What is Carbaglu used for?
Carbaglu is used to treat certain pediatric and adult patients with high ammonia levels. Carbaglu is used as:
- Add-on (adjunctive) therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency.
- Maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency.
- Add-on therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA).
How should I take Carbaglu?
- Read the instructions for use below for information about the right way to take Carbaglu.
- Disperse Carbaglu tablets in water. Do not swallow whole or crushed.
- Take Carbaglu immediately before meals or feedings.
- Carbaglu tablets dispersed in water can be administered orally or via a nasogastric tube or gastrostomy tube as described in the Instructions for Use.
What are the possible side effects of Carbaglu?
The most common adverse reactions (occurring in ≥ 13% of patients) in patients with acute and chronic hyperammonemia due to NAGS deficiency are:
- vomiting
- abdominal pain
- pyrexia
- tonsillitis
- anemia
- diarrhea
- ear infection
- infections
- nasopharyngitis
- hemoglobin decreased
- headache
The most common adverse reactions (≥ 5%) during hyperammonemic episodes in patients with acute hyperammonemia due PA or MMA are:
- neutropenia
- anemia
- vomiting
- electrolyte imbalance
- decreased appetite
- hypoglycemia
- lethargy/stupor
- encephalopathy
- pancreatitis/lipase increased
General information about the safe and effective use of Carbaglu
Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use Carbaglu for a condition for which it was not prescribed. Do not give Carbaglu to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your doctor or pharmacist for information about Carbaglu that is written for health professionals.
How should I store Carbaglu?
- Before opening, store Carbaglu in a refrigerator between 36°F to 46°F (2°C to 8°C) in the container it comes in.
- After opening, store Carbaglu at room temperature between 59°F to 86°F (15°C to 30°C). Do not store Carbaglu in a refrigerator after opening.
- Keep Carbaglu tablets in a tightly closed container to protect the tablets from moisture.
- Write the date the Carbaglu tablet container is opened on the container label. Throw away any unused tablets one month after opening the tablet container.
- Do not use Carbaglu tablets after the expiration date on the tablet container.
- Keep Carbaglu and all medicines out of the reach of children.
What are the ingredients in Carbaglu?
Active ingredient: Carglumic acid
Inactive ingredients: Microcrystalline cellulose, sodium lauryl sulfate, hypromelloses, croscarmellose sodium, silicon dioxide and sodium stearyl fumarate.
Instructions for use for Carbaglu
Carbaglu (CAR-buh-gloo)
(carglumic acid)
Tablets for oral suspension
Important information:
- Carbaglu tablets for oral suspension (Carbaglu tablet) must be mixed in water before taking. Carbaglu tablets should not be mixed in any other food or liquid.
- Do not swallow Carbaglu tablets whole.
- Do not crush Carbaglu tablets.
- Take Carbaglu right before meals or feedings.
- The Carbaglu tablet and water mixture has a slightly sour taste.
You may need to ask your healthcare provider or pharmacist for a medicine cup to measure the correct amount of water you will need to prepare the dose of Carbaglu.
The Carbaglu tablet has 3 lines used for splitting the tablet into 4 equal parts in order to get the prescribed dose. Ask your healthcare provider if you have any questions about how to split the tablet the right way or have any questions about the prescribed dose.
Taking Carbaglu tablets by mouth using a cup:
Children and Adults
1. Add a minimum of 2.5 mL of water into a small cup for each Carbaglu tablet, or each ½ or ¼ Carbaglu tablet, needed for the prescribed dose. For example:
- If the prescribed dose is 2 Carbaglu tablets, add a minimum of 5 mL of water into the cup.
- If the prescribed dose is 2 and a ¼ Carbaglu tablets, add a minimum of 7.5 mL of water into the cup.
- If the prescribed dose is 2 and a ½ Carbaglu tablets, add a minimum of 7.5 mL of water into the cup.
- Ask your healthcare provider if you are not sure of how much water you should use for the prescribed dose of Carbaglu.
2. Place the prescribed number of Carbaglu tablets into the water in the cup.
3. Carefully stir the Carbaglu tablet and water mixture in the cup to avoid spilling the mixture. Carbaglu tablets do not dissolve completely in water.
4. Swallow the Carbaglu tablet and water mixture right away.
5. Pieces of the tablet may remain in the cup. Add more water to the cup to rinse the cup and swallow the mixture right away.
6. Repeat step 5 until there are no pieces of the tablet left in the cup.
Taking Carbaglu tablets by mouth using an oral syringe:
Children
1. Add a minimum of 2.5 mL of water into a small cup for each Carbaglu tablet, or each ½ or ¼ Carbaglu tablet, needed for the prescribed dose. For example:
- If the prescribed dose is 2 Carbaglu tablets, add a minimum of 5 mL of water into the cup.
- If the prescribed dose is 2 and a ¼ Carbaglu tablets, add a minimum of 7.5 mL of water into the cup.
- If the prescribed dose is 2 and a ½ Carbaglu tablets, add a minimum of 7.5 mL of water into the cup.
- Ask your healthcare provider if you are not sure of how much water you should use for the prescribed dose of Carbaglu.
2. Place the prescribed number of Carbaglu tablets into the water in the cup.
3. Carefully stir the Carbaglu tablet and water mixture in the cup to avoid spilling the mixture. Carbaglu tablets do not dissolve completely in water.
4. Draw up all of the Carbaglu tablet and water mixture in the cup into an oral syringe.
5. Give your child the Carbaglu tablet and water mixture right away by placing the tip of the oral syringe along the inner cheek of their mouth, on either the right or left side. Slowly push all the way down on the plunger to give the medicine.
6. Pieces of the tablet may remain in the oral syringe. Refill the oral syringe with a minimum of 1 mL to 2 mL of water, and give your child the mixture right away.
7. Repeat step 6 until there are no pieces of the tablet left in the oral syringe.
Giving Carbaglu tablets through a nasogastric (NG) or gastrostomy tube (G-tube):
Children and Adults
1. Add a minimum of 2.5 mL of water into a small cup for each Carbaglu tablet, or each ½ or ¼ Carbaglu tablet, needed for the prescribed dose. For example:
- If the prescribed dose is 2 Carbaglu tablets, add a minimum of 5 mL of water into the cup.
- If the prescribed dose is 2 and a ¼ Carbaglu tablets, add a minimum of 7.5 mL of water into the cup.
- If the prescribed dose is 2 and a ½ Carbaglu tablets, add a minimum of 7.5 mL of water into the cup.
- Ask your healthcare provider if you are not sure of how much water you should use for the prescribed dose of Carbaglu.
2. Place the prescribed number of Carbaglu tablets into the water in the cup.
3. Carefully stir the Carbaglu tablet and water mixture in the cup to avoid spilling the mixture. Carbaglu tablets do not dissolve completely in water.
4. Draw up all of the Carbaglu tablet and water mixture in the cup into a catheter-tip syringe.
5. Connect the catheter-tip syringe to the NG tube or G-tube.
6. Give the Carbaglu tablet and water mixture through the NG tube or G-tube right away.
7. Pieces of the tablet may remain in the catheter-tip syringe or NG tube or G-tube.
8. Refill the catheter-tip syringe with 1 mL to 2 mL of water and flush the NG tube or G-tube right away.
9. Repeat step 8 until there are no pieces of the tablet left in the catheter-tip syringe or NG tube or G-tube.
How should I store Carbaglu?
- Before opening, store Carbaglu in a refrigerator between 36°F to 46°F (2°C to 8°C) in the container it comes in.
- After opening, store Carbaglu at room temperature between 59°F to 86°F (15°C to 30°C). Do not store Carbaglu in a refrigerator after opening.
- Keep Carbaglu tablets in a tightly closed container to protect the tablets from moisture.
- Write the date the Carbaglu tablet container is opened on the container label. Throw away any unused tablets one month after opening the tablet container.
- Do not use Carbaglu tablets after the expiration date on the tablet container.
- Keep Carbaglu and all medicines out of the reach of children.
Instructions for use issued 01/2021.
