Octreotide Acetate is known as the brand name Sandostatin, which is marketed by Novartis. With the patent for sandostatin expiring on May 18, 2015, the opportunities are wide open for researchers seeking to develop a generic form of this number one prescribed somatostatin analogue in the world. Octreotide acetate is a man-made protein which is similar to a hormone in the body called somatostatin. Octreotide lowers many substances in the body, like insulin, glucagon, growth hormones and chemicals that affect digestion. It is approved to treat both the flushing and severe diarrhea which are associated with carcinoid syndrome. LGM Pharma is a provider of the API octreotide acetate, CAS number 83150-76-9 and the TEVA API octreotide acetate, CAS number 79517-01-4.
Also indicated to reduce blood levels of the growth hormone and insulin-like growth factor, octreotide acetate aids patients with acromegaly who have had an inadequate response to or cannot tolerate other treatments like surgery, radiation therapy, or bromocriptine mesylate. The injection form of octreotide acetate is an immediate release, which is administered subcutaneously two or three times daily, and all of the medication is released into the body as soon as it is injected. Another form of octreotide acetate is available as a long acting release medication. Known as the brand name Sandostatin LAR Depot, this formulation of octreotide acetate is a somatostatin analogue which is administered by a healthcare professional every 28 days. This extended release form of octreotide acetate releases the medication into the body gradually over 28 days period. Long-term maintenance therapy of octreotide acetate is appropriate in several conditions. First, patients who are acromegalic and who have had an inadequate response to surgery and/or radiotherapy will find octreotide acetate appropriate. Octreotide acetate is also efficacious for the long-term treatment of the severe diarrhea and flushing episodes which are associated with metastatic carcinoid tumors, as well as the long-term treatment of profuse watery diarrhea which is associated with VIP-secreting tumors.
|A section of a rare lymph node metastasis from adenocarcinoid tumor (250 X). Image courtesy of medscape.com.|
Side effects vary depending on the condition the patient is being treated for. Patients with acromegaly may experience adverse effects from octreotide acetate such as gallstones, diarrhea, abdominal pain and flatulence. Those patients receiving octreotide acetate in conjunction with their treatments for carcinoid tumors may experience side effects of fatigue, back pain, headache, nausea and dizziness. Because octreotide acetate alters the balance between the counter-regulatory hormones, insulin, glucagon and growth hormones, hypoglycemia or hyperglycemia may result. Patients should also have thyroid screenings regularly, as octreotide acetate also suppresses the secretion of the thyroid stimulating hormone, which may result in hypothyroidism.
One of the numerous successful trials touting the benefits of octreotide acetate was titled the “Efficacy and Tolerability of long-acting Octreotide in the Treatment of Thymic Tumors: Results of a Pilot Trial” Published in the April 2012 volume of the American Journal of Clinical Oncology, approximately 44 patients with thymic malignancies were evaluated. Twenty-seven patients underwent an OctreoScan, and 12 of these patients were OctreoScan-positive. These “positive” patients were subsequently treated with the long-acting octreotide, at a dose of 20 milligrams, administered as an intramuscular injection, and given every 2 weeks. The average progression-free survival was 8 months for patients, and both the treatment compliance and tolerability were good for all of the evaluated patients. Researchers confirmed that octreotide acetate is a valid medication for the treatment of thymic malignancies, and the long-acting therapy appears to be safe and effectual.
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