Trophamine (10% Amino Acid Injection) - Intravenous

What Is Trophamine?

Trophamine is a nutritional amino acid solution given through the veins. It's typically used for young children and infants—although it's used sometimes in adults—who cannot get enough nutrition by mouth. Your body needs amino acids to help build protein. In addition, protein helps your body repair and grow.

A healthcare provider gives the nutrient-dense solution through a central line or peripheral vein ("parenteral nutrition"). For example, a healthcare provider would administer nutrition through your or your child's vein because their normal digestive tract can't be used or absorb nutrients well, or their protein needs are significantly increased (e.g., if your child is ill or injured).

What Is Trophamine Used For?

Infants or young children with low birth weight, digestive problems, are very sick or have another reason for not getting enough nutrients usually need extra nutrition to survive.

Trophamine is either injected in a central vein (central parenteral nutrition) or a peripheral vein like in the arm (peripheral parenteral nutrition). It provides partial nutritional supplementation and is given with hypertonic (larger material-to-fluid ratio than blood) dextrose (carbohydrate source) for extra calories, cysteine hydrochloride, electrolytes, vitamins, and minerals to meet most of your infant's or young child's nutrition needs.

Per pound of body weight, infants have higher calorie and amino acid needs than adults because they are growing fast. And infants may have even greater needs if they are sick. Trophamine solution is designed to be similar to the nutrition provided by breastfeeding but lacks antibodies and essential fatty acids (EFAs). EFAs are important for many body functions, including brain health. EFAs are crucial to children where periods of intense brain growth occur. EFAs can be added to Trophamine solution—especially if used for longer than five days—to prevent essential fatty acid deficiency (EFAD).

Children who receive treatment with Trophamine should experience the following:

• Weight gain
• Improved nitrogen balance
• Improved amino acid levels

How to take Trophamine

Trophamine is administered by a healthcare provider. Your or your child’s healthcare provider will decide whether it is best to give it through a central or peripheral vein.

Central line: Generally, central line administration is recommended when children need long-term treatment or when their nutritional status is severely deficient. Hypertonic dextrose has to be used to help the body produce protein (the body makes protein from amino acids). Insertion of a central catheter into a central vein requires a specialized procedure.

Peripheral line: The solution is typically given through a peripheral vein when it’s used short-term. Diluted amino acid solutions mixed with 5% to 10% dextrose (a carbohydrate source) solutions can be given through a peripheral vein.

Storage

Your or your child’s healthcare providers will typically manage the preparation and storage of Trophamine.

Trophamine should be mixed thoroughly before administration. It shouldn’t be stored after it’s mixed for use. Before mixing, it should be kept in its original unopened container at a temperature of 68 to 77 degrees Fahrenheit (20 to 25 degrees Celsius). It can briefly be in temperatures between 59 to 86 degrees Fahrenheit (15 to 30 degrees Celsius).

Off-Label Uses

Trophamine is not typically used off-label. However, it may be given to people with medical conditions with nutritional needs that can be helped with this solution. 

What Are the Side Effects of Trophamine?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or healthcare provider. You may report side effects to the Food and Drug Administration (FDA) at fda.gov/medwatch or 800-FDA-1088.

Trophamine is generally given under close medical supervision. If your child is receiving Trophamine, their healthcare providers are likely monitoring them closely for side effects and signs or symptoms of their medical condition.

Common Side Effects

The most common side effects of Trophamine include the following:

• Weight gain beyond the target weight
• Edema (swelling) of the body
• Laboratory abnormalities: High ammonia levels or blood urea nitrogen (BUN), mild metabolic acidosis (higher acid levels in the body), and low body fluid, which can cause decreased alertness
• Fever or redness at the infusion site due to infection
• Fluid extravasation (the solution or other fluid leaking into the surrounding tissue)

Your or your child’s medical team will monitor them for signs of these side effects. Side effects can be treated, so they don’t progress or become more severe. Let your or your child’s healthcare provider know if you notice any of these issues.

Severe Side Effects

Sometimes a severe reaction or side effect can occur due to Trophamine. Depending on the situation, your child may need treatment for the adverse effect and/or adjustment or discontinuation of the infusion.

Potential serious side effects of Trophamine include:

• Infusion site reaction: Redness, blood clots, inflammation.
• Phosphorus deficiency (hypophosphatemia): Causes there to not be enough oxygen in the body’s tissues and also acute hemolytic anemia.
• High phosphorus relative to calcium levels can cause cramps, tetany (severe muscle contraction), and muscular hyperexcitability (spontaneous muscle movement).
• Increased aluminum levels: Calcium and phosphate solutions like Trophamine contain aluminum (typically no more than 25 micrograms per liter (mcg/L)). Aluminum can be toxic if your child has kidney conditions or is premature (with less developed kidneys). Let your or your child’s healthcare provider know if you have questions or concerns about using Trophamine.

If your child has any of these reactions, the infusion will be stopped, and your child will receive treatment to reverse any side effects.

Long-Term Side Effects

This solution typically does not cause long-term side effects when used as directed. Aluminum levels should be monitored in premature infants or those with kidney issues to avoid long-term effects on the brain and other parts of the body. Other severe problems during the infusion (such as a blood clot or sepsis) may also have lasting effects on the body. Be sure to discuss any questions or concerns with your healthcare provider.

Dosage: How Much Trophamine Should I Take?

Your or your child’s healthcare providers will typically manage the dosage and administration of Trophamine based on several factors.

The amount of medicine you or your child are administered depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you or your child are administered the medicine depend on the medical problem for which you are using the medicine.

Modifications

Calcium and phosphate solutions like Trophamine contain aluminum. Aluminum can be toxic, especially if your child has kidney conditions or is premature (with less developed kidneys). 

Trophamine should be given to pregnant individuals only if there is a definite need. 

People over the age of 65 years may be more sensitive to fluid overload and electrolyte imbalances due to changes in kidney function. Your healthcare provider should carefully monitor your fluid and electrolyte levels.

Treatment with Trophamine should be avoided in people with inborn errors of amino acid or branched amino acid metabolism where the body has trouble breaking down amino acids (e.g., maple syrup urine disease, isovaleric acidemia), hypersensitivity to any amino acids in the solution, untreated anuria (kidneys don’t produce urine), or hepatic coma (brain function decline when the liver can’t remove toxins from the blood).

Missed Dose

Your or your child’s medical team should be carefully monitoring treatment and addressing any missed doses.

Overdose: What Happens If I Take Too Much Trophamine?

If a child has too much Trophamine, the infusion will be stopped, the child should be evaluated with a physical examination and blood tests, and any adverse effects should be treated. This can include fluid infusion to balance the body’s fluid and electrolyte levels.

Precautions

What Are Reasons I Shouldn’t Take Trophamine?

Treatment with Trophamine should be avoided in people with inborn errors of amino acid or branched amino acid metabolism where the body has trouble breaking down amino acids (e.g., maple syrup urine disease, isovaleric acidemia), hypersensitivity to any amino acids in the solution, untreated anuria (kidneys don’t produce urine), or hepatic coma (brain function decline when the liver can’t remove toxins from the blood).

Calcium and phosphate solutions like Trophamine contain aluminum (typically no more than 25 micrograms per liter (mcg/L)). Aluminum can be toxic if your child has kidney conditions or is premature (with less developed kidneys).

Let your child’s healthcare team know if you have questions or concerns about using Trophamine.

What Other Medications Interact With Trophamine?

Your healthcare provider will determine which additives should not be used or are not compatible with Trophamine. Talk with your or your child's healthcare provider if you have questions about interactions.

And be sure to talk with your healthcare provider about any other medicines you take or plan to take, including over-the-counter (OTC), nonprescription products, vitamins, herbs, or plant-based medicines.

What Medications Are Similar?

Trophamine is a type of total parenteral nutrition (TPN). Healthcare providers use various kinds of TPN in both adults and children. Premasol and Primene are similar to Trophamine. Premasol, however, does not contain sulfites.

How Can I Stay Healthy While Taking Trophamine?

If your child is taking Trophamine, you can help them stay healthy by doing the following:

• Avoid exposure to infections and wash your hands before touching your child.
• Maintain a stable temperature for your child (as directed by their healthcare provider) with socks and/or blankets as needed.
• Keep an eye on your child’s level of alertness. Tell their healthcare team if you notice any changes.
• Keep an eye on the infusion site for any swelling or redness. Tell the healthcare team if you notice any changes.
• And last but certainly not least, be sure to get some rest and take care of yourself so you can stay healthy.