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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]
  • Infections [see WARNINGS AND PRECAUTIONS]
  • Fat Overload Syndrome [see WARNINGS AND PRECAUTIONS]
  • Refeeding Syndrome [see WARNINGS AND PRECAUTIONS]
  • Diabetes/Hyperglycemia [see WARNINGS AND PRECAUTIONS]
  • Thrombophlebitis [see WARNINGS AND PRECAUTIONS]
  • Hepatobiliary disorders [see WARNINGS AND PRECAUTIONS]
  • Electrolyte Imbalance and Fluid Overload in renal impairment [see WARNINGS AND PRECAUTIONS]
  • Hypertriglyiceridemia [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 PERIKABIVEN® reflects exposure in 93 patients exposed for 5 to 7 days in 4 active-controlled trials. The pooled population exposed to PERIKABIVEN® was 18 to 87 years old, 48% female, 73% Caucasian. The enrolled patients had varied underlying conditions such as gastrointestinal disorders (55%), vascular disorders (30%), metabolism and nutrition disorders (28%), respiratory, thoracic, and mediastinal disorders (22%), and psychiatric disorders (20%). Most patients received peripheral intravenous infusion doses of > 80% of their target mean daily exposure. Adverse reactions occurring in at least 2% of patients who received PERIKABIVEN® are shown in Table 3.

Table 3: Adverse Reactions in > 2% of Patients Treated with PERIKABIVEN®

Adverse reaction PERIKABIVEN®
N=93 (%)
Hyperglycemia* 5 (5)
Hypokalemia 4 (4)
Pyrexia 4 ( 4)
Blood triglycerides increased 3 ( 3)
Phlebitis 2 (2)
Nausea 2 (2)
Pruritus 2 ( 2)
Gamma-glutamyltransferase increased 2 (2)
Blood alkaline phosphatase increased 2 ( 2)
Alanine aminotransferase increased 2 ( 2)
Blood glucose increased* 2 ( 2)
C-reactive protein increased 2 ( 2)
Blood urea increased 2 ( 2)
Hypoalbuminemia 2 (2)
* Terms as reported in clinical studies

Less common adverse reactions in ≤ 1% of patients who received PERIKABIVEN were hyperkalemia, hypomagnesaemia, hypernatremia, tachycardia, hypertension, thrombophlebitis, vomiting, jaundice, rash and increased blood bilirubin.

Post-Marketing Experience

The following additional adverse reactions have been identified during post-approval use of PERIKABIVEN® in countries where it is registered. Because these reactions are reported voluntarily post-approval from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure.

  • Gastrointestinal disorders: abdominal distension, abdominal pain
  • General disorders and administration site conditions: chest tightness
  • Hepatobiliary disorders: cholestasis
  • Immune system disorders: allergic reaction, anaphylaxis
  • Infections and infestations: infection
  • Vascular disorders: flushed face