Kabiven
Generic: DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE
Basic Information
Manufacturer
Fresenius Kabi USA, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
afeb4837-a759-4484-a76e-e04611c459e7
Indications & Usage
1 INDICATIONS AND USAGE KABIVEN 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.
KABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients.
Limitations of Use: KABIVEN 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 Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 )] .
KABIVEN 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.
KABIVEN 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 )
KABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients.
Limitations of Use: KABIVEN 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 Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 )] .
KABIVEN 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.
KABIVEN 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 )
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 [see Warnings and Precautions ( 5.13 )].
The most common adverse reactions (≥3%) are nausea, pyrexia, hypertension, vomiting, decreased hemoglobin, decreased total protein, hypokalemia, decreased potassium, and increased gamma glutamyltransferase.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The clinical data described for KABIVEN reflects exposure in 145 patients exposed for 7 days to 4 weeks in 7 active-controlled trials.
The pooled population exposed to KABIVEN was 25 to 87 years old, 35% female, 99% Caucasian.
The enrolled patients had varied underlying conditions such as gastrointestinal disorders (41%) neoplasms (48%), vascular disorders (35%) and other surgical procedures (21%).
Most patients received central intravenous infusion doses of ≥80% of their target mean daily exposure.
Adverse reactions occurring in at least 1% of patients who received KABIVEN are shown in Table 3 .
Table 3: Adverse Reactions in >1% of Patients Treated with KABIVEN * Terms as reported in clinical studies Adverse reaction KABIVEN N=145 (%) Nausea 22 (15) Pyrexia 13 (9) Hypertension 12 (8) Vomiting 8 (6) Hemoglobin decreased 8 (6) Protein total decreased 6 (4) Hypokalemia 6 (4) Blood potassium decreased 6 (4) Gamma-glutamyltransferase increased 6 (4) Hyperglycemia 3 (2) Blood alkaline phosphatase increased 2 (1) Blood calcium decreased 2 (1) Prothrombin time prolonged 2 (1) Pruritus 2 (1) Tachycardia 2 (1) Less common adverse reactions in ≤1% of patients who received KABIVEN were hyperkalemia, hypertriglyceridemia, headache, dizziness, dysgeusia, rash, eczema, blood glucose increased, and increase in blood triglycerides.
In a randomized active-controlled, double-blind, parallel-group, multi-center study that included 152 neonates and 9 patients ranging in age from 29 to 153 days who were expected to require PN for at least 28 days, parenteral nutrition-associated cholestasis (PNAC), a precursor to PNALD, developed more frequently in Intralipid-treated patients than in patients treated with a 4-oil mixed lipid emulsion.
Intralipid is the lipid emulsion component of KABIVEN.
PNAC (defined as direct bilirubin >2mg/dl with a second confirmed elevation >2mg/dl at least 7 days later) occurred in 11.5% (9/78) of Intralipid-treated patients and 2.4% (2/83) of patients treated with a 4-oil mixed lipid emulsion.
Most PNAC events occurred in patients who were treated for longer than 28 days.
The estimated cumulative incidence of PNAC is shown in the Kaplan-Meier cumulative incidence curve in Figure 1 .
Figure 1: Cumulative Incidence Curve of Time to Parenteral Nutrition-Associated Cholestasis (PNAC) with Standard Error Bars Monitor liver tests in patients treated with KABIVEN and consider discontinuation or dosage reduction if abnormalities occur.
Figure 1 6.2 Postmarketing Experience The following additional adverse reactions have been identified during post-approval use of KABIVEN in countries where it is registered.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure.
• Hepatobiliary disorders: cholestasis • Infections and infestations: infection • Nervous system disorders: subependymal hemorrhage • Immune system disorders: hypersensitivity reactions, including anaphylaxis [see Contraindications ( 4 ), Warnings and Precautions ( 5.4 )].
• 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 [see Warnings and Precautions ( 5.13 )].
The most common adverse reactions (≥3%) are nausea, pyrexia, hypertension, vomiting, decreased hemoglobin, decreased total protein, hypokalemia, decreased potassium, and increased gamma glutamyltransferase.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The clinical data described for KABIVEN reflects exposure in 145 patients exposed for 7 days to 4 weeks in 7 active-controlled trials.
The pooled population exposed to KABIVEN was 25 to 87 years old, 35% female, 99% Caucasian.
The enrolled patients had varied underlying conditions such as gastrointestinal disorders (41%) neoplasms (48%), vascular disorders (35%) and other surgical procedures (21%).
Most patients received central intravenous infusion doses of ≥80% of their target mean daily exposure.
Adverse reactions occurring in at least 1% of patients who received KABIVEN are shown in Table 3 .
Table 3: Adverse Reactions in >1% of Patients Treated with KABIVEN * Terms as reported in clinical studies Adverse reaction KABIVEN N=145 (%) Nausea 22 (15) Pyrexia 13 (9) Hypertension 12 (8) Vomiting 8 (6) Hemoglobin decreased 8 (6) Protein total decreased 6 (4) Hypokalemia 6 (4) Blood potassium decreased 6 (4) Gamma-glutamyltransferase increased 6 (4) Hyperglycemia 3 (2) Blood alkaline phosphatase increased 2 (1) Blood calcium decreased 2 (1) Prothrombin time prolonged 2 (1) Pruritus 2 (1) Tachycardia 2 (1) Less common adverse reactions in ≤1% of patients who received KABIVEN were hyperkalemia, hypertriglyceridemia, headache, dizziness, dysgeusia, rash, eczema, blood glucose increased, and increase in blood triglycerides.
In a randomized active-controlled, double-blind, parallel-group, multi-center study that included 152 neonates and 9 patients ranging in age from 29 to 153 days who were expected to require PN for at least 28 days, parenteral nutrition-associated cholestasis (PNAC), a precursor to PNALD, developed more frequently in Intralipid-treated patients than in patients treated with a 4-oil mixed lipid emulsion.
Intralipid is the lipid emulsion component of KABIVEN.
PNAC (defined as direct bilirubin >2mg/dl with a second confirmed elevation >2mg/dl at least 7 days later) occurred in 11.5% (9/78) of Intralipid-treated patients and 2.4% (2/83) of patients treated with a 4-oil mixed lipid emulsion.
Most PNAC events occurred in patients who were treated for longer than 28 days.
The estimated cumulative incidence of PNAC is shown in the Kaplan-Meier cumulative incidence curve in Figure 1 .
Figure 1: Cumulative Incidence Curve of Time to Parenteral Nutrition-Associated Cholestasis (PNAC) with Standard Error Bars Monitor liver tests in patients treated with KABIVEN and consider discontinuation or dosage reduction if abnormalities occur.
Figure 1 6.2 Postmarketing Experience The following additional adverse reactions have been identified during post-approval use of KABIVEN in countries where it is registered.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure.
• Hepatobiliary disorders: cholestasis • Infections and infestations: infection • Nervous system disorders: subependymal hemorrhage • Immune system disorders: hypersensitivity reactions, including anaphylaxis [see Contraindications ( 4 ), Warnings and Precautions ( 5.4 )].