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RELYVRIO™ Logo
RELYVRIO™ Logo

RELYVRIO™ is administered as an oral suspension1

RELYVRIO can be incorporated into the everyday lives of adults living with amyotrophic lateral sclerosis (ALS)1

RECOMMENDED
DOSING SCHEDULE1

RELYVRIO packet

First 3 weeks
1 packet per day1

RELYVRIO packet morning and evening dosing

AFTER 3 weeks
1 packet in the morning and 1 at night

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RELYVRIO MAY BE DOSED BY MOUTH OR FEEDING TUBE1

Preparation: RELYVRIO should be mixed with a cup (250 mL or 8 oz) of room temperature water and stirred vigorously (may require significant stirring or gentle crushing to dissolve) and should be taken or administered within 1 hour of mixing.1

  • Food: RELYVRIO should be taken before a snack or meal.1
  • Concomitant use: RELYVRIO may be taken alone or concomitantly with other therapies FDA-approved for ALS.2*

DOSING ADJUSTMENTS

  • No dose adjustment is needed for patients with mild hepatic or renal impairment
  • Avoid use in patients with moderate or severe hepatic or renal impairment

*Participants in CENTAUR could take riluzole, edaravone, both, or neither as part of standard of care ALS management.2

Before initiating therapy, it’s important to discuss expectations

Looking for a tool to help discuss expectations? Download a helpful resource below.

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OUTCOMES

RELYVRIO has been shown to help slow the loss of physical function. It does not stop the progression of ALS.1

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TOLERABILITY

RELYVRIO is generally well-tolerated. The most common adverse events were diarrhea, abdominal pain, nausea, and upper respiratory tract infection. Gastrointestinal side effects occurred throughout the study but were more frequent during the first 3 weeks of treatment.1

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DOSING

RELYVRIO may be taken alone or with other FDA-approved treatments for ALS.1

RELYVRIO will be available through specialty pharmacies, which can deliver the therapy right to your patient’s home.

  • Since RELYVRIO is a newly approved specialty product, it may take time to get the therapy to your patients. This is a normal part of the process for new specialty products
  • It all starts with submitting an enrollment form to the Amylyx Care Team (ACT)™. ACT will communicate updates to you and your patients to help them get access as soon as possible

MANAGING TASTE:
The taste of RELYVRIO can vary from person to person3

RELYVRIO may have a bitter aftertaste. In the clinical trial, participants were allowed to try to lessen or remove the bitter aftertaste by:

  • Using mint-flavored mouth strips or mouth spray immediately before or after taking RELYVRIO
  • Eating a small snack or honey after taking RELYVRIO
  • Drinking milk after taking RELYVRIO
  • Avoiding drinking fruit juice immediately afterward, as it can make the aftertaste worse
 

Knowing what to expect when starting RELYVRIO can help  
people with ALS along their treatment journey.

Learn about the patient support program and other resources

Access the Resources

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. Paganoni S, Hendrix S, Dickson SP, et al. Long-term survival of participants in the CENTAUR trial of sodium phenylbutyrate-taurursodiol in amyotrophic lateral sclerosis. Muscle Nerve. 2021;63(1):31-39. doi:10.1002/mus.27091 3. Paganoni S, Macklin EA, Hendrix S, et al. Trial of sodium phenylbutyrate-taurursodiol for amyotrophic lateral sclerosis. N Engl J Med. 2020;383(10)(suppl):919-930. Accessed December 13, 2021. https://www.nejm.org/doi/suppl/10.1056/ NEJMoa1916945/suppl_file/nejmoa1916945_appendix.pdf