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Fulyzaq ™ - Crofelemer

Fulyzaq ™ - Crofelemer. Manufacturer: Salix Pharmaceuticals, Inc. FDA Approval Date: 01/02/2013. Fulyzaq ™ - Crofelemer Clinical Application. Indications: Symptomatic relief of non-infectious diarrhea in patients with HIV/AIDS on anti-retroviral therapy Place in therapy:

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Fulyzaq ™ - Crofelemer

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  1. Fulyzaq™ - Crofelemer Manufacturer: Salix Pharmaceuticals, Inc. FDA Approval Date: 01/02/2013

  2. Fulyzaq™ - CrofelemerClinical Application • Indications: • Symptomatic relief of non-infectious diarrhea in patients with HIV/AIDS on anti-retroviral therapy • Place in therapy: • HIV/AIDS patients on anti-retroviral therapy who suffer from associated diarrhea

  3. Fulyzaq™ - CrofelemerClinical Application • Contraindications: • None • Warnings (and Black Box warnings) • None • Precautions • Rule out infectious etiologies of diarrhea prior to initiating Fulyzaq.

  4. Fulyzaq™ - CrofelemerClinical Application • Pregnancy: • C • Lactation: • Excretion in breast milk is unknown – use caution

  5. Fulyzaq™ - CrofelemerDrug Facts • Pharmacology: • Inhibitor of both cyclic adenosine monophosphate (cAMP)-stimulated cystic fibrosis transmembrane conductance regulator (CFTR) chloride ion channel, as well as the calcium-activated chloride ion channels (CaCC) at the luminal membrane of enterocytes • Blocks chloride secretion and accompanying high volume water loss in diarrhea, normalizing the flow of chloride and water in the GI tract

  6. Fulyzaq™ - CrofelemerDrug Facts • Pharmacokinetics: • A – Minimal absorption (plasma levels < 50 ng/mL) • D – Not yet determined • M – No metabolites identified • E – Not yet identified

  7. Fulyzaq™ - CrofelemerDrug Interactions • Drug Interactions – Object Drugs: • Lamivudine (20%) • Not clinically important • Drug Interactions – Precipitant Drugs: • No known

  8. Fulyzaq™ - CrofelemerAdverse Effects • Common Adverse Effects:

  9. Fulyzaq™ - CrofelemerMonitoring Parameters • Efficacy Monitoring: • Reduction in number of loose stools • Quality of life improvement • Toxicity Monitoring: • No reported experience with overdosage – minimal systemic absorption

  10. Fulyzaq™ - CrofelemerPrescription Information • Dosing: • 125 mg delayed release tablet taken twice daily, with or without food • Cost: • Not available

  11. Fulyzaq™ - CrofelemerLiterature Review: ADVENT Trial: Crofelemer for the Treatment of Secretory Diarrhea in HIV+ Individuals MacArthur R et al. Poster presented at: 19th Conference on Retroviruses and Opportunistic Infections; 2012 March 5-8; Seattle, WA.

  12. Fulyzaq™ - CrofelemerLiterature Review: • Objective: • Assess the safety and efficacy of crofelemer for chronic treatment of secretory diarrhea in HIV+ patients • Study Design: • Double blind, placebo controlled, multicenter, multistage MacArthur R et al. Poster presented at: 19th Conference on Retroviruses and Opportunistic Infections; 2012 March 5-8; Seattle, WA.

  13. Fulyzaq™ - CrofelemerLiterature Review: • Intervention: MacArthur R et al. Poster presented at: 19th Conference on Retroviruses and Opportunistic Infections; 2012 March 5-8; Seattle, WA.

  14. Fulyzaq™ - CrofelemerLiterature Review: • Inclusion: • 347 HIV+ patients on stable anti-retroviral therapy with a history of diarrhea for > 1 month • Exclusion: • Positive GI biopsy, GI culture, or stool test for multiple bacteria, bacterial toxin, ova and parasites, or viruses • History of ulcerative colitis, Crohn’s disease, celiac sprue, chronic pancreatitis, malabsorption, or any other GI disease associated with diarrhea MacArthur R et al. Poster presented at: 19th Conference on Retroviruses and Opportunistic Infections; 2012 March 5-8; Seattle, WA.

  15. Fulyzaq™ - CrofelemerLiterature Review: • Primary Endpoint: • Proportion of patients with a clinical response, defined as < 2 watery bowel movements per week during at least 2 of the 4 weeks of the placebo controlled phase MacArthur R et al. Poster presented at: 19th Conference on Retroviruses and Opportunistic Infections; 2012 March 5-8; Seattle, WA.

  16. Fulyzaq™ - CrofelemerLiterature Review: • Results: MacArthur R et al. Poster presented at: 19th Conference on Retroviruses and Opportunistic Infections; 2012 March 5-8; Seattle, WA.

  17. Fulyzaq™ - CrofelemerLiterature Review: • Adverse Events: MacArthur R et al. Poster presented at: 19th Conference on Retroviruses and Opportunistic Infections; 2012 March 5-8; Seattle, WA.

  18. Fulyzaq™ - CrofelemerLiterature Review: • Conclusions: • Crofelemer 125 mg twice daily effectively reduced secretory diarrhea in HIV+ subjects and had a safety profile similar to placebo MacArthur R et al. Poster presented at: 19th Conference on Retroviruses and Opportunistic Infections; 2012 March 5-8; Seattle, WA.

  19. Fulyzaq™ - CrofelemerSummary • Fulyzaq, crofelemer, is a first in class anti-diarrheal approved for the symptomatic relief of non-infectious diarrhea in adult pts with HIV/AIDS on anti-retroviral tx • Crofelemer acts by inhibiting both the CFTR chloride ion channel and the calcium-activated chloride ion channels (CaCC), resulting in normalized flow of chloride and water in the GI tract • Initial and max dosing of crofelemer is 125mg twice daily • No dose modifications are recommended with respect to CD4 cell count and HIV viral load • Lack of anti-motility properties could allow for future use in other patient populations, such as pediatrics

  20. Fulyzaq™ - CrofelemerReferences • http://www.fulyzaq.com/ • Fulyzaq (crofelemer) package insert. Salix Pharmaceuticals, Inc. Dec. 2012. • MacArthur R et al. Poster presented at: 19th Conference on Retroviruses and Opportunistic Infections; 2012 March 5-8; Seattle, WA.

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