Fulyzaq

Generic Name: crofelemer
Date of Approval: December 31,2012
Company: Salix Pharmaceuticals, Ltd.

Treatment for: HIV Associated Diarrhea

FDA Approves Fulyzaq

The U.S. Food and Drug Administration has approved Fulyzaq (crofelemer) 125 mg delayed-release tablets for the symptomatic relief of non-infectious diarrhea in adult patients with human immunodeficiency virus (HIV)/ acquired immune deficiency syndrome (AIDS) on anti-retroviral therapy (ART).

Important Safety Information for Fulyzaq

Fulyzaq (crofelemer) delayed-release tablets should not be used for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting crofelemer. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen.

In clinical studies, the most common adverse reactions (occurring in ≥ 3% patients and at a rate greater than placebo) were upper respiratory tract infection, bronchitis, cough, flatulence and increased bilirubin.

About Fulyzaq

Fulyzaq is a first-in-class, gastrointestinal agent derived on a sustainable basis from the Croton lechleri plant, native to northwestern South America. Fulyzaq acts as an anti-secretory, anti-diarrheal agent that works locally in the GI lumen and exhibits minimal systemic absorption. At the recommended dose of one 125 mg delayed-release tablet taken orally, twice daily, Fulyzaq works to inhibit both the cyclic adenosine monophosphate (cAMP)-stimulated cystic fibrosis transmembrane conductance regulator (CFTR) chloride ion (C1-) channel, and the calcium-activated C1- channels (CaCC).

Inhibiting CFTR and CaCC reduces the secretion of chloride ions, along with the water that enables their transport, out of the circulatory system and into the intestinal lumen. The secretion of chloride ions has been shown to cause diarrhea, with the associated symptoms of dehydration, electrolyte imbalance, abdominal cramping, urgency and increased frequency. Unlike other anti-diarrheal agents, Fulyzaq does not appear to affect gut motility.

Highlights of Fulyzaq Prescribing Information

These highlights do not include all the information needed to use Fulyzaq safely and effectively. See full prescribing information for Fulyzaq.

Indications and Usage

Fulyzaq is an anti-diarrheal indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy.

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Dosage and Administration

One 125 mg delayed-release tablet taken orally twice a day, with or without food.

Dosage Forms and Strengths

Delayed-Release Tablets: 125 mg

Contraindications

None.

Warnings and Precautions

Rule out infectious etiologies of diarrhea before starting crofelemer. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen.

Use In Specific Populations

• Pregnancy: Based on animal data, may cause fetal harm
• Pediatric Use: Safety and effectiveness of Fulyzaq has not been established in patients less than 18 years of age

Fulyzaq side effects

Most common adverse reactions (incidence ≥ 3%) are upper respiratory tract infection, bronchitis, cough, flatulence and increased bilirubin.

To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-866-669-7597 or FDA at 1-800- FDA-1088 or www.fda.gov/medwatch

See also: Fulyzaq side effects (in more detail)

Patient Counseling Information

• Instruct patients that Fulyzaq tablets may be taken with or without food.
• Instruct patients that Fulyzaq tablets should not be crushed or chewed. Tablets should be swallowed whole.