SE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Antiplatelet Agents and Anticoagulants: Prolonged bleeding time has been reported in patients taking antiplatelet agents or anticoagulants and oral omega-3 fatty acids. Periodically monitor bleeding time in patients receiving Omegaven and concomitant antiplatelet agents or anticoagulants. (7.1)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 7/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Administration Instructions
2.2 Admixing Instructions
2.3 Dosing Information
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Death in Preterm Infants due to Pulmonary Lipid Accumulation
5.2 Hypersensitivity Reactions
5.3 Risk of Infections
5.4 Fat Overload Syndrome
5.5 Refeeding Syndrome
5.6 Hypertriglyceridemia
5.7 Aluminum Toxicity
5.8 Monitoring and Laboratory Tests
5.9 Interference with Laboratory Tests
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Antiplatelet Agents and Anticoagulants
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. CLOSE
1 INDICATIONS AND USAGE
Omegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC).
Limitations of Use:
Omegaven is not indicated for the prevention of PNAC. It has not been demonstrated that Omegaven prevents PNAC in parenteral nutrition (PN)-dependent patients [see Clinical Studies (14)].
It has not been demonstrated that the clinical outcomes observed in patients treated with Omegaven are a result of the omega-6:omega-3 fatty acid ratio of the product [see Clinical Studies (14)].
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2 DOSAGE AND ADMINISTRATION
2.1 Administration Instructions
Omegaven can be administered alone or as part of a PN admixture.
Omegaven is for central or peripheral intravenous infusion. When administered with dextrose and amino acids, the choice of a central or peripheral venous route should depend on the osmolarity of the final infusate. Solutions with osmolarity of 900 mOsm/L or greater must be infused through a central vein.
Use a 1.2 micron in-line filter during administration.
Use a dedicated line for PN. Omegaven should be infused concurrently into the same vein as dextrose-amino acid solutions (as part of PN) by a Y-connector located closest to the infusion site; flow rates of each solution should be controlled separately by infusion pumps. Avoid multiple connections; do not connect multiple medications in series. Turn off the pump before the bottle runs dry.
Use a vented infusion set when Omegaven is infused from the bottle.
Do not use infusion sets and lines that contain di-2-ethylhexyl phthalate (DEHP). Infusion sets that contain polyvinyl chloride (PVC) components have DEHP as a plasticizer.
Prior to infusion, visually i |
