What is Welchol^® (colesevelam HCl)?

Welchol, along with diet and exercise, lowers LDL or "bad" cholesterol. It can be taken alone or with other cholesterol-lowering medications known as statins.

Welchol lowers LDL cholesterol in boys, and in girls who have had a menstrual period, ages 10 to 17 years, with a condition known as heterozygous familial hypercholesterolemia (a genetic disorder that causes high cholesterol) alone or with other cholesterol-lowering medications known as statins after inadequate control with diet alone.

Welchol, along with diet and exercise, also lowers blood sugar levels in adult patients with type 2 diabetes mellitus when added to other anti-diabetes medications (metformin, sulfonylureas, or insulin).

Welchol should not be used to treat type 1 diabetes or diabetic ketoacidosis.
Welchol has not been studied with all anti-diabetes medications.
Welchol has not been studied in children younger than 10 years old or in girls who have not had a menstrual period.

Welchol is available by prescription only. Ask your HCP if Welchol is right for you.

Welchol is not for everyone, especially those with:

• a history of intestinal blockage,
• blood triglyceride levels of greater than 500 mg/dL, or
• a history of pancreatitis (inflammation of the pancreas) due to high triglyceride levels.

Welchol has not been shown to prevent heart disease or heart attacks.

Tell your health care provider (HCP) if you have high triglycerides (greater than 300 mg/dL).

Tell your HCP if you have stomach or intestinal problems, including gastroparesis (when the stomach takes too long to empty its contents), abnormal contractions of the digestive system, a history of major gastrointestinal tract surgery, if you have trouble swallowing, or if you have vitamin A, D, E, or K deficiencies.

Welchol has known interactions with cyclosporine, glimepiride, glipizide, glyburide, levothyroxine, certain birth control pills, olmesartan medoxomil, and metformin extended release (ER). Welchol has not been studied with all combinations of drugs and supplements. Please tell your HCP about all medications and supplements you may be taking before beginning Welchol, as your HCP may tell you to take your other medications and supplements 4 hours before taking Welchol.

Remember to tell your HCP if you are pregnant, plan to become pregnant, or are breastfeeding.

Welchol (colesevelam HCl) for Oral Suspension should not be taken in its dry form.

Welchol for Oral Suspension is recommended for, but not limited to, use in appropriate pediatric patients as well as any patient who has difficulty swallowing.

Phenylketonurics: Welchol for Oral Suspension contains 27 mg phenylalanine per 3.75 gram dose.

In clinical trials, the adverse reactions observed in ≥2% of patients, and more commonly with Welchol than placebo ("sugar pill"), regardless of investigator assessment of causality seen in:

• Adult patients with high LDL ("bad") cholesterol were:
  constipation, indigestion, nausea, accidental injury, weakness, sore throat , flu-like symptoms, runny nose, and muscle aches
• Pediatric patients with high LDL ("bad") cholesterol were:
  inflamed nasal passages and throat, headache, fatigue, creatine phosphokinase (a muscle enzyme) increase, runny nose, and vomiting
• Adult patients with Type 2 Diabetes were:
  constipation, low blood sugar (hypoglycemia), indigestion (dyspepsia), nausea, high blood pressure (hypertension), and back pain

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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