Omegaven
Omegaven is an intravenous (IV) lipid supplement that's made with fish oil. It's a source of calories and fatty acids for children with liver problems caused by long-term parenteral nutrition (or TPN). This condition is called parenteral nutrition-associated cholestasis (PNAC). Omegaven is given as an infusion into the vein over 8 to 24 hours, depending on your child's needs. Side effects include vomiting and restlessness.
What is Omegaven?
What is Omegaven used for?
- Lipid supplement for children with liver problems from long-term nutrition through the vein (also called parenteral nutrition-associated cholestasis or PNAC)
How Omegaven works
Omegaven is an IV lipid (fat) supplement for children who can't receive nutrition by mouth.
Omegaven contains fish oil, which is a good source of omega-3 fatty acids. Omega-3 fatty acids have many important roles in the body. They provide energy and help cells work properly. They also help your child's body systems work as they should. These include the heart, blood vessels, lungs, immune system, liver, and hormones.
Drug facts
Side effects of Omegaven
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Vomiting (46%)
- Irritated or restless behavior (35%)
- Low heart rate (35%)
- Episodes of pauses in breathing (apnea; 20%)
- Viral infection (16%)
- Skin redness (12%)
Less Common Side Effects
- Rash
- Swollen area of pus
- Redness at injection site
- Stiff muscles
Omegaven serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious allergic reaction: hives, itching, flushing, breathing very fast, trouble breathing, fast heart rate, skin turning blue, fever, confusion, swelling of face or throat
- Serious infection: fever, trouble breathing, cough, diarrhea, stomach pain, weakness, sweating, chills
The following Omegaven side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Shortness of breath
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Omegaven
Pros
- Helps provide a source of calories and essential fats to children with PNAC
- Shown to improve PNAC by lowering inflammation
- Possible to give at home
Cons
- Not a good option if your child has an allergy to fish or egg, since it contains fish oil and egg proteins
- Not used to prevent PNAC
- Not approved for use in adults
Pharmacist tips for Omegaven
- Make sure your child follows up with the nutrition team and gets blood tests on time while taking Omegaven. The team will check fluid and electrolyte levels, blood sugar levels, liver and kidney function, and blood cell count to make sure it's safe. They'll also check the fatty acid and lipid levels. This helps the team see how well your child is absorbing Omegaven and if the dose needs to be changed.
- Usually, each Omegaven infusion takes 8 to 24 hours. How long it specifically takes depends on a few things. This includes your child's dose and how well their body breaks down and absorbs fat. Their prescriber will calculate how fast your child should get the medication (the infusion rate).
- If you're giving Omegaven at home, talk to your child's nutrition team to learn how to give it safely. It's important to follow the instructions to avoid hurting your child or wasting the medication. Never infuse Omegaven at a faster speed than prescribed. Ask the nutrition team if you're not sure how much to give, how fast to infuse, or how long it should take.
- Store Omegaven bottles at room temperature, and keep it in the box until you're ready to use it. Once it's connected to the infusion set, the Omegaven infusion should be completed within 12 hours unless otherwise instructed. Follow the nutrition team's instructions if they give you a specific way to infuse.
- Tell the healthcare team if your child is taking blood thinners like warfarin (Coumadin) or aspirin. Taking these medications with Omegaven might raise the risk of bleeding. The care team might periodically check your child's risk for bleeding after starting Omegaven.
Common questions about Omegaven
Yes. The FDA approved Omegaven in July 2018. It's used as a lipid supplement for children who have parenteral nutrition-associated cholestasis (PNAC). This is a type of liver problem that can happen with long-term parenteral nutrition.
No, Omegaven is only FDA approved for children. Some studies have tested lipid supplements like Omegaven in adults. But current guidelines from the American Society for Parenteral and Enteral Nutrition don't give clear recommendations for adult use. If you're an adult who has liver problems from IV nutrition, talk to your healthcare team. They might consider changing your IV lipid supplement or lowering the dose.
Omegaven is made from fish oil, which is rich in omega-3 fatty acids (EPA and DHA). These fatty acids are help keep many organs and cells in the body healthy. Fish-oil based products like Omegaven also have anti-inflammatory effects that can help lessen the risk of liver damage in children with PNAC. Ask your healthcare team if you have questions about the benefits of Omegaven.
Intralipid and Omegaven are IV lipid supplements that contain different types of fat. Intralipid contains soybean oil. It's high in omega-6 fatty acids that might cause inflammation. Omegaven contains fish oil, which is rich in omega-3 fatty acids. This type of fatty acid helps lower inflammation. Inflammation can cause problems like liver damage. So experts from the American Society for Parenteral and Enteral Nutrition don't usually recommend long-term use of Intralipid in children. The care team will choose the best IV lipid supplement for your child based on their nutritional needs and risk for complications.
Omegaven and SMOFlipid are different IV lipid supplements. They contain different types of fats and are approved for different groups of people. SMOFlipid is made of soybean oil, medium-chain triglycerides, olive oil, and fish oil. It's approved for people of all ages receiving IV nutrition who need a lipid supplement. Omegaven only has fish oil. It's only approved for children with PNAC, a liver problem caused by long-term IV nutrition. If a child has serious liver problems from SMOFlipid, their nutrition team will probably switch them over to Omegaven. Ask the nutrition team if you have questions about the differences between these lipid supplements.
Talk to your fertility specialist about whether Omegaven could help with in vitro fertilization (IVF). Its role isn't completely clear. But some researchers think that IV lipid supplements might help lower pregnancy loss and implantation failure. A study found that a different IV lipid supplement helped improve the chances of pregnancy for people going through IVF. Other research suggests that omega-3 fatty acids, which Omegaven is rich in, might increase the chances of a successful pregnancy. This included pregnancy using IVF. Keep in mind that using Omegaven for IVF is off-label. And more studies are needed to understand it effects on fertility and pregnancy.
You can't buy Omegaven over the counter. It needs a prescription from a healthcare professional. It's usually from a prescriber who specializes in IV nutrition. If you're giving Omegaven at home, the prescriber can help you get the medication from a pharmacy or the manufacturer.
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Risks and warnings for Omegaven
Omegaven can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk of serious harm if it's infused too fast
- Risk factors: Premature or low-weight babies
There have been reports of serious harm in children who got the Omegaven infusion too fast. This harm has included breathing problems and even death. Premature babies and babies who are small for their age are at higher risk.
Your child's nutrition team will carefully calculate the dose and speed for the Omegaven infusion based on your child's weight. They'll also check your child's triglyceride levels to see how well their body breaks down Omegaven. If you're giving Omegaven to your child at home, ask the nutrition team if you're not sure how much of the medication to give or how fast to give it.
Serious allergic reactions
- Risk factors: Allergy to fish or eggs
Omegaven can cause allergic reactions. It contains fish oil and egg proteins, so people with allergies to these products might be at risk. Signs of an allergic reaction can include breathing very fast, trouble breathing, fast heart rate, nausea, and vomiting. It can also include bluish skin, flushing, hives, dizziness, fever, and confusion. If your child has any of these symptoms, stop the Omegaven infusion right away and get medical help.
Risk of infections
- Risk factors: Weak immune system | Not properly cleaning or replacing IV catheters | Not completing the Omegaven infusion within 12 hours of opening it
It's possible for bacteria to grow inside Omegaven. This raise your child's risk of infection.
To avoid infections, make sure to keep your child's catheter (tube) clean. This helps prevent contamination. Also, make sure you know how to prepare and give Omegaven to your child properly. The Omegaven infusion should be completed within 12 hours of hooking it up to the infusion set. If you need to mix Omegaven with parenteral nutrition, the time limits for infusing the mixture are different.
Contact a member of the nutrition team if your child develops signs of an infection. Look out for fever, chills, sweating, and low appetite. Also check the site of your child's IV catheter often for redness, swelling, and discharge. These are also signs of infection.
Problems related to receiving too much lipids (fat overload syndrome)
Although rare, Omegaven can put your child at risk for fat overload syndrome. This is a condition where your child's body can't break down fats properly, causing the fats to build up in the blood. This problem usually goes away after stopping Omegaven.
If your child has a fever, headaches, breathing problems, and sudden bleeds, stop the Omegaven infusion and call their nutrition team right away. These can be signs of fat overload syndrome.
High triglyceride (fat) levels
- Risk factors: Lipid or cholesterol problems | High blood sugar (diabetes) | Children identified as obese
The healthcare team will check your child's triglyceride (fat) levels before starting Omegaven to make sure it's safe. Children with very high triglyceride levels can't use Omegaven. This is because the medication can make their fat levels dangerously high. High triglyceride levels can raise the risk of pancreatitis (inflammation of the pancreas).
The healthcare team will regularly check your child's triglyceride levels during treatment. If the levels get too high, they might need to stop Omegaven until the levels go down. Then, your child might be able to restart treatment at a lower dose.
Aluminum toxicity
- Risk factors: Kidney problems | Preterm babies | Long-term use
Omegaven contains aluminum. Aluminum can build up to toxic levels in children with kidney problems. This includes babies who were born early because they have underdeveloped kidneys. Too much aluminum in your child's body can lead to bone and brain problems.
Let your child's healthcare team know if your child has kidney problems. This makes sure they know to look out for signs of aluminum toxicity.
Omegaven dosage
Typical dosage for Omegaven
Omegaven is given as an infusion into the vein (intravenously or IV). It's usually given over 8 to 24 hours. Your child's prescriber will determine how fast your child will receive the infusion (the infusion rate).
The dose differs for each person. This is because it's based on your child's weight (in kg units), age, and medical conditions. It also depends on how well their body can absorb and break down fats.
In general, the dose typically ranges between 0.5 gram/kg and 1 gram/kg of Omegaven per day. Your child's prescriber will calculate the dose to make sure your child is getting the appropriate amount they need.
Omegaven contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Omegaven will not be safe for you to take.
- Allergy to fish or eggs
- Severe bleeding problems (related to problems with forming blood clots)
- Severely high triglyceride levels (greater than 1,000 mg/dL)
What are alternatives to Omegaven?
Omegaven images
