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Risperdal Consta Dosage

Generic name: risperidone
Dosage form: injection

This dosage information does not include all the information needed to use Risperdal Consta safely and effectively. See full prescribing information for Risperdal Consta.

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For patients who have never taken oral RISPERDAL®, it is recommended to establish tolerability with oral RISPERDAL® prior to initiating treatment with RISPERDAL® CONSTA®.

RISPERDAL® CONSTA® should be administered every 2 weeks by deep intramuscular (IM) deltoid or gluteal injection. Each injection should be administered by a health care professional using the appropriate enclosed safety needle [see Dosage and Administration (2.8)]. For deltoid administration, use the 1-inch needle alternating injections between the two arms. For gluteal administration, use the 2-inch needle alternating injections between the two buttocks. Do not administer intravenously.

Schizophrenia

The recommended dose for the treatment of schizophrenia is 25 mg IM every 2 weeks. Although dose response for effectiveness has not been established for RISPERDAL® CONSTA®, some patients not responding to 25 mg may benefit from a higher dose of 37.5 mg or 50 mg. The maximum dose should not exceed 50 mg RISPERDAL® CONSTA® every 2 weeks. No additional benefit was observed with dosages greater than 50 mg RISPERDAL® CONSTA®; however, a higher incidence of adverse effects was observed.

The efficacy of RISPERDAL® CONSTA® in the treatment of schizophrenia has not been evaluated in controlled clinical trials for longer than 12 weeks. Although controlled studies have not been conducted to answer the question of how long patients with schizophrenia should be treated with RISPERDAL® CONSTA®, oral risperidone has been shown to be effective in delaying time to relapse in longer-term use. It is recommended that responding patients be continued on treatment with RISPERDAL® CONSTA® at the lowest dose needed. The physician who elects to use RISPERDAL® CONSTA® for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.

Bipolar Disorder

The recommended dose for monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder is 25 mg IM every 2 weeks. Some patients may benefit from a higher dose of 37.5 mg or 50 mg. Dosages above 50 mg have not been studied in this population. The physician who elects to use RISPERDAL® CONSTA® for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.

General Dosing Information

A lower initial dose of 12.5 mg may be appropriate when clinical factors warrant dose adjustment, such as in patients with hepatic or renal impairment, for certain drug interactions that increase risperidone plasma concentrations [see Drug Interactions (7.11)] or in patients who have a history of poor tolerability to psychotropic medications. The efficacy of the 12.5 mg dose has not been investigated in clinical trials.

Oral RISPERDAL® (or another antipsychotic medication) should be given with the first injection of RISPERDAL® CONSTA® and continued for 3 weeks (and then discontinued) to ensure that adequate therapeutic plasma concentrations are maintained prior to the main release phase of risperidone from the injection site [see Clinical Pharmacology (12.3)].

Upward dose adjustment should not be made more frequently than every 4 weeks. The clinical effects of this dose adjustment should not be anticipated earlier than 3 weeks after the first injection with the higher dose.

In patients with clinical factors such as hepatic or renal impairment or certain drug interactions that increase risperidone plasma concentrations [see Drug Interactions (7.11)], dose reduction as low as 12.5 mg may be appropriate. The efficacy of the 12.5 mg dose has not been investigated in clinical trials.

Do not combine two different dose strengths of RISPERDAL® CONSTA® in a single administration.

Dosage in Special Populations

Elderly

For elderly patients treated with RISPERDAL® CONSTA®, the recommended dosage is 25 mg IM every 2 weeks. Oral RISPERDAL® (or another antipsychotic medication) should be given with the first injection of RISPERDAL® CONSTA® and should be continued for 3 weeks to ensure that adequate therapeutic plasma concentrations are maintained prior to the main release phase of risperidone from the injection site [see Clinical Pharmacology (12.3)].

Renal or Hepatic Impairment

Patients with renal or hepatic impairment should be treated with titrated doses of oral RISPERDAL® prior to initiating treatment with RISPERDAL® CONSTA®. The recommended starting dose is 0.5 mg oral RISPERDAL® twice daily during the first week, which can be increased to 1 mg twice daily or 2 mg once daily during the second week. If a total daily dose of at least 2 mg oral RISPERDAL® is well tolerated, an injection of 25 mg RISPERDAL® CONSTA® can be administered every 2 weeks. Oral supplementation should be continued for 3 weeks after the first injection until the main release of risperidone from the injection site has begun. In some patients, slower titration may be medically appropriate. Alternatively, a starting dose of RISPERDAL® CONSTA® of 12.5 mg may be appropriate. The efficacy of the 12.5 mg dose has not been investigated in clinical trials.

Patients with renal impairment may have less ability to eliminate risperidone than normal adults. Patients with impaired hepatic function may have an increase in the free fraction of the risperidone, possibly resulting in an enhanced effect [see Clinical Pharmacology (12.3)]. Elderly patients and patients with a predisposition to hypotensive reactions or for whom such reactions would pose a particular risk should be instructed in nonpharmacologic interventions that help to reduce the occurrence of orthostatic hypotension (e.g., sitting on the edge of the bed for several minutes before attempting to stand in the morning and slowly rising from a seated position). These patients should avoid sodium depletion or dehydration, and circumstances that accentuate hypotension (alcohol intake, high ambient temperature, etc.). Monitoring of orthostatic vital signs should be considered [see Warnings and Precautions (5.7)].

Reinitiation of Treatment in Patients Previously Discontinued

There are no data to specifically address reinitiation of treatment. When restarting patients who have had an interval off treatment with RISPERDAL® CONSTA®, supplementation with oral RISPERDAL® (or another antipsychotic medication) should be administered.

Switching from Other Antipsychotics

There are no systematically collected data to specifically address switching patients from other antipsychotics to RISPERDAL® CONSTA®, or concerning concomitant administration with other antipsychotics. Previous antipsychotics should be continued for 3 weeks after the first injection of RISPERDAL® CONSTA® to ensure that therapeutic concentrations are maintained until the main release phase of risperidone from the injection site has begun [see Clinical Pharmacology (12.3)]. For patients who have never taken oral RISPERDAL®, it is recommended to establish tolerability with oral RISPERDAL® prior to initiating treatment with RISPERDAL® CONSTA®. As recommended with other antipsychotic medications, the need for continuing existing EPS medication should be re-evaluated periodically.

Co-Administration of RISPERDAL® CONSTA® with Certain Other Medications

Co-administration of carbamazepine and other CYP 3A4 enzyme inducers (e.g., phenytoin, rifampin, phenobarbital) with risperidone would be expected to cause decreases in the plasma concentrations of the sum of risperidone and 9-hydroxyrisperidone combined, which could lead to decreased efficacy of RISPERDAL® CONSTA® treatment. The dose of risperidone needs to be titrated accordingly for patients receiving these enzyme inducers, especially during initiation or discontinuation of therapy with these inducers [see Drug Interactions (7.11)]. At the initiation of therapy with carbamazepine or other known CYP 3A4 hepatic enzyme inducers, patients should be closely monitored during the first 4–8 weeks, since the dose of RISPERDAL® CONSTA® may need to be adjusted. A dose increase, or additional oral RISPERDAL®, may need to be considered. On discontinuation of carbamazepine or other CYP 3A4 hepatic enzyme inducers, the dosage of RISPERDAL® CONSTA® should be re-evaluated and, if necessary, decreased. Patients may be placed on a lower dose of RISPERDAL® CONSTA® between 2 to 4 weeks before the planned discontinuation of carbamazepine or other CYP 3A4 inducers to adjust for the expected increase in plasma concentrations of risperidone plus 9-hydroxyrisperidone. For patients treated with the recommended dose of 25 mg RISPERDAL® CONSTA® and discontinuing from carbamazepine or other CYP3A4 enzyme inducers, it is recommended to continue treatment with the 25-mg dose unless clinical judgment necessitates lowering the RISPERDAL® CONSTA® dose to 12.5 mg or necessitates interruption of RISPERDAL® CONSTA® treatment. The efficacy of the 12.5 mg dose has not been investigated in clinical trials.

Fluoxetine and paroxetine, CYP 2D6 inhibitors, have been shown to increase the plasma concentration of risperidone 2.5–2.8 fold and 3–9 fold respectively. Fluoxetine did not affect the plasma concentration of 9-hydroxyrisperidone. Paroxetine lowered the concentration of 9-hydroxyrisperidone by about 10%. The dose of risperidone needs to be titrated accordingly when fluoxetine or paroxetine is co-administered. When either concomitant fluoxetine or paroxetine is initiated or discontinued, the physician should re-evaluate the dose of RISPERDAL® CONSTA®. When initiation of fluoxetine or paroxetine is considered, patients may be placed on a lower dose of RISPERDAL® CONSTA® between 2 to 4 weeks before the planned start of fluoxetine or paroxetine therapy to adjust for the expected increase in plasma concentrations of risperidone. When fluoxetine or paroxetine is initiated in patients receiving the recommended dose of 25 mg RISPERDAL® CONSTA®, it is recommended to continue treatment with the 25 mg dose unless clinical judgment necessitates lowering the RISPERDAL® CONSTA® dose to 12.5 mg or necessitates interruption of RISPERDAL® CONSTA® treatment. When RISPERDAL® CONSTA® is initiated in patients already receiving fluoxetine or paroxetine, a starting dose of 12.5 mg can be considered. The efficacy of the 12.5 mg dose has not been investigated in clinical trials. The effects of discontinuation of concomitant fluoxetine or paroxetine therapy on the pharmacokinetics of risperidone and 9-hydroxyrisperidone have not been studied. [see Drug Interactions (7.11)]

Instructions for Use

Dose pack components include:

Figure

RISPERDAL® CONSTA® requires close attention to the step-by-step 'Instructions for Use' to help avoid difficulties in the use of the kit.

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. It is recommended to administer immediately after reconstitution.

Remove the dose pack of RISPERDAL® CONSTA® from the refrigerator and allow it to come to room temperature for approximately 30 minutes prior to reconstitution.

  1. Flip off the plastic colored cap from the vial. Do not remove the grey rubber stopper. Wipe the top of the grey rubber stopper with an alcohol wipe and allow to dry.
    Figure
  2. Peel back the blister pouch and remove the SmartSite® Needle-Free Vial Access Device by holding between the white luer cap and the skirt. Do not touch the spike tip of the access device at any time.
    Figure
  3. It is very important that the SmartSite® Needle-Free Vial Access Device be placed on the vial correctly or the diluent could leak upon transfer to the vial.
    Place the vial on a hard surface. Hold the base of the vial. Orient the SmartSite® Needle-Free Vial Access Device vertically over the vial so that the spike tip is at the center of the vial's rubber stopper.
    Figure

    With a straight downward push, press the spike tip of the SmartSite® Needle-Free Vial Access Device through the center of the vial's rubber stopper until the device securely snaps onto the vial top.
    Figure
  4. Hold the base of the vial and swab the syringe connection point (blue circle) of the SmartSite® Needle-Free Vial Access Device with an alcohol wipe and allow to dry prior to attaching the syringe to the SmartSite® Needle-Free Vial Access Device.
    Figure
  5. The prefilled syringe has a white tip 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 OR CUT OFF THE WHITE CAP). Remove the white cap together with the rubber tip cap inside.
    Figure

    For all syringe assembly steps, hold the syringe only by the white collar located at the tip of the syringe. Holding the white collar will help to prevent the white collar from getting detached and ensure a good connection to the syringe. Be careful to not overtighten components when assembling. Overtightening connections may cause syringe component parts to loosen from the syringe body.
  6. While holding the white collar of the syringe, insert and press the syringe tip into the blue circle of the SmartSite® Needle-Free Vial Access Device and twist in a clockwise motion to secure the connection of the syringe to the SmartSite® Needle-Free Vial Access Device (avoid over-twisting). Hold the skirt of the SmartSite® Needle-Free Vial Access Device during attachment to prevent it from spinning.

    Keep the syringe and SmartSite® Needle-Free Vial Access Device aligned.
    Figure
  7. Inject the entire contents of the syringe containing the diluent into the vial.
    Figure
  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.
    Figure
    DO NOT STORE THE VIAL AFTER RECONSTITUTION OR THE SUSPENSION MAY SETTLE.
  9. Invert the vial completely and SLOWLY withdraw the entire content of the suspension from the vial into the syringe. Tear the section of the vial label at the perforation and apply the detached label to the syringe for identification purposes.
    Figure
  10. While holding the white collar of the syringe, unscrew the syringe from the SmartSite® Needle-Free Vial Access Device. Discard both the vial and vial access device appropriately.
    Figure
  11. Select the appropriate needle provided with the kit:

    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)
  12. 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.
    Figure
  13. 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. Seating the needle is an important step to secure the connection between the needle and the orange Needle-Pro® safety device.
    Figure
  14. RESUSPENSION OF RISPERDAL® CONSTA® WILL BE NECESSARY PRIOR TO ADMINISTRATION, AS SETTLING WILL OCCUR OVER TIME ONCE PRODUCT IS RECONSTITUTED. RESUSPEND THE MICROSPHERES IN THE SYRINGE BY SHAKING VIGOROUSLY.
  15. 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.
    Figure
  16. Tap the syringe gently to make any air bubbles rise to the top. Remove air in syringe by depressing the plunger rod, carefully and slowly, 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 immediately. Gluteal injection should be made into the upper-outer quadrant of the gluteal area. DO NOT ADMINISTER INTRAVENOUSLY.
    Figure

    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.
  17. After the 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 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.
    Figure

Stability after reconstitution: 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, but should always be resuspended prior to administration if not used immediately.

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

Do Not Reuse: Medical devices require specific material characteristics to perform as intended. These characteristics have been verified for single use only. Any attempt to re-process the device for subsequent re-use may adversely affect the integrity of the device or lead to deterioration in performance.

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