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Efficacy

LDL-C and A1C reductions

In the appropriate patient, as an adjunct to diet and exercise, Welchol is the only bile acid sequestrant FDA-approved to provide both LDL-C and A1C reductions in adults with primary hyperlipidemia and T2DM.

Welchol may provide benefits for adult patients with primary hyperlipidemia, T2DM, or both
According to the CDC National Diabetes Statistics Report of 2014, more than half of all T2DM patients had high LDL levels.1 With such a high patient prevalence, see the data below to determine if Welchol as an add-on therapy or monotherapy could help your patients achieve the LDL-C and A1C reductions they need.*

 

Please see Important Safety Information about Welchol below.

*Welchol is not right for everyone.

Statin and Clinical

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Alternative to Statin Titration

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Welchol Clinical Studies

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Important Safery Information

Indications

Welchol is indicated as an adjunct to diet and exercise to :

  • reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (statin)
  • reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia, as monotherapy or in combination with a statin after failing an adequate trial of diet therapy
  • improve glycemic control in adults with type 2 diabetes mellitus
Important Limitations of Use
  • Welchol should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis
  • Welchol has not been studied in type 2 diabetes in combination with a dipeptidyl peptidase-4 inhibitor
  • Welchol has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias
  • Welchol has not been studied in children younger than 10 years of age or in premenarchal girls

IMPORTANT SAFETY INFORMATION ABOUT WELCHOL (colesevelam HCI)

Contraindications

Welchol is contraindicated in:

  • individuals with a history of bowel obstruction
  • those with serum triglyceride (TG) concentrations of >500 mg/dL, or
  • those with a history of hypertriglyceridemia-induced pancreatitis.
Warnings and Precautions

The effect of Welchol on cardiovascular morbidity and mortality has not been determined.

Welchol can increase serum TG concentrations particularly when used in combination with pioglitazone, sulfonylureas, or insulin. Caution should be exercised when treating patients with TG levels >300 mg/dL.

Welchol may decrease the absorption of fat-soluble vitamins A, D, E, and K. Patients on vitamin supplements should take their vitamins at least 4 hours prior to Welchol. Caution should be exercised when treating patients with a susceptibility to vitamin K or fat-soluble vitamin deficiencies.

Caution should also be exercised when treating patients with gastroparesis, gastrointestinal motility disorders, a history of major gastrointestinal tract surgery, and when treating patients with dysphagia and swallowing disorders.

Welchol interacts with some drugs. Drugs with a known interaction with colesevelam (cyclosporine, glimepiride, glipizide, glyburide, levothyroxine, olmesartan medoxomil, oral contraceptives [ethinyl estradiol, norethindrone], and metformin extended release [ER]) should be administered at least 4 hours prior to Welchol. Drugs that have not been tested for interaction with colesevelam, especially those with a narrow therapeutic index, should also be administered at least 4 hours prior to Welchol. Alternatively, the physician should monitor drug levels of the co-administered drug.

To avoid esophageal distress, Welchol for Oral Suspension should not be taken in its dry form.

Due to tablet size, Welchol for Oral Suspension is recommended for, but not limited to, use in the pediatric population as well as in any patient who has difficulty swallowing tablets.

Phenylketonurics: Welchol for Oral Suspension contains 27 mg phenylalanine per 3.75 gram dose.

Adverse Reactions

In clinical trials, the adverse reactions observed in ≥2% of patients, and more commonly with Welchol than placebo, regardless of investigator assessment of causality seen in:

  • Adult patients with Primary Hyperlipidemia were: constipation, dyspepsia, nausea, accidental injury, asthenia, pharyngitis, flu syndrome, rhinitis, and myalgia
  • Pediatric patients with heFH primary hyperlipidemia were: nasopharyngitis, headache, fatigue, creatine phosphokinase increase, rhinitis, and vomiting
  • Adult patients with Type 2 Diabetes were: constipation, hypoglycemia, dyspepsia, nausea, hypertension, and back pain

Post-marketing experience: Due to the voluntary nature of these reports it is not possible to reliably estimate frequency or establish a causal relationship:

  • Increased seizure activity or decreased phenytoin levels have been reported in patients receiving phenytoin concomitantly with Welchol
  • Reduced International Normalized Ratio (INR) has been reported in patients receiving warfarin concomitantly with Welchol
  • Elevated thyroid-stimulating hormone (TSH) has been reported in patients receiving thyroid hormone replacement therapy
  • Dysphagia has been reported with both tablet and oral suspension formulations
Pregnancy

Welchol is Pregnancy Category B.

Please click here for Full Prescribing Information about Welchol.

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