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Colesevelam: Drug information

Colesevelam: Drug information
(For additional information see "Colesevelam: Patient drug information" and see "Colesevelam: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Welchol
Brand Names: Canada
  • APO-Colesevelam;
  • Lodalis
Pharmacologic Category
  • Antilipemic Agent, Bile Acid Sequestrant
Dosing: Adult
Diarrhea associated with bile acid malabsorption

Diarrhea associated with bile acid malabsorption (off-label use): Oral: 3.75 g/day in 1 or 2 divided doses (Beigel 2014; Wilcox 2014).

Hyperlipidemia, diabetes mellitus

Hyperlipidemia (primary), diabetes mellitus (type 2): Oral: 3.75 g/day in 1 or 2 divided doses.

Note: Use may be considered in patients with fasting triglyceride level ≤300 mg/dL who do not meet cholesterol treatment goals with dietary modification and other lipid lowering therapies (eg, maximally tolerated statin and ezetimibe) (AHA/ACC [Grundy 2018]).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

No dosage adjustments necessary; not absorbed from the gastrointestinal tract.

Dosing: Hepatic Impairment: Adult

No dosage adjustments necessary; not absorbed from the gastrointestinal tract.

Dosing: Pediatric

(For additional information see "Colesevelam: Pediatric drug information")

Note: Due to large tablet size, the manufacturer recommends packets of oral suspension for pediatric patients. Overall, with dyslipidemia management, lifestyle changes are recommended to be implemented for at least 6 to 12 months before beginning pharmacotherapy (AACE [Jellinger 2017]). Bile acid sequestrant therapy may be considered for LDL/apo B reduction and mild HDL increases but should not be used in pediatric patients with hypertriglyceridemia. Multivitamin supplementation recommended due to potential folic acid and cholecalciferol malabsorption (AACE [Jellinger 2017]).

Heterozygous familial hypercholesterolemia

Heterozygous familial hypercholesterolemia: Children ≥10 years and Adolescents: Oral: 3.75 g once daily or in divided doses twice daily.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Children ≥10 years and Adolescents: No adjustment necessary; not absorbed from the GI tract.

Dosing: Hepatic Impairment: Pediatric

Children ≥10 years and Adolescents: No dosage adjustment necessary; not absorbed from the GI tract.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Packet, Oral, as hydrochloride:

Welchol: 3.75 g (30 ea) [contains aspartame, propylene glycol alginate]

Welchol: 3.75 g (30 ea [DSC]) [sugar free; contains aspartame]

Generic: 3.75 g (30 ea)

Tablet, Oral, as hydrochloride:

Welchol: 625 mg

Generic: 625 mg

Generic Equivalent Available: US

Yes

Dosage Forms Considerations

Welchol contains phenylalanine 27 mg per 3.75 gram packet

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Packet, Oral, as hydrochloride:

Lodalis: 3.75 g (3.75 g) [contains aspartame, propylene glycol alginate]

Tablet, Oral, as hydrochloride:

Lodalis: 625 mg

Generic: 625 mg

Administration: Adult

Granules for oral suspension: Administer with meal(s). Powder is not to be taken in dry form (to avoid esophageal distress).

Tablets: Administer with meal(s) and a liquid. Due to tablet size, it is recommended that any patient who has trouble swallowing tablets should use the oral suspension form.

Administration: Pediatric

Oral:

Granules for oral suspension: Administer with meals. Dissolve in liquid prior to administration (see Preparation for Administration); do not take in dry form (to avoid esophageal distress).

Tablets: Due to tablet size, it is recommended that any patient who has trouble swallowing tablets, including pediatric patients, should avoid use of tablets and use the oral suspension or chewable bars dosage forms. Administer with meal(s) and a liquid.

Use: Labeled Indications

Diabetes mellitus, type 2: Improve glycemic control in adults with type 2 diabetes mellitus in conjunction with diet and exercise

Guideline recommendations: Colesevelam is not generally used in patients with type 2 diabetes but may be tried in specific situations (ADA 2021).

Hyperlipidemia (primary):

Management of elevated LDL-C in adults with primary hyperlipidemia in conjunction with diet and exercise.

Management of heterozygous familial hypercholesterolemia (heFH) in adolescent patients (males and postmenarcheal females 10 to 17 years of age) who are unable to reach LDL-C target levels despite an adequate trial of dietary therapy and lifestyle modification.

Use: Off-Label: Adult

Diarrhea associated with bile acid malabsorption

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Actual frequency may be dependent upon indication. Unless otherwise noted, frequency of adverse effects is reported for adult patients.

>10%: Gastrointestinal: Constipation (3% to 11%)

1% to 10%:

Cardiovascular: Cardiovascular toxicity (2%, including myocardial infarction, aortic stenosis, bradycardia), hypertension (2% to 3%)

Central nervous system: Headache (children and adults 4% to 8%), fatigue (children 4%)

Endocrine & metabolic: Hypertriglyceridemia (4% to 5%; >500 mg/dL: <1%; >1,000 mg/dL: <1%), hyperglycemia (3%), hypoglycemia (3%)

Gastrointestinal: Dyspepsia (3% to 8%), diarrhea (4%), nausea (children and adults 3% to 4%), gastroesophageal reflux disease (2%), periodontal abscess (2%), vomiting (children 2%)

Hematologic & oncologic: C-reactive protein increased (3%)

Infection: Influenza (children and adolescents 4%)

Neuromuscular & skeletal: Weakness (4%), back pain (2%), increased creatine phosphokinase (children and adults 2%), myalgia (2%)

Respiratory: Nasopharyngitis (children 5% to 6%), upper respiratory tract infection (children and adults 3% to 5%), flu-like symptoms (children 4%), pharyngitis (3%), rhinitis (children 2%)

<1%, postmarketing, and/or case reports: Abdominal distension, dysphagia, esophageal obstruction, fecal impaction, flatulence, worsening of hemorrhoids, increased serum transaminases, infection, intestinal obstruction, pancreatitis, unstable angina pectoris

Contraindications

History of bowel obstruction; serum TG concentrations of more than 500 mg/dL; history of hypertriglyceridemia-induced pancreatitis.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to colesevelam or any component of the formulation; biliary obstruction

Warnings/Precautions

Disease-related concerns:

• Gastrointestinal disease: Use is not recommended in patients with gastroparesis, other severe GI motility disorders, a history of major GI tract surgery, or patients at risk for bowel obstruction. Use tablets with caution in patients with dysphagia or swallowing disorders; use the oral suspension form of colesevelam due to large tablet size and risk for esophageal obstruction. Discontinue if symptoms of bowel obstruction occur (eg, severe abdominal pain, severe constipation).

• Hypertriglyceridemia: Bile acid sequestrants can increase serum triglyceride concentrations; severely elevated triglycerides can cause acute pancreatitis. The manufacturer contraindicates use if triglycerides exceed 500 mg/dL and in patients with a history of hypertriglyceridemia-induced pancreatitis. The American College of Cardiology/American Heart Association recommends avoiding use in patients with baseline fasting triglyceride levels ≥300 mg/dL (ACC/AHA [Grundy 2018]). Use with caution in patients using insulin, thiazolidinediones, or sulfonylureas (may cause increased triglyceride concentrations). Discontinue if symptoms of acute pancreatitis occur (eg, severe abdominal pain with or without nausea and vomiting).

• Patients susceptible to fat-soluble vitamin deficiencies: Use with caution in patients susceptible to fat-soluble vitamin deficiencies. Absorption of fat soluble vitamins A, D, E, and K may be decreased; patients should take vitamins ≥4 hours before colesevelam.

• Phenylketonuria: Some products may contain phenylalanine; use with caution.

Dosage form specific issues:

• Phenylalanine: Some products may contain phenylalanine.

Other warnings/precautions:

• Appropriate use: Primary hyperlipidemia: Has not been studied in types I, III, IV, and V dyslipidemias. Diabetes: Not for use in patients with diabetic ketoacidosis (DKA) or patients with type 1 diabetes mellitus. Unlike adults, colesevelam was not shown to improved glycemic control in pediatric patients 10 to 17 years of age with type 2 diabetes mellitus in clinical trials.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Amiodarone: Bile Acid Sequestrants may decrease the bioavailability of Amiodarone. Management: Consider alternatives to this combination due to the risk of subtherapeutic amiodarone serum concentrations. If amiodarone is coadministered with colesevelam, administer amiodarone at least 4 hours before colesevelam. Risk D: Consider therapy modification

Chenodiol: Bile Acid Sequestrants may decrease the serum concentration of Chenodiol. Management: Administration of chenodiol 5 hours or more after bile acid sequestrants may reduce the magnitude of this interaction. Monitor for decreased therapeutic effects of chenodiol in patients receiving bile acid sequestrants. Risk D: Consider therapy modification

Cholic Acid: Bile Acid Sequestrants may decrease the absorption of Cholic Acid. Management: Administer cholic acid at least 1 hour before or 4 to 6 hours after administration of any bile acid-binding products to minimize the potential for a significant interaction. Risk D: Consider therapy modification

Corticosteroids (Oral): Bile Acid Sequestrants may decrease the absorption of Corticosteroids (Oral). Risk C: Monitor therapy

CycloSPORINE (Systemic): Colesevelam may decrease the serum concentration of CycloSPORINE (Systemic). Management: Administer cyclosporine at least 4 hours prior to colesevelam. Monitor for decreased cyclosporine concentrations during concomitant colesevelam therapy. Risk D: Consider therapy modification

Deferasirox: Bile Acid Sequestrants may decrease the serum concentration of Deferasirox. Management: Avoid combination when possible; if the combination must be used, consider a 50% increase in initial deferasirox dose, with monitoring of serum ferritin concentrations and clinical responses to guide further dosing. Risk D: Consider therapy modification

Ethinyl Estradiol-Containing Products: Bile Acid Sequestrants may decrease the serum concentration of Ethinyl Estradiol-Containing Products. Management: Administer ethinyl estradiol-containing products 4 hours prior to the administration of a bile acid sequestrant. Risk D: Consider therapy modification

Ezetimibe: Bile Acid Sequestrants may decrease the absorption of Ezetimibe. Management: Administer ezetimibe at least 2 hours before or 4 hours after any bile acid sequestrant. Risk D: Consider therapy modification

Glimepiride: Colesevelam may decrease the serum concentration of Glimepiride. Management: Administer glimepiride at least 4 hours prior to colesevelam. Risk D: Consider therapy modification

GlipiZIDE: Colesevelam may decrease the serum concentration of GlipiZIDE. Management: Administer glipizide at least 4 hours prior to colesevelam. Risk D: Consider therapy modification

GlyBURIDE: Colesevelam may decrease the serum concentration of GlyBURIDE. Management: Administer glyburide at least 4 hours prior to colesevelam. Risk D: Consider therapy modification

Leflunomide: Bile Acid Sequestrants may decrease serum concentrations of the active metabolite(s) of Leflunomide. Management: Unless using this combination to intentionally enhance leflunomide elimination, consider an alternative to the bile acid sequestrants when possible. Separating drug administration is not likely to be effective at avoiding this interaction. Risk D: Consider therapy modification

Lomitapide: Bile Acid Sequestrants may decrease the absorption of Lomitapide. Management: Administer lomitapide at least 4 hours before or after administration of a bile acid sequestrant. Risk D: Consider therapy modification

Loop Diuretics: Bile Acid Sequestrants may decrease the absorption of Loop Diuretics. Risk C: Monitor therapy

Maralixibat: Bile Acid Sequestrants may decrease the serum concentration of Maralixibat. Management: Bile acid sequestrants should be administered either at least 4 hours before, or 4 hours after, maralixibat. Risk D: Consider therapy modification

Methotrexate: Bile Acid Sequestrants may decrease the absorption of Methotrexate. Risk C: Monitor therapy

Multivitamins/Fluoride (with ADE): Bile Acid Sequestrants may decrease the serum concentration of Multivitamins/Fluoride (with ADE). Management: Avoid concomitant administration of multivitamins and bile acid sequestrants (eg, cholestyramine). Separate administration of these agents by several hours to minimize the risk of an interaction. Risk D: Consider therapy modification

Multivitamins/Minerals (with ADEK, Folate, Iron): Bile Acid Sequestrants may decrease the serum concentration of Multivitamins/Minerals (with ADEK, Folate, Iron). Specifically, bile acid sequestrants may impair the absorption of fat-soluble vitamins. Management: Avoid concomitant administration of multivitamins and bile acid sequestrants (eg, cholestyramine). Separate administration of these agents by several hours to minimize the risk of an interaction. Risk D: Consider therapy modification

Multivitamins/Minerals (with AE, No Iron): Bile Acid Sequestrants may decrease the serum concentration of Multivitamins/Minerals (with AE, No Iron). Management: Avoid concomitant administration of multivitamins and bile acid sequestrants (e.g., cholestyramine). Separate administration of these agents by several hours to minimize the risk of an interaction. Risk D: Consider therapy modification

Mycophenolate: Bile Acid Sequestrants may decrease the serum concentration of Mycophenolate. Risk X: Avoid combination

Niacin: Bile Acid Sequestrants may decrease the absorption of Niacin. Management: Consider separating the administration times of niacin and bile acid sequestrants by a few hours in order to reduce the potential for decreased efficacy of these agents. Risk D: Consider therapy modification

Nonsteroidal Anti-Inflammatory Agents: Bile Acid Sequestrants may decrease the absorption of Nonsteroidal Anti-Inflammatory Agents. Risk C: Monitor therapy

Norethindrone: Colesevelam may decrease the serum concentration of Norethindrone. Management: Oral contraceptives containing ethinyl estradiol and norethindrone should be administered at least 4 hours before colesevelam. Risk D: Consider therapy modification

Obeticholic Acid: Bile Acid Sequestrants may decrease the serum concentration of Obeticholic Acid. Management: Administer obeticholic acid at least 4 hours before or at least 4 hours after the administration of bile acid sequestrants. Risk D: Consider therapy modification

Odevixibat: Bile Acid Sequestrants may decrease the serum concentration of Odevixibat. Management: Bile acid sequestrants should be administered either at least 4 hours before, or 4 hours after, odevixibat. Risk D: Consider therapy modification

Olmesartan: Colesevelam may decrease the serum concentration of Olmesartan. Management: Administer olmesartan at least 4 hours prior to colesevelam. Risk D: Consider therapy modification

Phenytoin: Colesevelam may decrease the serum concentration of Phenytoin. Management: Administer phenytoin at least 4 hours prior to colesevelam. Risk D: Consider therapy modification

Pravastatin: Bile Acid Sequestrants may decrease the serum concentration of Pravastatin. Management: Administer pravastatin at least 1 hour before or 4 hours after administration of bile-acid resins (eg, cholestyramine, colestipol, colesevelam) to minimize the risk for any significant interaction. Risk D: Consider therapy modification

Propranolol: Bile Acid Sequestrants may decrease the serum concentration of Propranolol. Risk C: Monitor therapy

Raloxifene: Bile Acid Sequestrants may decrease the absorption of Raloxifene. Management: Consider separating the doses of raloxifene and bile acid sequestrants by at least 4 hours. Risk D: Consider therapy modification

Taurursodiol: Bile Acid Sequestrants may decrease the absorption of Taurursodiol. Risk X: Avoid combination

Teriflunomide: Bile Acid Sequestrants may decrease the serum concentration of Teriflunomide. Management: Unless using this combination to intentionally enhance teriflunomide elimination, consider an alternative to the bile acid sequestrants when possible. Separating drug administration is unlikely to be effective at avoiding the interaction. Risk D: Consider therapy modification

Tetracyclines: Bile Acid Sequestrants may decrease the absorption of Tetracyclines. Risk C: Monitor therapy

Thiazide and Thiazide-Like Diuretics: Bile Acid Sequestrants may decrease the absorption of Thiazide and Thiazide-Like Diuretics. The diuretic response is likewise decreased. Management: Consider separating administraton of bile acid sequestrants and thiazide diuretics by at least 4 hours. Monitor for decreased therapeutic effects of thiazide diuretics if coadministered with a bile acid sequestrant. Risk D: Consider therapy modification

Thyroid Products: Bile Acid Sequestrants may decrease the serum concentration of Thyroid Products. Management: Administer oral thyroid products at least 4 h prior to colesevelam, and at least 1 h before or 4-6 h after cholestyramine. Specific recommendations for colestipol are not available. Monitor for decreased concentrations/effects of the thyroid product. Risk D: Consider therapy modification

Ursodiol: Bile Acid Sequestrants may decrease the serum concentration of Ursodiol. Management: Administer ursodiol 1 hour before or at least 4 to 5 hours after bile acid sequestrants to minimize the potential for any significant interaction. Monitor for decreased therapeutic effects of ursodiol in patients receiving bile acid sequestrants. Risk D: Consider therapy modification

Vancomycin: Bile Acid Sequestrants may diminish the therapeutic effect of Vancomycin. Management: Avoid concurrent administration of oral vancomycin and bile acid sequestrants when possible. If use of both agents is necessary, consider separating doses by at least 2 hours to minimize the significance of the interaction. Risk D: Consider therapy modification

Vitamin D Analogs: Bile Acid Sequestrants may decrease the serum concentration of Vitamin D Analogs. More specifically, bile acid sequestrants may impair absorption of Vitamin D Analogs. Management: Avoid concomitant administration of vitamin D analogs and bile acid sequestrants (eg, cholestyramine). Separate administration of these agents by several hours to minimize the potential risk of interaction. Monitor plasma calcium concentrations. Risk D: Consider therapy modification

Warfarin: Colesevelam may diminish the anticoagulant effect of Warfarin. Risk C: Monitor therapy

Reproductive Considerations

Colesevelam may reduce the efficacy of oral contraception; consult drug interactions database for detailed information.

Pregnancy Considerations

Colesevelam is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug.

Lipid concentrations increase during pregnancy as required for normal fetal development. When increases are greater than expected, supervised dietary intervention should be initiated. Bile acid sequestrants are recommended when treatment is needed, and therapy with colesevelam is preferred (Avis 2009; Jacobson 2015).

Colesevelam may interfere with maternal vitamin absorption; therefore, regular supplementation may not be adequate.

Breastfeeding Considerations

Due to lack of systemic absorption, colesevelam is not expected to be present in breast milk.

When treatment for hypercholesterolemia in breastfeeding women is needed, therapy with bile acid sequestrants may be considered, and therapy with colesevelam is preferred (Jacobson 2015; NICE 2008).

Dietary Considerations

Some products may contain phenylalanine.

Monitoring Parameters

Lipid profile (fasting or nonfasting) should be rechecked 4 to 12 weeks after starting therapy and every 3 to 12 months thereafter (AHA/ACC [Grundy 2018])

Diabetes mellitus, type 2: Serum glucose.

HbA1c: Monitor at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; monitor quarterly in patients in whom treatment goals have not been met, or with therapy change. Note: In patients prone to glycemic variability (eg, patients with insulin deficiency), or in patients whose HbA1c is discordant with serum glucose levels or symptoms, consider evaluating HbA1c in combination with blood glucose levels and/or a glucose management indicator (ADA 2021; KDIGO 2020).

Reference Range

Recommendations for glycemic control in patients with diabetes:

Nonpregnant adults with diabetes (ADA 2021):

HbA1c: <7% (a more aggressive [<6.5%] or less aggressive [<8%] HbA1c goal may be targeted based on patient-specific characteristics). Note: In patients using a continuous glucose monitoring system, a goal of time in range >70% with time below range <4% is recommended and is similar to a goal HbA1c <7%.

Preprandial capillary blood glucose: 80 to 130 mg/dL (more or less stringent goals may be appropriate based on patient-specific characteristics).

Peak postprandial capillary blood glucose (~1 to 2 hours after a meal): <180 mg/dL (more or less stringent goals may be appropriate based on patient-specific characteristics).

Older adults (≥65 years of age) (ADA 2021):

Note: Consider less strict targets in patients who are using insulin and/or insulin secretagogues (sulfonylureas, meglitinides) (LeRoith 2019).

HbA1c: <7% to 7.5% (healthy); <8% to 8.5% (complex/intermediate health). Note: Individualization may be appropriate based on patient and caregiver preferences and/or presence of cognitive impairment. In patients with very complex or poor health (ie, limited remaining life expectancy), consider making therapy decisions based on avoidance of hypoglycemia and symptomatic hyperglycemia rather than HbA1c level.

Preprandial capillary blood glucose: 80 to 130 mg/dL (healthy); 90 to 150 mg/dL (complex/intermediate health); 100 to 180 mg/dL (very complex/poor health).

Bedtime capillary blood glucose: 80 to 180 mg/dL (healthy); 100 to 180 mg/dL (complex/intermediate health); 110 to 200 mg/dL (very complex/poor health).

Classification of hypoglycemia (ADA 2021):

Level 1: 54 to 70 mg/dL; hypoglycemia alert value; initiate fast-acting carbohydrate (eg, glucose) treatment.

Level 2: <54 mg/dL; threshold for neuroglycopenic symptoms; requires immediate action.

Level 3: Hypoglycemia associated with a severe event characterized by altered mental and/or physical status requiring assistance.

Lipid treatment goals: May vary depending on clinical condition, different clinical practice guidelines and expert opinion. Refer to clinical practice guidelines for specific treatment goals.

Mechanism of Action

Cholesterol is the major precursor of bile acid. Colesevelam binds with bile acids in the intestine to form an insoluble complex that is eliminated in feces. This increased excretion of bile acids results in an increased oxidation of cholesterol to bile acid and a lowering of the serum cholesterol.

Pharmacokinetics

Onset of action:

Lipid lowering: Therapeutic: ~2 weeks

Reduction of hemoglobin A1c (Type II diabetes): 4-6 weeks initial onset; 12-18 weeks maximal effect

Absorption: None

Excretion: Urine (0.05%)

Pricing: US

Pack (Colesevelam HCl Oral)

3.75 g (per each): $22.45 - $22.49

Pack (Welchol Oral)

3.75 g (per each): $29.44

Tablets (Colesevelam HCl Oral)

625 mg (per each): $1.10 - $3.96

Tablets (Welchol Oral)

625 mg (per each): $4.91

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.

Brand Names: International
  • Andocholest (EG);
  • Cholestagel (AT, CZ, DE, DK, EE, ES, FI, FR, GB, HR, HU, IE, KW, LT, LU, MT, NL, NO, PL, SE, TR);
  • Chowell (EG);
  • Defatozin (EG);
  • Velamveros (EG);
  • Welchol (NO)


For country code abbreviations (show table)
  1. American Diabetes Association (ADA). Standards of medical care in diabetes–2021. Diabetes Care. 2021;44(suppl 1):S1-S232. https://care.diabetesjournals.org/content/44/Supplement_1. Accessed January 12, 2021.
  2. Avis HJ, Hutten BA, Twickler MT, et al. Pregnancy in women suffering from familial hypercholesterolemia: a harmful period for both mother and newborn? Curr Opin Lipidol. 2009;20(6):484-490. [PubMed 19741526]
  3. Beigel F, Teich N, Howaldt S, et al. Colesevelam for the treatment of bile acid malabsorption-associated diarrhea in patients with Crohn's disease: a randomized, double-blind, placebo-controlled study. J Crohns Colitis. 2014;8(11):1471-1479. doi: 10.1016/j.crohns.2014.05.009. [PubMed 24953836]
  4. Davidson MH, Dillon MA, Gordon B, et al. Colesevelam Hydrochloride (Cholestagel): A New, Potent Bile Acid Sequestrant Associated With a Low Incidence of Gastrointestinal Side Effects. Arch Intern Med. 1999;159(16):1893-1900. [PubMed 10493319]
  5. Fihn SD, Gardin JM, Abrams J, et al. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation. 2012;126(25):3097-3137. [PubMed 23166211]
  6. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol. Circulation. 2018:CIR0000000000000625. doi: 10.1161/CIR.0000000000000625. [PubMed 30586774]
  7. Jacobson TA, Maki KC, Orringer CE, et al; NLA Expert Panel. National Lipid Association recommendations for patient-centered management of dyslipidemia: Part 2 [published corrections appear in J Clin Lipidol. 2016;10(1):211]. J Clin Lipidol. 2015;9(6)(suppl):S1-S122.e1. [PubMed 26699442]
  8. Jellinger PS, Handelsman Y, Rosenblit PD, et al. American Association of Clinical Endocrinologists and American College of Endocrinology guidelines for management of dyslipidemia and prevention of cardiovascular disease. Endocr Pract. 2017;23(suppl 2):1-87. doi: 10.4158/EP171764.APPGL. [PubMed 28437620]
  9. Kidney Disease: Improving Global Outcomes (KDIGO). KDIGO 2020 clinical practice guideline for diabetes management in chronic kidney disease. Kidney Int. 2020;98(4S):S1-S115. [PubMed 32998798]
  10. Kuiper EM, van Erpecum KJ, Beuers U, et al. The potent bile acid sequestrant colesevelam is not effective in cholestatic pruritus: results of a double-blind, randomized, placebo-controlled trial. Hepatology. 2010;52(4):1334-1340. doi:10.1002/hep.23821 [PubMed 20683930]
  11. LeRoith D, Biessels GJ, Braithwaite SS, et al. Treatment of diabetes in older adults: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2019;104(5):1520-1574. doi: 10.1210/jc.2019-00198. [PubMed 30903688]
  12. Lindor KD, Bowlus CL, Boyer J, Levy C, Mayo M. Primary biliary cholangitis: 2018 practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2019;69(1):394-419. doi:10.1002/hep.30145 [PubMed 30070375]
  13. Lindor KD, Bowlus CL, Boyer J, Levy C, Mayo M. Primary biliary cholangitis: 2021 practice guidance update from the American Association for the Study of Liver Diseases. Hepatology. 2022;75(4):1012-1013. doi:10.1002/hep.32117 [PubMed 34431119]
  14. Lodalis (colesevelam) [product monograph]. Laval, Quebec, Canada: Bausch Health, Canada; December 2020.
  15. National Heart, Lung, and Blood Institute. Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents. Clinical Practice Guidelines. 2011. National Institutes of Health. http://www.nhlbi.nih.gov/guidelines/cvd_ped/peds_guidelines_full.pdf
  16. National Institute for Health and Care Excellence (2008) Clinical guidelines and evidence review for familial hypercholesterolaemia: the identification and management of adults and children with familial hypercholesterolaemia. London: NICE. (Clinical Guideline 71). http://www.nice.org.uk/CG71.
  17. Staels B, Kuipers F. Bile Acid Sequestrants and the Treatment of Type2 Diabetes Mellitus. Drugs. 2007;67(10):1383-1392. [PubMed 17600387]
  18. Stein EA, Marais AD, Szamosi T, et al. Colesevelam Hydrochloride: Efficacy and Safety in Pediatric Subjects With Heterozygous Familial Hypercholesterolemia. J Pediatr. 2010;156(2):231-6.e1-3. [PubMed 19879596]
  19. Steinmetz KL. Colesevelam Hydrochloride. Am J Health Syst Pharm. 2002;59:932-939. [PubMed 12040732]
  20. Stone NJ, Robinson J, Lichtenstein AH, et al, 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines [published online ahead of print November 12, 2013].Circulation. 2013; doi: 10.1161/01.cir.0000437738.63853.7a.
  21. Welchol (colesevelam) [prescribing information]. Basking Ridge, NJ: Daiichi Sankyo, Inc; July 2020.
  22. Welchol (colesevelam) [prescribing information]. South Plainfield, NJ: Cosette Pharmaceuticals Inc; February 2022.
  23. Wilcox C, Turner J, Green J. Systematic review: the management of chronic diarrhoea due to bile acid malabsorption. Aliment Pharmacol Ther. 2014;39(9):923-939. doi: 10.1111/apt.12684. [PubMed 24602022]
  24. Zieve FJ, Kalin MF, Schwartz SL, et al. Results of the Glucose-Lowering Effect of WelChol Study (GLOWS): A Randomized, Double-Blind, Placebo-Controlled Pilot Study Evaluating the Effect of Colesevelam Hydrochloride on Glycemic Control in Subjects With Type 2 Diabetes. Clin Ther. 2007;29(10):74-83. [PubMed 17379048]
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