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Sandostatin

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Sandostatin

Sandostatin

INDICATIONS

Acromegaly

Sandostatin® (octreotide acetate) is indicated to reduce blood levels of growth hormone and IGF-I (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. The goal is to achieve normalization of growth hormone and IGF-I (somatomedin C) levels (see DOSAGE AND ADMINISTRATION). In patients with acromegaly, Sandostatin (octreotide acetate) reduces growth hormone to within normal ranges in 50% of patients and reduces IGF-I (somatomedin C) to within normal ranges in 50%-60% of patients. Since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with Sandostatin (octreotide acetate) to reduce blood levels of growth hormone and IGF-I (somatomedin C) offers potential benefit before the effects of irradiation are manifested.

Improvement in clinical signs and symptoms or reduction in tumor size or rate of growth were not shown in clinical trials performed with Sandostatin (octreotide acetate) ; these trials were not optimally designed to detect such effects.

Carcinoid Tumors

Sandostatin (octreotide acetate) is indicated 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.

Sandostatin (octreotide acetate) studies were not designed to show an effect on the size, rate of growth or development of metastases.

Vasoactive Intestinal Peptide Tumors (VIPomas)

Sandostatin (octreotide acetate) is indicated for the treatment of the profuse watery diarrhea associated with VIP-secreting tumors. Sandostatin (octreotide acetate) studies were not designed to show an effect on the size, rate of growth or development of metastases.

DOSAGE AND ADMINISTRATION

Sandostatin® (octreotide acetate) may be administered subcutaneously or intravenously. Subcutaneous injection is the usual route of administration of Sandostatin (octreotide acetate) for control of symptoms. Pain with subcutaneous administration may be reduced by using the smallest volume that will deliver the desired dose. Multiple subcutaneous injections at the same site within short periods of time should be avoided. Sites should be rotated in a systematic manner.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if particulates and/or discoloration are observed. Proper sterile technique should be used in the preparation of parenteral admixtures to minimize the possibility of microbial contamination. Sandostatin (octreotide acetate) is not compatible in Total Parenteral Nutrition (TPN) solutions because of the formation of a glycosyl octreotide conjugate which may decrease the efficacy of the product.

Sandostatin (octreotide acetate) is stable in sterile isotonic saline solutions or sterile solutions of dextrose 5% in water for 24 hours. It may be diluted in volumes of 50-200 mL and infused intravenously over 15-30 minutes or administered by IV push over 3 minutes. In emergency situations (e.g., carcinoid crisis) it may be given by rapid bolus.

The initial dosage is usually 50 mcg administered twice or three times daily. Upward dose titration is frequently required. Dosage information for patients with specific tumors follows.

Acromegaly

Dosage may be initiated at 50 mcg t.i.d. Beginning with this low dose may permit adaptation to adverse gastrointestinal effects for patients who will require higher doses. IGF-I (somatomedin C) levels every 2 weeks can be used to guide titration. Alternatively, multiple growth hormone levels at 0-8 hours after Sandostatin® (octreotide acetate) administration permit more rapid titration of dose. The goal is to achieve growth hormone levels less than 5 ng/mL or IGF-I (somatomedin C) levels less than 1.9 U/mL in males and less than 2.2 U/mL in females. The dose most commonly found to be effective is 100 mcg t.i.d., but some patients require up to 500 mcg t.i.d. for maximum effectiveness. Doses greater than 300 mcg/day seldom result in additional biochemical benefit, and if an increase in dose fails to provide additional benefit, the dose should be reduced. IGF-I (somatomedin C) or growth hormone levels should be re-evaluated at 6-month intervals.

Sandostatin (octreotide acetate) should be withdrawn yearly for approximately 4 weeks from patients who have received irradiation to assess disease activity. If growth hormone or IGF-I (somatomedin C) levels increase and signs and symptoms recur, Sandostatin (octreotide acetate) therapy may be resumed.

Carcinoid Tumors

The suggested daily dosage of Sandostatin (octreotide acetate) during the first 2 weeks of therapy ranges from 100-600 mcg/day in 2-4 divided doses (mean daily dosage is 300 mcg). In the clinical studies, the median daily maintenance dosage was approximately 450 mcg, but clinical and biochemical benefits were obtained in some patients with as little as 50 mcg, while others required doses up to 1500 mcg/day. However, experience with doses above 750 mcg/day is limited.

VIPomas

Daily dosages of 200-300 mcg in 2-4 divided doses are recommended during the initial 2 weeks of therapy (range 150-750 mcg) to control symptoms of the disease. On an individual basis, dosage may be adjusted to achieve a therapeutic response, but usually doses above 450 mcg/day are not required.

HOW SUPPLIED

Sandostatin® (octreotide acetate) Injection is available in 1-mL ampuls and 5-mL multi-dose vials as follows:

Ampuls

50 mcg/mL octreotide (as acetate)

Package of 10 ampuls ............................................... NDC 0078-0180-01

100 mcg/mL octreotide (as acetate)

Package of 10 ampuls ...............................................NDC 0078-0181-01

500 mcg/mL octreotide (as acetate)

Package of 10 ampuls ...............................................NDC 0078-0182-01

Multi-Dose Vials

200 mcg/mL octreotide (as acetate)

Box of one ................................................................NDC 0078-0183-25

1000 mcg/mL octreotide (as acetate)

Box of one ...............................................................NDC 0078-0184-25

Storage

For prolonged storage, Sandostatin (octreotide acetate) ampuls and multi-dose vials should be stored at refrigerated temperatures 2°C-8°C (36°F-46°F) and store in outer carton in order to protect from light. At room temperature, (20°C-30°C or 70°F-86°F), Sandostatin (octreotide acetate) is stable for 14 days if protected from light. The solution can be allowed to come to room temperature prior to administration. Do not warm artificially. After initial use, multiple-dose vials should be discarded within 14 days. Ampuls should be opened just prior to administration and the unused portion discarded. Dispose unused product or waste properly.

Rev: Aug 2008. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936.

Last reviewed on RxList: 2/22/2010
This monograph has been modified to include the generic and brand name in many instances.

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