ABOUT CHOLBAM

CHOLBAM is a prescription medicine that may help increase cholic acid, an essential bile acid needed for digestion and liver function.

CHOLBAM may help support liver function

CHOLBAM is a prescription medicine. It is a bile acid treatment used for:

  • Treatment of bile acid synthesis disorders (malfunction in the production of bile acid in the liver) due to a lack of a single enzyme responsible for bile acid production
  • Treatment (in addition to other treatments) of peroxisomal disorders (a loss of function in important parts of the cell), including Zellweger spectrum disorders, in patients who show signs or symptoms of liver disease, pale stools due to too much fat, or problems resulting from not absorbing certain vitamins (A, D, E, K)

The safety and effectiveness of CHOLBAM on symptoms outside of the liver have not been studied.

Treating bile acid synthesis disorder (BASD) with CHOLBAM

In patients with BASD, cholic acid—an essential bile acid—is missing or is not produced by the liver. Therefore, patients may be given a cholic acid medication to help replace this necessary bile acid.

Liver with bile acid deficiency

Liver with oral bile acid replacement therapy

CHOLBAM increases missing cholic acid and may help reduce the abnormal production of bile acids and toxic buildup.

CHOLBAM may help people:

  • Absorb vitamins and nutrients (aid in gaining weight and growing taller)
  • Avoid or reduce liver injury

Individual results may vary. Not all patients will experience similar levels of response. CHOLBAM has only been shown to help lessen the signs and symptoms that are related to liver disease.

CHOLBAM has a well-established safety profile

CHOLBAM helps patients absorb what matters. 
It has been FDA approved since 2015.

CHOLBAM is used for the treatment of BASDs, which are caused by defects in an enzyme that makes bile acids.

The safety and effectiveness of CHOLBAM on symptoms outside of the liver have not been studied.

As with any medication, there is a possibility of side effects. In clinical studies, the most common side effect in about 2% of patients taking CHOLBAM was diarrhea. All other side effects were 1% of patients.

Patients taking CHOLBAM will need to undergo laboratory testing periodically while on treatment to assess liver function. CHOLBAM may worsen liver function.

Call your or your loved one's doctor right away if any of the following occur, as these may be signs of worsening liver function::

  • Yellowing of the skin or whites of the eyes
  • Dark or brown (tea-colored) urine
  • Pain on the right side of the stomach
  • Bleeding or bruising that occurs more easily than normal
  • Increased tiredness

Most common adverse reactions in Trials 1 and 2

Adverse Reactions

Trial 1

Trial 2

Overall (%)

Diarrhea

1

2*

3 (2%)

Reflux esophagitis

1

0

1 (1%)

Malaise

1

0

1 (1%)

Jaundice

1

0

1 (1%)

Skin lesion

1

0

1 (1%)

Nausea

0

1*

1 (1%)

Abdominal pain

0

1*

1 (1%)

Intestinal polyp

0

1*

1 (1%)

Urinary tract infection

0

1*

1 (1%)

Peripheral neuropathy

0

1

1 (1%)

*Adverse reactions that occurred in new patients.

Discuss with your or your loved one's doctor any side effects that concern you. You can also view the CHOLBAM full Prescribing Information for additional details.

Talk to a health care provider to learn more about CHOLBAM.

 

CHOLBAM is a daily treatment

Mirum Access Plus can make starting CHOLBAM easier