When you enroll a patient in the Amylyx Care Team (ACT)TM Support Program, you have prescribed them RELYVRIOTM (sodium phenylbutyrate and taurursodiol) and are helping them receive personalized support throughout their treatment journey.
ACT team members will work alongside you and your practice to help provide support throughout the treatment process for patients and their caregivers.
ACT Care Coordinator
*Out-of-pocket costs related to medication, appointments, evaluations, testing, or other related services are not covered by the RELYVRIO Co-Pay Program. The RELYVRIO Co-Pay Program is not available for prescriptions purchased under Medicare, Medicaid, TRICARE, or other federal- and state-funded programs. Amylyx reserves the right to amend or terminate the Program at any time without notice. Co-pay amounts after applying co-pay assistance may depend on the patient’s insurance plan and may vary. The RELYVRIO Co-Pay Program is intended to help patients afford RELYVRIO.
Use this form to get your patients started with RELYVRIO and enrolled in ACT.
See the guide to the RELYVRIO Enrollment Form below to learn how to complete the form.
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Helpful tips on how to complete the RELYVRIO Enrollment Form and get your patients started.
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Use this template to help you write a letter of appeal to reviewers on behalf of your patient.
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Use this template to help you write a letter of medical necessity on behalf of your patient, including a summary of the patient’s history and rationale for treatment.
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Learn more about how ACT works with you to support patients.
DownloadWARNINGS 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.
RELYVRIO is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults.
For more information about RELYVRIO, please see the full Prescribing Information.
We can provide you with educational resources and the RELYVRIO Enrollment Form to get your patients started on RELYVRIO and enrolled in the ACT Support Program.
Let them know they will receive personalized support as they start and continue on RELYVRIO.
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.
RELYVRIO is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults.
For more information about RELYVRIO, please see the full Prescribing Information.
Reference: 1. RELYVRIO. Package insert. Amylyx Pharmaceuticals Inc; 2022.
