relyvrio
sodium phenylbutyrate · by amylyx
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Overview
Sodium Phenylbutyrate Tablets, USP for oral administration contain sodium phenylbutyrate, USP. Sodium phenylbutyrate is a white to yellowish-white powder which is freely soluble in water and has a strong salty taste. Sodium phenylbutyrate also is freely soluble in methanol, sparingly soluble in ethanol and practically insoluble in methylene chloride, acetone and diethyl ether. It is known chemically as 4-phenylbutyric acid, sodium salt with a molecular weight of 186.18 g/mol and the molecular formula C 10 H 11 O 2 Na. Chemical Structure: Each tablet of sodium phenylbutyrate tablets, USP contains 500 mg of sodium phenylbutyrate, USP and the inactive ingredients calcium stearate, colloidal silicon dioxide, magnesium stearate and microcrystalline cellulose. FDA approved dissolution specifications differs from the USP. structure
How to use
For oral use only. The use of sodium phenylbutyrate tablets is indicated for children weighing more than 20 kg and for adults. The usual total daily dose of sodium phenylbutyrate tablets for patients with urea cycle disorders is 450 to 600 mg/kg/day in patients weighing less than 20 kg, or 9.9 to 13.0 g/m 2 /day in larger patients. The tablets is to be taken in equally divided amounts with each meal or feeding (i.e., three to six times per day). The safety or efficacy of doses in excess of 20 grams (40 tablets) per day has not been established.
Side effects
The assessment of clinical adverse events came from 206 patients treated with sodium phenylbutyrate. Adverse events (both clinical and laboratory) were not collected systematically in these patients, but were obtained from patient visit reports by the 65 co-investigators. Causality of adverse effects is sometimes difficult to determine in this patient population because they may result from either the underlying disease, the patient’s restricted diet, intercurrent illness, or sodium phenylbutyrate. Furthermore, the rates may be underestimated because they were reported primarily by parent or guardian and not the patient. Clinical Adverse Events In female patients, the most common clinical adverse event reported was amenorrhea/menstrual dysfunction (irregular menstrual cycles), which occurred in 23% of the menstruating patients. Decreased appetite occurred in 4% of all patients. Body odor (probably caused by the metabolite, phenylacetate) and bad taste or taste aversion were each reported in 3% of patients. Other adverse events reported in 2% or fewer patients were: Gastrointestinal : abdominal pain, gastritis, nausea and vomiting; constipation, rectal bleeding, peptic ulcer disease, and pancreatitis each occurred in one patient. Hematologic : aplastic anemia and ecchymoses each occurred in one patient. Cardiovascular : arrhythmia and edema each occurred in one patient. Renal :…
Warnings
Important safety information
Each sodium phenylbutyrate tablet contains 62 mg of sodium (9.2% w/w) (corresponding to 124 mg of sodium per gram of sodium phenylbutyrate [12.4% w/w]). Sodium phenylbutyrate should be used with great care, if at all, in patients with congestive heart failure or severe renal insufficiency, and in clinical states in which there is sodium retention with edema. Because sodium phenylbutyrate is metabolized in the liver and kidney, and phenylacetylglutamine is primarily excreted by the kidney, use caution when administering the drug to patients with hepatic or renal insufficiency or inborn errors of beta oxidation. Probenecid is known to inhibit the renal transport of many organic compounds, including hippuric acid, and may affect renal excretion of the conjugated product of sodium phenylbutyrate as well as its metabolite. Use of corticosteroids may cause the breakdown of body protein and increase plasma ammonia levels.
May treat
Dosage forms
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Frequently asked questions
- What is Relyvrio?
- Sodium Phenylbutyrate Tablets, USP for oral administration contain sodium phenylbutyrate, USP. Sodium phenylbutyrate is a white to yellowish-white powder which is freely soluble in water and has a strong salty taste. Sodium phenylbutyrate also is freely soluble in methanol, sparingly soluble in ethanol and practically insoluble in methylene chloride, acetone and diethyl ether. It is known chemically as 4-phenylbutyric acid, sodium salt with a molecular weight of 186.18 g/mol and the molecular formula C 10 H 11 O 2 Na. Chemical Structure: Each tablet of sodium phenylbutyrate tablets, USP contains 500 mg of sodium phenylbutyrate, USP and the inactive ingredients calcium stearate, colloidal silicon dioxide, magnesium stearate and microcrystalline cellulose. FDA approved dissolution specifications differs from the USP. structure
- What does Relyvrio treat?
- Relyvrio (Sodium Phenylbutyrate) is indicated for anemia, sickle cell, cystic fibrosis, myeloproliferative disorders, beta-thalassemia, per its drug-label indications. This is general reference, not medical advice.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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