Safety

General information, not medical advice

Your prescriber and the leaflet in your pack know your situation. This page does not.

  • Follow your prescriber and the leaflet
  • Don't start, stop, or change a dose on your own
  • Doses and warnings differ by country and product
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Relyvrio Powder: Uses, Dosage, Side Effects, Precautions and Alternates

· 4 min read

Relyvrio Powder: Uses, Dosage, Side Effects, Precautions and Alternates
Generic namesodium phenylbutyrate and taurursodiol
Drug classMiscellaneous central nervous system agents
FormsPowder for oral suspension, supplied in single-dose packets
Relyvrio Powder: Uses, Dosage, Side Effects, Precautions and Alternates product

Quick overview

Relyvrio Powder combines sodium phenylbutyrate and taurursodiol, two active ingredients classed as miscellaneous central nervous system agents, to treat amyotrophic lateral sclerosis (ALS) in adults. It was voluntarily removed from the U.S. and Canadian markets in April 2024 after disappointing results from a later clinical trial, though patients already using it could continue through a free drug program. The combination was studied for slowing physical decline and supporting motor neuron health, but this benefit was not confirmed in the later Phase 3 trial.

What is Relyvrio Powder

Relyvrio is a powder medicine that combines two active ingredients, sodium phenylbutyrate and taurursodiol, to treat amyotrophic lateral sclerosis (ALS) in adults. It was voluntarily removed from the U.S. and Canadian markets in April 2024 after disappointing results from a later clinical trial, but patients already using it could continue through a free drug program.

Relyvrio Powder uses

  • Amyotrophic lateral sclerosis (ALS)
  • Treatment studied for slowing physical decline in ALS
  • Support for maintaining muscle function in ALS
  • Support for daily activities in ALS patients
  • Treatment investigated to protect motor neurons

Benefits of Relyvrio Powder

  • Was developed to treat ALS.
  • Was studied for slowing physical decline.
  • Aimed to help maintain daily functioning.
  • Was intended to support motor neuron health.
  • Benefit was not confirmed in the later Phase 3 trial.

How Relyvrio Powder works

Doctors are not exactly sure how Relyvrio works in ALS, but it's thought that its two ingredients together may help protect nerve cells from dying by reducing stress inside the cells and improving how their energy-producing parts function.

Relyvrio Powder dosage

Mix the contents of one packet into a cup of room temperature water and stir well before taking it. Take the mixed dose within one hour of preparing it, either by mouth or through a feeding tube. Take this medicine before a snack or a meal. For the first three weeks, take one packet once a day; after that, take one packet twice a day. Taking it with a high-fat meal can reduce how well your body absorbs part of the medicine, so timing around meals matters. Do not take aluminum-based antacids while using this medicine, as they can interfere with how it is absorbed.

Age groupDose
Under 18 yearsNot recommended
18–64 years3 g + 1 g, once/day
65+ years3 g + 1 g, once/day

Available forms and strengths

  • Powder for oral suspension, supplied in single-dose packets

Side effects of Relyvrio Powder

Common

  • Diarrhea
  • Abdominal pain or discomfort
  • Nausea
  • Upper respiratory tract infection
  • Fatigue
  • Increased saliva production
  • Dizziness

Serious

  • New or worsening diarrhea, especially in people with conditions affecting bile acid circulation, the pancreas, or the intestines
  • Salt (sodium) retention, which can be a concern for people with heart failure, high blood pressure, or kidney problems

Warnings and precautions

  • People with conditions that affect bile acid circulation, the pancreas, or the intestines may be at higher risk for worsening diarrhea on this medicine and may absorb it less well. Talk to a specialist if you have these conditions, and watch for new or worsening diarrhea.
  • This medicine has a high salt (sodium) content. People who need to watch their salt intake, such as those with heart failure, high blood pressure, or kidney problems, should consider the amount of sodium in each dose and be monitored by their doctor.
  • Avoid taking certain other medicines together with this one, including bile acid-binding drugs like cholestyramine, colestipol, or colesevelam, the drug cyclosporine, aluminum-based antacids, probenecid, and certain other specialized drugs, because they can change how well this medicine works or is absorbed.
  • There is no information on whether Relyvrio is safe during pregnancy in humans. 
  • Animal studies raised concerns about harm to offspring, so patients should tell their doctor if they become pregnant or plan to become pregnant while taking this medicine.
  • It isn't known whether this medicine passes into breast milk or how it might affect a nursing baby. Discuss your personal situation with your healthcare provider before breastfeeding while on this medicine.
  • No dose change is needed for mild kidney problems, but this medicine should be avoided in people with moderate or severe kidney impairment.
  • No dose change is needed for mild liver problems, but this medicine should be avoided in people with moderate or severe liver impairment.
  • It isn't known how alcohol interacts with this medicine. Talk to your doctor about drinking alcohol while taking it.

Storage

  • Store at 68°F to 77°F (20°C to 25°C), with short-term changes allowed between 59°F and 86°F (15°C to 30°C)
  • Protect from moisture
  • Once mixed with water, the suspension can be kept for up to 1 hour at room temperature; throw away any unused mixed suspension after 1 hour

When to see a doctor

  • Tell your healthcare provider right away if you develop new or worsening diarrhea while taking this medicine.
  • Tell your healthcare provider about any side effect that bothers you or doesn't go away.
  • Let your doctor know right away if you become pregnant or are planning to become pregnant while taking this medicine.

Alternatives

  • Tofersen
  • Edaravone
  • Riluzole

Watch the video

Video: Relyvrio Powder: Uses, Dosage, Side Effects, Precautions and Alternates

FAQs

What is Relyvrio Powder used for?

Relyvrio Powder was used to treat amyotrophic lateral sclerosis (ALS) in adults. It was studied for slowing physical decline, supporting muscle function and daily activities, and protecting motor neurons.

Is Relyvrio Powder still available?

Relyvrio Powder was voluntarily removed from the U.S. and Canadian markets in April 2024 after disappointing results from a later clinical trial. Patients already using it could continue through a free drug program.

How is Relyvrio Powder taken?

The contents of one packet are mixed into a cup of room temperature water, stirred well, and taken within one hour of preparing it, either by mouth or through a feeding tube, before a snack or meal. For the first three weeks, one packet is taken once a day; after that, one packet is taken twice a day.

What are the common side effects of Relyvrio Powder?

Common side effects include diarrhea, abdominal pain or discomfort, nausea, upper respiratory tract infection, fatigue, increased saliva production, and dizziness.

What precautions should be taken with Relyvrio Powder?

Relyvrio Powder has a high sodium content, so people with heart failure, high blood pressure, or kidney problems should be monitored. It should be avoided in moderate or severe kidney or liver impairment, and aluminum-based antacids should not be taken with it.

General information, not medical advice

Your prescriber and the leaflet in your pack know your situation. This page does not.

  • Follow your prescriber and the leaflet
  • Don't start, stop, or change a dose on your own
  • Doses and warnings differ by country and product
Facts checked by a personSourcesFull disclaimer

Sources

  1. https://www.wikidoc.org/index.php/RELYVRIO
  2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216660s000lbledt.pdf
  3. https://www.drugs.com/relyvrio.html