References — Somatuline® Depot

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References

1. Somatuline^® Depot [prescribing information]. Paris, France: Beaufour Ipsen Pharma; Tercica, Inc.; 2007.

2. Data on file. Brisbane, Calif: Tercica, Inc.; 2007.

3. Pearce JMS. Pituitary tumours and acromegaly (Pierre Marie's disease). Journal of Neurology, Neurosurgery and Psychiatry. 2002;73:394.

4. Jane JA, Jr., Thapar K, Laws ER, Jr., Acromegaly: historical perspectives and current therapy. J Neurooncol. 2001;54(2):129-37.

5. Colao A, Ferone D, Marzullo P, Lombardi G. Systemic Complications of Acromegaly: Epidemiology, Pathogenesis, and Management. Endocrine Reviews. 2004;25(1):102-152.

6. AACE Acromegaly Guidelines Task Force. Endocrine Pract. 2004;10:213-225.

7. Rajasoorya C, Holdaway IM, Wrightson P, et al. Clin Endocrinol. 1994:41:95-102.

8. Melmed S. Medical progress. Acromegaly. N Engl J Med. 2006;356(879):2558-2573.

9. Lim EM, Pullan P. Biochemical Assessment and Long-Term Monitoring in Patients with Acromegaly: Statement from a Joint Consensus Conference of The Growth Hormone Research Society and The Pituitary Society. J Clin Endocrinol Metab. 2004;89:3099-102.

10. Bronstein M, Musolino N, Jallad R, et al. Pharmacokinetic profile of lanreotide Autogel in patients with acromegaly after four deep subcutaneous injections of 60, 90 or 120 mg every 28 days. Clin Endocrinol (Oxf). 2005;63:514-519.

11. Sandostatin^® LAR^® Depot [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2006.

12. Patel YC, Srikant CB. Subtype selectivity of peptide analogs for all five cloned human somatostatin receptors (hsstr 1-5). Endocrinology. 1994;135:2814-2817.

IMPORTANT SAFETY INFORMATION

Somatuline^® Depot (lanreotide) Injection is a somatostatin analog indicated for the long-term treatment of patients with acromegaly who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy.

Lanreotide may reduce gallbladder motility and lead to gallstone formation. Periodic monitoring may be needed. Patients treated with Somatuline^® Depot may experience hypoglycemia or hyperglycemia. Glucose levels monitoring is recommended and antidiabetic treatment adjusted accordingly. Lanreotide may lead to a decrease in heart rate. Use with caution in at-risk patients.

Patients with moderate and severe renal impairment or moderate and severe hepatic impairment should begin treatment with Somatuline^® Depot 60mg.

There are no adequate and well controlled studies in pregnant women. Because animal reproduction studies are no always predictive of human responses, Somatuline^® Depot should be used during pregnancy only if the potential benefit justifies risk to the fetus. A decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.

Somatuline^® Depot may decrease the bioavailability of cyclosporine. Cyclosporine dose may need to be adjusted to maintain levels.

Patients receiving beta-blockers, calcium channel blockers, or other drugs that affect heart rate may need dose adjustments. Somatuline^® Depot may reduce the intestinal absorption of co-administered drugs. Caution should be used.

The most common adverse reactions (incidence >5%) are diarrhea, cholelithiasis, abdominal pain, nausea, injection site reaction, flatulence, arthralgia, and loose stools.

Please see Full Prescribing Information for additional important information.

SOMATULINE^® DEPOT IS MARKETED BY TERCICA, INC. AND MANUFACTURED BY IPSEN PHARMA BIOTECH (SIGNES, FRANCE).

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