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 labeling: Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants [see Warnings and Precautions (5.1) ] Risk of Parenteral Nutrition Associated Liver Disease [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) ] Adverse reactions include administration site reactions (e.g., erythema, extravasation, pain, phlebitis, pruritus, swelling), hyperlipidemia, hypercoagulability, thrombophlebitis, thrombocytopenia.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact B.
Braun Medical Inc.
at 1-833-425-1464 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 directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions reported with other intravenous lipid emulsions include hyperlipidemia, hypercoagulability, thrombophlebitis, and thrombocytopenia.
Adverse reactions reported in long-term use with other intravenous lipid emulsions include hepatomegaly, jaundice due to central lobular cholestasis, splenomegaly, thrombocytopenia, leukopenia, abnormalities in liver function tests, brown pigmentation of the liver and overloading syndrome (focal seizures, fever, leukocytosis, hepatomegaly, splenomegaly and shock).
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Nutrilipid 20%.
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 drug exposure.
General disorders and administration site conditions: extravasation, infusion site erythema, infusion site pain, infusion site phlebitis, infusion site pruritus, and infusion site swelling.
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, 8.4 ) Hypersensitivity reactions: Monitor for signs or symptoms.
Like all medications, Nutrilipid I.v. Fat Emulsion 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: