Octreotide acetate injectable suspension is a long-acting medication administered via deep intramuscular injection.
What's in the Octreotide Acetate Injection Kit?
Each single dose of octreotide acetate comes in a comprehensive injection kit, containing:
One vial of octreotide acetate powder for injectable suspension.
A pre-filled syringe with the solution for reconstitution (diluent).
One vial adapter for drug reconstitution.
One 1.5-inch, 19-gauge safety needle.
Essential Steps for Reconstitution and Administration
Successful preparation and administration of octreotide acetate for injectable suspension depend on precise technique. Follow these steps carefully:
1. Kit Preparation and Warming
Remove the octreotide acetate kit from refrigerated storage.
Do not open the kit or attempt to speed up the warming process.
Allow the kit to sit at room temperature for a minimum of 30 minutes before starting reconstitution. The kit can be left out for longer, but do not exceed 24 hours.
If the kit has been out for less than 24 hours, it can be re-refrigerated.
2. Preparing the Vial
Once the kit has reached room temperature, place the vial on a hard surface.
Gently tap the vial to ensure all powder settles at the bottom.
Remove the plastic cap from the vial and clean the rubber stopper with an alcohol wipe.
3. Attaching the Vial Adapter
Peel the blister packaging and remove the vial adapter by holding it between the white lure cap and the skirt. Avoid touching the tip of the adapter.
Place the vial on a flat surface.
Position the vial adapter on top of the vial and push it down firmly until it snaps into place with an audible click.
Once the adapter is in place, clean its tip with an alcohol wipe.
4. Preparing the Syringe and Adding Diluent
Peel off the outer syringe label.
Inspect the syringe to ensure there are no visible particles.
Snap off the smooth white cap from the pre-filled syringe containing the diluent solution.
Screw the syringe onto the vial adapter.
Slowly push the plunger all the way down to transfer all the diluent solution into the vial.
5. Saturation and Suspension
After transferring the solution, let the vial stand for a minimum of 2 minutes but no longer than 5 minutes. This allows the diluent to fully saturate the powder. (It's normal for the plunger rod to move up slightly due to overpressure).
During this saturation period, prepare the patient for injection.
After saturation, ensure the plunger is pushed all the way down in the syringe.
Keep the plunger pressed and shake the vial moderately in a horizontal direction for a minimum of 30 seconds until a uniform milky suspension forms.
If you observe any granules or particles, indicating incomplete suspension, repeat moderate shaking for another 30 seconds.
Octreotide acetate suspension must be prepared immediately before administration.
6. Drawing the Dose
Turn the syringe and vial upside down.
Slowly pull the plunger back to draw the contents from the vial into the syringe.
Unscrew the syringe from the vial adapter. Your dose of octreotide acetate is now ready for administration.
Critical Reconstitution Actions to Remember
Failure to follow these three critical actions can result in improper drug delivery:
Room Temperature Kit: The injection kit must reach room temperature (at least 30 minutes, not exceeding 24 hours) before reconstitution.
Full Saturation: After adding the diluent, allow the vial to stand for 2 to 5 minutes to ensure the powder is fully saturated.
Uniform Suspension: After saturation, shake the vial moderately for a minimum of 30 seconds until a uniform milky suspension is formed.
Administering the Injection
Prepare the injection site (left or right gluteus) with an alcohol wipe.
Screw the safety injection needle onto the syringe.
If administration is delayed, gently reshake the syringe to maintain a milky, uniform suspension.
Pull the protective cover off the needle.
Gently tap the syringe to remove any visible bubbles and expel them.
Proceed immediately to administration as any delay may lead to sedimentation.
Injection Technique
Octreotide acetate for injectable suspension must be given only by deep intramuscular (IM) injection into the left or right gluteal muscle. Never administer intravenously or subcutaneously.
Insert the needle fully into the left or right gluteus at a 90-degree angle to the skin.
Once inserted, slowly pull back the plunger to check for blood vessel penetration. If a blood vessel is penetrated, reposition the needle.
If inserted correctly, depress the plunger with steady pressure until the syringe is empty.
Withdraw the needle from the injection site and activate the needle safety guard.
Activating the Safety Guard
Activate the safety guard over the needle using one of two methods:
Press the hinge section of the safety guard down onto a hard surface.
Push the hinge forward with your finger.
An audible click confirms proper activation.
Post-Injection Procedures
Record the injection site in the patient record. Always alternate the injection site monthly.
Dispose of the syringe immediately in a Sharps container.
Dispose of unused products or waste material in accordance with local requirements.
Important Safety Information and Indications
Octreotide acetate for injectable suspension is indicated for patients where initial octreotide acetate injection has been effective and tolerated. It is used for:
Long-term maintenance therapy in acromegalic patients with inadequate response to surgery/radiotherapy, or for whom these are not options, to reduce GH and IGF-1 levels to normal.
Long-term treatment of severe diarrhea and flushing episodes associated with metastatic carcinoid tumors.
Long-term treatment of profuse watery diarrhea associated with VIP-secreting tumors.
Note: The effect of octreotide acetate on tumor size, growth rate, and metastasis development has not been determined for carcinoid and VIP-secreting tumors.
Warnings and Precautions
Gallbladder Abnormalities: Cholelithiasis (gallstones) and complications (cholecystitis, cholangitis, pancreatitis) may occur. Monitor patients periodically. Discontinue and treat appropriately if complications are suspected.
Glucose Metabolism: Hypoglycemia or hyperglycemia may occur. Monitor blood glucose levels when initiating or altering treatment, and adjust anti-diabetic treatment accordingly.
Thyroid Function: Hypothyroidism may occur. Baseline and periodic assessment of thyroid function (TSH, total and/or free T4) is recommended.
Cardiac Function: Bradycardia, arrhythmia, conduction abnormalities, and other ECG changes may occur. Use with caution in at-risk patients.
Nutrition: Octreotide may alter absorption of dietary fats. Monitoring of vitamin B12 and zinc levels (for patients on TPN) is recommended.
Drug Interactions
Monitor and possibly adjust doses for drugs used with octreotide acetate, including:
Cyclosporine
Insulin
Oral hypoglycemic agents
Beta-blockers
Bromocriptine
Octreotide may affect the absorption of orally administered drugs. Use caution with drugs mainly metabolized by CYP3A4 with a low therapeutic index. Octreotide should be discontinued at least 4 weeks prior to Lutetium Lu 177 dotatate dosing due to competitive binding.
Adverse Reactions
In Acromegalic Patients, common adverse reactions include:
Biliary abnormalities (52%)
Diarrhea (36%)
Abdominal pain/discomfort (29%)
Flatulence (26%)
Constipation (19%)
Headache (15%)
Anemia (15%)
In Carcinoid Tumor and VIP-Secreting Tumor Patients, common adverse reactions include:
Kevin Van, PharmD, BCPS (Editor)