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INDICATION(S) AND IMPORTANT SAFETY INFORMATION

What is CARBAGLU?

Carbaglu^® (carglumic acid) tablets for oral suspension 200 mg is a prescription medicine used in adults and children to:

supplement standard of care treatment for acute high blood ammonia levels (hyperammonemia) due to the lack or shortage of NAGS enzyme activity.
maintain normal blood ammonia levels due to the lack or shortage of NAGS enzyme activity.
supplement standard of care treatment for acute high blood ammonia levels (hyperammonemia) due to propionic acidemia (PA) or methylmalonic acidemia (MMA).

IMPORTANT SAFETY INFORMATION

Before starting CARBAGLU, tell your healthcare provider (HCP) about all your medical conditions, including if you are pregnant or plan to become pregnant, breastfeeding or plan to breastfeed. Tell your HCP about all the medicines you take, including any prescription and over-the-counter medicines, vitamins, or herbal supplements.

Tell your healthcare provider if you are pregnant. Women with NAGS deficiency who are exposed to CARBAGLU during pregnancy can participate in a pregnancy surveillance program that monitors pregnancy outcomes.

What are the possible side effects of CARBAGLU?

The most common side effects of CARBAGLU in studies for NAGS deficiency (in ≥13% of patients) are: vomiting, abdominal pain, fever, inflammation of the tonsils, reduced red cells in the blood, diarrhea, ear infection, infections, inflammation of the throat and nasal passages, hemoglobin decreased in red blood cells, and headache.

The most common side effects of CARBAGLU in studies for PA and MMA (in ≥5% of patients) are: lower than normal white blood cells, reduced red cells in the blood, vomiting, abnormal levels of minerals in the body, decreased appetite, low blood sugar levels, lack of energy/unresponsiveness, brain disease that alters brain structure or function, and inflammation of the pancreas / increase in a type of protein made by the pancreas that helps the body digest fats.

These are not all the possible side effects of CARBAGLU. Call your healthcare provider for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Call FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

CARBAGLU^® (carglumic acid) is available as 200 mg tablets for oral suspension.

Please see the accompanying full Prescribing Information, including Instructions for Use.

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