Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Adverse reactions described elsewhere in this Prescribing Information are: • Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants [see Warnings and Precautions ( 5.1 )] • Parenteral Nutrition-Associated Liver Disease and Other Hepatobiliary Disorders [see Warnings and Precautions ( 5.2 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] • Infections [see Warnings and Precautions ( 5.4 )] • Fat Overload Syndrome [see Warnings and Precautions ( 5.5 )] • Refeeding Syndrome [see Warnings and Precautions ( 5.6 )] • Hypertriglyceridemia [see Warnings and Precautions ( 5.7 )] • Aluminum Toxicity [see Warnings and Precautions ( 5.8 )] • Essential Fatty Acid Deficiency [see Warnings and Precautions ( 5.9 )] Most common adverse drug reactions (≥5%) from clinical trials in adults were nausea, vomiting, and hyperglycemia.
Most common adverse drug reactions (≥5%) from clinical trials in pediatric patients were anemia, vomiting, increased gamma-glutamyltransferase, and nosocomial infection.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 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 includes exposure in 399 patients (229 adults;
170 pediatric) in 9 clinical trials.
Adult patients were 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.
5 WARNINGS AND PRECAUTIONS • Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Acute respiratory distress, metabolic acidosis, and death after rapid infusion of intravenous lipid emulsions have been reported.
( 5.1 , 8.4 ) • Parenteral Nutrition-Associated Liver Disease: Increased risk in patients who receive parenteral nutrition for greater than 2 weeks, especially preterm neonates.
Monitor liver tests;
if abnormalities occur, consider discontinuation or dosage reduction.
( 5.2 , 6.1 , 8.4 ) • Hypersensitivity Reactions: Monitor for signs or symptoms.
Like all medications, Smoflipid can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: