%), palmitoleic acid (4% to 10%), myristic acid (2% to 7%), and arachidonic acid (0.2% to 2.0%). Additionally, the mean contents of linoleic acid and alpha linolenic acid are 1.5% and 1.1%, respectively. The fish oil component has a total omega-3 fatty acid content of 40% to 54%. The empirical formula, molecular weight, and chemical structure of the main fatty acid components are:
Figure
Omegaven 5 g/50 mL contains 5 grams of fish oil and 0.6 g egg phospholipids, 1.25 g glycerin, 7.5 to 15 mg dl-alpha-tocopherol, 0.015 g sodium oleate, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 9) packaged in a single-dose 50-mL glass bottle enclosed with a rubber stopper. The phosphate content of the drug product is 0.75 mmol.
The mean content of the two major fatty acid components in 50 mL are 1.0 g EPA (range: 0.6 to 1.5 g) and 0.96 g DHA (range: 0.7 to 1.7 g). Additionally, the mean content of linoleic acid, alpha-linolenic acid, and arachidonic acid per 50 mL are 0.16 g, 0.07 g, and 0.13 g, respectively.
Omegaven 10 g/100 mL contains 10 grams of fish oil and 1.2 g egg phospholipids, 2.5 g glycerin, 15 to 30 mg dl-alpha-tocopherol, 0.03 g sodium oleate, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 9) packaged in a single-dose 100-mL glass bottle enclosed with rubber stopper. The phosphate content of the drug product is 1.5 mmol. The mean content of the two major fatty acid components in 100 mL are 2.0 g EPA (range: 1.2 to 3.0 g) and 1.9 g DHA (range: 1.3 to 3.3 g). Additionally, the mean content of linoleic acid, alpha-linolenic acid, and arachidonic acid per 100 mL are 0.31g, 0.13 g, and 0.25 g; respectively.
The total energy content of Omegaven is 112 kcal/100 mL (1.12 kcal/mL), including lipids, phospholipids, and glycerol.
Omegaven has an osmolality of approximately 342 mOsm/kg water (which represents an osmolarity of 273 mOsm/L).
Omegaven contains no more than 25 mcg/L of aluminum.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Omegaven provides a biologically utilizable source of calories and essential fatty acids.
Fatty acids serve as an important substrate for energy production. The most common mechanism of action for energy production derived from fatty acid metabolism is beta oxidation. Fatty acids are also important for membrane structure and function, as precursors for bioactive molecules (such as prostaglandins), and as regulators of gene expression.
12.3 Pharmacokinetics
The plasma concentrations of EPA and DHA, the major fatty acids in Omegaven, as well as linoleic acid and alpha-linolenic acid (essential fatty acids) were measured along with the markers of essential fatty acid status in 58 pediatric patients with PNAC after an intravenous infusion of 1 mg/kg/day of Omegaven over 10 weeks. Five patients received Omegaven as the exclusive lipid source, and all others received concurrent enteral or oral nutrition.
Figure 1 Mean Plasma Concentrations of Fatty Acids Over 10 Weeks of Omegaven Infusion in Pediatric Patients with PNAC
Figure 1
Error bars represent ± 1 standard deviation (SD).
Numbers at the top of plots represent the number of patients at each time point
If more than one value was available for a patient at any given time point, the average was used.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No studies have been performed with fish oil triglycerides to eva luate the carcinogenic potential or its effect on fertility.
Fish oil triglycerides was ne |
