RISPERDAL® CONSTA® (risperidone) Long Acting Injection
For Patients For Caregivers For Healthcare Providers For Billing Support Important Safety Information


Instructions for Using
Product profile
Dosing card
Other information
Access the Medical Information Center
Full US Prescribing Information
Sitemap
Global Resources
Tell a friend
Privacy Policy
Legal Notice
Printer Friendly
 Text Size:  S | M |  L
 
 
 
Instructions for Using RISPERDAL® CONSTA®
Instructions For Use

RISPERDAL® CONSTA® must be reconstituted only in the diluent supplied in the dose pack, and must be administered with the needle supplied in the dose pack. 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.

Flip off the plastic colored cap from the vial
 1. Flip off the plastic colored cap from the vial.
Peel back the blister pouch
 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.
Peel back the blister pouch
Place vial on a hard surface
 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.
Swab the syringe connection point
 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.
Twist off the white cap
 5. The prefilled syringe has a white cap consisting of 2 parts: a knurled collar and a smooth cap. To open the syringe, hold the syringe by the knurled collar and snap off the smooth cap (DO NOT TWIST OFF THE CAP). Remove the white cap together with the rubber tip 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.
Press the syringe tip into the blue circle
 6. While holding the white collar of the syringe, press the syringe tip into the blue circle of the SmartSite® Access Device and twist in a clockwise motion to attach the syringe to the SmartSite® Access Device. Hold the skirt of the SmartSite® Access Device during attachment to prevent it from spinning. Keep the syringe and SmartSite Access Device aligned.
Inject the entire contents of the syringe
 7. Inject the entire contents of the syringe containing the diluent into the vial.
Shake the vial vigorously
 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 particles will be visible in liquid, but no dry particles remain.
9. Do not store the vial after reconstitution or the suspension may settle. If 2 minutes pass before injection, re-suspend by shaking vigorously.
Invert the vial completely and slowly withdraw the suspension
 10. Invert the vial completely and slowly withdraw the suspension from the vial. Tear section of the vial label at the perforation and apply detached label to syringe for identification purposes.
Unscrew the syringe
 11. While holding the white collar of the syringe, unscrew the syringe from the SmartSite® Access Device. Discard both the vial and access device appropriately.
Peel the blister pouch
 12. Peel the blister pouch of the Needle-Pro® device open halfway. Grasp sheath using the plastic peel pouch. While holding the white collar of the syringe, attach the leur connection of the Needle-Pro® device to the syringe with an easy clockwise twisting motion.
13. If 2 minutes pass before injection, re-suspend by shaking vigorously.
Pull the sheath away from the needle
 14. While holding the white collar of the syringe, pull the sheath away from the needle - do not twist the sheath because it could result in loosening the needle.
Pull sheath away from the needle

15. Tap the syringe gently to make any air bubbles rise to the top. De-aerate syringe by moving plunger rod carefully forward, with needle in an upward position. Inject entire contents of the syringe intramuscularly (IM) into the upper-outer quadrant of the gluteal area within 2 minutes to avoid settling. DO NOT ADMINISTER INTRAVENOUSLY.

WARNING: To avoid a needle stick injury with a contaminated needle, do not:

  • intentionally disengage the Needle-Pro® device
  • attempt to straighten the needle or engage Needle-Pro® device if the needle is bent or damaged
  • mishandle the needle protection device that could lead to protrusion of the needle from it
Snap needle into the orange safety guard before discarding
 16. After injection is complete, use only one hand and tabletop or other hard surface to snap needle into the orange needle protector device before discarding. Discard needle appropriately.

Snap needle into the orange safety guard before discarding

Upon suspension in the diluent, it is recommended to use RISPERDAL® CONSTA® immediately. RISPERDAL® CONSTA® must be used within 6 hours of suspension. Resuspension of RISPERDAL® CONSTA® will be necessary prior to administration, as settling will occur over time once the product is in suspension. Keeping the vial upright, shake vigorously back and forth for as long as it takes to resuspend the microspheres. Once in suspension, the product should not be exposed to temperatures above 77° F (25° C).

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

 

RISPERDAL® CONSTA® (risperidone) long-acting injection is indicated for the treatment of schizophrenia.

IMPORTANT SAFETY INFORMATION FOR RISPERDAL® CONSTA®


Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. RISPERDAL® CONSTA® (risperidone) is not approved for the treatment of patients with dementia-related psychosis.

Cerebrovascular Adverse Events (CAEs): CAEs, including fatalities, have been reported in elderly patients with dementia-related psychosis taking oral risperidone in clinical trials. The incidence of CAEs with risperidone was significantly higher than with placebo. RISPERDAL® CONSTA® is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with the use of antipsychotic medications, including RISPERDAL® CONSTA®. Clinical manifestations include muscle rigidity, fever, altered mental status and evidence of autonomic instability (see full Prescribing Information). Management should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems.

Tardive Dyskinesia (TD): TD is a syndrome of potentially irreversible, involuntary, dyskinetic movements that may develop in patients treated with antipsychotic medications. The risk of developing TD and the likelihood that dyskinetic movements will become irreversible are believed to increase with duration of treatment and total cumulative dose. Elderly patients appeared to be at increased risk for TD. Prescribing should be consistent with the need to minimize the risk of TD. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.

Hyperglycemia and Diabetes: Hyperglycemia, some cases extreme and associated with ketoacidosis, hyperosmolar coma or death has been reported in patients treated with atypical antipsychotics (APS), including RISPERDAL® CONSTA®. Patients starting treatment with APS who have or are at risk for diabetes should undergo fasting blood glucose testing at the beginning of and during treatment. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing.

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, RISPERDAL® CONSTA® elevates prolactin levels and the elevation persists during chronic administration. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents.

Orthostatic Hypotension: RISPERDAL® CONSTA® may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope, especially during the initial dose-titration period. Monitoring should be considered in patients for whom this may be of concern.
RISPERDAL® CONSTA® should be used with caution in patients with known cardiovascular disease, and conditions that would predispose patients to hypotension.

Potential for Cognitive and Motor Impairment: RISPERDAL® CONSTA® has the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that RISPERDAL® CONSTA® does not affect them adversely.

Seizures: RISPERDAL® CONSTA® should be used cautiously in patients with a history of seizures.

Suicide: The possibility of suicide attempt is inherent in psychotic illnesses. Close supervision of high-risk patients should accompany drug therapy.

Symptoms (EPS): The overall incidence of EPS-related adverse events in patients treated with 25 mg and 50 mg of RISPERDAL® CONSTA® and placebo, respectively, were akathisia* (4%, 11%, 6%), Parkinsonism** (8%, 15%, 9%) and tremor (0%, 3%, 0%).
* Akathisia and restlessness
** Extrapyramidal disorder, musculoskeletal stiffness, muscle rigidity, and bradykinesia

Weight Gain: In a 12-week trial, the percentage of patients experiencing weight gain (>7% of baseline body weight) was 6% placebo versus 9% RISPERDAL® CONSTA®.

Maintenance Treatment: Patients should be periodically reassessed to determine the need for continued treatment.

Commonly Observed Adverse Reactions for RISPERDAL® CONSTA®: The most common adverse reactions in clinical trials (≥5%) were headache, Parkinsonism, dizziness, akathisia, fatigue, constipation, dyspepsia, sedation, weight increase, pain in extremities, and dry mouth.

01CS1053

For more information, read the full US Prescribing Information by clicking here.



Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

Home   Janssen.com   Site Map   Contact Us   

© Ortho-McNeil-Janssen Pharmaceuticals, Inc. 2003 – 2008. This site is published by Janssen®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. which is solely responsible for its contents. This site is intended for visitors from the United States.
This page was last updated on: Jul 21 2008 at 17:59:47 EDT