Teva | octreotide acetate for injestable suspension for gluteal intramuscular use

FOR HEALTHCARE PROFESSIONALS ONLY

How to Administer Teva’s Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use

Preparation and Administration of Octreotide Acetate for Injectable Suspension

Successful preparation and administration of Octreotide Acetate for Injectable Suspension relies on proper suspension technique. 
It should only be administered by a trained healthcare provider.

Follow each of the steps outlined in the instruction booklet to ensure complete saturation of the powder and its uniform
suspension prior to deep intragluteal injection. It is critical that Octreotide Acetate for Injectable Suspension and the diluent be allowed to reach room temperature and then be mixed immediately prior to injection.

Ensure that the powder is completely suspended at the time of injection. If you have questions about preparation and/or administration of Octreotide Acetate for Injectable Suspension, please call 1-888-838-2872.

Teva Octreotide How to Administer

Preparing and Administering Octreotide Acetate for Injectable Suspensions, for gluteal intramuscular use

View Instruction Booklet

Packaging and Storage 

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use is available in single-dose kits containing an 8-mL single-dose vial of 10 mg, 20 mg or 30 mg strength, a prefilled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1.5” 19-gauge safety injection needle.
An instruction booklet for the preparation of drug suspension for injection is also included with each kit.

Package Contents 

  • One single-dose vial containing Octreotide Acetate for Injectable Suspension
  • One vial adapter for drug product reconstitution
  • One prefilled syringe containing diluent solution for reconstitution
  • One 1.5” 19-gauge safety injection needle

For prolonged storage, Octreotide Acetate for Injectable Suspension should be stored at refrigerated temperatures between
2°C to 8°C (36°F to 46°F) and protected from light until the time of use. Octreotide Acetate for Injectable Suspension
drug product kit should remain at room temperature for 30 to 60 minutes prior to preparation of the drug suspension.
However, after preparation the drug suspension must be administered immediately.

For more information on Octreotide Acetate for Injectable Suspension, see the full Prescribing Information.

Preparing and Administering

ATTENTION: There are 3 critical steps in the reconstitution of Octreotide Acetate for Injectable Suspension.
Not following them could result in failure to deliver the drug appropriately.

  • The injection kit must reach room temperature. Remove the injection kit from the fridge and let the kit stand at room
    temperature for a minimum of 30 minutes before reconstitution, but do not exceed 24 hours.
  • After adding the diluent solution, ensure that the powder is fully saturated by letting the vial stand for a minimum of 2 minutes
    and up to 5 minutes.
  • After saturation, shake the vial moderately in a horizontal direction for a minimum of 30 seconds, until uniform
    suspension is formed.

12 Steps of Administration

Toggle for more information on 12 steps of administration

Step 1

30 min

  • Remove the Octreotide Acetate for Injectable Suspension kit from refrigerated storage.

ATTENTION: It is essential to start the reconstitution process only after the injection kit has reached room temperature. Let the kit stand at room temperature for a minimum of 30 minutes before reconstitution, but do not exceed 24 hours.

Note: The injection kit can be re-refrigerated if needed.

Step 2

  • Remove the plastic cap from the vial and clean the rubber stopper of the vial with an alcohol wipe.

Step 3

  • Peel the blister film and remove the vial adapter from its packaging by holding between the white luer cap and the skirt. DO NOT touch the tip of the access device at any time.
  • Place the vial on a flat surface. Position the vial adapter on top of the vial and push it fully down so that it snaps in place, confirmed by an audible “click”.
  • CLEAN the tip of the vial adapter with an alcohol wipe.

Step 4

  • Peel off outer syringe label.
  • Inspect syringe to ensure there are no visible particles.

Step 5

  • Snap off the smooth white cap from the syringe prefilled with diluent solution and screw the syringe onto the vial adapter.
  • Slowly push the plunger all the way down to transfer all the diluent solution in the vial.

Step 6

5 min

ATTENTION: It is essential to let the vial stand for a minimum of 2 minutes and up to 5 minutes to ensure that the diluent has fully saturated the powder.

Note: It is normal if the plunger rod moves up as there might be a slight overpressure in the vial.

  • At this stage prepare the patient for injection.

Step 7

  • After the saturation period, make sure that the plunger is pushed all the way down in the syringe.

ATTENTION: Keep the plunger pressed and shake the vial moderately in a horizontal direction for a minimum of 30 seconds so that the powder is completely suspended (uniform milky suspension). Repeat moderate shaking for another 30 seconds if the powder is not completely suspended.

Step 8

  • Turn syringe and vial upside down, slowly pull the plunger back and draw the entire contents from the vial into the syringe.
  • Unscrew the syringe from the vial adapter.

Step 9

  • Prepare the injection site with an alcohol wipe.
  • Screw the safety injection needle onto the syringe.
  • Gently re-shake the syringe to a milky uniform suspension.
  • Pull the protective cover straight off the needle.
  • Gently tap the syringe to remove any visible bubbles and expel them from the syringe.
  • Proceed immediately to Step 10 for administration to the patient. Any delay may result in sedimentation.

Step 10

Injection sites - 90º angle

  • Octreotide Acetate for Injectable Suspension must be given only by deep intragluteal injection, NEVER intravenously.
  • Insert the needle fully into the left or right gluteus at a 90º angle to the skin.
  • Slowly pull back the plunger to check that no blood vessel has been penetrated (reposition if a blood vessel has been penetrated).
  • Depress the plunger with steady pressure until the syringe is empty. Withdraw the needle from the injection site and activate the safety guard (as shown in Step 11).

Step 11

  • Activate the safety guard over the needle in one of the 2 methods shown:
    • 1 - either press the hinged section of the safety guard down onto a hard surface (figure A).
    • 2 - or push the hinge forward with your finger (figure B).
  • An audible “click” confirms the proper activation.
  • Note: Record injection site on patient’s record and alternate monthly.

Step 12

  • Dispose of syringe immediately (in a sharps container).

Special precautions for disposal: any unused product or waste material should be disposed of in accordance with local requirements.

Important Safety Information

What is the most important information I should know about octreotide acetate for injectable suspension?

Treatment with octreotide acetate for injectable suspension may affect gallbladder function, with reports of gallstones resulting in complications (inflammation of the gallbladder, bile duct, and pancreas, and requiring surgical removal of the gallbladder); sugar metabolism; thyroid and heart function; and nutritional absorption, which may require monitoring by your doctor. Tell your doctor if you experience signs or symptoms of gallstones or any of their complications.

Patients with carcinoid tumors and VIP-secreting tumors should adhere closely to their scheduled return visits for reinjection in order to minimize exacerbation of symptoms. 

Patients with acromegaly should adhere to their return visit schedule to help assure steady control of GH and IGF-1 levels.

What should I tell my doctor before taking octreotide acetate for injectable suspension?

Tell your doctor if you have a history of heart disease or are taking other medications, including cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, and bromocriptine.

What are the possible side effects of octreotide acetate for injectable suspension?

In acromegalic patients, the most common side effects of octreotide acetate for injectable suspension include gallstones, diarrhea, abdominal pain, gas, flu-like symptoms, constipation, headache, low red blood cells, injection-site pain, gallstones, high blood pressure, dizziness and fatigue.

In carcinoid tumor and VIP-secreting tumor patients, the most common side effects of octreotide acetate for injectable suspension include back pain, fatigue, headache, abdominal pain, nausea, and dizziness.

These are not all of the possible side effects of octreotide acetate for injectable suspension. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

What is octreotide acetate for injectable suspension?

Octreotide acetate for injectable suspension is a prescription medication used in patients in whom initial treatment with octreotide acetate injection has been shown to be effective and tolerated for:

  • Long-term maintenance therapy in acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy, is not an option to reduce GH and IGF-1 levels to normal.
  • Long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors.
  • Long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors.

In patients with carcinoid tumors and VIP-secreting tumors, the effect of octreotide acetate injection and octreotide acetate for injectable suspension on tumor size, rate of growth and development of metastases, has not been determined.

Please see the full Prescribing Information.