Achieving Impressive Tumor Shrinkage
Sandostatin® LAR Depot (octreotide acetate for injectable suspension) demonstrated tumor shrinkage* in 2 open-label studies (N=143)1
- 20% median reduction in tumor volume at Week 24 (N=143)1
- 36% median reduction in tumor volume at Week 48 (n=94)1
The majority of patients had impressive tumor volume reduction (>20%) (N=68)2
- No patients in this study were found to have increased tumor volume†2
- >20% shrinkage of tumor volume occurred in2:
- 63% of all patients at 24 weeks (N=68)
- 75% of all patients at 48 weeks (N=68) - A subanalysis revealed >20% shrinkage in2:
- 100% of patients with microadenomas (n=8)
- Approximately 70% of patients with macroadenomas (n=60)
*Shrinkage is defined as >20% reduction from initial tumor volume.
†Outside the ±20% measurement area.
Long-term, Well-Tolerated Therapy in Acromegaly
Table 1. Adverse Events Occurring in ≥15% of
Carcinoid Tumor and VIPoma Patients in Study 1
|
Adverse Events Occurring in >= 10% of Acromegalic Patients in Phase 4 Study1 |
||
|---|---|---|
| WHO: Preferred Term |
Sandostatin® LAR n=76 n (%) |
Surgery n=64 n (%) |
| Diarrhea | 36 (47.4) | 2 (3.1) |
| Cholelithiasis | 29 (38.2) | 3 (4.7) |
| Abdominal Pain | 19 (25.0) | 2 (3.1) |
| Nausea | 12 (15.8) | 5 (7.8) |
| Alopecia | 10 (13.2) | 5 (7.8) |
| Injection site pain | 9 (11.8) | 0 |
| Abdominal Pain upper | 8 (10.5) | 0 |
| Headache | 8 (10.5) | 6 (9.4) |
| Epistaxis | 0 | 7 (10.9) |
Based on the results of a postmarketing randomized Phase 4 study. 104 treatment naïve ('de novo') acromegalic patients were randomized to either pituitary surgery or 20 mg of Sandostatin® LAR Depot . Crossover was allowed according to treatment response and a total of 76 patients were exposed to Sandostatin® LAR Depot. Approximately half of the patients initially randomized to Sandostatin® LAR Depot were exposed to Sandostatin® LAR Depot up to 1 year. The majority of these patients were exposed to 30 mg every 4 weeks.1
Important Information
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Downloadable Resources
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‡WHO=World Health Organization.
Important Safety Information
Carcinoid Syndrome:
Sandostatin® LAR Depot (octreotide acetate for injectable suspension) is indicated for long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors and for the long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors in patients in whom initial treatment with immediate release Sandostatin® (octreotide acetate) Injection has been shown to be effective and tolerated.
Important Safety Information:
As with immediate release Sandostatin® Injection, the most frequently reported drug-related adverse events were biliary disorders (62%), gastrointestinal disorders (14% to 38%), and injection-site pain (20% to 50%). Hypoglycemia (4%), hyperglycemia (27%), sinus bradycardia (19%), conduction abnormalities (9%), and arrhythmias (3%) have been reported.
The controlled clinical trials that support the marketing clearance for Sandostatin® LAR Depot did not include determination of effect on tumor size or rate of growth. Sandostatin® LAR Depot is not indicated for tumor shrinkage.
Acromegaly
Sandostatin® LAR Depot (octreotide acetate for injectable suspension) is indicated for long-term maintenance therapy in acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. The goal of treatment in acromegaly is to reduce GH and IGF-1 levels to normal.
Important Safety Information:
As with immediate release Sandostatin® Injection, the most frequently reported drug-related adverse events were biliary disorders (52%), gastrointestinal disorders (7% to 36%), and injection-site pain (2% to 11%). Hypoglycemia (2%), hyperglycemia (15%), and hypothyroidism (2%) have been reported. While not measured in acromegalic patients receiving Sandostatin® LAR Depot, ECG changes have been reported in patients receiving immediate release Sandostatin® Injection; the degree to which these abnormalities are related to octreotide acetate is not clear, as many acromegalics have cardiovascular disease. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
