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| Hello, |
| I am pleased to inform you that RELYVRIO™ (sodium phenylbutyrate and taurursodiol), previously known as AMX0035, is FDA approved for the treatment of amyotrophic lateral sclerosis (ALS) in adults.1 RELYVRIO is an oral fixed-dose combination treatment for adults living with ALS shown to help slow the loss of physical function.1 |
| To learn more, please see the full Prescribing Information and RELYVRIO-HCP.com. |
| RELYVRIO Packaging Configurations1 |
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| Carton of 7 single-dose packets |
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7 |
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73063-0035-04* |
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$1,563.03 |
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| Carton of 56 single-dose packets, contained in 4 boxes with 14 single-dose packets per box |
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56 |
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73063-0035-03* |
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$12,504.24 |
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| * |
NDCs displayed as 11-digit codes. To convert a 10-digit code in the 5-3-2 format to 11 digits, a zero is added to the beginning of the second segment. |
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| NDC=National Drug Code; WAC=wholesale acquisition cost. |
| RELYVRIO is available from a limited distribution network of specialty pharmacies. |
| Specialty Pharmacy Distribution Network |
| SPECIALTY PHARMACY |
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CONTACT INFORMATION |
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For more information on RELYVRIO, you can visit
RELYVRIO-HCP.com. You can also email Strategic_Accounts@amylyx.com to contact us or to request more information. |
| Please see full Prescribing Information and Important Safety Information immediately below. |
| INDICATION |
| RELYVRIO is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults. |
| 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. |
| Please see full Prescribing Information for RELYVRIO. |
| If you would like to receive additional information or schedule a meeting to discuss RELYVRIO, please email Strategic_Accounts@amylyx.com. |
Sincerely,
The Amylyx Team |
References: 1. RELYVRIO Prescribing Information. Amylyx Pharmaceuticals, Inc; 2022.
2. Micromedex® RED BOOK® online. Accessed October 10, 2022.
https://www.micromedexsolutions. com/micromedex2/librarian/CS/85E71A/ND_PR/ evidencexpert/ND_P/evidencexpert/DUPLICATIONSHIELDSYNC/9DDC58/ND_PG/ evidencexpert/ND_B/evidencexpert/ND_AppProduct/evidencexpert/ND_T/evidencexpert/ PFActionId/redbook.ShowProductSearchResults?SearchTerm=RELYVRIO&searchType= redbookProduct Name&searchTermId=53475&searchContent=REDBOOK&searchFilterAD= filterADActive&searchFilterRepackager=filterExclude Repackager&searchPattern= %5Erelyvrio |
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| AMYLYX, the Amylyx logo, and all related names, logos, product and service names, designs, and slogans are trademarks of Amylyx or its affiliates or licensors. You must not use such marks without the prior written permission of Amylyx. RELYVRIO is a trademark of Amylyx Pharmaceuticals, Inc. |
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| © 2022 Amylyx Pharmaceuticals, Inc. All rights reserved. PM-00072 10/22 |
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