Octreotide (Page 4 of 4)
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Octreotide acetate should be withdrawn yearly for approximately 4 weeks from patients who have received irradiation to assess disease activity.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 therapy may be resumed.
Carcinoid Tumors
The suggested daily dosage of octreotide acetate 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 1,500 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 in preservative free single-dose vials:
Product Code | Unit of Sale | Strength | Each |
PRX370601 | NDC 63323-376-04 Unit of 10 | 100 mcg per mL, 1 mL fill in a 2 mL vial | NDC 63323-376-41 1 mL Single Dose Vial |
PRX370701 | NDC 63323-377-04 Unit of 10 | 500 mcg per mL, 1 mL fill in a 2 mL vial | NDC 63323-377-41 1 mL Single Dose Vial |
Storage
For prolonged storage, octreotide acetate single dose 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. Single dose vials should be opened just prior to administration and the unused portion discarded. Dispose unused product or waste properly.
The container closure is not made with natural rubber latex.
PREMIERProRx® is a registered trademark of Premier Healthcare Alliance, L.P., used under license.
Manufactured by:
Fresenius Kabi
Lake Zurich, IL 60047
www.fresenius-kabi.com/us
451396B
Revised: April 2022
PACKAGE LABEL — PRINCIPAL DISPLAY — Octreotide 1 mL Single Dose Vial Label
NDC 63323-376-41 PRX370601
Octreotide Acetate Injection
100 mcg per mL
For Subcutaneous or Intravenous Use
Preservative free.
Protect from light.
Discard unused portion.
1 mL Single Dose Vial Rx only
PACKAGE LABEL — PRINCIPAL DISPLAY — Octreotide 1 mL Single Dose Vial Tray Label
NDC 63323-376-04 PRX370601
Octreotide Acetate Injection
100 mcg per mL
For Subcutaneous or Intravenous Use
Preservative free.
10 x 1 mL
Single Dose Vials Rx only
PACKAGE LABEL — PRINCIPAL DISPLAY — Octreotide 1 mL Single Dose Vial Label
NDC 63323-377-41 PRX370701
Octreotide Acetate Injection
500 mcg per mL
For Subcutaneous or Intravenous Use
Preservative free.
Protect from light.
Discard unused portion.
1 mL Single Dose Vial Rx only
PACKAGE LABEL — PRINCIPAL DISPLAY — Octreotide 1 mL Single Dose Vial Tray Label
NDC 63323-377-04 PRX370701
Octreotide Acetate Injection
500 mcg per mL
For Subcutaneous or Intravenous Use
Preservative free.
10 x 1 mL
Single Dose Vials Rx only
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OCTREOTIDE octreotide acetate injection, solution | |||||||||||||||||
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Labeler — Fresenius Kabi USA, LLC (608775388) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Fresenius Kabi USA, LLC | 023648251 | analysis (63323-376), manufacture (63323-376), analysis (63323-377), manufacture (63323-377) |
Revised: 06/2022 Fresenius Kabi USA, LLC
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