Diarrhea, HIV/AIDs-related (receiving antiretroviral therapy): Oral: 125 mg twice daily. Note: Before starting treatment, rule out infectious etiologies of diarrhea.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet Delayed Release, Oral:
Mytesi: 125 mg [contains methylparaben, propylparaben]
No
Fulyzaq has been renamed to Mytesi as of September 2016. Product strengths and formulations remain the same.
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
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.
None known.
There are no known significant interactions.
Systemic absorption following oral administration is limited; maternal use 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
Tablet, EC (Mytesi Oral)
125 mg (per each): $47.49
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