Pronunciation:

fat e-MULL-shun

Brand Names:

• Clinolipid
• Liposyn
• Omegaven

Dosage Forms:

• Emulsion

Classifications:

Therapeutic—

Parenteral Lipids

Uses of This Medicine:

Fat emulsions are used for nutritional support in patients who are unable to get enough fat in their diet, usually because of certain illnesses (eg, parenteral nutrition-associated cholestasis) or recent surgery. Fats are used by the body for energy and to form substances needed for normal body functions.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Omegaven® in children. However, children are more likely to have unwanted effects (eg, agitation, slow heartbeat, vomiting). Safety and efficacy have been established in children.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Intralipid® in children.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of Omegaven® in the elderly.

No information is available on the relationship of age to the effects of Intralipid® in geriatric patients.

Breast-feeding—

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

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to egg, fish, or soybean proteins, olive oil, or safflower oil or
• Bleeding disorder, severe or
• Hyperlipidemia (high triglycerides or fats in the blood), severe or
• Lipid metabolism disorders, severe—Should not be used in patients with these conditions.

• Blood problems or
• Diabetes or
• Liver disease or
• Lung or breathing problems or
• Pancreatitis (inflammation or swelling of the pancreas), history of—Use with caution. May make these conditions worse.

• Electrolyte imbalance or
• Fluid disorder or
• Metabolic disorders, severe—Should be corrected first before receiving this medicine.

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

• Infection—May decrease your body's ability to fight infections.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Undernourished patients, severely—May cause refeeding syndrome. Monitor and increase nutrient intake slowly for the patients.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress closely while you are receiving this medicine. This will allow your doctor to 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, difficult, 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.

Side Effects of This Medicine:

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 or nurse immediately if any of the following side effects occur:

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. 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

Agitation

redness of the skin

redness, swelling, or pain at the injection site

Less common

Itchy skin

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.