Important Safery Information
What is Welchol® (colesevelam HCI)?
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.
Important Safety Information About Welchol (colesevelam HCI)
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.
For patients having difficulty affording their Daiichi Sankyo medication, please call the Daiichi Sankyo Patient Assistance Program at 1-866-268-7327 for more information or visit www.dsi.com/news/patientassistance.html.
Click here for full Product Information about Welchol.
§Savings Card Offer: Eligibility Criteria and Terms & Conditions
To the Patient: You must present this card to pharmacist along with your WELCHOL® (colesevelam HCl) prescription to participate in the program. For patients with commercial insurance, savings per prescription of WELCHOL will apply after the following out-of-pocket expenses are met: $10 per prescription for a 30-day supply of WELCHOL or $0 per prescription for a 90-day supply of WELCHOL. Offer may not be combined with any other program offer or discount for WELCHOL. Savings for WELCHOL are subject to a maximum benefit of $150 per 30-day prescription or $450 per 90-day prescription. If you have questions regarding your eligibility or benefits, or wish to discontinue participation, call (866) 566-4606 (8 AM – 8 PM ET, M-F). When you use this card, you are certifying that you understand the program rules, regulations, and terms and conditions. You are not eligible if you are enrolled in any state or federal health care program, including, but not limited to, Medicare Part D or Medicaid, VA, DOD, or TRICARE/CHAMPUS; or where taxed, restricted, or prohibited by law; or if you do not otherwise comply with the terms of this card. Further, you agree to discontinue using the card if you enroll in any state or federal health care program during the program period. Offer valid in US and Puerto Rico only.
To the Pharmacist: When you use this card, you are certifying that the patient is not enrolled in any federal, state, or other governmental programs for this prescription.
- Submit transaction to McKesson Corporation, using BIN #610524.
- If primary coverage exists, input card information as secondary coverage and transmit using the COB segment of NCPDP transaction. Applicable discounts will be displayed in the transaction response.
- Acceptance of this card and your submission of claims for the WELCHOL ADDvantage Program™ are subject to LoyaltyScript® program Terms and Conditions posted at www.mckesson.com/mprs.
- Patient not eligible if enrolled in any state or federal health care program, including, but not limited to, Medicare Part D or Medicaid, VA, DOD, or TRICARE/CHAMPUS, or where taxed, restricted or prohibited by law. Offer valid in US and Puerto Rico only.
- LoyaltyScript® is not an insurance card. For questions regarding setup, claim transmissions, patient eligibility, or other issues, call LoyaltyScript® for the WELCHOL Savings Plan at (866) 566-4606 (8 AM – 8 PM ET, M-F).
Daiichi Sankyo, Inc., reserves the right to rescind, revoke, or amend this program, at any time, without notice.
Trademarks not owned by Daiichi Sankyo, Inc., are property of their respective owners.
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