Version October 2024
Diarrhea, HIV/AIDS-related (receiving antiretroviral therapy) (alternative agent): Note: For use in patients with persistent symptoms despite treatment with antimotility agents (eg, loperamide, diphenoxylate/atropine) (Ref). Before starting treatment, rule out infectious etiologies of diarrhea.
Oral: 125 mg twice daily.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Central nervous system: Anxiety (2%), depression (1% to 2%), dizziness (1% to 2%)
Dermatologic: Acne vulgaris (1% to 2%), dermatitis (1% to 2%)
Gastrointestinal: Flatulence (3%), nausea (3%), abdominal distention (2%), giardiasis (2%), hemorrhoids (2%), abdominal pain (1% to 2%), constipation (1% to 2%), dyspepsia (1% to 2%), gastroenteritis (1% to 2%), xerostomia (1% to 2%)
Genitourinary: Urinary tract infection (2%), pollakiuria (1% to 2%)
Hematologic & oncologic: Decreased white blood cell count (1% to 2%)
Hepatic: Increased serum bilirubin (3%), increased serum ALT (2%), increased direct serum bilirubin (1% to 2%), increased indirect serum bilirubin (1% to 2%), increased serum AST (1% to 2%)
Infection: Herpes zoster (1% to 2%)
Neuromuscular & skeletal: Arthralgia (3%), back pain (3%), musculoskeletal pain (2%), limb pain (1% to 2%)
Renal: Nephrolithiasis (1% to 2%)
Respiratory: Upper respiratory tract infection (6%), bronchitis (4%), cough (4%), nasopharyngitis (2%), sinusitis (1% to 2%)
There are no contraindications listed in the manufacturer's labeling.
Disease-related concerns:
• HIV/AIDS: CD4 cell count and viral load do not have a clinical impact on crofelemer treatment; no adjustments are necessary based on CD4 cell count or viral load.
• Infectious diarrhea: Crofelemer is not indicated for infectious diarrhea; there is a risk of inadequate or delayed treatment if used when infectious diarrhea is present. Rule out infectious causes for diarrhea prior to initiating treatment.
Fulyzaq has been renamed to Mytesi as of September 2016. Product strengths and formulations remain the same.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet Delayed Release, Oral:
Mytesi: 125 mg [contains methylparaben, propylparaben]
No
Tablet, EC (Mytesi Oral)
125 mg (per each): $49.63
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral:
May administer without regard to food. Swallow whole; do not crush or chew.
Bariatric surgery: Tablet, delayed release: Refer to institutional protocols as appropriate.
Diarrhea, HIV/AIDs-related (receiving antiretroviral therapy): Symptomatic relief of noninfectious diarrhea in patients with HIV/AIDS on antiretroviral therapy
Crofelemer may be confused with sevelamer
None known.
There are no known significant interactions.
Systemic absorption following oral administration is limited; use during pregnancy is not expected to result in fetal exposure.
It is not known if crofelemer is present in breast milk; however, systemic absorption following oral administration is limited.
Crofelemer is approved for use in persons with HIV infection. Due to the risk of HIV transmission, breastfeeding is not recommended.
Inhibits cyclic adenosine monophosphate (cAMP)-stimulated cystic fibrosis transmembrane conductance regulator (CFTR) chloride ion channel and calcium activated chloride ion channels at the enterocyte luminal membrane. This regulates fluid secretion and water loss (high volume) due to diarrhea, normalizing chloride ion and water flow in the GI tract.
Absorption: Minimal systemic absorption
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