CROFELEMER

Other

Brand names: MYTESI

Oral

Mechanism of Action

12.1 Mechanism of Action Crofelemer is an inhibitor of both the cyclic adenosine monophosphate (cAMP)-stimulated cystic fibrosis transmembrane conductance regulator (CFTR) chloride ion (Cl¯) channel, and the calcium-activated Cl¯ channels (CaCC) at the luminal membrane of enterocytes. The CFTR Cl¯ channel and CaCC regulate Cl¯ and fluid secretion by intestinal epithelial cells. Crofelemer acts by blocking Cl¯ secretion and accompanying high volume water loss in diarrhea, normalizing the flow of Cl¯ and water in the gastrointestinal tract.

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS None. None ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Risks of Treatment in Patients with Infectious Diarrhea : Consider infectious etiologies of diarrhea before starting treatment to reduce the risk of inappropriate therapy and worsening disease
1 Risks of Treatment in Patients with Infectious Diarrhea Before starting MYTESI, rule out infectious etiologies of diarrhea
If infectious etiologies are not considered, and MYTESI is initiated based on a presumptive diagnosis of non-infectious diarrhea, then there is a risk that patients with infectious etiologies will not receive the appropriate treatments, and their disease may worsen

Known Side Effects

7 documented side effects by frequency

Drug Not Working

>10%

Diarrhea

1-10%

Anxiety

1-10%

Fatigue

0.1-1%

Constipation

0.1-1%

Depression

0.1-1%

Dizziness

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral