blood or vomit that looks like coffee grounds;
• any wound that will not heal;
• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• fever, chills, cough with mucus, chest pain, feeling short of breath; or
• liver problems --loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes).

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

Common side effects may include:

• abnormal blood tests;
• high blood pressure;
• tiredness;
• dry mouth;
• diarrhea;
• swelling;
• rash; or
• constipation.

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.

What other drugs will affect selpercatinib?

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

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 --take selpercatinib 2 hours before or 2 hours after taking the antacid; or
• stomach acid medicines (such as cimetidine, famotidine, Axid, Pepcid, Tagamet, and others) --take selpercatinib dose 2 hours before or 10 hours after you take the other medicine.

Other drugs may affect selpercatinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about selpercatinib.