Octreotide

Octreotide Acetate Injection Solution for injection or infusion General Octreotide Acetate Injection (octreotide acetate) therapy is indicated for control of symptoms in patients with metastatic carcinoid and vasoactive intestinal peptide-secreting tumours (VIPomas) as well as in patients with acromegaly.

Data are insufficient to determine whether octreotide acetate decreases the size, rate of growth, or development of metastases in patients with these tumours. Octreotide Acetate Injection is also indicated for the prevention of complications following pancreatic surgery in patients undergoing high risk procedures.

Octreotide Acetate Injection is also indicated for the emergency management of bleeding gastro-oesophageal varices in patients with cirrhosis and as protection from re-bleeding. Octreotide Acetate Injection is used in association with specific intervention such as endoscopic sclerotherapy.

Carcinoid Tumours Octreotide Acetate Injection is indicated for the symptomatic treatment of metastatic carcinoid tumours where it suppresses or inhibits the severe diarrhoea and flushing episodes associated with the disease. Vasoactive Intestinal Peptide Tumours (VIPomas) Octreotide Acetate Injection is indicated for the treatment of the profuse watery diarrhoea associated with VIP-secreting tumours.

Symptomatic control and reduction of growth hormone (GH) and IGF-1 plasma levels in patients with acromegaly who are inadequately controlled by surgery or radiotherapy. Octreotide is also indicated for acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.

g. 1). Octreotide is not an anti-tumour therapy and is not curative in these patients. Prevention of complications following pancreatic surgery. Emergency management to stop bleeding and to protect from re-bleeding owing to gastro- oesophageal varices in patients with cirrhosis.

Octreotide is to be used in association with specific treatment such as endoscopic sclerotherapy. Treatment of Thyroid Stimulating Hormones (TSH)-secreting pituitary adenomas: - when secretion has not normalised after surgery and/or radiotherapy - in patients in whom surgery is inappropriate - in irradiated patients, until radiotherapy is effective.

1 INDICATIONS AND USAGE Octreotide Acetate Injection is a somatostatin analogue indicated: Acromegaly : To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses.

1 ) Carcinoid Tumors : For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. 2 ) Vasoactive Intestinal Peptide Tumors (VIPomas) : For the treatment of profuse watery diarrhea associated with VIP-secreting tumors.

3 ) Limitations of Use Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with Octreotide Acetate Injection; these trials were not optimally designed to detect such effects.

Oczyesa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.