Primary Hyperlipidemia

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. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate [See Clinical Studies].

In patients with coronary heart disease (CHD) or CHD risk equivalents such as diabetes mellitus, LDL-C treatment goals are < 100 mg/dL. An LDL-C goal of < 70 mg/dL is a therapeutic option on the basis of recent trial evidence. If LDL-C is at goal but the serum triglyceride (TG) value is > 200 mg/dL, then non-HDL cholesterol (non-HDL-C) (total cholesterol [TC] minus high density lipoprotein cholesterol [HDL-C]) becomes a secondary target of therapy. The goal for non-HDL-C in persons with high serum TG is set at 30 mg/dL higher than that for LDL-C.

Type 2 Diabetes Mellitus

WELCHOL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [See Clinical Studies].

Diabetes mellitus is considered a CHD risk equivalent. In addition to glycemic control, intensive lipid control is warranted [See INDICATIONS and WARNINGS and PRECAUTIONS].

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.

Primary Hyperlipidemia

The recommended dose of WELCHOL, whether used as monotherapy or in combination with an HMG-CoA reductase inhibitor, is 6 tablets once daily or 3 tablets twice daily. WELCHOL should be taken with a meal and liquid.

WELCHOL can be dosed at the same time as an HMG-CoA reductase inhibitor or the two drugs can be dosed apart [See Clinical Studies].

After initiation of WELCHOL, lipid levels should be analyzed within 4 to 6 weeks.

Type 2 Diabetes Mellitus

The recommended dose of WELCHOL is 6 tablets once daily or 3 tablets twice daily. WELCHOL should be taken with a meal and liquid.

Dosage Forms And Strengths

625 mg tablets are off-white, oval, film-coated and imprinted with "Sankyo" and "C01" on one side.

WELCHOL (colesevelam hydrochloride), 625 mg, is supplied as an off-white, solid tablet imprinted with the word "Sankyo" and "C01" on one side." WELCHOL tablets are available as follows:

• Bottles of 180 - NDC 65597-701-18

Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Brief exposure to 40°C (104°F) does not adversely affect the product. Protect from moisture.

Manufactured for: Daiichi Sankyo, Inc. Parsippany, New Jersey 07054. Manufactured by: Patheon Inc. Toronto, Ontario M3B, 1Y5 Active Ingredient: Product of Austria. Licensed from: Genzyme Corporation. FDA Rev date: 1/18/2008

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