Relyvrio (sodium phenylbutyrate/taurursodiol)
Amyotrophic Lateral Sclerosis Agents - Others Oral Powder In Packet (Ea)
Last reviewed · Source: First Databank (FDB) drug data
Overview
USES: This medication is used to treat a certain type of nerve disease called amyotrophic lateral sclerosis (ALS, also commonly called Lou Gehrig's disease). This medication contains 2 drugs: sodium phenylbutyrate and taurursodiol (also known as ursodoxicoltaurine). It helps slow down loss of physical function due to this disease.
However, it is not a cure for ALS, and it does not reverse nerve damage or muscle weakness.
Generic name: sodium phenylbutyrate/taurursodiol
Pronunciation: (SOE-dee-um FEN-il-BUE-ti-rate/taur-UR-so-DYE-ol)
Drug class: Amyotrophic Lateral Sclerosis Agents - Others
Therapeutic class: Locomotor System
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Relyvrio
Indications
The following indications are listed for Relyvrio:
- Amyotrophic Lateral Sclerosis
Dosing
No dosing information is available for this tab.
No dosing information is available for this tab.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Relyvrio 3 Gm-1 Gm Powder Pkt | Maintenance | Take 1 packet by oral route 2 times per day mixed in 8 ounces of roomtemperature water, stir vigorously, and take within 1 hour. |
No dosing information is available for this tab.
Drug interactions
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Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
Sodium Phenylbutyrate-Taurursodiol/Hdac Inhibitors
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: The mechanism of the increased gastrointestinal (GI) adverse effects with concurrent sodium phenylbutyrate-taurursodiol (sodium phenylbutyrate-ursodoxicoltaurine) and other HDAC inhibitors is not known. Phenylbutyrate is a pan-histone deacetylase (HDAC) inhibitor.(1,2)
CLINICAL EFFECTS: Concurrent use of sodium phenylbutyrate-taurursodiol (sodium phenylbutyrate-ursodoxicoltaurine) and another HDAC inhibitor may result in GI adverse effects including nausea and vomiting.
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The US manufacturer recommends avoiding use of other HDAC inhibitors in patients taking sodium phenylbutyrate-taurursodiol (sodium phenylbutyrate-ursodoxicoltaurine).(1) The CA manufacturer states sodium phenylbutyrate-taurursodiol should not be coadministered wiht other HDAC inhibitors.(2)
DISCUSSION: Concurrent use of sodium phenylbutyrate-taurursodiol (sodium phenylbutyrate-ursodoxicoltaurine) and another HDAC inhibitor may result in increased GI adverse effects.(1,2) HDAC inhibitors include: belinostat, panobinostat, phenylbutyrate, romidepsin, sodium butyrate, and valproic acid.
Sodium Phenylbutyrate-Taurursodiol/Oat3 Inhibitors
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: Inhibitors of organic anion transporter 3 (OAT3) may inhibit the renal elimination of conjugated sodium phenylbutyrate and sodium phenylbutyrate metabolites.(1,2)
CLINICAL EFFECTS: Concurrent use of organic anion transporter 3 (OAT3) inhibitors may result in an increase in both the therapeutic and toxic effects of sodium phenylbutyrate.(1,2)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The US manufacturer of sodium phenylbutyrate-taurursodiol (sodium phenylbutyrate-ursodoxicoltaurine) states that concurrent use with organic anion transporter 3 (OAT3) inhibitors should be avoided.(1) The Canadian manufacturer of sodium phenylbutyrate-taurursodiol states that OAT3 inhibitors should not be used with sodium phenylbutyrate-taurursodiol.(2)
DISCUSSION: Probenecid may inhibit the renal elimination of conjugated sodium phenylbutyrate and sodium phenylbutyrate metabolites.(1,2) OAT3 inhibitors linked to this monograph include: cabotegravir, leflunomide, nitisinone, probenecid, teriflunomide, and vadadustat.(3)
Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
Hdac Inhibitors/Vorinostat
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: The mechanism of the increased thrombocytopenia and gastrointestinal bleeding with concurrent vorinostat and other HDAC inhibitors is not known.
CLINICAL EFFECTS: Concurrent use of vorinostat and another HDAC inhibitor may result in severe thrombocytopenia and gastrointestinal bleeding.
PREDISPOSING FACTORS: The risk for bleeding episodes may be greater in patients with disease-associated factors (e.g. thrombocytopenia). Drug associated risk factors include concurrent use of multiple drugs which inhibit anticoagulant/antiplatelet metabolism and/or have an inherent risk for bleeding (e.g. NSAIDs).
PATIENT MANAGEMENT: The manufacturer recommends close monitoring of patients taking vorinostat with other HDAC inhibitors. The platelet count should be monitored every 2 weeks for the first 2 months.(1) If concurrent therapy is warranted, monitor patients receiving concurrent therapy for signs of blood loss, including decreased hemoglobin, hematocrit, fecal occult blood, and/or decreased blood pressure and promptly evaluate patients with any symptoms. When applicable, perform agent-specific laboratory test (e.g. INR, aPTT) to monitor efficacy and safety of anticoagulation. Discontinue anticoagulation in patients with active pathologic bleeding. Instruct patients to report any signs and symptoms of bleeding, such as unusual bleeding from the gums or nose; unusual bruising; red or black, tarry stools; red, pink or dark brown urine; acute abdominal or joint pain and/or swelling.
DISCUSSION: Concurrent use of vorinostat and another HDAC inhibitor may result in severe thrombocytopenia and gastrointestinal bleeding. The manufacturer recommends monitoring the platelet count every 2 weeks for the first 2 months.(1) HDAC inhibitors include: belinostat, panobinostat, phenylbutyrate, romidepsin, sodium butyrate, and valproic acid.
Sodium Phenylbutyrate-Taurursodiol/Al Antacids;Bile Acid Seq
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: Aluminum-based antacids and bile acid sequestrants (including cholestyramine, colestipol, and colesevelam) may bind to sodium phenylbutyrate-taurursodiol (sodium phenylbutyrate-ursodoxicoltaurine), which may decrease gastrointestinal absorption and impair enterohepatic recirculation of sodium phenylbutyrate-taurursodiol.(1)
CLINICAL EFFECTS: Simultaneous administration of an aluminum-based antacid or bile acid sequestrants (including cholestyramine, colestipol, or colesevelam) may result in decreased absorption and effectiveness of sodium phenylbutyrate-taurursodiol (sodium phenylbutyrate-ursodoxicoltaurine).(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The US manufacturer of sodium phenylbutyrate-taurursodiol (sodium phenylbutyrate-ursodoxicoltaurine) states that concurrent therapy with aluminum-based antacids or bile acid sequestrants should be avoided. Consider alternative acid lowering agents or cholesterol lowering agents in patients taking sodium phenylbutyrate-taurursodiol.(1) The Canadian manufacturer of sodium phenylbutyrate-taurursodiol recommends not using bile acid sequestrants with sodium phenylbutyrate-taurursodiol.(2) The Canadian manufacturer of sodium phenylbutyrate-taurursodiol states that if aluminum-based antacids are required, administer antacids at least 2 hours prior to or 2 hours after the administration of sodium phenylbutyrate-taurursodiol.(2)
DISCUSSION: Aluminum-based antacids have been shown to adsorb bile acids in vitro. Bile acid sequestrants (including cholestyramine, colestipol, or colesevelam) reduce bile acid absorption.(1)
There are no moderate interactions for this drug.
Contraindications
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There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- Cholecystitis
- Chronic heart failure
- Kidney disease with likely reduction in glomerular filtration rate (GFr)
- Malabsorption states
- Pancreatitis
Adverse reactions
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Rare or Very Rare
- Atrial fibrillation
- Atrioventricular block
- Bundle branch block
- Deep venous thrombosis
- Diverticulitis of gastrointestinal tract
- Edema
- Hyperchloremia
- Hypochloremia
- Increased alanine transaminase
- Increased aspartate transaminase
- Intraventricular conduction delay
- Irregular menstrual periods
- Leukocytosis
- Leukopenia
More Frequent
- Acute abdominal pain
- Diarrhea
- Nausea
Less Frequent
- Anorexia
- Body odor
- Constipation
- Depression
- Drowsy
- Dysgeusia
- Fatigue
- Flatulence
- Vomiting
Rare or Very Rare
- Aphthous stomatitis
- Blepharospasm
- Chest pain
- Cough
- Dental discoloration
- Drug-induced hot flash
- Dyspepsia
- Dyspnea
- Flushing
- General weakness
- Headache disorder
- Intestinal hypermotility
- Migraine
- Mood changes
- Muscle fasciculation
- Palpitations
- Pharyngitis
- Polyuria
- Proteinuria
- Sinusitis
- Skin rash
- Tachycardia
- Urinary tract infection
Precautions
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ICD codes
| Code | Type | Description |
|---|---|---|
| Amyotrophic lateral sclerosis | ||
| G12.21 | ICD10CM | Amyotrophic lateral sclerosis |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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