AHFS Class:

68:29.04 Somatostatin Agonists

Generic Name

• Octreotide Acetate

Octreotide acetate injection is available in 1-mL ampuls or single-dose vials containing 0.05 mg (50 mcg), 0.1 mg (100 mcg), and 0.5 mg (500 mcg) of octreotide and in 5-mL multiple-dose vials containing 0.2 mg (200 mcg) and 1 mg (1000 mcg) of octreotide in each mL.³⁶⁴⁸; ³⁶⁴⁹

Each mL of the short-acting Sandostatin (Novartis) formulation also contains lactic acid 3.4 mg, mannitol 45 mg, and sodium bicarbonate and additional lactic acid to adjust pH in water for injection.³⁶⁴⁸

Octreotide acetate injection also is available in several differing formulations.³⁶⁴⁹; ³⁶⁵⁰; ³⁶⁵¹ Octreotide acetate (Hikma) in single- and multiple-dose vials contains in each mL L-lactic acid 3 mg, sodium chloride 7 mg, and sodium hydroxide in water for injection.³⁶⁴⁹ Octreotide acetate (Sagent) in single- and multiple-dose vials contains in each mL sodium chloride 7 mg, glacial acetic acid 2 mg, and sodium acetate trihydrate 2 mg in water for injection.³⁶⁵⁰ Octreotide acetate (Teva) in single- and multiple-dose vials contains in each mL glacial acetic acid 2 mg, sodium acetate trihydrate 2 mg, and mannitol 45 mg in water for injection.³⁶⁵¹ All 5-mL multiple-dose vials also contain the preservative phenol at a concentration of 5 mg/mL.³⁶⁴⁹; ³⁶⁵⁰; ³⁶⁵¹

Octreotide acetate injection also is available in prefilled pens for single-patient-use to be administered by subcutaneous injection³⁶⁵³ and as a long-acting injectable depot suspension for intragluteal injection.³⁶⁵²

pH

Octreotide acetate (Novartis, Hikma, Sagent) injection has a pH ranging from 3.9 to 4.5.³⁶⁴⁸; ³⁶⁴⁹; ³⁶⁵⁰

Octreotide acetate (Teva) injection has a pH ranging from 3.7 to 4.7.³⁶⁵¹

Trade Name(s)

SandoSTATIN

Octreotide acetate may be administered by subcutaneous injection or intravenously.³⁶⁴⁸; ³⁶⁴⁹; ³⁶⁵⁰; ³⁶⁵¹ Pain with subcutaneous injection may be reduced by using the smallest volume that will deliver the dose.³⁶⁴⁸; ³⁶⁴⁹; ³⁶⁵⁰; ³⁶⁵¹ Subcutaneous injection sites should be rotated.³⁶⁴⁸; ³⁶⁴⁹; ³⁶⁵⁰; ³⁶⁵¹ Multiple subcutaneous injections at the same site within a short time should be avoided.³⁶⁴⁸; ³⁶⁴⁹; ³⁶⁵⁰; ³⁶⁵¹

Following dilution in 50 to 200 mL of sodium chloride 0.9% or dextrose 5%, octreotide also may be administered by intravenous injection over 3 minutes or by infusion over 15 to 30 minutes.³⁶⁴⁸; ³⁶⁴⁹; ³⁶⁵⁰; ³⁶⁵¹ In emergency situations (e.g., carcinoid crisis), manufacturers state that the drug may be administered by rapid bolus injection.³⁶⁴⁸; ³⁶⁴⁹; ³⁶⁵⁰; ³⁶⁵¹

NOTE: Do not confuse octreotide acetate injection with the injectable depot suspension product, which cannot be given by these routes of administration.³⁶⁵²

Octreotide acetate injection is a clear solution.³⁶⁴⁸; ³⁶⁴⁹; ³⁶⁵⁰; ³⁶⁵¹ For prolonged storage, ampuls and vials should be stored under refrigeration at 2 to 8°C and protected from light (e.g., by storing in the outer carton).³⁶⁴⁸; ³⁶⁴⁹; ³⁶⁵⁰; ³⁶⁵¹ The solution can be allowed to come to room temperature prior to administration; the solution should not be warmed artificially.³⁶⁴⁸; ³⁶⁴⁹; ³⁶⁵⁰; ³⁶⁵¹ Manufacturers state that octreotide acetate injection can be stored at room temperature for up to 14 days when protected from light.³⁶⁴⁸; ³⁶⁴⁹; ³⁶⁵⁰; ³⁶⁵¹

Multiple-dose vials should be discarded within 14 days after initial use.³⁶⁴⁹; ³⁶⁵⁰; ³⁶⁵¹

The manufacturers state that octreotide acetate injection should not be added to total parenteral nutrition solutions because of the formation of a glycosyl octreotide conjugate that may decrease the product’s efficacy,³⁶⁴⁸; ³⁶⁴⁹; ³⁶⁵⁰; ³⁶⁵¹ although the clinical value of this administration approach has been debated.²¹³⁶

Syringes

The stability of octreotide acetate injection (Sandoz) 0.2 mg/mL packaged as 1 mL in 3-mL polypropylene syringes sealed with tip caps (Becton Dickinson) was evaluated at 3 and 23°C both exposed to and protected from normal room light. No octreotide acetate loss was found in 29 days stored at 3°C protected from light, but about 7 to 9% loss occurred in 15 to 22 days exposed to light. At 23°C, the drug was less stable. Although results were variable, more than 10% loss occurred in about 2 weeks. Maximum storage of 1 week at 23°C, whether protected from light or not, was recommended.²⁰²⁰

In a similar study, the stability of octreotide acetate injection (Sandoz) 0.2 mg/mL was evaluated for 60 days stored at 5 and -20°C (light conditions unspecified). The undiluted octreotide acetate injection was packaged as 1 mL in 3-mL polypropylene syringes (Terumo) and sealed with a cap. A loss of about 6% at both storage conditions after 60 days was found.²⁰²¹

Sorption

The manufacturer indicates that octreotide, a peptide, has the potential for adsorption to plastic and, possibly, glass.¹⁵⁴⁰ However, the drug was not adsorbed to glass infusion bottles or a polyvinyl chloride (PVC) administration set at a concentration of 5 mcg/mL in sodium chloride 0.9%.¹³⁷¹

Standardize 4 Safety

One or more standardized concentrations for this drug have been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care. (See Standardize 4 Safety in Users Guide.) Recommendations developed to date through this initiative are available at www.ashp.org/pharmacy-practice/standardize-4-safety-initiative.

Table 1: Standardize 4 Safety Continuous IV Infusion Standard Concentrations for Octreotide³⁶³⁵

Solution Compatibility

Additive Compatibility

Drugs in Syringe Compatibility

Y-Site Injection Compatibility (1:1 Mixture)

For a list of references cited in the text of this monograph, search the monograph titled References.

ASHP^® Injectable Drug Information^TM. Selected Revisions September 12, 2024. © Copyright, 2024. American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.