crofelemer (Rx)

Brand and Other Names:Mytesi
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet, delayed-release

  • 125mg
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Noninfectious Diarrhea

Antidiarrheal indicated for noninfectious diarrhea in patients with HIV/AIDS on antiretroviral therapy

125 mg PO BID

Short Bowel Syndrome (Orphan)

Orphan designation for treatment of short bowel syndrome

Sponsor

  • Napo Pharmaceuticals, Inc; 201 Mission Street, Suite 2375; San Francisco, California 94105

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

and crofelemer

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Upper respiratory tract infection (5.7%)

            Bronchitis (3.9%)

            Cough (3.5%)

            Flatulence (3.1%)

            Increased bilirubin (3.1%)

            Nausea (2.6%)

            Back pain (2.6%)

            Arthralgia (2.6%)

            Urinary tract infection (2.2%)

            Nasopharyngitis (2.2%)

            Musculoskeletal pain (2.2%)

            Hemorrhoids (2.2%)

            Giardiasis (2.2%)

            Anxiety (2.2%)

            Increased ALT (2.2%)

            Abdominal distension (2.2%)

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            Warnings

            Contraindications

            None

            Cautions

            Not indicated for infectious diarrhea; before initiating, rule out infectious etiologies of diarrhea

            If initiated based on a presumptive diagnosis of noninfectious diarrhea, then there is a risk that patients with infectious etiologies will not receive the appropriate treatments, and their disease may worsen

            In vitro studies have shown that crofelemer has the potential to inhibit CYP3A4 and transporters MRP2 and OATP1A2 at concentrations expected in the gut; unlikely to inhibit systemically because minimally absorbed

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            Pregnancy & Lactation

            Pregnancy Category: C Lactation: Unknown whether distributed in human breast milk

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Botanical substance derived from the red latex of Croton lechleri Müll. Arg. (Euphorbiaceae)

            Inhibitor of both 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; CFTR Cl channel and CaCC regulate Cl and fluid secretion by intestinal epithelial cells

            Acts by blocking Cl secretion and accompanying high volume water loss in diarrhea, normalizing the flow of Cl and water in the GI tract

            Pharmacokinetics

            Absorption: Minimal; below the level of quantitation (ie, 50 ng/mL)

            Distribution: Not determined

            Metabolism: No metabolites identified

            Elimination: Not identified

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            Administration

            Oral Administration

            May take with or without food

            Swallow tablet whole; do not crush, chew, or dissolve

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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