Resmetirom

Resmetirom is used for treatment of adult patients with nonalcoholic steatohepatitis (NASH; liver inflammation and damage caused by build up of fat in the liver) with moderate to advanced liver fibrosis (changes in liver tissue seen with early liver damage) but not cirrhotic (scarring of the liver that keeps the liver from functioning properly). Resmetirom is in a class of medications called thyroid hormone receptor (THR)-beta agonists. It works by keeping the liver from forming fat.

Resmetirom comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take resmetirom at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take resmetirom exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

It may take time before you feel the full benefit of resmetirom. Continue to take resmetirom even if you feel well. Do not stop taking resmetirom without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking resmetirom,

• tell your doctor and pharmacist if you are allergic to resmetirom, any other medications, or any of the ingredients in resmetirom tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• Some medications should not be taken with resmetirom. Other medications may cause dosing changes or extra monitoring when taken with resmetirom. Make sure you have discussed any medications you are currently taking or plan to take before starting resmetirom with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking resmetirom, please get the advice of your doctor or pharmacist.
• tell your doctor if you have or have ever had liver, kidney or gallbladder disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking resmetirom, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Resmetirom may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• nausea
• itching
• abdominal pain
• vomiting
• dizziness
• constipation

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately {or get emergency medical treatment}:

• tiredness, nausea, vomiting, fever, rash, yellowing of the skin or white part of your eyes, pain in the upper right side of the stomach
• nausea, vomiting, fever, or stomach pain

Resmetirom may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to resmetirom.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Rezdiffra^®