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RELYVRIO™ Logo
RELYVRIO™ Logo

Slow functional decline.
Help extend independence.1

RELYVRIOTM is an FDA-approved, oral fixed-dose combination treatment for adults living with amyotrophic lateral sclerosis (ALS), shown to help slow the loss of physical function, which may help extend independence.1

RELYVRIOTM is an FDA-approved, oral fixed-dose combination treatment for adults living with amyotrophic lateral sclerosis (ALS), shown to help slow the loss of physical function, which may help extend independence.1

Mean als functional rating
scale-revised score was

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2.32

POINTS higher
vs placebo (P=0.034; 95% CI: 0.18-4.47)

at the end of the 6-month randomized phase.1

See the Data

Each point decrease on the ALSFRS-R represents lost capability in performing activities fundamental to daily life.2

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BULBAR

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GROSS MOTOR

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FINE MOTOR

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RESPIRATORY

Gwen
Diagnosed with ALS

Rachel, living with ALS

SLOW DISEASE
PROGRESSION

RELYVRIO is an FDA-approved, oral fixed-dose combination treatment for adults living with ALS shown to help slow the loss of physical function.1

Explore Efficacy
Renee, living with ALS

GENERALLY
WELL-TOLERATED

The most common adverse reactions with RELYVRIO were diarrhea, abdominal pain, nausea, and upper respiratory tract infection.1

See Safety Data
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Personalized
Support

The Amylyx Care Team (ACT)TM provides resources to help support the care of people living with ALS as they start and continue on RELYVRIO.

Learn More About ACT

Setting Expectations

Before initiating therapy, it’s important to let patients know what to expect about topics like efficacy, safety, dosing, and more.

Learn More

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Risk in Patients With Enterohepatic Circulation Disorders, Pancreatic Disorders, or Intestinal Disorders

RELYVRIO contains taurursodiol, which is a bile acid. In patients with disorders that interfere with bile acid circulation, there may be an increased risk for worsening diarrhea, and patients should be monitored appropriately for this adverse reaction. Pancreatic insufficiency, intestinal malabsorption, or intestinal diseases that may alter the concentration of bile acids may also lead to decreased absorption of either of the components of RELYVRIO. Because different enterohepatic circulation, pancreatic, and intestinal disorders have varying degrees of severity, consider consulting with a specialist. Patients with disorders of enterohepatic circulation (eg, biliary infection, active cholecystitis), severe pancreatic disorders (eg, pancreatitis), and intestinal disorders that may alter concentrations of bile acids (eg, ileal resection, regional ileitis) were excluded from the study; therefore, there is no clinical experience in these conditions.

Use in Patients Sensitive to High Sodium Intake

RELYVRIO has a high salt content. Each initial daily dosage of 1 packet contains 464 mg of sodium; each maintenance dosage of 2 packets daily contains 928 mg of sodium. In patients sensitive to salt intake (eg, those with heart failure, hypertension, or renal impairment), consider the amount of daily sodium intake in each dose of RELYVRIO and monitor appropriately.

CONTRAINDICATIONS

None.

ADVERSE REACTIONS

The most common adverse reactions (at least 15% and at least 5% greater than placebo) with RELYVRIO were diarrhea, abdominal pain, nausea, and upper respiratory tract infection. Gastrointestinal-related adverse reactions occurred throughout the study but were more frequent during the first 3 weeks of treatment.

You may report side effects to FDA at 1-800-FDA-1088.

INDICATION

RELYVRIO is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults.

For more information about RELYVRIO, please see the full Prescribing Information.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Risk in Patients With Enterohepatic Circulation Disorders, Pancreatic Disorders, or Intestinal Disorders

RELYVRIO contains taurursodiol, which is a bile acid. In patients with disorders that interfere with bile acid circulation, there may be an increased risk for worsening diarrhea, and patients should be monitored appropriately for this adverse reaction. Pancreatic insufficiency, intestinal malabsorption, or intestinal diseases that may alter the concentration of bile acids may also lead to decreased absorption of either of the components of RELYVRIO. Because different enterohepatic circulation, pancreatic, and intestinal disorders have varying degrees of severity, consider consulting with a specialist. Patients with disorders of enterohepatic circulation (eg, biliary infection, active cholecystitis), severe pancreatic disorders (eg, pancreatitis), and intestinal disorders that may alter concentrations of bile acids (eg, ileal resection, regional ileitis) were excluded from the study; therefore, there is no clinical experience in these conditions.

Use in Patients Sensitive to High Sodium Intake

RELYVRIO has a high salt content. Each initial daily dosage of 1 packet contains 464 mg of sodium; each maintenance dosage of 2 packets daily contains 928 mg of sodium. In patients sensitive to salt intake (eg, those with heart failure, hypertension, or renal impairment), consider the amount of daily sodium intake in each dose of RELYVRIO and monitor appropriately.

CONTRAINDICATIONS

None.

ADVERSE REACTIONS

The most common adverse reactions (at least 15% and at least 5% greater than placebo) with RELYVRIO were diarrhea, abdominal pain, nausea, and upper respiratory tract infection. Gastrointestinal-related adverse reactions occurred throughout the study but were more frequent during the first 3 weeks of treatment.

You may report side effects to FDA at 1-800-FDA-1088.

INDICATION

RELYVRIO is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults.

For more information about RELYVRIO, please see the full Prescribing Information.

References: 1. RELYVRIO. Package insert. Amylyx Pharmaceuticals Inc; 2022. 2. Cedarbaum JM, Stambler N, Malta E, et al. The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. BDNF ALS Study Group (Phase III). J Neurol Sci. 1999;169(1-2):13-21. doi:10.1016/s0022-510x(99)00210-5