Medical Editor: John P. Cunha, DO, FACOEP
Smoflipid (lipid injectable emulsion), for intravenous use is a lipid injectable emulsion indicated in adults as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Common side effects of Smoflipid include:
- high blood sugar (hyperglycemia)
- abdominal pain
- increased blood triglycerides
- high blood pressure (hypertension)
- severe infection (sepsis)
- urinary tract infection
- device related infection
The recommended dosage of Smoflipid depends on age, energy expenditure, clinical status, body weight, tolerance, ability to metabolize, and consideration of additional energy given to the patient. Smoflipid may interact with anticoagulants. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before receiving Smoflipid; it is unknown if it would affect a fetus. It is unknown if Smoflipid passes into breast milk. Consult your doctor before breastfeeding.
Our Smoflipid (lipid injectable emulsion), for intravenous use 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.
Adverse reactions described elsewhere in labeling:
- Death in Preterm Infants [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Risk of Catheter-Related Infections [see WARNINGS AND PRECAUTIONS]
- Fat Overload Syndrome [see WARNINGS AND PRECAUTIONS]
- Refeeding Syndrome [see WARNINGS AND PRECAUTIONS]
- Aluminum Toxicity [see WARNINGS AND PRECAUTIONS]
- Risk of Parenteral Nutrition-Associated Liver Disease [see WARNINGS AND PRECAUTIONS]
- Hypertriglyceridemia [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety database for Smoflipid reflects exposure in 229 patients exposed for 5 days to 4 weeks in 5 clinical trials. The pooled population exposed to Smoflipid was adult patients up to 89 years old (20 to 89 years of age), 43% female, and 99% Caucasian. The most frequently reported medical histories in the Smoflipid group were surgical and medical procedures (84%), neoplasms (57%), gastrointestinal disorders (53%), vascular disorders (37%), and infections and infestations (20%).
Smoflipid was used as a component of PN which also included dextrose, amino acids, vitamins, and trace elements. Two of the 5 studies were performed with Smoflipid as a component of PN delivered in a 3-chamber bag.
Adverse reactions occurring in at least 1% of patients who received Smoflipid are shown in Table 2.
Table 2: Adverse Reactions in > 1% of Patients Treated with Smoflipid
|Adverse Reaction||Number of Patients in Smoflipid Group (N=229)||Number of Patients in Comparator Group (N=230)|
|Nausea||20 (9%)||26 (11%)|
|Vomiting||15 (7%)||12 (5%)|
|Hyperglycemia||12 (5%)||5 (2%)|
|Flatulence||10 (4%)||4 (2%)|
|Pyrexia||9 (4%)||11 (5%)|
|Abdominal pain||8 (4%)||5 (2%)|
|Blood triglycerides increased||6 (3%)||4 (2%)|
|Hypertension||6 (3%)||9 (4%)|
|Sepsis||5 (2%)||4 (2%)|
|Dyspepsia||5 (2%)||1 (0%)|
|Urinary tract infection||4 (2%)||3 (1%)|
|Anemia||4 (2%)||2 (1%)|
|Device related infection||4 (2%)||2 (1%)|
Less common adverse reactions in ≤ 1% of patients who received Smoflipid were dyspnea, leukocytosis, diarrhea, pneumonia, cholestasis, dysgeusia, increased blood alkaline phosphatase, increased gamma-glutamyltransferase, increased C-reactive protein, tachycardia, liver function test abnormalities, headache, pruritis, dizziness, rash and thrombophlebitis.
The following adverse reactions have been identified during post-approval use of Smoflipid 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.
Infections and Infestations: infection
Respiratory, Thoracic and Mediastinal Disorders: dyspnea
Read the entire FDA prescribing information for Smoflipid (Smoflipid)