Welchol

WELCHOL- colesevelam hydrochloride tablet, film coated
WELCHOL- colesevelam hydrochloride for suspension
Daiichi Sankyo Inc.

1 INDICATIONS AND USAGE

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.

WELCHOL is indicated to reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) who are unable to reach LDL-C target levels despite an adequate trial of dietary therapy and lifestyle modification.

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.

1.3 Limitations of Use

  • WELCHOL should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis.
  • The effect of WELCHOL on cardiovascular morbidity and mortality has not been determined.
  • WELCHOL has not been studied in type 2 diabetes in combination with a dipeptidyl peptidase 4 inhibitor.
  • 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.

2 DOSAGE AND ADMINISTRATION

2.1 Testing Prior to Initiation of WELCHOL

Obtain lipid parameters, including triglyceride (TG) levels, before starting WELCHOL. WELCHOL is contraindicated in patients with TG levels >500 mg/dL [see Contraindications (4) and Warnings and Precautions (5.1)].

2.2 Recommended Dosage in Primary Hyperlipidemia and Type 2 Diabetes Mellitus

The recommended dosage of WELCHOL for adults and children 10 to 17 years old with primary hyperlipidemia is 3.75 grams daily. The recommended dosage of WELCHOL for adults with type 2 diabetes mellitus is 3.75 grams daily. WELCHOL should be taken as follows:

Tablets

Take 6 tablets once daily or 3 tablets twice daily. Due to tablet size, WELCHOL for oral suspension is recommended for use in the pediatric population.

For Oral Suspension

Take one packet once daily.

2.3 Important Dosing Information for Primary Hyperlipidemia

WELCHOL can be dosed at the same time as a statin, or WELCHOL and the statin can be dosed apart. Monitor lipid levels within 4 to 6 weeks after initiation of WELCHOL.

2.4 Administration Instructions

Tablets

Take WELCHOL tablets with a meal and liquid. For patients with difficulty swallowing tablets, use WELCHOL for oral suspension [see Warnings and Precautions (5.2)].

For Oral Suspension

To prepare, empty the entire contents of one packet into a glass or cup. Add 1 cup (8 ounces) of water, fruit juice, or diet soft drinks. Stir well and drink. Take WELCHOL oral suspension with meals. Do not take WELCHOL oral suspension in its dry form. Due to tablet size, WELCHOL for oral suspension is recommended for use in the pediatric population.

3 DOSAGE FORMS AND STRENGTHS

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

4 CONTRAINDICATIONS

WELCHOL is contraindicated in patients with:

5 WARNINGS AND PRECAUTIONS

5.1 Hypertriglyceridemia and Pancreatitis

WELCHOL, like other bile acid sequestrants, can increase serum TG concentrations. Hypertriglyceridemia can cause acute pancreatitis.

WELCHOL had effects on serum TG (median increase 5% compared to placebo) in trials of patients with primary hyperlipidemia.

In trials in patients with type 2 diabetes, greater increases in TG levels occurred when WELCHOL was used as monotherapy (median increase 9.7% compared to placebo) and when WELCHOL was used in combination with pioglitazone (median increase 11% compared to placebo in combination with pioglitazone), sulfonylureas (median increase 18% compared to placebo in combination with sulfonylureas), and insulin (median increase 22% compared to placebo in combination with insulin) [see Adverse Reactions (6.1)].

Obtain lipid parameters, including TG levels, before starting WELCHOL and periodically thereafter. WELCHOL is contraindicated in patients with TG levels >500 mg/dL or patients with a history of hypertriglyceridemia-induced pancreatitis [see Contraindications (4)]. Patients with TG levels greater than 300 mg/dL could have greater increases in serum TG levels with WELCHOL and may require additional TG monitoring. Instruct patients to discontinue WELCHOL and seek prompt medical attention if the symptoms of acute pancreatitis occur (e.g., severe abdominal pain with or without nausea and vomiting). Discontinue WELCHOL if TG levels exceed 500 mg/dL [see Adverse Reactions (6.1)].

5.2 Gastrointestinal Obstruction

Postmarketing cases of bowel obstruction have occurred with WELCHOL [see Adverse Reactions (6.2)]. Because of its constipating effects, WELCHOL is not recommended in patients with gastroparesis, other gastrointestinal motility disorders, and in those who have had major gastrointestinal tract surgery and who may be at risk for bowel obstruction. WELCHOL is contraindicated in patients with a history of bowel obstruction [see Contraindications (4)]. Instruct patients to promptly discontinue WELCHOL and seek medical attention if severe abdominal pain or severe constipation occurs.

Because of the tablet size, WELCHOL tablets can cause dysphagia or esophageal obstruction. For patients with difficulty swallowing tablets, use WELCHOL for oral suspension.

5.3 Vitamin K or Fat-Soluble Vitamin Deficiencies

WELCHOL may decrease the absorption of fat-soluble vitamins A, D, E, and K. Patients with a susceptibility to deficiencies of vitamin K (e.g., patients on warfarin, patients with malabsorption syndromes) or other fat-soluble vitamins may be at increased risk when taking WELCHOL.

Patients on oral vitamin supplementation should take their vitamins at least 4 hours prior to WELCHOL [see Drug Interactions (7.1)].

5.4 Drug Interactions

WELCHOL reduces gastrointestinal absorption of some drugs. Administer drugs with a known interaction at least 4 hours prior to WELCHOL [see Drug Interactions (7)].

Due to the potential for decreased absorption of other drugs that have not been tested for interaction, especially those with a narrow therapeutic index, consider administering at least 4 hours prior to WELCHOL [see Clinical Pharmacology (12.3)].

5.5 Risks in Patients with Phenylketonuria (PKU)

Phenylalanine can be harmful to patients with PKU. WELCHOL for oral suspension contains phenylalanine, a component of aspartame. Each 3.75 gram packet contains 27 mg of phenylalanine. Before prescribing WELCHOL for oral suspension to a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including WELCHOL for oral suspension.

5.6 Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of macrovascular disease risk reduction with WELCHOL.

6 ADVERSE REACTIONS

The following important adverse reactions are described below and elsewhere in the labeling:

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