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aIncludes preferred terms of abdominal pain, abdominal pain upper/lower, abdominal discomfort.
bIncludes preferred terms of myalgia, musculoskeletal discomfort, musculoskeletal pain, back pain.
cIncludes preferred terms of infusion site extravasation, injection site discomfort, injection site granuloma, injections site hematoma, injection site hemorrhage, injection site induration, injection site mass, injections site nodule, injection site pain, injection site pruritus, injection site rash, injection site reaction, injection site swelling.
dIncludes preferred terms of diabetes mellitus, glucose tolerance impaired, hyperglycemia, type 2 diabetes mellitus.
eIncludes preferred terms of hypertension, hypertensive crisis.
fIncludes preferred terms of depression, depressed mood.
*Includes one or more serious adverse events (SAEs) defined as any event that results in death, is life-threatening, results in hospitalization or prolongation of hospitalization, results in persistent or significant disability, results in congenital anomaly/birth defect, or may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed.
**Defined as hazardous to well-being, significant impairment of function or incapacitation.
Adverse events occurring by Week 16 in ELECT in ≥5% of Somatuline Depot-treated patients and occurring at least 5% more than in placebo-treated patients were headache (12% vs 5%), dizziness (7% vs 0%), and muscle spasm (5% vs 0%).
To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.