Sodium Phenylbutyrate (SOE-dee-um fen-il-BUE-ti-rate), Taurursodiol (taur-ur-so-DYE-ol)

Treats amyotrophic lateral sclerosis (ALS).

Brand Name(s):

Relyvrio

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take this medicine before a snack or a meal.
• This medicine can be taken by mouth or given through a feeding tube.
• Empty one packet of this medicine in a cup containing 8 ounces of room temperature water and stir well. Take the mixture within 1 hour after mixing.
• 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.
• Throw away any unused liquid 1 hour after mixing.

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 sodium phenylbutyrate/taurursodiol works. Tell you doctor if you are using any of the following:
  • Cyclosporine, probenecid
  • Antacid that contains aluminum
  • Bile acid sequestrant (including cholestyramine, colesevelam, colestipol)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, pancreas problem, bowel problem, heart failure, or high blood pressure.
• Your doctor will check your progress and the effects of this medicine at regular visits. 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
• Diarrhea, nausea, stomach pain

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

• Runny or stuffy nose

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