Medical Editor: John P. Cunha, DO, FACOEP
Kabiven (amino acids, electrolytes, dextrose and lipid) Injectable Emulsion 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. Common side effects of Kabiven include:
- high blood pressure
- decreased hemoglobin
- decreased total protein
- low levels of potassium in the blood (hypokalemia)
- increased gamma glutamyltransferase
- itching, and
- fast heart rate
The dosage of Kabiven is individualized based on the patient's clinical condition, body weight and nutritional/fluid requirements, as well as additional energy given orally/enterally to the patient. Kabiven may interact with coumarin and coumarin derivatives. Tell your doctor all medications and supplements you use. During pregnancy, Kabiven should be administered only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Kabiven (amino acids, electrolytes, dextrose and lipid) Injectable Emulsion Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information.
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Infections [see WARNINGS AND PRECAUTIONS]
- Fat Overload Syndrome [see WARNINGS AND PRECAUTIONS]
- Refeeding Syndrome [see WARNINGS AND PRECAUTIONS]
- Diabetes/Hyperglycemia [see WARNINGS AND PRECAUTIONS]
- Vein Damage and Thrombosis [see WARNINGS AND PRECAUTIONS]
- Hepatobiliary Disorders [see WARNINGS AND PRECAUTIONS]
- Electrolyte Imbalance and Fluid Overload in Renal Impairment [see WARNINGS AND PRECAUTIONS]
- Hypertriglyceridemia [see WARNINGS AND PRECAUTIONS]
- Aluminum Toxicity [see WARNINGS AND PRECAUTIONS]
Clinical Trial 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®
|Hemoglobin decreased||8 (6)|
|Protein total decreased||6 (4)|
|Blood potassium decreased||6 (4)|
|Gamma-glutamyltransferase increased||6 (4)|
|Blood alkaline phosphatase increased||2 (1)|
|Blood calcium decreased||2 (1)|
|Prothrombin time prolonged||2 (1)|
|* Terms as reported in clinical studies|
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.
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
Read the entire FDA prescribing information for Kabiven (Amino Acids, Electrolytes, Dextrose and Lipid Injectable Emulsion)