RECENT MAJOR CHANGES

Dosage and Administration (2) 07/2011
Warnings and Precautions (5.4)07/2011

INDICATIONS AND USAGE

WELCHOL is a bile acid sequestrant indicated as an adjunct to diet and exercise to

• reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (statin) (1.1).
• 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 (1.2).

Important Limitations of Use (1.3):

• Do not use for glycemic control in type 1 diabetes or for treating 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 pre-menarchal girls.

DOSAGE AND ADMINISTRATION

• WELCHOL Tablets: The recommended dose is 6 tablets once daily or 3 tablets twice daily. WELCHOL Tablets should be taken with a meal and liquid (2.1, 2.2)
• WELCHOL for Oral Suspension: The recommended dose is one 3.75 gram packet once daily or one 1.875 gram packet twice daily. To prepare, empty the entire contents of one packet into a glass or cup. Add ½ to 1 cup (4 to 8 ounces) of water, fruit juice, or diet soft drinks. Stir well and drink. WELCHOL for Oral Suspension should be taken with meals. To avoid esophageal distress, WELCHOL for Oral Suspension should not be taken in its dry form. (2.1, 2.2)

DOSAGE FORMS AND STRENGTHS

Tablets: 625 mg (3)

Oral suspension: 3.75 gram packet, 1.875 gram packet (3)

CONTRAINDICATIONS

• Do not use in patients with a history of bowel obstruction (4)
• Do not use in patients with serum triglyceride (TG) concentrations >500 mg/dL (4)
• Do not use in patients with a history of hypertriglyceridemia-induced pancreatitis (4)

WARNINGS AND PRECAUTIONS

• The effect of WELCHOL on cardiovascular morbidity and mortality has not been determined (5.1).
• WELCHOL can increase TG, particularly when used with insulin or sulfonylureas. Marked hypertriglyceridemia can cause acute pancreatitis. The effect of hypertriglyceridemia on the risk of coronary artery disease is uncertain. Monitor lipids, including TG and non-high density lipoprotein cholesterol (non-HDL-C) (5.2).
• Bile acid sequestrants may decrease absorption of fat-soluble vitamins. Use caution in patients susceptible to fat-soluble vitamin deficiencies (5.3).
• Because of its constipating effects, WELCHOL is not recommended in patients at risk of bowel obstruction (e.g., patients with gastroparesis, other gastrointestinal motility disorders or a history of major gastrointestinal surgery) (5.4).
• WELCHOL reduces gastrointestinal absorption of some drugs. Administer drugs with a known interaction with colesevelam 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, monitor drug levels of the co-administered drug (5.5, 7, 12.3).
• WELCHOL for Oral Suspension contains 24 mg phenylalanine per 1.875 gram packet and 48 mg phenylalanine per 3.75 gram packet (5.6, 11)

ADVERSE REACTIONS

In clinical trials, the most common (incidence ≥2% and greater than placebo) adverse reactions with WELCHOL included constipation, dyspepsia, and nausea. In the diabetes trials, the overall incidence of hypoglycemia was 3.0% in WELCHOL-treated patients and 2.3% in placebo-treated patients(6.1).