Relyvrio is a prescription medicine used to treat adults with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease.

ALS is a neurodegenerative disease caused by motor neuron death in the brain and spinal cord.

The two ingredients contained in Relyvrio work together to reduce motor neuron cell death and inflammation, and slow down disease progression.

What is Relyvrio used to treat?

Relyvrio is used to treat adults with amyotrophic lateral sclerosis (ALS).

Motor neuron loss in ALS leads to deteriorating muscle function, the inability to move and speak, respiratory paralysis, and eventually death.

It is not known if this medicine is safe and effective in children.

• Your healthcare provider will tell you how much Relyvrio to take and when to take it.
• Empty 1 packet of Relyvrio in a cup (8 ounces) of room temperature water and stir well.
• Relyvrio can be taken by mouth or through a feeding tube within 1 hour of preparing. Throw away (discard) any unused Relyvrio after 1 hour.
• Relyvrio should be taken before a snack or meal.
• Avoid taking antacids that contain aluminum while you are receiving treatment with Relyvrio. If you need an antacid, talk to your healthcare provider about the best one for you to take.

Usual Adult Dose for Amyotrophic Lateral Sclerosis

- The recommended dosage is 1 packet (3 g sodium phenylbutyrate and 1 g taurursodiol) daily for the first 3 weeks, and then 1 packet twice daily thereafter.

- Comment: can be administered orally or via feeding tube.

- Use: treatment of amyotrophic lateral sclerosis (ALS) in adults.

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

• have pancreas, liver, or intestinal problems.
• have heart failure, including congestive heart failure.
• have high blood pressure.
• have kidney problems.
• are pregnant or plan to become pregnant. It is not known if Relyvrio will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Relyvrio passes into your breast milk. You and your healthcare provider should decide the best way to feed your baby.

Relyvrio may cause serious side effects, including:

• Changes in bile acid levels. Relyvrio may increase bile acid levels and cause worsening diarrhea if you already have problems with your liver, bile ducts, or pancreas. Your healthcare provider should monitor you for these side effects. Some disorders of the pancreas, bile ducts, or intestines may also make it harder to absorb Relyvrio.
• Salt (sodium) retention. Relyvrio contains a high amount of salt. For people who are sensitive to salt intake, such as people with heart failure, high blood pressure, or kidney problems, limit the amount of salt you eat and drink.

Talk to your healthcare provider about the total amount of daily salt that is right for you. Your healthcare provider will monitor you for signs and symptoms of salt retention during your treatment.

The most common side effects include:

• diarrhea
• abdominal pain
• nausea
• upper respiratory tract infection.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, and any taurursodiol products, such as tauroursodeoxycholic acid (TUDCA).

Relyvrio may affect the way other medicines work, and other medicines may affect how Relyvrio works.

Especially tell your doctor if you take:

• cholestyramine, colestipol, or colesevelam;
• cyclosporine;
• aluminum-based antacids;
• probenecid;
• vorinostat, romidepsin, panobinostat, or belinostat.

There are many other drugs that may interact with Relyvrio. Check with your healthcare provider before you start treatment.