Octreotide Acetate (Page 4 of 5)

OVERDOSAGE

A limited number of accidental overdoses of octreotide acetate injection in adults have been reported. In adults, the doses ranged from 2,400 to 6,000 mcg/day administered by continuous infusion (100 to 250 mcg/hour) or subcutaneously (1,500 mcg 3 times a day). Adverse events in some patients included arrhythmia, complete atrioventricular block, hypotension, cardiac arrest, brain hypoxia, pancreatitis, hepatitis steatosis, hepatomegaly, lactic acidosis, flushing, diarrhea, lethargy, weakness, and weight loss.

Octreotide acetate injection given in intravenous (IV) boluses of 1 mg (1,000 mcg) to healthy volunteers did not result in serious ill effects, nor did doses of 30 mg (30,000 mcg) given intravenously over 20 minutes and of 120 mg (120,000 mcg) given intravenously over 8 hours to research patients.

If overdose occurs, symptomatic management is indicated. Up-to-date information about the treatment of overdose can often be obtained from the National Poison Control Center at 1-800-222-1222.

Drug Abuse and Dependence

There is no indication that octreotide acetate has potential for drug abuse or dependence. Octreotide acetate levels in the central nervous system are negligible, even after doses up to 30,000 mcg.

DOSAGE AND ADMINISTRATION

Octreotide acetate injection may be administered subcutaneously or intravenously. Subcutaneous injection is the usual route of administration of octreotide acetate injection 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. Octreotide acetate injection 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.

Octreotide acetate injection 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 to 200 mL and infused intravenously over 15 to 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 3 times daily. Upward dose titration is frequently required. Dosage information for patients with specific tumors follows.

Acromegaly

Dosage may be initiated at 50 mcg 3 times a day. Beginning with this low dose may permit adaptation to adverse gastrointestinal effects for patients who will require higher doses. Insulin growth factor-1 (IGF-1; somatomedin C) levels every 2 weeks can be used to guide titration. Alternatively, multiple growth hormone (GH) levels at 0 to 8 hours after octreotide acetate injection administration permit more rapid titration of dose. The goal is to achieve GH levels less than 5 ng/mL or IGF-1 (somatomedin C) levels less than 1.9 unit/mL in males and less than 2.2 unit/mL in females. The dose most commonly found to be effective is 100 mcg 3 times a day, but some patients require up to 500 mcg 3 times a day 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-1 (somatomedin C) or GH levels should be reevaluated at 6-month intervals.

Octreotide acetate injection should be withdrawn yearly for approximately 4 weeks from patients who have received irradiation to assess disease activity. If GH or IGF-1 (somatomedin C) levels increase and signs and symptoms recur, octreotide acetate injection therapy may be resumed.

Carcinoid Tumors

The suggested daily dosage of octreotide acetate injection during the first 2 weeks of therapy ranges from 100 to 600 mcg/day in 2 to 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 to 300 mcg in 2 to 4 divided doses are recommended during the initial 2 weeks of therapy (range, 150 to 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

Octreotide Acetate Injection is available as follows:

NDC 0641-6174-10, 50 mcg/mL octreotide (as acetate), 1 mL Single Dose amber vial supplied in a carton of 10

NDC 0641-6175-10, 100 mcg/mL octreotide (as acetate), 1 mL Single Dose amber vial supplied in a carton of 10

NDC 0641-6176-10, 500 mcg/mL octreotide (as acetate), 1 mL Single Dose amber vial supplied in a carton of 10

NDC 0641-6177-01, 200 mcg/mL octreotide (as acetate), 5 mL Multiple Dose amber vials individually boxed

NDC 0641-6178-01, 1,000 mcg/mL octreotide (as acetate), 5 mL Multiple Dose amber vials individually boxed

Storage

For prolonged storage, Octreotide Acetate Injection vials should be stored at refrigerated temperatures 2°C to 8°C (36°F to 46°F) and protected from light. At room temperature, (20°C to 30°C or 70°F to 86°F), Octreotide Acetate Injection 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, the 5 mL multiple dose vials should be discarded within 14 days. Dispose unused product or waste properly.

To report SUSPECTED ADVERSE REACTIONS , contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For Product Inquiry call 1-877-845-0689.

Manufactured by:

Hikma Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922

Revised July 2021

462-729-05

PRINCIPAL DISPLAY PANEL 50 mcg/mL

NDC 0641-6174 -01 Rx only
Octreotide
Acetate Injection
50 mcg/mL
For
Subcutaneous or
Intravenous Use
Store at 2º to 8ºC1 mL Single Dose Vial

PRINCIPAL DISPLAY PANEL 100 mcg/mL

NDC 0641-6175 -01 Rx only
Octreotide
Acetate Injection
100 mcg/mL
For
Subcutaneous or
Intravenous Use
Store at 2º to 8ºC1 mL Single Dose Vial

PRINCIPAL DISPLAY PANEL 500 mcg/mL

NDC 0641-6176 -01 Rx only
Octreotide
Acetate Injection
500 mcg/mL
For
Subcutaneous or
Intravenous Use
Store at 2º to 8ºC
1 mL Single Dose Vial

PRINCIPAL DISPLAY PANEL 1,000 mcg/5 mL (200 mcg/mL)

NDC 0641-6177 -01 Rx only
Octreotide
Acetate Injection
1,000 mcg per 5 mL
(200 mcg/mL)
For Subcutaneous or Intravenous Use 5 mL Multiple Dose Vial