chenodiol (Rx)

Brand and Other Names:Chenodal
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Dosing & Uses

AdultPediatric

Radiolucent Gallstone Dissolution

For dissolution of gallstones; effective only in the treatment of cholesterol-rich, radiolucent gallstones (not radiopaque stones) in well-opacifying gallbladders

Monotherapy: 250 mg PO q12hr for 2 weeks initially, then increase by 250 mg/day at weekly intervals, up to 13-16 mg/kg/day divided q12hr PO  

Combination therapy (off-label): 5-7.5 mg/kg/day PO qHS in combination with ursodeoxycholic acid, with or without adjuvant lithotripsy

Xanthomatosis (Orphan)

Indicated for treatment of cerebrotendinous xanthomatosis

Orphan indication sponsor

  • Dr. Falk Pharma GmbH; Leinenweberstrasse 5, 9041; Freiburg, Germany
  • Sigma-Tau Pharmaceuticals, Inc; 9841 Washingtonian Blvd, Suite 500; Gaithersburg, MD 20878
  • Manchester Pharmaceuticals, Inc; 8236 Benson Ct; Fort Collins, CO 80525

Administration

Indicated in patients whom selective surgery would be undertaken except for the presence of increased surgical risk because of systemic disease or age

Successful dissolution is more likely if the stones are floatable or small

Safety of use beyond 24 months is not established

Safety and efficacy not established

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Interactions

Interaction Checker

and chenodiol

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (6)

                • aluminum hydroxide

                  aluminum hydroxide decreases levels of chenodiol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

                • calcium carbonate

                  calcium carbonate decreases levels of chenodiol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

                • crofelemer

                  crofelemer increases levels of chenodiol by Other (see comment). Use Caution/Monitor. Comment: Crofelemer has the potential to inhibit transporters MRP2 and OATP1A2 at concentrations expected in the gut; unlikely to inhibit systemically because minimally absorbed.

                • eluxadoline

                  eluxadoline increases levels of chenodiol by decreasing metabolism. Use Caution/Monitor. Eluxadoline may increase the systemic exposure of coadministered OATP1B1 substrates.

                • sodium bicarbonate

                  sodium bicarbonate decreases levels of chenodiol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

                • sodium citrate/citric acid

                  sodium citrate/citric acid decreases levels of chenodiol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

                Minor (3)

                • cholestyramine

                  cholestyramine decreases levels of chenodiol by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

                • colesevelam

                  colesevelam decreases levels of chenodiol by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

                • colestipol

                  colestipol decreases levels of chenodiol by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

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                Adverse Effects

                >10%

                Diarrhea (30-40%)

                Biliary pain (10-15%)

                Increased aminotransferase (>30%)

                Frequency Not Defined

                Abdominal cramps

                Nausea

                Vomiting

                Abdominal pain

                Constipation

                Heartburn

                Flatulence

                Increased LFT's

                Increased LDL and total cholesterol

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                Warnings

                Black Box Warnings

                Not an appropriate treatment for many patients with gallstones because of potential hepatotoxicity, poor response rate in some patient subgroups, and increased rate of cholecystectomy in other subgroups

                Reserve for carefully selected patients

                Treatment must include systematic monitoring for liver function alterations

                Contraindications

                Gallstone complication requiring surgery

                Known hepatocyte or bile ductal abnormalities, inflammatory bowel disease

                Pregnancy

                Cautions

                Orphan drug status, for use in surgical high-risk patients with radiolucent stones

                Breastfeeding

                Concomitant use with clofibrate

                Hepatotoxicity

                Dose related diarrhea occurs

                50% of cases have stone recurrence in 5 yr

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                Pregnancy & Lactation

                Pregnancy Category: X

                Lactation: unknown whether cevimeline is distributed into breast milk, avoid using in nursing women

                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

                Chenodiol itself is a primary acid excreted into the bile, constitutes 1/3 of total biliary bile acid; drug action on gallstone dissolution relies on negative feedback effect on the rate-limiting enzyme for synthesis of cholesterol and bile

                Pharmacokinetics

                Onset: initial response for gallstone dissolution: 3-6 month

                Bioavailability: 81-100%

                Excretion: Mainly in feces (80%)

                Metabolism: After absorption, chenodiol is conjugated with glycine or taurine in the liver and rapidly located in the bile; conjugated chenodiol is then reabsorbed in terminal ileum and jejunum, completing the enterohepatic cycle; lithocholic acid (inactive) is formed in the intestine by bacterial dehydroxylation of unabsorbed chenodiol (active); conjugated, sulfated and excreted in the bile; hepatotoxic in animals

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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Chenodal oral
                -
                250 mg tablet

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                chenodiol oral

                CHENODIOL - ORAL

                (KEE-noe-DYE-ol)

                COMMON BRAND NAME(S): Chenodal

                USES: Chenodiol is used to dissolve certain types of gallstones (non-calcified). Chenodiol is a bile acid. Chenodiol may be tried before surgery in patients that are at high risk of complications from gallstone surgery. If the gallstones do not dissolve, emergency surgery may still be needed.

                HOW TO USE: Take this medication by mouth with or without food, usually twice a day: once in the morning and once at night, or as directed by your doctor.Dosage is based on your medical condition, weight, and response to treatment.Aluminum-containing antacids and certain drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol) can decrease how much of this medication your body absorbs. If you are taking any of these medications, separate them from chenodiol by at least 4 hours.To reduce your risk of side effects such as diarrhea, your doctor will direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Tell your doctor if you have severe diarrhea. Your doctor may need to lower your dose or stop the medication.Do not increase your dose or take this medication more often without your doctor's approval. Your condition will not improve any faster, and the risk of serious side effects may be increased.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Do not stop taking this medication without talking with your doctor.It may take up to 24 months before the gall stones are completely dissolved. Your doctor will order tests (gall bladder sonograms or x-rays) to check your progress. Keep all medical appointments. Tell your doctor if your condition persists or worsens (stomach/abdominal pain, nausea, or vomiting).

                SIDE EFFECTS: Diarrhea, nausea, or heartburn may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This drug may cause serious (possibly fatal) liver disease. Your doctor will order blood tests to check for liver problems. It is very important to keep all lab appointments. Seek immediate medical attention if you have any symptoms of liver damage, including: yellowing eyes/skin, dark urine, unusual/extreme tiredness, severe stomach/abdominal pain, persistent nausea/vomiting.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: Before taking chenodiol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems (such as hepatitis, cirrhosis), a certain red blood cell problem (hemolysis), regular use/abuse of alcohol.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication must not be used during pregnancy. It may harm an unborn baby. Estrogen-containing birth control may increase your risk of gall stones. Discuss the use of reliable forms of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.It is unknown whether this drug passes into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.Some products that may interact with this drug include: estrogens (such as estradiol, estrogen pills/patch/cream, birth control pills/patch/ring), "blood thinners" (such as warfarin).This document does not contain all possible interactions. Before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as liver tests, cholesterol tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.Maintaining a normal weight and a diet high in fiber (such as bran) and low in cholesterol/carbohydrates may help prevent gall stones. Ask your doctor, pharmacist, or nutritionist for more information.

                MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

                STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

                Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                Formulary

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                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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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.