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RELYVRIO™ was generally well-tolerated in the CENTAUR trial1

ADVERSE REACTIONS REPORTED IN >5% OF RELYVRIO-TREATED PARTICIPANTS WITH ALS AND AT LEAST 5% GREATER THAN PLACEBO1*

Adverse Reaction

RELYVRIO
n=89
(%)

PLACEBO
n=48
(%)

Diarrhea

25

19

Abdominal pain

21

13

Nausea

18

13

Upper respiratory tract infection

18

10

Fatigue

12

6

Salivary hypersecretion

11

2

Dizziness

10

4

*Study 1 is the CENTAUR trial.

Adverse reaction is composed of several similar terms.

  • In the CENTAUR trial, 6% of participants taking RELYVRIO and 4% of participants taking placebo died during the 24-week study, which appeared to be related to ALS disease progression1

Incidence of Gastrointestinal (GI) Adverse Events by Study Week2,3

Chart of GI-related adverse events during the study

Originally randomized to placebo + SOC (n=48)

Originally randomized to RELYVRIO + SOC (n=89)

GI-related AEs occurred throughout the study, but were more frequent during the first 3 weeks of treatment.

GI-related AEs occurred throughout the study, but were more frequent during the first 3 weeks of treatment.

Chart of GI-related adverse events during the study

Originally randomized to placebo + SOC (n=48)

Originally randomized to RELYVRIO + SOC (n=89)

  • The most common GI events reported in the RELYVRIO + SOC group were nausea, diarrhea, and abdominal pain1
  • GI-related AEs occurred throughout the study and generally decreased to the same level as placebo for the rest of the trial4

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(opens a PDF document in a new window).

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(opens a PDF document in a new window).

References: 1. RELYVRIO. Package insert. Amylyx Pharmaceuticals Inc; 2022. 2. 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 3. Data on file. Amylyx Pharmaceuticals, Inc. 4. Paganoni S, Macklin EA, Hendrix S, et al. Trial of sodium phenylbutyrate-taurursodiol for amyotrophic lateral sclerosis. N Engl J Med. 2020;383(10):919-930. doi:10.1056/NEJMoa1916945