Carbaglu

Generic name: Carglumic Acid
Drug class: Miscellaneous uncategorized agents

Usage of Carbaglu

Carbaglu 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.

Carbaglu is used to treat hyperammonemia (HYE-per-AM-moe-NEE-mee-a), a urea cycle disorder caused by lack of a certain liver enzyme.

Carbaglu is usually given with other medications to treat this lifelong disorder.

Carbaglu side effects

Get emergency medical help if you have signs of an allergic reaction to Carbaglu: 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:

changes in your mental status, thinking problems, drowsiness, loss of balance, involuntary eye movements;

pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting;

low blood sugar - headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky;

signs of an electrolyte imbalance - increased thirst or urination, constipation, muscle pain or weakness, leg cramps, numbness or tingling, feeling jittery, irregular heartbeats, fluttering in your chest, or a choking feeling;

signs of an ear infection - fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child;

low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or

low white blood cell counts - fever, mouth sores, skin sores, sore throat, cough, trouble breathing.

Common Carbaglu side effects may include:

low blood sugar;

anemia;

electrolyte imbalance;

low white blood cell counts;

ear pain, trouble hearing, drainage from the ear;

abnormal lab tests;

decreased appetite, vomiting, diarrhea, stomach pain;

fever, infections;

decreased alertness, feeling very weak or tired;

changes in mental status;

headache; or

stuffy nose, sore throat.

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.

Before taking Carbaglu

Carbaglu 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.

Follow your doctor's instructions about taking Carbaglu if you are pregnant. It is very important to control your ammonia levels during pregnancy. Do not stop taking this medicine without your doctor's advice, and tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of Carglumic acid on the baby.

It may not be safe to breastfeed while using Carbaglu. Ask your doctor about any risk.

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How to use Carbaglu

Usual Adult Dose of Carbaglu for Hyperammonemia:

The total daily dose should be divided into 2 to 4 doses and rounded to the nearest 100 mg. Initial dose: 100 to 250 mg/kg orally per day in 2 to 4 divided doses immediately prior to meals. Concomitant administration of other ammonia lowering therapies is recommended. Dosing should be titrated based on individual patient plasma ammonia levels and clinical symptoms. Maintenance dose: Usually less than 100 mg/kg orally per day in 2 to 4 divided doses immediately prior to meals. The recommended maintenance dose should be titrated to target normal plasma ammonia level for age.

Usual Pediatric Dose of Carbaglu for Hyperammonemia:

The total daily dose should be divided into 2 to 4 doses. Initial dose: 100 to 250 mg/kg orally per day in 2 to 4 divided doses immediately prior to meals or feedings. Concomitant administration of other ammonia lowering therapies is recommended. Dosing should be titrated based on individual patient plasma ammonia levels and clinical symptoms. Maintenance dose: Usually less than 100 mg/kg orally per day in 2 to 4 divided doses immediately prior to meals or feedings.

Warnings

Avoid eating foods that are high in protein when you first start taking Carbaglu. Follow your doctor's instructions about any other restrictions on food, beverages, or activity. If you skip a meal, do not take your dose of Carbaglu. Wait until your next meal.

To be sure Carbaglu 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.

Tell your doctor about all of your medical conditions.

What other drugs will affect Carbaglu

Other drugs may interact with carglumic acid, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Disclaimer

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