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Prescribing Information

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About Cosette

To contact us with questions or concerns about a Cosette Pharmaceuticals product,
please call us: 1-800-922-1038

WELCHOL is a registered trademark of Cosette Pharmaceuticals, Inc.
© 2022 Cosette Pharmaceuticals, Inc. CP-US-WC-001   06/22

Important Safety Information

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

Welchol is not for everyone, especially those with:

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

Tell your health care provider (HCP) if you have high triglycerides (greater than 300 mg/dL). High levels of triglycerides in your blood can cause acute pancreatitis (inflammation of the pancreas). Discontinue Welchol and seek prompt medical attention if the symptoms of acute pancreatitis occur.

Welchol should not be taken 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, by those who might be at risk for intestinal blockage, or if you have vitamin A, D, E, or K deficiencies. Tell your HCP if you have any of these conditions.

Cases of intestinal blockage have occurred. Discontinue Welchol and seek medical attention if severe abdominal pain or severe constipation occurs.

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 vitamins/supplements you may be taking before beginning Welchol, as your HCP may tell you to take your other medications and vitamins/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 packet. Phenylalanine can be harmful to patients with phenylketonuria (PKU).

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 (dyspepsia), 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.

Please see full Prescribing Information for Welchol® (colesevelam HCl).