Omegaven

What is Omegaven used for?

Omegaven is a prescription medicine that is used to aid diet needs. It is used to give nutrition to the body.

Description

Omegaven (fish oil triglycerides) is a sterile, nonpyrogenic, white, homogenous emulsion for intravenous infusion as a supply of calories in patients with PNAC. Each mL of Omegaven contains 0.1 g of fish oil, 0.012 g egg phospholipids, 0.025 g glycerin, 0.15 to 0.3 mg dl-alpha-tocopherol, 0.3 mg sodium oleate, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 9). The phosphate content is 0.015 mmol/mL.

The fish oil included in Omegaven is a triglyceride mixture consisting of esters of long-chain saturated fatty acids and unsaturated fatty acids with the following structure:

 Mechanism of Action

Omegaven provides a biologically utilizable source of calories and essential fatty acids.

Fatty acids serve as an important substrate for energy production. The most common mechanism of action for energy production derived from fatty acid metabolism is beta oxidation. Fatty acids are also important for membrane structure and function, as precursors for bioactive molecules (such as prostaglandins), and as regulators of gene expression.

Before taking Omegaven, tell your doctor:

• If you are allergic to Omegaven; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have bleeding problems.
• If you have high triglycerides, talk with your doctor.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Omegaven with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Omegaven?

• Tell all of your health care providers that you take Omegaven. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Omegaven.
• Unsafe allergic effects may rarely happen.
• High triglyceride levels have happened with Omegaven. Tell your doctor if you have ever had high triglyceride levels.
• This medicine may contain aluminum. There is a chance of aluminum toxicity if you are on Omegaven for a long time. The risk is greater if you have kidney problems. The risk is also higher in premature infants. Talk with the doctor.
• Watch premature infants closely. Very bad and sometimes deadly side effects have happened due to too much fat getting into the lungs. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Omegaven while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Omegaven best taken?

Use Omegaven as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Omegaven that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Fast breathing.
• Shortness of breath.
• Chest pain or pressure or a fast heartbeat.
• Slow heartbeat.
• Dizziness or passing out.
• Blue or gray skin color.
• Very upset stomach or throwing up.
• Headache.
• Sweating a lot.
• Feeling confused.
• Feeling agitated.
• Flushing.
• Feeling very tired or weak.
• Any unexplained bruising or bleeding.
• Swelling, redness, or oozing where Omegaven goes into the body.

What are some other side effects of Omegaven?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Omegaven?

• If you need to store Omegaven at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 50 mL Vial Carton Label

• NDC 63323-205-50 255050
• Omegaven®
• (fish oil triglycerides) Injectable emulsion
• 5 grams per 50 mL
• (0.1 grams per mL)
• For intravenous use only. Rx only
• Sterile.
• Store below 25°C. (77°F). Do not freeze.
• Use only if the emulsion is homogeneous.
• See prescribing information.
• Not made with natural rubber latex
• 10 x 50 mL
• Single-Dose bottle-
• Discard Unused Portion

PACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 100 mL Vial Label

• NDC 63323-205-31 255100
• Omegaven®
• (fish oil triglycerides) Injectable emulsion
• 10 grams per 100 mL
• (0.1 grams per mL)
• Energy: 112 kcal per 100 mL
• For intravenous use only. Rx only
• 100 mL Single-Dose bottle – Discard Unused Portion

 

PACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 100 mL Vial Carton Label

• NDC 63323-205-00 255100
• Omegaven®
• (fish oil triglycerides) Injectable emulsion
• 10 grams per 100 mL
• (0.1 grams per mL)
• For intravenous use only. Rx only
• Sterile.
• Store below 25°C. (77°F). Do not freeze.
• Use only if the emulsion is homogeneous.
• See prescribing information.
• Not made with natural rubber latex
• 10 x 100 mL Single-Dose bottle-
• Discard Unused Portion

SRC: NLM .