Carbaglu

Name: Carbaglu

Adverse Effects

Note: Adverse effects are derived from retrospective case series of 23 patients

>10%

Vomiting (26%)

Abdominal pain (17%)

Pyrexia (17%)

Tonsillitis (17%)

Anemia (13%)

Ear infection (13%)

Diarrhea (13%)

Nasopharyngitis (13%)

Headache (13%)

1-10%

Asthenia (9%)

Somnolence (9%)

Dysgeusia (9%)

Hyperhidrosis (9%)

Weakness (9%)

Pneumonia (9%)

Anorexia (9%)

Weight loss (9%)

Influenza (9%)

Rash (9%)

Carbaglu Drug Class

Carbaglu is part of the drug class:

  • Amino acids and derivatives

What should i discuss with my healthcare provider before taking carglumic acid (carbaglu)?

Tell your doctor about all of your medical conditions.

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.

FDA pregnancy category C. It is not known whether carglumic acid will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether carglumic acid passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using carglumic acid.

What is carglumic acid?

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 is the most important information I should know about carglumic acid?

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.

Carglumic acid side effects

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:

  • vomiting, diarrhea, stomach pain;

  • 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.

Carbaglu Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Chills
  • cough or hoarseness
  • decreased weight
  • diarrhea
  • fever or chills
  • general feeling of discomfort or illness
  • headache
  • increased sweating
  • joint pain
  • loss of appetite
  • lower back or side pain
  • muscle aches and pains
  • nausea
  • painful or difficult urination
  • pale skin
  • runny nose
  • shivering
  • sore throat
  • sweating
  • trouble sleeping
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
  • Fast, pounding, or irregular heartbeat or pulse
  • increase in mucous from the lungs
  • restlessness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abdominal or stomach pain
  • change in hearing
  • change in taste
  • congestion
  • ear drainage
  • earache or pain in the ear
  • lack or loss of strength
  • loss of taste
  • rash
  • sleepiness or unusual drowsiness
  • stuffy or runny nose
  • swollen glands

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Warnings and Precautions

5.1 Hyperammonemia

Any episode of acute symptomatic hyperammonemia should be treated as a life-threatening emergency. Treatment of hyperammonemia may require dialysis, preferably hemodialysis, to remove a large burden of ammonia. Uncontrolled hyperammonemia can rapidly result in brain injury/damage or death, and prompt use of all therapies necessary to reduce plasma ammonia levels is essential.

Management of hyperammonemia due to NAGS deficiency should be done in coordination with medical personnel experienced in metabolic disorders. Ongoing monitoring of plasma ammonia levels, neurological status, laboratory tests and clinical responses in patients receiving Carbaglu is crucial to assess patient response to treatment.

5.2 Therapeutic Monitoring

Plasma ammonia levels should be maintained within normal range for age via individual dose adjustment.

5.3 Nutritional Management

Since hyperammonemia is the result of protein catabolism, complete protein restriction is recommended to be maintained for 24 to 48 hours and caloric supplementation should be maximized to reverse catabolism and nitrogen turnover.

Packaging and labeling

Carbaglu bottle label - 60 Tablets in Bottle

Carbaglu carton label - 60 Tablets in Bottle

Carbaglu bottle label - 5 Tablets in Bottle

Carbaglu carton label - 5 Tablets in Bottle

Carbaglu  
carglumic acid tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52276-312
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Carglumic acid (Carglumic acid) Carglumic acid 200 mg
Inactive Ingredients
Ingredient Name Strength
Cellulose, Microcrystalline 270 mg
Sodium Lauryl Sulfate 0.50 mg
HYPROMELLOSES 4.0 mg
Croscarmellose sodium 19.0 mg
Silicon Dioxide 1.5 mg
SODIUM STEARYL FUMARATE 5.0 mg
Product Characteristics
Color white (Bar-shaped) Score 3 pieces
Shape RECTANGLE (Bar-shaped) Size 18mm
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:52276-312-05 5 TABLET in 1 BOTTLE
2 NDC:52276-312-60 60 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022562 03/18/2010
Labeler - Orphan Europe, SARL (767598352)
Registrant - Orphan Europe, SARL (767598352)
Establishment
Name Address ID/FEI Operations
Aesica Pharmaceuticals GmbH 341737465 manufacture(52276-312)
Revised: 11/2015   Orphan Europe, SARL

Important information

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.

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 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.

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

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.

Before taking this medicine

Tell your doctor about all of your medical conditions.

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.

FDA pregnancy category C. It is not known whether Carbaglu will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Carbaglu. It is not known whether carglumic acid passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using Carbaglu.

How should I take Carbaglu?

Take Carbaglu exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

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

Carbaglu is usually taken 2 to 4 times each day, just before each meal or feeding. Follow your doctor's instructions.

Do not chew, crush, or swallow the Carbaglu tablet whole. Place it into a glass of water and allow the tablet to disperse in the liquid. The tablet will not dissolve completely. Drink this mixture right away. To make sure you get the entire dose, add a little more liquid to the same glass, swirl gently and drink right away.

The Carbaglu tablet may be taken with an oral syringe as follows: Place a 200-milligram tablet into an oral syringe and draw 2.5 milliliters of water into the syringe. Shake until the tablet is dispersed and then empty the syringe into your mouth. Refill the syringe with water, shake gently, and empty into your mouth.

The Carbaglu tablet can also be given through a nasogastric (NG) feeding tube as follows: Disperse the tablet in an oral syringe as directed above. Attach the syringe to the NG tube and push the plunger down to empty the syringe into the tube. Then flush the tube with more water to wash the contents down.

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.

Store unopened bottles of Carbaglu tablets in the refrigerator, do not freeze. After opening the bottle, store at room temperature away from moisture and heat. Do not store opened bottles in the refrigerator. Keep the bottle tightly closed when not in use.

When you open the bottle, write the date on the bottle. Throw away any unused tablets 1 month (30 days) after the date of opening, or if the expiration date printed on the label has passed.

What should I avoid?

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.

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