Cholbam Capsule: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Cholbam (cholic acid) is a bile acid medicine used to treat bile acid synthesis disorders caused by single enzyme defects, and as an add-on treatment for certain peroxisomal disorders. It supplies a bile acid that the body cannot make on its own, helping with fat digestion and nutrient absorption while reducing the buildup of harmful substances in the liver. It is taken by mouth with food, and regular blood tests are needed to monitor liver function during treatment.

What is Cholbam Capsule

Cholbam is a bile acid medicine. Bile acids are made naturally by the body to help digest fats and certain nutrients. People with certain bile acid disorders cannot make this bile acid normally, which can make it harder for the body to absorb important nutrients and can let toxic bile acids build up and harm the liver.

Cholbam Capsule uses

• Treatment of bile acid synthesis disorders due to single enzyme defects (SEDs)
• Adjunctive treatment of peroxisomal disorders (PDs) including Zellweger spectrum disorders in patients who have liver disease, fatty stools (steatorrhea), or problems absorbing fat-soluble vitamins

Benefits of Cholbam Capsule

• Helps normalize bile acid production in the body so fats and nutrients can be digested and absorbed properly
• Can reduce liver inflammation and improve liver test results in people who respond to treatment

How Cholbam Capsule works

Cholic acid is a natural bile acid normally made by the liver from cholesterol. In people with these bile acid disorders, the body cannot make enough of this bile acid, so harmful in-between substances build up and damage the liver. Taking Cholbam supplies the missing bile acid, which helps restore normal bile flow, helps the body digest fats and absorb fat-soluble vitamins, and signals the liver to stop overproducing the harmful substances.

Cholbam Capsule dosage

Take Cholbam with food. Swallow the capsule whole; do not crush or chew it. If you cannot swallow a capsule whole, open it and sprinkle the contents into a spoonful of soft food such as mashed potatoes or apple puree, or mix with infant formula or breast milk for younger children. Stir the mixture for 30 seconds and give or take it right away; do not save the mixture for later use. The granules will not dissolve in the food or liquid, so expect to see fine granules.

Take this medicine at least 1 hour before, or 4 to 6 hours after, taking a bile acid binding resin or an aluminum-based antacid. When you take your dose, avoid taking other oral medicines at the same time, since this medicine can affect how well your body absorbs them. This medicine is not approved for use in anyone younger than 3 weeks old.

If you miss a dose, take it as soon as you remember, but skip it if it is almost time for your next dose; do not take two doses at once. You will need regular blood tests to monitor your liver function while taking this medicine.

Available forms and strengths

• Capsules (50 mg and 250 mg)

Side effects of Cholbam Capsule

Common

• Diarrhea
• Acid reflux (reflux esophagitis)
• General ill feeling (malaise)
• Yellowing of the skin or eyes (jaundice)
• Skin sores or lesions
• Nausea
• Abdominal pain
• Intestinal polyp
• Urinary tract infection
• Numbness, tingling, or burning pain in hands or feet (peripheral neuropathy)

Serious

• Signs of worsening liver problems: nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, yellowing of the skin or eyes
• Blood in your stools or changes in bowel habits such as diarrhea or constipation
• Pain or burning when you urinate
• Signs of an allergic reaction: hives, difficulty breathing, swelling of the face, lips, tongue, or throat

Warnings and precautions

• This medicine can make liver damage worse. Your doctor needs to check your liver function regularly with blood tests while you are taking this medicine, and treatment may need to be stopped if your liver function worsens or doesn't improve within a few months of starting treatment.
• Avoid taking this medicine together with cyclosporine or similar drugs that block bile acid transport, since this can cause bile acids to build up in the liver and cause symptoms. If it can't be avoided, your doctor will monitor your liver blood tests closely.
• Medicines called bile acid binding resins (such as cholestyramine, colestipol, or colesevelam) and aluminum-containing antacids can reduce how well this medicine works, so they need to be spaced apart from your dose.
• Use Cholbam only under specialist supervision, particularly regarding kidney function.
• Tell your doctor about all medicines and supplements you take.
• Seek medical advice if you develop worsening jaundice, dark urine, or severe abdominal pain.
• There have been no formal studies of this medicine in pregnant women or in animals. A small number of published reports of women taking cholic acid during pregnancy for a related condition had healthy babies, but this is not enough evidence to know the risk during pregnancy. If you become pregnant while taking this medicine, you may be asked to join a pregnancy registry that tracks outcomes.
• This bile acid occurs naturally in human breast milk, but no studies have looked at whether taking this medicine affects breast milk or a breastfed baby. Your doctor will weigh the benefits of breastfeeding against your need for this medicine and any possible risks to the baby.

Storage

• Store at room temperature, 20–25°C.
• Keep in the original container, tightly closed.
• Protect from moisture and excessive heat.
• Keep out of reach of children.

When to see a doctor

• Get emergency help right away if you have signs of an allergic reaction, such as hives, trouble breathing, or swelling of the face, lips, tongue, or throat.
• Call your doctor right away if your skin or the whites of your eyes turn yellow, your urine turns dark or tea-colored, you have pain on the right side of your stomach, you bruise or bleed more easily than normal, or you feel unusually tired or weak — these can be signs of liver problems.
• Call your doctor right away if you notice blood in your stools, changes in bowel habits, or pain or burning when you urinate.
• If you think you or someone else may have taken too much of this medicine, get emergency medical help or contact a poison control center right away.

Alternatives

• Ursodiol
• Chenodiol
• Cholic acid