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CHOLBAM- cholic acid capsule


  1. Patient Information
  2. Advise Patients:
  3. Pregnancy Registry:

Patient Information 

Exacerbation of Liver Impairment

  • Advise patients that they will need to undergo laboratory testing periodically while on treatment to assess liver function.
  • Advise patients that CHOLBAM may worsen liver impairment and that they should immediately report to their health care provider any symptoms associated with liver impairment (e.g., skin or the whites of eyes turn yellow, urine turns dark or brown [tea colored], pain on the right side of stomach, bleeding or bruising occurs more easily than normal, or increased lethargy)

Administration

Advise Patients: 

  • to take CHOLBAM with food.
  • to take CHOLBAM at least one hour before or 4 to 6 hours after taking a bile acid binding resin or an aluminum-based antacid.
  • not to crush or chew the capsules.
  • for infants and children who cannot swallow capsules, the capsules can be opened and the contents mixed with either infant formula or expressed breast milk (for younger children), or soft food such as mashed potatoes or apple puree (for older children and adults) in order to mask any unpleasant taste:
    1. Hold the capsule over the prepared liquid/food, gently twist open, and allow the contents to fall into the liquid/food.
    2. Mix the entire capsule contents with one or two tablespoonfuls (15 mL to 30 mL) of infant formula, expressed breast milk, or soft food such as mashed potatoes or apple puree.
    3. Stir for 30 seconds.
    4. The capsule contents will remain as fine granules in the milk or food, and will not dissolve.
    5. Administer the mixture immediately.

Pregnancy Registry: 

Advise patients there is a pregnancy surveillance program that monitors pregnancy outcomes in women exposed to CHOLBAM during pregnancy[seeUse in Specific Populations (8.1)].

CHOLBAM is a trademark of Retrophin, Inc.

Revised: March 2015

Manufactured by:
Patheon France SA
38300 Bourgoin-Jallieu, France

Manufactured for:
Manchester Pharmaceuticals, Inc. A wholly owned subsidiary of Retrophin, Inc. San Diego, CA 92130
For further information, please call 844-246-5226



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