Perikabiven 333 mg/100mL
Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine · INJECTION, EMULSION · Fresenius Kabi USA, LLC
Perikabiven is an intravenous nutritional supplement that provides essential amino acids, dextrose, and lipids to support protein synthesis and energy needs in patients who cannot eat or absorb nutrients normally. It is used to help maintain nutritional status in patients requiring parenteral nutrition support.
Key Facts
- Brand Name
- Perikabiven
- Generic Name
- Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine
- NDC Code (Product)
63323-714- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 333 mg/100mL
- Dosage Form
- INJECTION, EMULSION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA200656
- Drug Class
- Amino Acid [EPC]; Lipid Emulsion [EPC]
- Marketing Start
- 08/25/2014
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE PERIKABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PERIKABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients. PERIKABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PERIKABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients. ( 1 ) Limitations of Use: Not recommended for use in pediatric patients <2 years including preterm infants because the fixed content of the formulation does not meet nutritional requirements in this age group. ( 1 , 5.1 , 8.4 ) Limitations of Use: PERIKABIVEN is not recommended for use in pediatric patients under the age of 2 years, including preterm infants because the fixed content of the formulation does not meet the nutritional requirements of this age group [see Wa…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • For intravenous infusion into a peripheral or central vein. ( 2.1 , 5.11 ) • See full prescribing information regarding preparation, administration, instructions for use, the recommended dosage in adults, and dosage modifications for patients with renal impairment. ( 2.1 , 2.2 , 2.3 , 2.4 ) 2.1 Administration • PERIKABIVEN is for intravenous infusion into a peripheral or central vein [see Warnings and Precautions ( 5.11 )]. • Use a 1.2 micron in-line filter. • Use of a vented intravenous administration set with the vent in the open position could result in air embolism. • Use a dedicated line without any connections. Multiple connections could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed. • Do not exceed the recommended maximum infusion rate of 3.7 mL/kg/hour [see Dosage and Administration ( 2.4 ) and Warnings and Precautions ( 5.1 )]. • Ceftriaxone must not be administered simultaneously with calcium-containing intravenous solutions such as PERIKABIVEN via a Y-site due to precipitation. However, in patients other than neonates, ceftriaxone…
Contraindications
4 CONTRAINDICATIONS The use of PERIKABIVEN is contraindicated in: • Neonates (28 days of age or younger) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone calcium salt precipitation in the neonate's bloodstream [see Limitations of Use ( 1 ), Warnings and Precautions ( 5.5 ), Use in Specific Populations ( 8.4 )]. • Patients with known hypersensitivity to egg, soybean, peanut or any of the active or inactive ingredients in PERIKABIVEN [see Warnings and Precautions ( 5.4 )] ; • Patients with severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentration >1,000 mg/dL) [see Warnings and Precautions ( 5.10 )]. • Patients with inborn errors of amino acid metabolism • Patients with cardiopulmonary instability (including pulmonary edema, cardiac insufficiency, myocardial infarction, acidosis and hemodynamic instability requiring significant vasopressor support) • Patients with hemophagocytic syndrome • Concomitant treatment with ceftriaxone in neonates (28 days of age or younger). ( 4 ) • Known hypersensitivity to egg, soybean, peanut or any of the active ingredients …
Drug Interactions
7 DRUG INTERACTIONS Coumarin and coumarin derivatives, including warfarin: Anticoagulant activity may be counteracted; monitor laboratory parameters. ( 7.1 ) 7.1 Ceftriaxone Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with calcium-containing parenteral nutrition solutions, such as PERIKABIVEN, in the same intravenous administration line. Do not administer ceftriaxone simultaneously with PERIKABIVEN, via a Y-site. However, ceftriaxone and PERIKABIVEN, may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid [see Dosage and Administration ( 2.1 )]. Deaths have occurred in neonates (28 days of age or younger) who received concomitant intravenous calcium-containing solutions with ceftriaxone resulting from calcium-ceftriaxone precipitates in the lungs and kidneys, even when separate infusion lines were used [see Contraindications ( 4 ), Use in Specific Populations ( 8.4 )]. 7.2 Coumarin and Coumarin Derivatives The soybean oil present in PERIKABIVEN has vitamin K 1 . Vitamin K 1 can reverse the anticoagulant activity of coumarin or coumarin derivatives, which work by blocking recycling of vitami…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information. • Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants [see Warnings and Precautions ( 5.1 )]. • Parenteral Nutrition-Associated Liver Disease and Other Hepatobiliary Disorders [see Warnings and Precautions ( 5.2 )]. • Pulmonary Embolism and Respiratory Distress due to Pulmonary Vascular Precipitates [see Warnings and Precautions ( 5.3 )]. • Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )]. • Precipitation with Ceftriaxone [see Warnings and Precautions ( 5.5 )]. • Infections [see Warnings and Precautions ( 5.6 )]. • Fat Overload Syndrome [see Warnings and Precautions ( 5.7 )]. • Refeeding Syndrome [see Warnings and Precautions ( 5.8 )]. • Diabetes and Hyperglycemia [see Warnings and Precautions ( 5.9 )]. • Hypertriglyceridemia [see Warnings and Precautions ( 5.10 )]. • Vein Damage and Thrombosis [see Warnings and Precautions ( 5.11 )]. • Electrolyte Imbalance and Fluid Overload in Patients with Decreased Renal Function [see Warnings and Precautions ( 5.12 )]. • Aluminum Toxicity [s…
Frequently Asked Questions
What is Perikabiven used for?
Perikabiven is an intravenous nutritional supplement that provides essential amino acids, dextrose, and lipids to support protein synthesis and energy needs in patients who cannot eat or absorb nutrients normally. It is used to help maintain nutritional status in patients requiring parenteral nutrition support.
Is Perikabiven a controlled substance?
Perikabiven is not classified as a controlled substance by the DEA.
What is the generic name for Perikabiven?
The generic name for Perikabiven is Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine. There are 1 other brand versions of Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine.
What is the NDC code for Perikabiven 333 mg/100mL?
The NDC (National Drug Code) for Perikabiven 333 mg/100mL is 63323-714, listed by Fresenius Kabi USA, LLC.