Resmetirom (res-me-TIR-om)

Treats non-alcoholic steatohepatitis.

Brand Name(s):

Rezdiffra

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how resmetirom works. Tell your doctor if you are using atorvastatin, clopidogrel, cyclosporine, gemfibrozil, pravastatin, rosuvastatin, or simvastatin.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, other liver problems, or gallbladder problems (including gallstones).
• This medicine may cause the following problems:
  • Liver problems
  • Gallbladder problems, including cholelithiasis, cholecystitis, obstructive pancreatitis (gallstones)
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Sudden and severe stomach pain, fever, lightheadedness

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, stomach upset
• Dizziness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088