Patient Medication Information: uses, side effects, how to take - Ammivo
What AMMIVO is used for:
AMMIVO is a medicine used in children and adults to lower high ammonia levels in the blood. Ammonia is a waste product made when the body breaks down protein. Too much ammonia can harm the brain. This can happen in people with a condition called urea cycle disorders, where the body cannot properly break down protein.
How AMMIVO works:
AMMIVO is a nitrogen-binding agent that lowers high ammonia levels in people with urea cycle disorders. It contains two ingredients: sodium phenylacetate and sodium benzoate. These ingredients bind nitrogen (from protein) and help remove it from the body. This lowers ammonia levels.
AMMIVO is sometimes used with other treatments to help work better. These may include :
- changes to your diet,
- use of a medicine called arginine,
- dialysis (a treatment that removes ammonia from your blood).
The ingredients in AMMIVO are:
Medicinal ingredient(s): Sodium phenylacetate and sodium benzoate
Non-medicinal ingredients: Hydrochloric acid, sodium hydroxide, and water for injection
AMMIVO comes in the following dosage form(s):
Solution, 100 mg/mL sodium phenylacetate and 100 mg/mL sodium benzoate.
Do not use AMMIVO if:
- You are allergic to sodium phenylacetate or sodium benzoate.
- You are allergic to any other ingredients in AMMIVO, or to any part of the container.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AMMIVO. Talk about any health conditions or problems you may have, including if you:
- Are taking other medicines to manage urea cycle disorders
Have problems with your:
- kidneys, including kidney failure or other kidney diseases
- liver, including liver failure or other liver diseases
- heart, including heart failure or other heart diseases
Are pregnant, think you might be pregnant, or are planning to become pregnant. It is not known if this medicine may harm your unborn baby. You and your healthcare professional will decide if you should receive this medicine during pregnancy.
- Are breastfeeding. It is unknown if this medicine passes into breast milk. You and your healthcare professional will decide if you should receive this medicine while breastfeeding.
Other warnings you should know about:
- It is important to treat high ammonia levels right away. If the ammonia in your blood stays too high for too long, it can harm your brain.
- Your healthcare professional will check your health regularly, including blood tests, while you are receiving AMMIVO. This helps make sure the medicine is working and that you are not having any side effects.
- AMMIVO can lower the level of potassium in your body. Your healthcare professional will check your potassium levels with blood tests.
- AMMIVO contains salt (sodium). It should be used carefully if you have heart or kidney problems, because it can make your body hold onto extra water (fluid).
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Some medicines can change how AMMIVO works. You may need more frequent blood tests.
- Salicylates are medicines used to relieve pain, reduce fever, and reduce swelling. Sodium benzoate, an ingredient in AMMIVO, may cause salicylates to stay in the body longer, which can increase their levels in the body.
- Antibiotics, such as penicillin or probenecid (used to treat gout), can slow down how AMMIVO is removed from your body.
- Valproic acid (used to treat seizures) may increase ammonia levels in your blood.
- Corticosteroids (medicines that reduce swelling and calm the immune system) may increase the breakdown of protein in your body and raise ammonia levels in your blood.
How to take AMMIVO:
AMMIVO will be given to you by a healthcare professional in a hospital setting:
- Your healthcare professional will ensure that it is prepared correctly before it is given to you.
You will receive at least two doses of AMMIVO:
- The first dose will be given to you for 90 to 120 minutes.
- The second dose will be given to you over 24 hours. Additional 24-hour infusions will be given to you as needed.
- AMMIVO will be injected through a central line. A central line is a tube that goes to a large vein in your neck, chest, or arm.
Usual dose:
- Your healthcare professional will decide how much AMMIVO you need and how long you will be given it.
- The usual dose is based on your weight and/or height.
Overdose:
Your healthcare professional will monitor you for signs and symptoms of an overdose. If an overdose is suspected, your healthcare professional will act accordingly to manage your side effects.
Symptoms of an overdose with AMMIVO include:
- irritability
- fatigue
- confusion, disorientation, or poor attention span
- a reduced level of alertness
- loss of consciousness
- difficulty breathing or breathing faster than normal
- dehydration, increased thirst, or increased urination
| If you think you, or a person you are caring for, have received too much AMMIVO, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
|---|
Possible side effects from using AMMIVO:
These are not all the possible side effects you may have when taking AMMIVO. If you experience any side effects not listed here, tell your healthcare professional.
- fatigue, weakness, or shortness of breath
- diarrhea
- vomiting
- fever
- ear pain
- agitation
- low blood pressure (hypotension): Signs include dizziness or lightheadedness, feeling faint or fainting, and blurred vision
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Very Common | |||
| Pain or discomfort at the injection site: burning, itching, redness, pain, swelling, blisters, skin sores, or fluid leaking where the medicine is injected into your body. | ✓ | ||
| Common | |||
| Acidosis (too much acid in the blood): confusion, fast breathing, fast heartbeat, a heartbeat that does not feel normal, very bad stomach pain, feel very sleepy, shortness of breath, or feeling very tired or weak | ✓ | ||
| Hyperammonemia (too much ammonia in the blood): irritability or mood changes, vomiting, headache, or confusion | ✓ | ||
Blood sugar problems
| ✓ | ||
| Hypokalemia (low potassium): like muscle pain or weakness, muscle cramps, or heartbeat that does not feel normal | ✓ | ||
Low blood cell counts may include:
| ✓ | ✓ | |
| Urinary tract infection: pain or pressure in your stomach or pelvic area, cloudy, foul-smelling pee, urinating more often than normal, pain when you pee, or blood in your pee | ✓ | ||
Nervous (neurological) problems: feeling very sleepy or tired, feeling lightheaded, headaches, changes in taste, changes in hearing, feeling confused or disoriented, memory problems, worsening of existing nerve problems, seizures | ✓ | ✓ | |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
AMMIVO will be stored by your healthcare professional or the hospital as follows:
- Store between 15°C and 30°C.
Your healthcare professional will not use this medicine if:
- there are particles in the bottle or dispenser,
- the solution appears cloudy or discoloured, or
- the product is leaking
If you want more information about AMMIVO:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.sterimaxinc.com; or by calling 1-800-881-3550.
Date of Authorization: 2026-09-16