RISPERDAL® CONSTA® (risperidone) Instructions for Use1

Dose pack components include:

Dose pack components

RISPERDAL® CONSTA® must be reconstituted only in the diluent supplied in the dose pack, and must be administered with only the appropriate needle supplied in the dose pack for gluteal (2-inch needle) or deltoid (1-inch needle) administration. All components are required for administration. Do not substitute any components of the dose pack. To assure that the intended dose of risperidone is delivered, the full contents from the vial must be administered. Administration of partial contents may not deliver the intended dose of risperidone.

Remove the dose pack of RISPERDAL® CONSTA® from the refrigerator and allow it to come to room temperature prior to reconstitution.

  1. Flip off the plastic colored cap from the vial.

    Step one

  2. Peel back the blister pouch and remove the SmartSite® Needle-Free Vial Access Device by holding the white luer cap. Do not touch the spike tip of the access device at any time.

    Step twoStep two

  3. Place vial on a hard surface. Hold the base of the vial. Orient the SmartSite® Access Device vertically over the vial so that the spike tip is at the center of the vial's rubber stopper. With a straight downward push, press the spike tip of the SmartSite® Access Device through the center of the vial's rubber stopper until the device securely snaps onto the vial top.

    Step three

  4. Swab the syringe connection point (blue circle) of the SmartSite® Access Device with preferred antiseptic prior to attaching the syringe to the SmartSite® Access Device.

    Step four

  5. The prefilled syringe has a white cap consisting of 2 parts: a white collar and a smooth white cap. To open the syringe, hold the syringe by the white collar and snap off the smooth white cap (DO NOT TWIST OFF THE WHITE CAP). Remove the white cap together with the rubber-tipped cap inside.
    For all syringe assembly steps, hold the syringe only by the white collar located at the tip of the syringe. Be careful to not overtighten components when assembling. Overtightening connections may cause syringe component parts to loosen from the syringe body.

    Step five

  6. While holding the white collar of the syringe, insert and press the syringe tip into the blue circle of the SmartSite® Access Device and twist in a clockwise motion to secure the connection of the syringe to the SmartSite® Access Device (avoid over twisting). Hold the skirt of the SmartSite® Access Device during attachment to prevent it from spinning. Keep the syringe and SmartSite® Access Device aligned.

    Step six

  7. Inject the entire contents of the syringe containing the diluent into the vial.

    Step seven

  8. Shake the vial vigorously while holding the plunger rod down with the thumb for a minimum of 10 seconds to ensure a homogeneous suspension. When properly mixed, the suspension appears uniform, thick, and milky in color. The microspheres will be visible in liquid, but no dry microspheres remain.

    Step eight

  9. Do not store the vial after reconstitution or the suspension may settle. If 2 minutes pass before injection, resuspend by shaking vigorously.
  10. Invert the vial completely and slowly withdraw the suspension from the vial into the syringe. Tear section of the vial label at the perforation and apply detached label to syringe for identification purposes.

    Step ten

  11. While holding the white collar of the syringe, unscrew the syringe from the SmartSite® Access Device. Discard both the vial and vial access device appropriately.

    Step eleven

  12. Select the appropriate needle:
    For GLUTEAL injection, select the 20G TW 2-inch needle (longer needle with yellow-colored hub in blister with yellow print).
    For DELTOID injection, select the 21G UTW 1-inch needle (shorter needle with green-colored hub in blister with green print).
  13. Peel the blister pouch of the Needle-Pro® safety device open halfway. Grasp the transparent needle sheath using the plastic peel pouch. To prevent contamination, be careful not to touch the orange Needle-Pro® safety device's luer connector. While holding the white collar of the syringe, attach the luer connection of the orange Needle-Pro® safety device to the syringe with an easy clockwise twisting motion.

    Step thirteen

  14. While continuing to hold the white collar of the syringe, grasp the transparent needle sheath and seat the needle firmly on the orange Needle-Pro® safety device with a push and a clockwise twist.

    Step fourteen

  15. If 2 minutes pass before injection, resuspend by shaking vigorously.
  16. While holding the white collar of the syringe, pull the transparent needle sheath straight away from the needle. DO NOT TWIST the sheath as the luer connections may be loosened.

    Step sixteen

  17. Tap the syringe gently to make any air bubbles rise to the top. Remove air in syringe by depressing the plunger rod while holding the needle in an upright position. Inject the entire contents of the syringe intramuscularly (IM) into the selected gluteal or deltoid muscle of the patient within 2 minutes to avoid settling. Gluteal injection should be made into the upper-outer quadrant of the gluteal area. DO NOT ADMINISTER INTRAVENOUSLY.

    Step seventeen

    WARNING: To avoid a needle stick injury with a contaminated needle:

    • Do not use free hand to press the Needle-Pro® safety device over the needle
    • Do not intentionally disengage the Needle-Pro® safety device
    • Do not attempt to straighten the needle or engage Needle-Pro® safety device if the needle is bent or damaged
    • Do not mishandle the Needle-Pro® safety device, as it may cause the needle to protrude from the Needle-Pro® safety device
  18. After injection is complete, press the needle into the orange Needle-Pro® safety device using a one-handed technique. Perform a one-handed technique by GENTLY pressing the orange Needle-Pro® safety device against a tabletop or other hard, flat surface. AS THE ORANGE NEEDLE-PRO® SAFETY DEVICE IS PRESSED, THE NEEDLE WILL FIRMLY ENGAGE INTO THE ORANGE NEEDLE-PRO® SAFETY DEVICE. Visually confirm that the needle is fully engaged into the orange Needle-Pro® safety device before discarding. Discard needle appropriately. Also discard the other (unused) needle provided in the dose pack.

    Step eighteen

Upon suspension of the microspheres in the diluent, it is recommended to use RISPERDAL® CONSTA® immediately. If RISPERDAL® CONSTA® is not administered within 2 minutes of reconstitution, settling of the microspheres will occur and resuspension by shaking is necessary prior to administration. Keeping the vial upright, shake vigorously back and forth for as long as it takes to resuspend the microspheres. Once in suspension, the product may remain at room temperature (do not expose to temperatures above 77° F [25° C]). RISPERDAL® CONSTA® must be used within 6 hours of suspension.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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Safety and Tolerability