Label Changes for:
Sandostatin (octreotide acetate) injection and Sandostatin LAR Depot Injection
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2010
USE IN SPECIFIC POPULATIONS
- Safety and efficacy of Sandostatin LAR Depot in the pediatric population have not been demonstrated.
- No formal controlled clinical trials have been performed to evaluate the safety and effectiveness of Sandostatin LAR Depot in pediatric patients under 6 years of age. In post-marketing reports, serious adverse events, including hypoxia, necrotizing enterocolitis, and death, have been reported with Sandostatin use in children, most notably in children under 2 years of age. The relationship of these events to octreotide has not been established as the majority of these pediatric patients had serious underlying co-morbid conditions.
- The mean octreotide concentration after 6 doses of 40 mg Sandostatin LAR Depot administered by IM injection every four weeks was approximately 3 ng/mL. Steady-state concentration was achieved after 3 injections of a 40 mg dose.