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RISPERDAL® CONSTA® (risperidone) is indicated for the treatment of schizophrenia [see Clinical Studies (14.1)].
RISPERDAL® CONSTA® is indicated as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder [see Clinical Studies (14.2, 14.3)].
There is currently no drug history available for this drug.
Risperidone is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is:
Risperidone is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl.
RISPERDAL® CONSTA® (risperidone) Long-Acting Injection is a combination of extended-release microspheres for injection and diluent for parenteral use.
The extended-release microspheres formulation is a white to off-white, free-flowing powder that is available in dosage strengths of 12.5 mg, 25 mg, 37.5 mg, or 50 mg risperidone per vial. Risperidone is micro-encapsulated in 7525 polylactide-co-glycolide (PLG) at a concentration of 381 mg risperidone per gram of microspheres.
The diluent for parenteral use is a clear, colorless solution. Composition of the diluent includes polysorbate 20, sodium carboxymethyl cellulose, disodium hydrogen phosphate dihydrate, citric acid anhydrous, sodium chloride, sodium hydroxide, and water for injection. The microspheres are suspended in the diluent prior to injection.
RISPERDAL® CONSTA® is provided as a dose pack, consisting of a vial containing the microspheres, a pre-filled syringe containing the diluent, a SmartSite® Needle-Free Vial Access Device, and two Needle-Pro® safety needles (a 21 G UTW 1-inch needle with needle protection device for deltoid administration and a 20 G TW 2-inch needle with needle protection device for gluteal administration).
Risperdal Consta Manufacturers
- Janssen Pharmaceuticals, Inc.
Risperdal Consta | Janssen Pharmaceuticals, Inc.
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.2.1 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.2.2 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.2.3 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.2.4 Dosage in Special Populations
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)].2.5 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.2.6 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.2.7 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)]2.8 Instructions for Use
SINGLE-USE DEVICEStep 1 Assemble components Take out dose pack Connect vial adapter to vial Wait 30 minutes
Remove dose pack from the refrigerator and allow to sit at room temperature for at least 30 minutes before reconstituting.
Do not warm any other way. Remove cap from vial
Flip off colored cap from vial.
Wipe top of the grey stopper with an alcohol swab. Allow to air dry.
Do not remove grey rubber stopper. Prepare vial adapter
Hold sterile blister as shown. Peel back and remove paper backing.
Do not remove vial adapter from blister.
Do not touch spike tip at any time. This will result in contamination. Connect vial adapter to vial
Place vial on a hard surface and hold by the base. Center vial adapter over the grey rubber stopper. Push vial adapter straight down onto vial top until it snaps securely into place.
Do not place vial adapter on at an angle or diluent may leak upon transfer to the vial.
Connect prefilled syringe to vial adapter Remove sterile blister
Keep vial vertical to prevent leakage.
Hold base of vial and pull up on the sterile blister to remove.
Do not shake.
Do not touch exposed luer opening on vial adapter.
This will result in contamination. Use proper grip
Hold by white collar at the tip of the syringe.
Do not hold syringe by the glass barrel during assembly.
Holding the white collar, snap off the white cap.
Do not twist or cut off the white cap.
Do not touch syringe tip. This will result in contamination.
The broken-off cap can be discarded. Connect syringe to vial adapter
Hold vial adapter by skirt to keep stationary.
Hold syringe by white collar then insert tip into the luer opening of the vial adapter.
Do not hold the glass syringe barrel. This may cause the white collar to loosen or detach.
Attach the syringe to the vial adapter with a firm clockwise twisting motion until it feels snug.
Do not over-tighten. Over-tightening may cause the syringe tip to break. Step 2 Reconstitute microspheres Inject diluent
Inject entire amount of diluent from syringe into the vial.
Suspend microspheres in diluent
Continuing to hold down the plunger rod, shake vigorously for at least 10 seconds, as shown.
Check the suspension. When properly mixed, the suspension appears uniform, thick and milky in color. Microspheres will be visible in the liquid.
Immediately proceed to the next step so suspension does not settle. Transfer suspension to syringe
Invert vial completely. Slowly pull plunger rod down to withdraw entire contents from the vial into the syringe. Remove vial adapter
Hold white collar on the syringe and unscrew from vial adapter.
Tear section of the vial label at the perforation. Apply detached label to the syringe for identification purposes.
Discard both vial and vial adapter appropriately. Step 3 Attach needle Select appropriate needle
Choose needle based on injection location (gluteal or deltoid). Attach needle
Peel blister pouch open part way and use to grasp the base of the needle, as shown.
Holding the white collar on the syringe, attach syringe to needle luer connection with a firm clockwise twisting motion until snug.
Do not touch needle luer opening. This will result in contamination. Resuspend microspheres
Fully remove the blister pouch.
Just before injection, shake syringe vigorously again, as some settling will have occurred. Step 4 Inject dose Remove transparent needle protector
Move the needle safety device back towards the syringe, as shown. Then hold white collar on syringe and carefully pull the transparent needle protector straight off.
Do not twist transparent needle protector, as the luer connection may loosen. Remove air bubbles
Hold needle upright and tap gently to make any air bubbles rise to the top.
Slowly and carefully press plunger rod upward to remove air. Inject
Immediately inject entire contents of syringe intramuscularly (IM) into the gluteal or deltoid muscle of the patient.
Gluteal injection should be made into the upper-outer quadrant of the gluteal area.
Do not administer intravenously. Secure needle in safety device
Using one hand, place needle safety device at a 45 degree angle on a hard, flat surface. Press down with a firm, quick motion until needle is fully engaged in safety device.
Avoid needle stick injury:
Do not use two hands.
Do not intentionally disengage or mishandle the needle safety device.
Do not attempt to straighten the needle or engage the safety device if the needle is bent or damaged. Properly dispose of needles
Check to confirm needle safety device is fully engaged.
Discard in an approved sharps container.
Also discard the unused needle provided in the dose pack.
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