What is Retevmo?

Important Facts About RETEVMO^® (reh-TEHV-moh). It is also known as selpercatinib.

RETEVMO is a prescription medicine that is used to treat certain cancers caused by an abnormal gene, called RET, in:

• adults with non-small cell lung cancer (NSCLC) that has spread.
• adults and children 12 years of age and older with advanced medullary thyroid cancer (MTC) or MTC that has spread, who need a medicine that can be taken by mouth or injection.
• adults and children 12 years of age and older with advanced thyroid cancer or thyroid cancer that has spread, who need a medicine that can be taken by mouth or injection, and who have received radioactive iodine and it did not work or is no longer working.

Your doctor will perform a test to make sure that RETEVMO is right for you.

It is not known if RETEVMO is safe and effective in children younger than 12 years of age.

RETEVMO may cause serious side effects, including:

Liver problems: Liver problems (higher levels of liver enzymes) are common with RETEVMO and may sometimes be serious. Your doctor will do blood tests before and during treatment with RETEVMO to check for liver problems. Tell your doctor right away if you get any of the following symptoms of liver problems during treatment:

If you develop liver problems while taking RETEVMO, your doctor may lower your dose, stop treatment for a while, or stop treatment permanently.

High blood pressure (hypertension): High blood pressure is common with RETEVMO. It may sometimes be serious. You should check your blood pressure regularly during treatment with RETEVMO. Tell your doctor if you get any of the following symptoms during treatment:

Heart rhythm changes (QT prolongation) can happen. These may be serious. RETEVMO may cause very slow, very fast, or irregular heartbeats. Tell your doctor right away if you get any of the following symptoms during treatment:

Bleeding problems: RETEVMO can cause bleeding, which can be serious and may lead to death. Tell your doctor if you have any signs of bleeding during treatment, including:

Allergic reactions: RETEVMO can cause a fever, rash, or pain in muscles or joints, especially in the first month of treatment. Tell your doctor if you get any of these symptoms. Your doctor may stop treatment for a while or lower your dose of RETEVMO.

Tumor lysis syndrome (TLS): TLS is caused by a fast breakdown of cancer cells. TLS can cause you to have kidney failure and the need for dialysis treatment, an abnormal heartbeat, and may sometimes lead to hospitalization. Your healthcare provider may do blood tests to check you for TLS. You should stay well hydrated during treatment with RETEVMO. Call your healthcare provider or get emergency medical help right away if you develop any of these symptoms during treatment with RETEVMO:

Risk of wound healing problems: Wounds may not heal well during treatment with RETEVMO. Tell your doctor if you plan to have any surgery before or during treatment with RETEVMO.

• You should stop taking RETEVMO at least 7 days before planned surgery.
• Your doctor should tell you when you may start taking RETEVMO again after surgery.

The most common side effects of RETEVMO are:

RETEVMO may affect the ability to have children for both females and males. Talk to your doctor if you want to have children and you are thinking about starting treatment with RETEVMO.

• RETEVMO can harm your unborn baby. You should not become pregnant during treatment with RETEVMO.
• If you are able to become pregnant:
  • Your doctor will do a pregnancy test before you start treatment with RETEVMO.
  • You should use effective birth control (contraception) during treatment and for at least 1 week after the final dose of RETEVMO. Talk to your doctor about birth control methods that may be right for you.
  • Tell your doctor right away if you become pregnant or think you might be pregnant during treatment with RETEVMO.
• Males with partners who are able to become pregnant should use effective birth control during treatment with RETEVMO and for at least 1 week after the final dose of RETEVMO.

These are not all the possible side effects with RETEVMO. If you are concerned about side effects, talk to your doctor. Tell your doctor about any side effects you have. You can also report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before taking RETEVMO, tell your doctor about all your medical conditions, including if you:

• have liver problems
• have high blood pressure
• have heart problems, including a condition called QT prolongation
• have bleeding problems
• plan to have surgery. You should stop taking RETEVMO at least 7 days before your planned surgery.
• are pregnant or plan to become pregnant. See section above for additional information.
• are breastfeeding or plan to breastfeed. It is not known if RETEVMO passes into your breast milk. Do not breastfeed during treatment with RETEVMO and for 1 week after the last dose.

Also tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how RETEVMO works.

• You should avoid taking certain medicines when also taking RETEVMO. These include:
  • St. John’s wort,
  • proton-pump inhibitors (PPIs) such as dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole sodium, and rabeprazole,
  • H2 blockers such as famotidine, nizatidine, and cimetidine,
  • antacids that contain aluminum, magnesium, calcium, simethicone, or buffered medicines.

If you cannot avoid taking PPIs, H2 blockers, or antacids, see the “How to take with certain other medicines” section below for more information. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

• Take RETEVMO exactly as your doctor tells you.
• Your doctor may stop treatment or change your dose of RETEVMO if you have side effects. Do not change your dose or stop taking RETEVMO unless your doctor tells you.
• Swallow RETEVMO capsules whole. Do not chew or crush the capsules.
• RETEVMO is taken by mouth, usually 2 times a day with or without food.
• RETEVMO doses should be taken 12 hours apart.
• If you vomit after taking a dose of RETEVMO, do not take an extra dose. Take the next dose of RETEVMO at your scheduled time.
• Do not take a missed dose of RETEVMO unless it is more than 6 hours until your next scheduled dose.
• If you take too much RETEVMO, call your doctor or go to the nearest hospital emergency room right away.

• If you take a PPI (such as dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole sodium, or rabeprazole), take RETEVMO with food.
• If you take an antacid that contains aluminum, magnesium, calcium, simethicone, or buffered medicines, take RETEVMO 2 hours before or 2 hours after taking the antacid.
• If you take an H2 blocker (such as famotidine, nizatidine, or cimetidine), take RETEVMO 2 hours before or 10 hours after taking the H2 blocker.