Fat emulsion (Intravenous)

Fat emulsions are used to help provide nutrition to patients who cannot get enough fat in their diet, often due to specific illnesses (for example, parenteral nutrition-associated cholestasis) or recent surgery. The body uses fats for energy and to create substances necessary for normal functions.

This medicine should only be given by your doctor or under their direct supervision.

It is very important that your doctor checks your or your child's progress closely while receiving this medicine. This will help your doctor see if the medicine is working properly. Blood and urine tests will be needed to check for unwanted effects.

This medicine may cause acute respiratory distress syndrome and metabolic acidosis in newborns and infants after rapid infusion. Check with your doctor right away if your child has blue lips, fingernails, or skin, difficulty breathing, confusion, drowsiness, fast breathing, muscle tremors, nausea, restlessness, stomach cramps, or unusual tiredness or weakness.

This medicine may cause serious allergic reactions. Check with your doctor right away if you have bluish color of fingernails, lips, skin, palms, or nail beds, blurred vision, chest tightness, confusion, cough, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, fast, pounding, or irregular heartbeat or pulse, nausea, sweating, trouble breathing, unusual tiredness or weakness, or vomiting.

This medicine may increase your risk of developing infections. Avoid being near people who are sick or have infections while you or your child are receiving this medicine. Wash your hands often. Tell your doctor if you have any kind of infection before you start receiving this medicine. Also, tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

Call your doctor right away if you or your child start to have a cough that will not go away, weight loss, night sweats, fever, chills, or flu-like symptoms, such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill. These may be signs that you have an infection.

This medicine may cause a rare condition called fat overload syndrome. Tell your doctor right away if you or your child have a fever, chills, cough, sore throat, right upper abdominal or stomach pain and fullness, or unusual bleeding, bruising, or weakness.

Call your doctor if you or your child have redness, swelling, pain, or infection at the injection site.

This medicine may cause electrolyte imbalance, fluid overload, and aluminum toxicity (too much aluminum in the blood), which may damage the brain and can be life-threatening. Talk to your doctor if you have concerns.

Before you have any medical tests, tell the medical doctor in charge that you are receiving this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it will provide. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any specific problems in children that would limit the usefulness of Omegaven® in pediatric patients. However, children may be more likely to experience unwanted effects (e.g., agitation, slow heartbeat, vomiting). Safety and effectiveness have been confirmed in children.

Studies have not shown any specific problems in children that would limit the usefulness of Intralipid® in pediatric patients.

Geriatric

Studies have not been conducted to determine how age affects the effects of Omegaven® in elderly patients.

There is no information available on how age affects the effects of Intralipid® in geriatric patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction might occur. In these situations, your doctor may want to adjust the dose, or other precautions may be needed. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Allergy to egg, fish, or soybean proteins, olive oil, or safflower oil or
• Severe bleeding disorder or
• Severe hyperlipidemia (high triglycerides or fats in the blood) or
• Severe lipid metabolism disorders—This medicine should not be used in patients with these conditions.

• Blood problems or
• Diabetes or
• Liver disease or
• Lung or breathing issues or
• History of pancreatitis (inflammation or swelling of the pancreas)—Use with caution. This medicine may worsen these conditions.

• Electrolyte imbalance or
• Fluid disorder or
• Severe metabolic disorders—These should be corrected first before receiving this medicine.

• Hypertriglyceridemia (high triglycerides or fats in the blood)—Use with caution. This may increase the risk of pancreas issues.

• Infection—This may lower your body's ability to fight infections.

• Kidney disease—Use with caution. The effects may be heightened due to slower removal of the medicine from the body.

• Severely undernourished patients—This may cause refeeding syndrome. Monitor and gradually increase nutrient intake for these patients.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects happen:

More common

• Accumulation of pus
• black, tarry stools
• bladder pain
• bloody or cloudy urine
• bluish lips or skin
• chest pain or discomfort
• chills
• cough
• diarrhea
• difficult, burning, or painful urination
• excessive muscle tone
• fever
• frequent urge to urinate
• general feeling of discomfort or illness
• headache
• hoarseness
• joint pain
• lightheadedness, dizziness, or fainting
• loss of appetite
• lower back or side pain
• muscle aches, pains, stiffness, tension, or tightness
• nausea
• pale skin
• runny nose
• shivering
• slow or irregular heartbeat
• sore throat
• sweating
• swollen, red, tender area of infection
• trouble sleeping
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Rare

• Back pain
• fast heartbeat
• hives

Incidence not known

• Bleeding gums
• blue lips, fingernails, or skin
• changes in skin color
• changes in urination
• chest tightness
• confusion
• coughing up blood
• difficulty in breathing or swallowing
• drowsiness
• fruit-like breath odor
• increased menstrual flow or vaginal bleeding
• increased thirst
• muscle cramps or tremors
• numbness, tingling, pain, or weakness in the hands or feet
• nosebleed
• paralysis
• prolonged bleeding from cuts
• rash
• red or dark brown urine
• red or black, tarry stools
• restlessness
• stomach pain or cramps
• swelling and redness in the lower leg
• trouble breathing

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. Your health care professional may also be able to suggest 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

• Agitation
• redness of the skin
• redness, swelling, or pain at the injection site

Less common

• Itchy skin

Other side effects not listed may also happen 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.

In the U.S.

• Clinolipid
• Liposyn
• Omegaven

Available Dosage Forms:

• Emulsion

Therapeutic Class: Parenteral Lipids

A nurse or other trained health professional will give you or your child this medicine in a medical facility. It may be used alone or added to your or your baby's TPN bag. It is given through a needle placed into one of your veins.