ty of patients were also considered to have low, very-low, or extremely-low birth weights (76%; 82%), with birth weight categories as follows: extremely-low birth weight (34%; 24%); very-low birth weight (17%; 21%); low birth weight (25%; 37%).
The efficacy analysis population had more males (51%; 59%) than females, and the majority of patients were White (60%; 66%).
At baseline, the median age-adjusted body weight (Z-score) was -1.3 for the Omegaven group and -1.1 for the historical control group; 27% and 28% were low-for-age in body weight, 43% and 40% were low-for-age in body height/length, and 25% and 15% were low-for-age in head circumference for the Omegaven and historical control groups, respectively (low-for-age corresponded to Z-scores less than or equal to -1.9 for each growth parameter). In the efficacy analysis population, baseline median DBil, AST, and ALT levels were 3.8 mg/dL, 101 U/L, and 67 U/L, respectively, for the Omegaven group; and 3.8 mg/dL, 115 U/L, and 52 U/L, respectively, for the historical control group.
The median (range) of the duration of treatment was 2.7 months (5 days to 8 years) for the Omegaven group and 3.6 months (16 days to 2 years) for the historical control group.
The changes in median age-adjusted body weight (Z-scores) over time for Omegaven-treated patients (FIGURE 2) appeared similar to those for historical control patients. In both the Omegaven and historical control groups, there was an initial decline in all growth parameters (weight, height/length, head circumference) over the initial weeks of treatment, followed by catch-up growth and more age-appropriate values through the remainder of the study. By comparing the Omegaven study data to age-standardized Fenton and World Health Organization (WHO) growth charts to assess age appropriate growth in patients with PNAC, patients treated with Omegaven as their exclusive lipid source also achieved age-appropriate growth.
Figure 2 Median Age-Adjusted Body Weight (Z-scores) Over Time in Omegaven-Treated Pediatric Patients with PNAC in Study 1 and Study 2*
Figure 2
BL = baseline
Error bars represent interquartile ranges.
*Data from pair-matched Omegaven patients were truncated at week 132. Median values are only shown for visits with data from at least 2 patients at a particular visit.
In the combined analysis from Study 1 and Study 2, the number of Omegaven and historical control patients who achieved full enteral feeding by the end of the study was 52 (63%) patients and 24 (59%) patients, respectively. The median time to full enteral feeding was approximately 15 weeks for both groups.
At the end of the studies, the median DBil level for Omegaven-treated patients was 0.60 mg/dL (interquartile range: 0.1 to 2.8 mg/dL). The Kaplan-Meier estimate of the median time for DBil values to return to less than 2.0 mg/dL was approximately 5.7 weeks [see Dosage and Administration (2.3), Adverse Reactions (6.1)].
16 HOW SUPPLIED/STORAGE AND HANDLING
Omegaven (fish oil triglycerides) injectable emulsion, 5 g/50 mL and 10 g/100 mL (0.1 g/mL) is a white, homogenous, sterile emulsion supplied as follows:
50 mL single-dose glass bottle NDC 63323-205-21
Carton of 10 x 50 mL NDC 63323-205-50
100 mL single-dose glass bottle NDC 63323-205-31
Carton of 10 x 100 mL NDC 63323-205-00
The stopper used as the bottle closure is not made with natural rubber latex, PVC, or DEHP.
Storage and Handling
Store below 25°C (77°F). Avoid excessive heat. Do not fr |
