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]
- 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