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Octreotide acetate should be withdrawn yearly for approximately 4 weeks from patients who have received irradiation to assess disease activity.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

PremierProRx Logo

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 Label
(click image for full-size original)

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 Tray Label
(click image for full-size original)

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 Label
(click image for full-size original)

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

PACKAGE LABEL -- PRINCIPAL DISPLAY -- Octreotide 1 mL Single Dose Vial Tray Label
(click image for full-size original)
OCTREOTIDE
octreotide acetate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-377
Route of Administration SUBCUTANEOUS, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTREOTIDE ACETATE (OCTREOTIDE) OCTREOTIDE 500 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 7 mg in 1 mL
ACETIC ACID 2 mg in 1 mL
SODIUM ACETATE 2 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-377-04 10 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (63323-377-41)
1 NDC:63323-377-41 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (63323-377-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077457 03/14/2006
OCTREOTIDE
octreotide acetate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-376
Route of Administration SUBCUTANEOUS, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTREOTIDE ACETATE (OCTREOTIDE) OCTREOTIDE 100 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 7 mg in 1 mL
ACETIC ACID 2 mg in 1 mL
SODIUM ACETATE 2 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-376-04 10 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (63323-376-41)
1 NDC:63323-376-41 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (63323-376-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077457 03/14/2006
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

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.