In this section:
Surgery
Surgery is the first course of action recommended for most patients. The goal of surgery is to remove the tumor and normalize GH and IGF-1 levels. If successful, hormone control is reestablished. If not, medical therapy may be the next choice1-3.
| Surgery Advantages4 | Disadvantages4 |
|---|---|
| Possible cure if tumor is completely removed | Success depends on size and location of tumor |
| Possible GH and IGF-1 control, as well as symptom relief, even if resection is incomplete | Invasive procedure |
| May be surgical complications |
Medical Therapy
Somatostatin Analogues (SAs)
Somatostatin analogues, including immediate-release Sandostatin® Injection and long-acting Sandostatin® LAR Depot, work directly at the site of the pituitary tumor by reducing the secretion of hormones that cause the symptoms of acromegaly5.
Both Sandostatin® Injection and Sandostatin® LAR Depot have been used in clinical practice for more than 20 years, with over 800,000 patient-years of experience and over 600 clinical trials6, 7.*† Somatostatin analogues may also be used instead of surgery in patients at risk for complications from anesthesia, patients with heart or lung complications, or patients whose tumors are large but not next to the optic nerve1, 8-10.
*Combined use of immediate-release Sandostatin® Injection and Sandostatin® LAR Depot for all approved indications.
†Includes both ongoing and completed trials for all approved indications.
|
Somatostatin Analogue Advantages4 |
Disadvantages10 |
|---|---|
| Control of hypersecretion at the site of the tumor where hormone overproduction starts | Patients may not tolerate possible side effects |
| Reduces GH and IGF-1 levels in the majority of patients | Ongoing cost |
| Improves symptoms | |
| Can be administered as once-a-month therapy | |
| Long-term safety profile |
Radiotherapy
Radiotherapy involves the use of radiation to kill rapidly growing tumor cells. After radiation, tumors typically stop growing and may even begin to shrink; however, elevated hormone levels fall much more slowly. Medical therapy with an SA is often needed to normalize hormone levels and control symptoms before radiation starts to work10.
| Radiotherapy Advantages10 | Disadvantages10 |
|---|---|
| Reduces GH and IGF-1 levels | Takes a long time to show effectiveness |
| Relatively few side effects | Potential for pituitary and optic nerve damage |
| Risk of secondary malignancy4 |
INDICATIONS AND USAGE
Sandostatin® LAR Depot (octreotide acetate for injectable suspension) is indicated for patients in whom initial treatment with immediate release Sandostatin® (octreotide acetate) Injection has been shown to be effective and tolerated for:
- Long-term maintenance therapy in acromegalic patients who have had 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).
- Long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors.
- Long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors.
In patients with carcinoid syndrome and VIPomas, the effect of Sandostatin Injection and Sandostatin LAR Depot on tumor size, rate of growth and development of metastases has not been determined.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions:
- Gallbladder abnormalities may occur: Patients should be monitored periodically.
- Glucose Metabolism: Hypoglycemia or hyperglycemia may occur. Blood glucose levels should be monitored when Sandostatin LAR Depot treatment is initiated or when the dose is altered. Antidiabetic treatment should be adjusted accordingly.
- Thyroid Function: Hypothyroidism may occur. Baseline and periodic assessment of thyroid function (TSH, total and/or free T4) is recommended.
- Cardiac Function: Bradycardia, arrhythmia, conduction abnormalities, and other EKG changes may occur. The relationship of these events to octreotide acetate is not established because many of these patients have underlying cardiac disease. Use with caution in at-risk patients.
- Nutrition: Octreotide may alter absorption of dietary fats. Monitoring of vitamin B12 levels is recommended during therapy with Sandostatin LAR Depot. Patients on total parenteral nutrition (TPN) and octreotide should have periodic monitoring of zinc levels.
Drug Interactions: The following drugs require monitoring and possible dose adjustment when used with Sandostatin LAR Depot: cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, bromocriptine. Octreotide has been associated with alterations in nutrient absorption, so it may have an effect on absorption of orally administered drugs. Drugs mainly metabolized by CYP3A4 and which have a low therapeutic index should be used with caution.
Adverse Reactions: The most common adverse reactions occurring in patients receiving Sandostatin LAR Depot are:
- Acromegaly: biliary abnormalities (52%), diarrhea (36-48%), cholelithiasis (13-38%), abdominal pain or discomfort (11-29%), flatulence (26%), influenza-like symptoms (20%), constipation (19%), headache (15%), anemia (15%), hyperglycemia (15%), injection site pain (2-14%), hypertension (13%), dizziness (12%), fatigue (11%), nausea (10%), vomiting (7%), hypothyroidism (2%), hypoglycemia (2%), and goiter (2%).
- Carcinoid Tumors and VIPomas: biliary abnormalities (62%), injection site pain (20-50%), nausea (24-41%), abdominal pain (10-35%), fatigue (8-32%), headache (16-30%), hyperglycemia (27%), back pain (8-27%), constipation or vomiting (15-21%), dizziness (18-20%), sinus bradycardia (19%), pruritus (18%), URTI (10-18%), myalgia (4-18%), flatulence (9-16%), arthropathy (8-15%), rash (15%), generalized pain (4-15%), sinusitis (5-12%), conduction abnormalities (9%), hypoglycemia (4%), and arrhythmia (3%).
