Fat emulsion (Intravenous route)
Deaths due to intravascular fat accumulation in the lungs in preterm infants after infusion of intravenous fat emulsion have been reported in the medical literature . Autopsy findings included intravascular fat accumulation in the lungs. Preterm infants and low-birth-weight infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion . Use caution when treating premature and low birth weight infants with intravenous fat emulsion and strictly adhere to the recommended total daily dose and hourly infusion rates. Hourly infusion rate should be as slow as possible in each case and fat should not in any case exceed 1 g fat/kg in four hours. Carefully monitor serum triglycerides and/or plasma free fatty acid levels in these patients . .
Uses of This Medicine:
Fat emulsions are used as dietary supplements for 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 available only with your doctor's prescription.
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:
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.
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.
Use of Clinolipid® is not indicated in children. Safety and efficacy have not been established.
Appropriate studies have not been performed on the relationship of age to the effects of Omegaven® in the elderly.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Clinolipid® in the elderly.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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.
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
- Gallbladder problems (gallstones) or
- Heart failure or
- Liver disease or
- Pancreatitis (inflammation or swelling of the pancreas), history of or
- Pulmonary edema (fluid in the lungs)—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 this medicine in a medical facility. It is given through a needle placed into one of your veins.
Clinolipid® may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine. Follow the instructions given.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take 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 take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form (emulsion):
- For nutritional supplement:
- Adults—Dose is based on the patient's total nutrition requirements and tolerance and must be determined by your doctor. The starting dose is 0.5 to 1 milliliter (mL) per minute injected slowly into a vein for 15 to 30 minutes. Your doctor may increase the dose as needed.
- Children—Use is not recommended.
- For nutritional supplement:
Precautions While Using This Medicine:
It is very important that your doctor check your or your child's progress weekly while receiving fat emulsions to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Allergic reactions may occur while you or your child are receiving this medicine. Tell your doctor right away if you or your child have the following symptoms: rapid, shallow breathing, trouble breathing, fast heartbeat, lightheadedness, dizziness, or fainting, nausea or vomiting, rash or itching skin, or a fever or chills.
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.
This medicine may cause parenteral nutrition associated liver disease (PNALD). This usually occurs in patients who have been receiving parenteral nutrition for a long time, especially preterm infants. Check with your doctor right away if you have dark urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, yellow skin or eyes.
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). 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:
- More common
- Accumulation of pus
- black, tarry stools
- bladder pain
- bloody or cloudy urine
- bluish lips or skin
- chest pain or discomfort
- difficult, burning, or painful urination
- excessive muscle tone
- frequent urge to urinate
- general feeling of discomfort or illness
- joint pain
- lightheadedness, dizziness, or fainting
- loss of appetite
- lower back or side pain
- muscle aches and pains
- muscle stiffness, tension, or tightness
- pale skin
- runny nose
- slow or irregular heartbeat
- sore throat
- swollen, red, tender area of infection
- trouble sleeping
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- Back pain
- fast heartbeat
- Incidence not known
- Bleeding gums
- changes in skin color
- changes in urination
- coughing up blood
- difficulty in breathing or swallowing
- fruit-like breath odor
- increased menstrual flow or vaginal bleeding
- increased thirst
- prolonged bleeding from cuts
- red or dark brown urine
- red or black, tarry stools
- stomach pain
- swelling and redness in the lower leg
- More common
- redness of the skin
- redness, swelling, or pain at the injection site
- Less common
- Itchy skin
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:
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:
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.
Last Updated: 6/18/2019