crofelemer

(redirected from Fulyzaq)

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 ?
To that end, FDA has approved Fulyzaq (crofelemer), which is derived from the red sap of the Croton lechleri plant, to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection.
The safety and efficacy of Fulyzaq were established in a clinical trial of 374 HIV-positive patients on stable antiretroviral therapy with a history of diarrhea lasting one month or longer.
6% of patients taking Fulyzaq experienced clinical response compared with 8% taking placebo.
FULYZAQ is a locally-acting, minimally-absorbed drug derived from a botanical source.
According to Salix, the jury found that Salix was in compliance with its contractual obligations in commercializing Fulyzaq (crofelemer) in the U.
Its Fulyzaq drug would most likely be just a modest contributor to Salix's pipeline, but the approval brings positivity to the company.
375 g, GIAZO (TM)(balsalazide disodium) tablets, COLAZAL (balsalazide disodium) Capsule, METOZOLV ODT (metoclopramide HCl), RELISTOR (methylnaltrexone bromide) Subcutaneous Injection, FULYZAQ (TM)(crofelemer) delayed-release tablets, SOLESTA, DEFLUX, PEPCID (famotidine) for Oral Suspension, DIURIL (Chlorothiazide) Oral Suspension, AZASAN (Azathioprine) Tablets, USP, 75/100 mg, ANUSOL-HC 2.
According to FDA's press release regarding the approval, "The safety and efficacy of Fulyzaq were established in a clinical trial of 374 HIV-positive patients on stable antiretroviral therapy[ART] with a history of diarrhea lasting one month or longer.
4) According to a Salix press release, the company expects Fulyzaq to be available to patients in early 2013.
FDA approves Fulyzaq (TM)(crofelemer) 125 mg delayed-release tablets for the symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy (ART) [press release].