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®
|Pyrexia||4 ( 4)|
|Blood triglycerides increased||3 ( 3)|
|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)|
|* 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.
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