Cholbam

Cholbam is a prescription medication used to treat rare bile acid synthesis disorders due to single enzyme defects and is used for patients with peroxisomal disorders (including Zellweger spectrum disorders).

Cholbam comes in capsule form and is usually taken once or twice daily with food. Do not chew, divide, or break Cholbam capsules. Swallow capsules whole.

Common side effects of Cholbam include diarrhea, feeling tired, yellowing of the skin, skin lesions, nausea, vomiting, abdominal pain, and urinary tract infections.

Cholbam is a prescription medication used to treat pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects and for patients with peroxisomal disorders.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Asklepion

Serious side effects have been reported with Cholbam. See the “Cholbam Precautions” section.

Common side effects of Cholbam inlcude:

• diarrhea
• feeling tired
• yellowing of the skin
• skin lesions
• nausea
• vomiting
• abdominal pain
• urinary tract infections

This is not a complete list of Cholbam side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Bile Salt Efflux Pump inhibitors such as cyclosporine (Neoral, Gengraf, Sandimmune, Restasis)
• Bile acid resins such as cholestyramine (Questran, Prevalite), colesevelam (Welchol), and colestipol (Colestid)
• Aluminum-based antacids

This is not a complete list of Cholbam drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Cholbam including the following:

• Liver impairment. Monitor liver function while taking Cholbam.

Do not take Cholbam if you:

• are allergic to Cholbam or to any of its ingredients

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Cholbam, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Cholbam, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Cholbam or to any of its ingredients
• have liver problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-controlled studies that have been done in pregnant women or animals. Cholbam should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

There is a pregnancy surveillance program that monitors pregnancy outcomes in women exposed to Cholbam during pregnancy and women who become pregnant during Cholbam treatment are encouraged to enroll. Contact your healthcare provider for more information.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Cholbam crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Cholbam.

Take Cholbam exactly as prescribed.

Cholbam comes in capsule form and is usually taken once or twice daily with food. Do not chew, divide, or break Cholbam capsules. Swallow capsules whole.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take 2 doses of Cholbam at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

The recommended dosage for Cholbam is 10-15 mg/kg, divided into 1 or 2 doses daily. Doses should be adjusted on patient response to treatment and the presence of side effects.

If you take too much Cholbam, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If Cholbam is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Cholbam at room temperature between 15°C and 30°C (59°F and 86°F).
• Keep this and all medications out of the reach of children.