What does it mean if my advanced cancer is RET-positive?

Certain advanced cancers can be driven by a gene in your body. One of those genes is RET. There are many different types of advanced cancers that can be driven by RET, including pancreatic cancer, colon cancer, and breast cancer.

Talk to your doctor to see if your cancer is RET-positive.

RET=rearranged during transfection.

Retevmo is available for certain RET-positive advanced cancers

Retevmo may help by targeting what is driving your RET-positive advanced cancer

Retevmo was studied in the largest clinical trial of people with RET-positive cancers. The trial included people with certain advanced cancers, like pancreatic cancer, colon cancer, and breast cancer, and all had tumors that were eligible to be evaluated for shrinkage. The trial evaluated how many people responded to treatment, which means their tumors either shrank or disappeared completely, and how long the response lasted.

Retevmo may affect both healthy cells and tumor cells, which can result in side effects, some of which can be serious.

**Retevmo has been shown to shrink tumors in some adults with certain RET-positive advanced cancers**

of the 41 people had an objective response, meaning their tumors shrank by 30% or more

Responses lasted a median^* of 24.5 months

^*Median is the middle number in a range of numbers.

SELECT SAFETY INFORMATION

RETEVMO may cause serious side effects, including:

Allergic reactions: RETEVMO can cause a fever, rash, or pain in muscles or joints, especially during the first month of treatment. Tell your doctor if you get any of these symptoms.

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. TLS can 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:

nausea
vomiting
weakness
swelling

shortness of breath
muscle cramps
seizures

Learn how to take Retevmo

Retevmo dosing

Read more about what could be driving your cancer

What is RET?

Warnings - RETEVMO may cause serious side effects, including:

Liver problems: Liver problems (increased liver enzymes) can happen during treatment with RETEVMO and may sometimes be serious. Your healthcare provider will do blood tests before and during treatment with RETEVMO to check for liver problems. Tell your healthcare provider right away if you get any of the following symptoms of liver problems during treatment:

yellowing of your skin or the white part of your eyes (jaundice)
dark, “tea-colored” urine
sleepiness
bleeding or bruising

loss of appetite
nausea or vomiting
pain on the upper right side of your stomach area

Lung problems: RETEVMO may cause severe or life-threatening inflammation (swelling) of the lungs during treatment, that can lead to death. Tell your healthcare provider right away if you get any new or worsening lung symptoms, including:

shortness of breath

cough

fever

High blood pressure (hypertension): High blood pressure is common with RETEVMO. It may sometimes be severe. You should check your blood pressure regularly during treatment with RETEVMO. If you develop blood pressure problems, your healthcare provider may prescribe medicine to treat your high blood pressure. Tell your healthcare provider if you have increased blood pressure readings or get any symptoms of high blood pressure, including:

confusion
headaches
shortness of breath

dizziness
chest pain

Heart rhythm changes (QT prolongation). RETEVMO may cause very slow, very fast, or irregular heartbeats. Your healthcare provider may perform tests before and during treatment with RETEVMO to check the activity of your heart and the levels of body salts (electrolytes) and thyroid-stimulating hormone (TSH) in your blood. Tell your healthcare provider right away if you get any of the following symptoms:

loss of consciousness
fainting
dizziness

a change in the way your heart beats (heart palpitations)

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

vomiting blood or if your vomit looks like coffee-grounds
pink or brown urine
red or black stools that look like tar
coughing up blood or blood clots
unusual bleeding or bruising of your skin
menstrual bleeding that is heavier than normal

unusual vaginal bleeding
nose bleeds that happen often
drowsiness or difficulty being awakened
confusion
headache
change in speech

Allergic reactions: RETEVMO can cause a fever, rash, or pain in muscles or joints, especially during the first month of treatment. Tell your healthcare provider if you get any of these symptoms.

Tumor lysis syndrome (TLS): TLS is caused by a fast breakdown of cancer cells. TLS can cause you to have kidney failure, the need for dialysis treatment, and an abnormal heartbeat. TLS can 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:

nausea
vomiting
weakness
swelling

shortness of breath
muscle cramps
seizures

Risk of wound healing problems: Wounds may not heal well during treatment with RETEVMO. Tell your healthcare provider 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 healthcare provider should tell you when you may start taking RETEVMO again after surgery.

Low thyroid hormone levels in your blood (hypothyroidism). Your healthcare provider will do blood tests to check your thyroid function before and during treatment with RETEVMO. Tell your healthcare provider right away if you develop signs or symptoms of low thyroid hormone levels, including:

weight gain
feeling cold

tiredness that worsens or does not go away
constipation

Hip joint problems (slipped capital femoral epiphysis or slipped upper femoral epiphysis) in children. Tell your healthcare provider right away if you develop sign and symptoms of hip problems, including hip or knee pain or a painless limp.

Common side effects

The most common side effects of RETEVMO in adults with solid tumors include:

swelling of your arms, legs, hands, and feet (edema)
diarrhea
tiredness
dry mouth

stomach-area (abdominal) pain
constipation
rash
nausea
headache

The most common side effects of RETEVMO in children 2 years and older with solid tumors include:

muscle and bone pain
diarrhea
headache
nausea
vomiting

coronavirus infection
stomach-area (abdominal) pain
tiredness
fever
bleeding

The most common severe abnormal laboratory test results with RETEVMO in adults with solid tumors include decreased white blood cell count, increased liver enzymes, decreased levels of sodium in the blood, and decreased levels of calcium in the blood.

The most common severe abnormal laboratory test results with RETEVMO in children 2 years and older with solid tumors include decreased levels of calcium in the blood, decreased red blood cell count, and decreased white blood cell count.

RETEVMO may affect the ability to have children for both females and males. Talk to your healthcare provider 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 healthcare provider will do a pregnancy test before you start treatment with RETEVMO.
- You should use effective birth control (contraception) during treatment and for 1 week after your last dose of RETEVMO. Talk to your healthcare provider about birth control methods that may be right for you.
- Tell your healthcare provider 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 1 week after your last 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 using

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

have liver problems
have lung or breathing problems other than lung cancer
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 your last dose.

Also tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RETEVMO may affect the way other medicines work and other medicines may affect how RETEVMO works, and may increase your risk of side effects.

During treatment with RETEVMO, you should avoid taking:
- 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.

How to take RETEVMO

Take RETEVMO exactly as your healthcare provider tells you.
Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with RETEVMO if you have side effects. Do not change your dose or stop taking RETEVMO unless your healthcare provider tells you.
Swallow RETEVMO capsules and tablets whole. Do not break, crush, or chew.
Do not give RETEVMO capsules to your child if they are unable to swallow a capsule.
Take RETEVMO with or without food.
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 healthcare provider or go to the nearest hospital emergency room right away.

How to take RETEVMO with certain other medicines

If you take a PPI (such as dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole sodium, or rabeprazole), take RETEVMO with food.
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.
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.

Learn more

RETEVMO is a prescription medicine available as 40 mg and 80 mg capsules, and 40 mg, 80 mg, 120 mg, and 160 mg tablets. For more information, call 1-800-545-5979 or go to www.Retevmo.com.

This summary provides basic information about RETEVMO. It does not include all information known about this medicine. Read the information that comes with your medicine each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other health care provider about RETEVMO and how to take it. Your doctor is the best person to help you decide if RETEVMO is right for you.

SE CON BS ALL 27SEP2024

RETEVMO^® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

INDICATIONS AND SAFETY SUMMARY

RETEVMO^® (reh-TEHV-moh) is used to treat certain cancers caused by abnormal RET genes in:

adults with locally advanced non-small cell lung cancer (NSCLC) or NSCLC that has spread.
adults and children 2 years of age and older with advanced medullary thyroid cancer (MTC) or MTC that has spread, who require a medicine by mouth or injection (systemic therapy).
adults and children 2 years of age and older with advanced thyroid cancer or thyroid cancer that has spread who require a medicine by mouth or injection (systemic therapy), and who have received radioactive iodine and it did not work or is no longer working.
adults and children 2 years of age and older with locally advanced solid tumors (cancers) or solid tumors that have spread, and have gotten worse (progressed) on or after other treatment or there are no satisfactory treatment options.^*

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

It is not known if RETEVMO is safe and effective when used in children younger than 2 years of age for the treatment of:

advanced MTC or MTC that has spread who require a medicine by mouth or injection.
advanced thyroid cancer or thyroid cancer that has spread who require a medicine by mouth or injection, and have received radioactive iodine and it did not work or is no longer working.
locally advanced solid tumors or solid tumors that have spread, and have gotten worse on or after other treatment or there are no satisfactory treatment options.

in children for other conditions.

^* This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information about clinical benefit of Retevmo for this use.