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Safety Profile

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Welchol Delivers Efficacy Without Systemic Absorption1

Welchol does not enter the bloodstream, so you can provide add-on efficacy without systemic absorption.

  • Welchol binds to bile acids in the intestine
  • No dosage adjustment is required in patients with hepatic or renal impairment

Welchol (colesevelam HCl)

In primary hyperlipidemia

  • 9 years of proven safety in the treatment of primary hyperlipidemia1
  • Over 1 million prescriptions filled annually2
  • Does not induce or inhibit CYP-450 enzymes

In T2DM studies

  • Incidence of hypoglycemia was similar between the Welchol and placebo groups (3.0% vs 2.3%)1
    • No incidence of severe hypoglycemia was reported1
  • Welchol was not associated with weight gain1

Most common adverse reactions1

Welchol (colesevelam HCl)

Welchol may increase triglyceride levels, especially in patients on a sulfonylurea- or insulin-based therapy. Periodic monitoring of lipid parameters including TG and non–HDL-C levels is recommended. The long-term effect of hypertriglyceridemia on the risk of coronary artery disease is uncertain.


Please see Important Safety Information about Welchol below

New Formulation

A new way to take down two with one

*Phenylketonurics: Welchol for Oral Suspension contains 48 mg phenylalanine per 3.75 gram dose.

Learn More

References

1. Welchol (colesevelam HCI). Prescribing Information. Daiichi Sankyo, Inc., Parsippany, NJ, 2009.

2. IMS NPA TRx Data 2000-2007.

IMPORTANT INFORMATION ABOUT WELCHOL (colesevelam HCl)

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 hydroxymethylglutaryl-coenyme (HMG CoA) reductase inhibitor
  • 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 as monotherapy or in combination with a dipeptidyl peptidase 4 inhibitor and has not been extensively studied in combination with thiazolidinediones
  • 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

Contraindications

Welchol is contraindicated in individuals with bowel obstruction, those with serum triglyceride (TG) concentrations of >500 mg/dL, or 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 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, major gastrointestinal tract surgery, and when treating patients with dysphagia and swallowing disorders.

Welchol reduces gastrointestinal absorption of some drugs. Drugs with a known interaction with colesevelam (glyburide, levothyroxine, and oral contraceptives [ethinyl estradiol, norethindrone]) 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 48 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:

  • Adults with Primary Hyperlipidemia were: constipation (11.0% vs 7.0%), dyspepsia (8.3% vs 3.5%), nausea (4.2% vs 3.9%), accidental injury (3.7% vs 2.7%), asthenia (3.6% vs 1.9%), pharyngitis (3.2% vs 1.9%), flu syndrome (3.2% vs 3.1%), rhinitis (3.2% vs 3.1%) and myalgia (2.1% vs 0.4%)
  • Pediatric patients with heFH primary hyperlipidemia were: nasopharyngitis (6.2% vs 4.6%), headache (3.9 vs 3.1%), fatigue (3.9% vs 1.5%), creatine phosphokinase increase (2.3% vs 0.0%), rhinitis (2.3% vs 0.0%) and vomiting (2.3% vs 1.5%)
  • Adult patients with Type 2 Diabetes were: constipation (8.7% vs 2.0%), nasopharyngitis (4.1% vs 3.6%), dyspepsia (3.9% vs 1.4%), hypoglycemia (3.0% vs 2.3%), nausea (3.0% vs 1.4%) and hypertension (2.8% vs 1.6%)

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) in patients receiving thyroid hormone replacement therapy.

Pregnancy

Welchol is Pregnancy Category B.

Please see Full Prescribing Information for Welchol by clicking here.

This information is intended for U.S. healthcare professionals only.
© 2009 Daiichi Sankyo, Inc.

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