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Caprylidene

Pronunciation: kap-RIL-i-deen
Class: Medium chain triglycerides

Trade Names:
Axona
- Powder for oral solution 40 g (20 g of medium-chain triglycerides [MCTs])

Pharmacology

Induces hyperketonemia and provides an alternative energy substrate to glucose in the brains of patients with Alzheimer disease.

Pharmacokinetics

Absorption

After oral administration, caprylidene is processed by lipase in the gut, and the resulting medium-chain fatty acids are absorbed into the portal vein.

Distribution

The ketone body beta-hydroxybutyrate crosses the blood-brain barrier and is then taken up by neurons.

Slideshow: Flashback: FDA Drug Approvals 2013

Metabolism

The medium-chain fatty acids rapidly pass directly to the liver, where they undergo obligate oxidation.

Special Populations

Renal Function Impairment

No clinical studies have been performed in patients with renal insufficiency.

Hepatic Function Impairment

No clinical studies have been performed in patients with hepatic insufficiency.

Children

No clinical studies have been performed in children.

Gender

No significant findings were associated with patient's response by sex.

Race

No significant findings were associated with patient's response by race or ethnicity.

Indications and Usage

For the clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer disease.

Contraindications

Allergy to milk or soy.

Dosage and Administration

Adults

PO 40 g/day (1 packet of caprylidene powder, containing 20 g of MCTs) taken during breakfast.

General Advice

  • The contents of each packet should be added to 4 to 8 oz (118 to 236 mL) of water, as preferred, shaken until fully blended, and consumed immediately.
  • Administer orally once a day during breakfast.
  • Caprylidene is a medical food containing a proprietary formulation of MCTs, specifically caprylic triglyceride.

Storage/Stability

Store at 59° to 86°F, sealed and protected from light and moisture.

Drug Interactions

None well documented.

Adverse Reactions

Cardiovascular

Hypertension (5%).

CNS

Dizziness (7%); headache (6%); fatigue (4%).

GI

Diarrhea (24%); nausea (20%); abdominal distension, flatulence (17%); dyspepsia (9%); abdominal pain (5%).

Genitourinary

Urinary tract infection (5%).

Respiratory

Cough, rhinitis (4%).

Miscellaneous

Pain (4%).

Precautions

Monitor

Periodically monitor triglycerides in patients who meet the criteria indicative of metabolic syndrome.


Children

No clinical studies have been performed in children.

Hypersensitivity

Contains palm or coconut oil, caseinate (milk-derived protein), whey (milk), and lecithin (soy). Do not administer to patients with known allergies to these components.

Elevated triglycerides

Observed in patients with probable metabolic syndrome.

GI conditions

Use with caution in patients with a history of GI inflammatory conditions, such as irritable bowel syndrome, diverticular disease, chronic gastritis, and severe gastroesophageal reflux disease.

Ketoacidosis

Use with caution in patients at risk for ketoacidosis (eg, alcoholism, poorly controlled diabetes).

Renal effects

Mild increases in BUN, uric acid, or creatinine were observed.

Overdosage

Symptoms

Diarrhea.

Patient Information

  • Advise patients that caprylidene is a medical food product distributed by prescription and must be administered under the supervision of a health care provider.
  • Counsel patients that mild GI symptoms (eg, diarrhea, dyspepsia, flatulence, unsettled stomach) may occur. Medications such as simethicone, antacids, and antidiarrheals may be useful.
  • Inform patients to take caprylidene with food.

Copyright © 2009 Wolters Kluwer Health.

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