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The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information.

  • Hypersensitivity reactions [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®

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)
* 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.

Post-Marketing 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