Cholbam (cholic acid) is approved for use to treat certain adults and children with rare genetic conditions that affect the liver called bile acid synthesis disorders and peroxisomal disorders. This medication belongs to a drug class called bile acids that work to help your body make more bile acid. Side effects aren't typically common, but can sometimes include diarrhea. This medication might raise your risk for worsening liver problems.
Certain genetic conditions that affect how your body makes bile acid (bile acid synthesis disorders)
Peroxisomal disorders (including Zellweger spectrum disorders) in people with signs of liver problems, bile problems, or problems absorbing certain vitamins
People with bile acid synthesis disorders and certain peroxisomal disorders can't make healthy bile acid. Bile acid normally helps the body break down and absorb nutrients, the liver to work properly, and get rid of waste from the body. Without enough healthy bile acid, toxic waste builds up in the body, which can lead to liver damage.
Cholbam (cholic acid) is a bile acid replacement medication. It's not completely clear how the medication works, but it's thought to help keep the right amount of healthy bile acids in your body. This might help your body absorb essential nutrients and lessen harm to the liver.
Source:Â DailyMed
Only medication approved for rare genetic conditions that cause abnormal bile acid levels and liver problems
Safe to use in infants and children
Can open capsules and sprinkle contents on soft foods or milk for easy swallowing
Might have to take twice a day
Requires frequent blood tests to check on your liver
Brand-name medication only
Take Cholbam (cholic acid) with food. Swallow the capsules whole. Don't crush or chew the capsules.
If you have trouble swallowing pills or if you're giving Cholbam (cholic acid) to a child, you can open the capsule and mix the medication into soft food (e.g., applesauce, mashed potatoes), infant formula, or breast milk. This can help the medication taste better. After you carefully pour the medication over 1 or 2 tablespoons of food or liquid, stir for 30 seconds. The medication won't dissolve and it will look like fine sand. Take or give the mixture right away.
Take Cholbam (cholic acid) at least 1 hour before or 4 to 6 hours after taking any antacids that contain aluminum (e.g., Mylanta) or any bile acid sequestrants (e.g., cholestyramine (Prevalite), colesevelam (Welchol)). Taking Cholbam (cholic acid) too close to these medications might make it work less well.
Make sure to get your regular blood work done on time while you're taking Cholbam (cholic acid). These blood tests help your provider make sure the medication isn't damaging your liver.
Cholbam (cholic acid) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: History of liver problems
Some people had worsened liver problems during treatment with Cholbam (cholic acid). Tell your provider if you have any types of liver problems before you start taking this medication so your care team can follow up with you more closely. You'll need to get blood tests done often while you're taking Cholbam (cholic acid) so your provider can check on your liver.
You'll need to stop Cholbam (cholic acid) if your lab results show signs of worsening liver problems or if you start to have worsening symptoms. Get medical help right away if you have yellowing of the skin or eyes (jaundice), dark urine, pain in the upper right side of your stomach, nausea, or vomiting because these can be signs of liver damage.
Your provider will calculate the dose based on your body weight. The typical dose is 10 mg/kg to 15 mg/kg of weight taken by mouth once per day. This dose can also be split into 2 equal doses throughout the day.
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Demczko, M., et al. (2022). Peroxisomal disorders. Merck Manual Consumer Version.
Global Foundation for Peroxisomal Disorders. (n.d.). Peroxisomal disorders.
Manchester Pharmaceuticals, LLC. (2023). Cholbam- colic acid capsule [package insert]. DailyMed.
MedlinePlus. (2023). Vitamins.
National Organization for Rare Disorders. (2020). Bile acid synthesis disorders.
National Organization for Rare Disorders. (2020). Zellweger spectrum disorders.
Shulpekova, Y., et al. (2022). The role of bile acids in the human body and in the development of diseases. Molecules.
Tholey, D., et al. (2023). Cholestasis. Merck Manual Consumer Version.
U.S. Food and Drug Administration. (2020). Drug trials snapshot: Cholbam (peroxisomal disorders).
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