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Medications and Drugs

Brand Names: Carbaglu

Generic Name: carglumic acid (Pronunciation: kar GLOO mik AS id)

What is carglumic acid (Carbaglu)?

Carglumic acid is a man-made form of an enzyme that occurs naturally in the liver. This enzyme is necessary for processing excess nitrogen produced when the body metabolizes proteins. Without this enzyme, nitrogen builds up in the form of ammonia and is not removed from the body. Ammonia is very toxic when it circulates in blood and tissues and can cause permanent brain damage, coma, or death.

Carglumic acid is used to treat hyperammonemia (HYE-per-AM-moe-NEE-mee-a), a urea cycle disorder caused by lack of a certain liver enzyme. Carglumic acid is usually given with other medications to treat this lifelong disorder.

Carglumic acid may also be used for purposes not listed in this medication guide.

What are the possible side effects of carglumic acid (Carbaglu)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
  • pain or fullness in your ear, hearing problems.

Less serious side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about carglumic acid (Carbaglu)?

Avoid eating foods that are high in protein when you first start taking carglumic acid. Follow your doctor's instructions about any other restrictions on food, beverages, or activity.

Your doctor may occasionally change your dose to make sure you get the best results. Dose adjustments are especially important as your child grows.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. A buildup of ammonia in the blood can quickly cause brain injury or death. Do not miss any follow up visits to your doctor for blood tests. Every person with a urea cycle disorder should remain under the care of a doctor.

If you skip a meal, do not take your dose of carglumic acid. Wait until your next meal.

Carglumic acid is only part of a complete program of treatment that may also include a special diet and other medications. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you should eat or avoid to help control your condition.



Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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