1 INDICATIONS AND USAGE
Colesevelam hydrochloride 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 a hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (statin) (
1.1).
reduce LDL-C levels in boys and post-menarchal 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.
Important Limitations of Use (
1.3):
Do not use for glycemic control in type 1 diabetes or for treating diabetic ketoacidosis.
Colesevelam hydrochloride has not been studied in type 2 diabetes in combination with a dipeptidyl peptidase 4 inhibitor.
Colesevelam hydrochloride has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
Colesevelam hydrochloride has not been studied in children younger than 10 years of age or in pre-menarchal girls.
1.1 Primary Hyperlipidemia
Colesevelam hydrochloride 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 a hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (statin).
Colesevelam hydrochloride is indicated as monotherapy or in combination with a statin to reduce LDL-C levels in boys and post-menarchal 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.
1.3 Important Limitations of Use
Colesevelam hydrochloride should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis.
Colesevelam hydrochloride has not been studied in type 2 diabetes in combination with a dipeptidyl peptidase 4 inhibitor.
Colesevelam hydrochloride has not been studied in pediatric patients with type 2 diabetes.
Colesevelam hydrochloride has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
Colesevelam hydrochloride has not been studied in children younger than 10 years of age or in pre-menarchal girls.