crofelemer

crofelemer

(kro-fel-e-mer) ,

Fulyzaq

(trade name)

Classification

Therapeutic: antidiarrheals
Pharmacologic: catechins
Pregnancy Category: C

Indications

Symptomatic relief of non-infectious diarrhea in HIV-infected patients currently receiving antiretroviral therapy.

Action

A natural product derived from Croton lechleri, a species of flowering plant.
Inhibits cyclic adenosine monophosphate (cAMP)-stimulated cystic fibrosis transmembrane conductance regulator (CTFR) chloride ion channels and the calcium-activated chloride channels on luminal membranes of enterocytes. Blocks chloride secretion and water loss by inhibiting chloride channels on the membranes of enterocytes.

Therapeutic effects

Decreased incidence and severity of diarrhea.

Pharmacokinetics

Absorption: Minimal absorption following oral administration.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: Unknown.

Time/action profile

ROUTEONSETPEAKDURATION
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Contraindications/Precautions

Contraindicated in: None noted.
Use Cautiously in: Infectious causes of diarrhea (evaluate and treat prior to use); Obstetric: Use during pregnancy only if clearly needed; Lactation: Breast feeding should be avoided by HIV-infected patients; Pediatric: Safe and effective use in children <18 yr has not been established.

Adverse Reactions/Side Effects

Central nervous system

  • anxiety

Ear, Eye, Nose, Throat

  • nasopharyngitis

Respiratory

  • bronchitis
  • cough
  • upper respiratory tract infection

Gastrointestinal

  • abdominal distention
  • flatulence
  • hemorrhoids
  • nausea
  • ↑ liver function tests

Genitourinary

  • urinary tract infection

Musculoskeletal

  • arthralgia
  • back pain
  • muscuoloskeletal pain

Interactions

Drug-Drug interaction

Due to minimal systemic absorption, interactions are unlikely.

Route/Dosage

Oral (Adults) 125 mg twice daily.

Availability

Delayed-release tablets: 125 mg

Nursing implications

Nursing assessment

  • Assess for abdominal distention, presence of bowel sounds, and usual pattern of bowel function.
  • Assess color, consistency, and amount of stool produced.

Potential Nursing Diagnoses

Diarrhea (Indications)

Implementation

  • Oral: Administer tablets twice daily with or without food. Swallow tablets whole; do not crush, break, or chew.

Patient/Family Teaching

  • Instruct patient to take crofelemer as directed.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes

  • Decreased incidence and severity of diarrhea.
References in periodicals archive ?
Napo intends to submit documentation in the first half of 2018 to the FDA for the planned formulation of crofelemer appropriate for feeding tube administration to support this investigation.
Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.
There are four gastrointestinal agents: crofelemer (Fulyzaq; antidiarrheal), linaclotide (Linzess; laxative), teduglutide (Gattex; short bowel syndrome), and the combination of sodium picosulfate, magnesium oxide, and citric acid (Prepopik; osmotic laxative).
The drug, Crofelemer 125 mg, is aimed at treating diarrhoea in patients with HIV/ AIDS and on anti- retroviral therapy.
According to the US Food and Drug Administration (FDA) the agency is to take some more time to review the Salix Pharmaceuticals' new drug application (NDA) for crofelemer 125 mg tablets, which is designed to provide symptomatic relief of non-infectious diarrhea in patients with HIV/AIDS on anti-retroviral therapy.
METOZOLVTM ODT (metoclopramide), crofelemer, budesonide foam and rifaximin for additional indications are under development.
Phase II trials were recently completed in the United States for crofelemer, a derivative obtained from the sap of the South American Croton lechleri tree.
Napo has already signed agreements with several pharmaceutical houses in China, India, and elsewhere to develop crofelemer products that will meet the specific needs of the peoples of those regions.
Napo's proprietary, patented gastrointestinal compound, crofelemer, is a first-in-class anti-secretory agent sustainably harvested from the rainforest.
The active pharmaceutical ingredient in Mytesi is crofelemer, Napo's proprietary, patented gastrointestinal anti-secretory agent sustainably harvested from the rainforest.
Crofelemer, budesonide foam, RELISTOR([R]), Lumacan([R]) and rifaximin for additional indications are under development.