Omegaven (Intravenous)

Fat emulsions are used to provide nutrition to patients who cannot get enough fat from 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 body functions.

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

It is very important for your doctor to closely monitor your or your child's progress while receiving this medicine. This will help your doctor determine if the medicine is working properly. Blood and urine tests will be necessary to check for side effects.

This medicine may cause acute respiratory distress syndrome and metabolic acidosis in newborns and infants if given too quickly. Contact your doctor immediately if your child has blue lips, fingernails, or skin, difficulty breathing, confusion, drowsiness, rapid breathing, muscle tremors, nausea, restlessness, stomach cramps, or unusual tiredness or weakness.

This medicine may lead to serious allergic reactions. Contact your doctor right away if you experience bluish discoloration of fingernails, lips, skin, palms, or nail beds, blurred vision, chest tightness, confusion, cough, dizziness, faintness, or lightheadedness when standing up suddenly, rapid, pounding, or irregular heartbeat or pulse, nausea, sweating, trouble breathing, unusual tiredness or weakness, or vomiting.

This medicine may increase your risk of infections. Avoid close contact with sick individuals while you or your child are receiving this medicine. Wash your hands frequently. Inform your doctor if you have any kind of infection before starting this medicine, and also mention if you have ever had an infection that wouldn’t go away or one that kept coming back.

Call your doctor immediately if you or your child develop a persistent cough, weight loss, night sweats, fever, chills, or flu-like symptoms such as a runny or stuffy nose, headache, blurred vision, or general feeling of illness. These may indicate an infection.

This medicine may cause a rare condition called fat overload syndrome. Inform your doctor right away if you or your child experience fever, chills, cough, sore throat, pain or fullness in the right upper abdomen or stomach, or unusual bleeding, bruising, or weakness.

Contact your doctor if you or your child experience 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 harm the brain and can be life-threatening. Discuss any concerns with your doctor.

Before undergoing any medical tests, inform the medical doctor in charge that you are receiving this medicine. The results of some tests may be influenced by this medicine.

Do not take other medicines unless you have discussed them 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 need to consider the risks against the benefits. Here are important points to think about:

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 about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Research so far shows no pediatric-specific issues that would limit the use of Omegaven® in children. However, children may be more likely to experience unwanted effects (like agitation, slow heartbeat, or vomiting). Safety and effectiveness have been confirmed in children.

Research so far shows no pediatric-specific issues that would limit the use of Intralipid® in children.

Geriatric

There have been no studies on how Omegaven® affects elderly patients.

No information is available on how Intralipid® affects elderly patients.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if a reaction might happen. In such cases, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain foods due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine works. Be sure to tell your doctor if you have any other medical conditions, 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 these cases.

• 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. It may worsen these conditions.

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

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

• Infection—It may reduce your body's ability to fight infections.

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

• Severely undernourished patients—This may lead to refeeding syndrome. Monitor and increase nutrient intake slowly for these patients.

Along with its needed 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 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. 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.

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.