Axona safety

Axona increases ketone body concentrations to safe but effective levels*1

  • The plasma concentration of β-hydroxybutyrate (BHB) ketone following Axona administration was mild, similar to that seen in the early phases of a low-carbohydrate diet
  • When tested at twice the recommended dose, Axona had no significant effect on:
    • - Total cholesterol
    • - Very low-density lipoprotein (LDL) cholesterol
    • - LDL cholesterol
    • - High-density lipoprotein cholesterol

Plasma concentration of BHB ketone under various conditions1

Intervention
Average BHB levels (mM)
› 12-hour fast
 0.08-0.1
› Axona (20 g; 2 hours postdose)
 0.36
› Low-carbohydrate diet
 0.4-0.65
› Ketogenic diet
 0.3-1.6
› Starvation (5-6 weeks)
 4-8
› Diabetic ketoacidosis
 9-10


Adverse events were generally mild1,2

  • Diarrhea was the most frequently reported adverse event; however, the incidence was reduced when Axona was mixed with a meal replacement drink
  • Gas and nausea were other commonly reported adverse events
  • Discontinuation rates due to any gastrointestinal-related event also declined once the Axona mixer was switched
  • To reduce the chance of gastrointestinal adverse events, Axona should be titrated gradually over 7 days, before patients begin to take one 40 g packet per day

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Axona may be used concurrently with Alzheimer’s drug treatments1

  • Approximately 80% of trial participants took Axona concurrently with one or more approved medications for Alzheimer’s disease
  • Axona may be taken alone or with Alzheimer's disease therapies, including acetylcholinesterase inhibitors and N-methyl-D-aspartic acid receptor antagonists

Learn more about how Axona fits into mild to moderate Alzheimer’s disease management


Axona contains safe ingredients2

  • Axona is manufactured, labeled, and distributed in accordance with strict Food and Drug Administration (FDA) guidelines
  • All ingredients are Generally Recognized As Safe or FDA-approved food additives


Safety information2

  • Axona is a prescription medical food intended for the clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer's disease
  • Axona should be used with caution in patients who are at risk for ketoacidosis, for example, patients with a history of alcohol abuse and poorly controlled diabetics; or those who have a history of inflammation of the gastrointestinal system, metabolic syndrome, and/or renal dysfunction. Axona contains caseinate and whey (dairy), and lecithin (soy). Contains: milk and soy