Contraindications

Welchol is contraindicated in:

• those with serum triglyceride (TG) concentrations of >500 mg/dL,
• those with a history of hypertriglyceridemia-induced pancreatitis, or
• individuals with a history of bowel obstruction.

Warnings and Precautions

Welchol can increase serum TG concentrations, particularly when used in combination with pioglitazone, sulfonylureas, or insulin. Hypertriglyceridemia can cause acute pancreatitis. Instruct patients to discontinue Welchol and seek prompt medical attention if the symptoms of acute pancreatitis occur. Caution should be exercised when treating patients with TG levels >300 mg/dL.

Welchol is not recommended in patients with gastroparesis, gastrointestinal motility disorders, a history of major gastrointestinal tract surgery, those who might be at risk for bowel obstruction, and when treating patients with dysphagia and swallowing disorders. Postmarketing cases of bowel obstruction have occurred with Welchol. Instruct patients to promptly discontinue Welchol and seek medical attention if severe abdominal pain or severe constipation occurs.

Welchol may decrease the absorption of fat-soluble vitamins A, D, E, and K. Patients on oral vitamin supplements should take their vitamins at least 4 hours prior to Welchol. Caution should be exercised when treating patients with a susceptibility to vitamin K deficiencies (e.g., patients on warfarin, patients with malabsorption syndromes), or fat-soluble vitamin deficiencies.

Welchol interacts with some drugs. Drugs with a known interaction with colesevelam (cyclosporine, glimepiride, glipizide, glyburide, levothyroxine, olmesartan medoxomil, oral contraceptives [ethinyl estradiol, norethindrone], and metformin extended-release [ER]) should be administered at least 4 hours prior to Welchol. Due to the potential for decreased absorption of other drugs that have not been tested for interaction with colesevelam, especially those with a narrow therapeutic index, consider administering at least 4 hours prior to Welchol. Alternatively, the physician should monitor drug levels of the co-administered drug, when appropriate.

Welchol for Oral Suspension should not be taken in its dry form.

Due to tablet size, Welchol for Oral Suspension is recommended for, but not limited to, use in the pediatric population as well as in any patient who has difficulty swallowing tablets.

Phenylketonurics: Welchol for Oral Suspension contains 27 mg phenylalanine per 3.75 gram packet. Phenylalanine can be harmful to patients with phenylketonuria (PKU).

Adverse Reactions

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

• Adults with Primary Hyperlipidemia were:
  constipation, dyspepsia, nausea, accidental injury, asthenia, pharyngitis, flu syndrome, rhinitis, and myalgia
• Pediatric patients with HeFH primary hyperlipidemia were:
  nasopharyngitis, headache, fatigue, creatine phosphokinase increase, rhinitis, and vomiting
• Adult patients with Type 2 Diabetes were:
  constipation, hypoglycemia, dyspepsia, nausea, hypertension, and back pain

Post-marketing experience: Due to the voluntary nature of these reports it is not possible to reliably estimate frequency or establish a causal relationship:

• Increased seizure activity or decreased phenytoin levels have been reported in patients receiving phenytoin concomitantly with Welchol
• Reduced International Normalized Ratio (INR) has been reported in patients receiving warfarin concomitantly with Welchol
• Elevated thyroid-stimulating hormone (TSH) has been reported in patients receiving thyroid hormone replacement therapy
• Dysphagia has been reported with both tablet and oral suspension formulations

Pregnancy

Welchol is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. Limited available data on the use of Welchol are insufficient to determine a drug associated risk of major congenital malformations or miscarriage.

There are no adequate and well-controlled studies of colesevelam HCl use in pregnant women.

Females and Males of Reproductive Potential

Use of Welchol may reduce the efficacy of oral contraceptives. Patients should be advised to take oral contraceptives at least 4 hours prior to taking Welchol.

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