Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine

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 or excipients. ( 4 ) • Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides >1,000 mg/dL). ( 4 , 5.10 ) • Inborn errors of amino acid metabolism. ( 4 ) • Cardiopulmonary instability. ( 4 ) • Hemophagocytic syndrome. ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary The limited available data on the use of PERIKABIVEN in pregnant women are not sufficient to inform a drug-associated risk. However, there are clinical considerations if PERIKABIVEN is used in pregnant women [see Clinical Considerations ]. Animal reproduction studies have not been conducted with PERIKABIVEN. The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk Severe malnutrition in a pregnant woman is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality. Parenteral nutrition should be considered if a pregnant woman's nutritional requirements cannot be fulfilled by oral or enteral intake.