Relyvrio

Generic name: sodium phenylbutyrate and taurursodiol
Dosage form: powder for oral suspension
Drug class: Miscellaneous central nervous system agents

Medically reviewed by Judith Stewart, BPharm. Last updated on Apr 8, 2024.

What is Relyvrio?

Relyvrio was 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 were reported to work together to reduce motor neuron cell death and inflammation, and slow down disease progression.

Relvrio was voluntarily discontinued from the U.S. and Canadian markets for new patients on 4 April, 2024 following unfavorable results from the Phase 3 Phoenix trial. Existing patients can be transitioned to a free drug program if they wish to stay on treatment after consulting with their physician.

What was Relyvrio used to treat?

Relyvrio was 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 was not known if this medicine was safe and effective in children.

Before taking Relyvrio

Before they started treatment, patients needed to tell their healthcare provider about all of their medical conditions, including if they:

• had pancreas, liver, or intestinal problems.
• had heart failure, including congestive heart failure.
• had high blood pressure.
• had kidney problems.
• were pregnant or plan to become pregnant. It was not known if Relyvrio would harm an unborn baby
• were breastfeeding or plan to breastfeed. It was not known if Relyvrio passed into breast milk. 

Related/similar drugs

riluzole, Radicava, edaravone, sodium phenylbutyrate / taurursodiol, tofersen, Rilutek

What other drugs affected Relyvrio?

Relyvrio could affect the way other medicines worked, and other medicines affected the way Relyvrio worked. Medicines of concern included:

• cholestyramine, colestipol, or colesevelam;
• cyclosporine;
• aluminum-based antacids;
• probenecid;
• vorinostat, romidepsin, panobinostat, or belinostat
• taurursodiol products, such as tauroursodeoxycholic acid (TUDCA).

How was Relyvrio taken?

• 1 packet of Relyvrio was added to a cup (8 ounces) of room temperature water and stirred well.
• Relyvrio was taken by mouth or through a feeding tube within 1 hour of preparation before a snack or meal.

Dosage information

Usual Adult Dose for Amyotrophic Lateral Sclerosis

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

Relyvrio side effects

Relyvrio could 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.

What were the ingredients in Relyvrio?

Active ingredients: sodium phenylbutyrate, taurursodiol
Inactive ingredients: acacia, dibasic sodium phosphate maltodextrin, medium-chain triglycerides, mixed berry flavoring, other flavoring ingredients, silicon dioxide, sodium stearyl fumarate, sorbitol, and sucralose.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer