Drug Class: The approval date is August 25, 2014.
Company: Intravenous nutritional products are a type of drug.
Company: Fresenius Kabi USA
Treatment for: Parenteral Nutrition
The Food and Drug Administration has approved both Kabiven and Perikabiven
Parenteral nutrition (PN) products with amino acids, electrolytes, dextrose, and lipids that come in a three-chamber bag have been approved by the U.S. Food and Drug Administration. The three-chamber bag makes it easier to give parenteral nutrition because it has a solution that is already mixed and can be kept on the shelf until the patient needs it.
When to use it and when not to use it
- Kabiven and Perikabiven are both used to give calories, protein, electrolytes, and essential fatty acids to adult patients who need parenteral nutrition when oral or enteral nutrition isn’t possible, isn’t enough, or isn’t safe. Kabiven and Perikabiven can be given to adults to prevent or treat a lack of essential fatty acids or a negative nitrogen balance.
- Kabiven is meant to be given through an IV into a central vein.
- Perikabiven is given through an IV in a peripheral vein or a central vein.
- Neither Kabiven nor Perikabiven is recommended for use in children younger than 2 years, including preterm babies, because the fixed amounts of ingredients in these medicines don’t meet the nutritional needs of children this age.
Important Safety Information:
- It has been written that preterm babies have died.
- The autopsy showed that fat had built up inside the blood vessels in the lungs.
- Babies born early or with a low birth weight have trouble getting rid of intravenous lipid emulsion and have higher levels of free fatty acids in their blood after lipid emulsion infusion.
Contraindications
- If you are allergic to egg, soy proteins, peanut proteins, corn or corn products, or any of the active ingredients or inactive ingredients.
- Severe hyperlipidemia or severe lipid metabolism disorders with serum triglycerides of more than 1000 mg/dL.
- Imperfect metabolism of amino acids from birth.
- Instability in the heart and lungs.
- The Hemophagocytic Syndrome.
Warnings and Safety Measures
- Kabiven is a hypertonic drug that, if infused into a peripheral vein, can cause vein irritation, vein damage, and even thrombosis. Kabiven should only be given through a central vein.
- Keep an eye out for any signs or symptoms of hypersensitivity reactions and stop the infusion if they happen.
- Closely watch the patient for signs and symptoms of infection, high triglycerides, high blood sugar, and problems with refeeding.
- Keep an eye on changes in electrolytes, liver and kidney function, fluid status, and coagulation parameters in the lab. Change the rate and amount of Kabiven and Perikabiven based on how the patient is doing.
Contact Fresenius Kabi USA, LLC, Vigilance & Medical Affairs at 1-800-551-7176 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch to report SUSPECTED ADVERSE REACTIONS.
Please look at the full prescribing information for Kabiven and Perikabiven, which includes the Boxed Warning.
Information for patients about the drug Kabiven
- Kabiven is only given through an infusion through a catheter in the central vein.
- There may be allergic reactions.
- When medicines are given through an IV, there is a chance of infection and sepsis.
- Kabiven can cause side effects like nausea and vomiting, too much fat in the blood (called lipids), high blood sugar, abnormally high levels of transaminase and bilirubin, or high or low levels of electrolytes in the blood.
- They should talk to their doctor if they have signs of an allergic reaction, infection, high or low blood sugar, nausea, vomiting, fluid retention, or any other health problem.
- Get regular lab tests and check in with their healthcare provider regularly.
- Tell their doctor if they start or stop taking any prescription or over-the-counter drugs or supplements. This will help avoid drug interactions and side effects.
- Tell people the following when they give themselves a Kabiven injection at home:
- Patients and/or carers must be taught how to check Kabiven, turn it on, and give it.
- Follow the Kabiven instructions for inspection, activation, and use.
- Don’t go against the instructions for giving the medicine.
- Check the product before you use it for signs of damage, dirt, or discoloration.
- Throw away the bag if any of the following happen:
- There were signs that the bag was broken.
- There are more than one white chambers.
- The answer is yellow.
- Every seal has been broken
- Store Kabiven between 20°C and 25°C (68°F and 77°F) until it’s time to use it.
- Activate the bag right before using it, or put it in the fridge at 2 to 8°C (36 to 46°F) for up to 24 hours. Throw away any leftovers.
- After activation and before administration, carefully check the bag to see if the lipid emulsion has separated, which can be seen as yellowish streaks or yellowish droplets in the mixed emulsion. If this happens, throw away the bag.
Information for Perikabiven patients about counselling
- A peripheral or central vein catheter is used to give an infusion of perikabiven.
- There may be allergic reactions.
- Formulations given intravenously carry a risk of infection and sepsis.
- Perikabiven may cause side effects like nausea and vomiting, too much fat in the blood (called lipids), high blood sugar, abnormally high levels of transaminase and bilirubin, or abnormally high or low levels of blood electrolytes.
- They should talk to their doctor if they have signs of an allergic reaction, infection, high or low blood sugar, nausea, vomiting, fluid retention, or any other health problem.
- Get regular lab tests and check in with their healthcare provider regularly.
- Tell their doctor if they start or stop taking any prescription or over-the-counter drugs or supplements. This will help avoid drug interactions and side effects.
- Tell people the following when they give themselves a Perikabiven injection at home:
- Patients and/or carers must be taught how to check Perikabiven, turn it on, and give it.
- Follow the instructions for how to inspect, activate, and give Perikabiven.
- Don’t go against the instructions for giving the medicine.
- Check the product before you use it for signs of damage, dirt, or discoloration.
- There were signs that the bag was broken.
- Visible damage to the bag.
- Solution is yellow.
- More than one chamber is white.
- Every seal has been broken.
- Store Perikabiven between 20°C and 25°C (68°F and 77°F) until it is ready to be used.
- Activate the bag right before using it, or put it in the fridge at 2 to 8°C (36 to 46°F) for up to 24 hours. Throw away any leftovers.
- After activation and before giving the medicine, check the bag carefully to see if the lipid emulsion has separated. This can be seen as a yellowish streak or a buildup of yellowish droplets in the mixed emulsion. If this happens, throw away the bag.
For more details
Talk to your doctor or other healthcare provider to make sure that the information on this page applies to your situation.
