Primary Hyperlipidemia

WELCHOL is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (statin).

WELCHOL is indicated as monotherapy or in combination with a statin to reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present:

1. LDL-C remains ≥ 190 mg/dL or
2. LDL-C remains ≥ 160 mg/dL and
   • there is a positive family history of premature cardiovascular disease or
   • two or more other CVD risk factors are present in the pediatric patient.

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 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.
• WELCHOL has not been studied in children younger than 10 years of age or in premenarchal girls.

Primary Hyperlipidemia

The recommended dose of WELCHOL Tablets in adults, whether used as monotherapy or in combination with a statin, is 6 tablets once daily or 3 tablets twice daily. WELCHOL Tablets should be taken with a meal and liquid.

The recommended dose of WELCHOL for Oral Suspension, in adults and children 10 to 17 years of age, 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. Due to tablet size, it is recommended that any patient who has difficulty swallowing tablets use WELCHOL for Oral Suspension.

WELCHOL can be dosed at the same time as a statin 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 Tablets is 6 tablets once daily or 3 tablets twice daily. WELCHOL should be taken with a meal and liquid.

The recommended dose of WELCHOL for Oral Suspension 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.

Dosage Forms And Strengths

• Tablets: 625 mg tablets are off-white, oval, film-coated and imprinted with “Sankyo” and “C01” on one side.
• Oral Suspension: a white to pale yellow powder containing yellow granules packaged in single-dose packets: 3.75 gram single-dose packet, 1.875 gram single-dose packet.

Storage And Handling

WELCHOL (colesevelam hydrochloride) Tablets, 625 mg, are 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.

WELCHOL (colesevelam hydrochloride) for Oral Suspension is a white to pale yellow powder containing yellow granules. WELCHOL for Oral Suspension is available as follows:

1.875 gram single-dose packet Cartons of 60 packets – NDC 65597-903-60

3.75 gram single-dose packet Cartons of 30 packets – NDC 65597-902-30

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Marketed by: Daiichi Sankyo, Inc. Parsippany, New Jersey 07054

Last reviewed on RxList: 7/24/2012
This monograph has been modified to include the generic and brand name in many instances.