1 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.
1.1 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: a. LDL-C remains
190 mg/dL or b. 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 (14.1)].
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.
1.2 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 (14.2)].
Diabetes mellitus is considered a CHD risk equivalent. In addition to glycemic control, intensive lipid control is warranted [See Indications and Usage (1.1) and Warnings and Precautions (5.2)].
1.3 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 pre-menarchal girls.