PERSERIS — risperidone
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. PERSERIS ® is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)].
1 INDICATIONS AND USAGE
PERSERIS is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14)].
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
Administer PERSERIS by a healthcare provider as a subcutaneous injection in the abdomen or back of the upper arm. Do not administer PERSERIS by any other route.
For detailed preparation and administration instructions, see Dosage and Administration (2.4).
For patients who have never taken risperidone, establish tolerability with oral risperidone prior to initiating PERSERIS.
Initiate PERSERIS at a dose of 90 mg or 120 mg once monthly by subcutaneous injection. Do not administer more than one dose (90 mg or 120 mg total) per month.
For patients switching from oral risperidone:
- 3 mg of oral risperidone per day, administer a 90 mg PERSERIS dose one day after the last oral risperidone dose.
- 4 mg of oral risperidone per day, administer a 120 mg PERSERIS dose one day after the last oral risperidone dose.
Patients who are on stable oral risperidone doses lower than 3 mg per day or higher than 4 mg per day may not be candidates for PERSERIS [see Clinical Pharmacology (12.3) and Clinical Studies (14)].
Neither a loading dose nor any supplemental oral risperidone is recommended. When a dose of PERSERIS is missed, administer the next PERSERIS injection as soon as possible.
2.2 Dosage Recommendations for Patients with Renal or Hepatic Impairment
Prior to initiating treatment with PERSERIS in patients with renal or hepatic impairment, titrate with oral risperidone up to at least 3 mg daily. Following oral titration, and based on clinical response and tolerability, the recommended dosage of PERSERIS is 90 mg once monthly [see Use in Specific Populations (8.6, 8.7) and Clinical Pharmacology (12.3)].
2.3 Dosage Recommendations for Concomitant Use with Strong CYP2D6 Inhibitors and Strong CYP3A4 Inducers
Co-administration with Strong CYP2D6 Inhibitors
Between 2 to 4 weeks prior to initiating a strong CYP2D6 inhibitor (such as fluoxetine or paroxetine), switch patients (if applicable) to the lowest PERSERIS dosage (90 mg once monthly) to adjust for the expected increase in plasma concentrations of risperidone [see Drug Interactions (7.1)].
Co-administration with Strong CYP3A4 Inducers
With concomitant use of PERSERIS 90 mg and strong CYP3A4 inducers (such as carbamazepine), increase the PERSERIS dosage to 120 mg once monthly and consider starting additional oral risperidone therapy. In patients already receiving PERSERIS 120 mg once monthly, additional oral risperidone therapy may need to be considered.
Upon discontinuation of a strong CYP3A4 inducer in a patients receiving PERSERIS 120 mg once monthly, re-evaluate the dosage of PERSERIS or any additional oral risperidone therapy and, if necessary, decrease to adjust for the expected increase in plasma concentration of risperidone.
Upon discontinuation of a strong CYP3A4 inducer in a patient receiving PERSERIS 90 mg once monthly, continue treatment with the 90 mg dose unless clinical judgment necessitates interruption of PERSERIS treatment [see Drug Interactions (7.1)].
2.4 Preparation and Administration Instructions
- Read the instructions for preparation and administration below and consider referring to the separate Healthcare Provider “Instructions for Use” for additional preparation and administration considerations.
- For subcutaneous injection only. Do not inject by any other route.
- Allow package to come to room temperature for at least 15 minutes prior to preparation. Prepare medication when you are ready to administer the dose.
1 CHECK CONTENTS
Each carton of PERSERIS contains (Figure 1):
One Liquid Syringe () prefilled with the delivery system. Inspect liquid solution for foreign particles. This is the syringe you will use to inject the patient.
One Powder Syringe () prefilled with Risperidone powder. Inspect syringe for consistency of powder color and for foreign particles.
One sterile 18-gauge, 5/8-inch safety needle.
2 TAP POWDER SYRINGE
Hold the Powder Syringe upright and tap the barrel of the syringe to dislodge the packed powder (Figure 2). Note: Powder can become packed during shipping.
3 UNCAP LIQUID AND POWDER SYRINGES
Remove the cap from the Liquid Syringe , then remove the cap from the Powder Syringe (Figure 3).
Holding both syringes in your non-dominant hand can help with this step.
4 CONNECT THE SYRINGES
Place the Liquid Syringe on top of the Powder Syringe (to prevent powder spillage) and connect the syringes by twisting approximately ¾ turn (Figure 4). Do not over tighten.
Keep your fingers off the plungers during this step to avoid spillage of the medication.
5 MIX THE PRODUCT
Failure to fully mix the medication could result in incorrect dosage.
- Transfer the contents of the Liquid Syringe into the Powder Syringe.
- Gently push the Powder Syringe plunger until you feel resistance (to wet powder and avoid compacting).
- Repeat this gentle back-and-forth process for 5 cycles.
- Continue mixing the syringes for an additional 55 cycles.
- This mixing can be more vigorous than when premixing.
See Figure 5 for an illustration of a correct full cycle.
When fully mixed, the product should be a cloudy suspension that is uniform in color. It can vary from white to yellow-green in color. If you see any clear areas in the mixture, continue to mix until the distribution of the color is uniform. The product is designed to deliver risperidone 90 mg or 120 mg.
6 PREPARE INJECTION SYRINGE
Failure to aspirate the liquid from the Powder Syringe may result in incorrect dosage.
- First, transfer all contents into the Liquid Syringe (Figure 6).
- Next, perform the following actions SIMULTANEOUSLY:
- maintain slight pressure on the Powder Syringe plunger and
- pull back gently on the Liquid Syringe plunger while twisting the syringes apart.
- Finally, attach the safety needle by twisting until finger tight.
- Check that medication is uniform in color and free from foreign particles.
7 PREPARE THE SUBCUTANEOUS INJECTION SITE(S)
This medication is to be injected subcutaneously in the abdomen or back of the upper arm (Figure 7).
Choose an injection site with adequate subcutaneous tissue that is free of skin conditions (e.g., nodules, lesions, excessive pigment).
Do not inject into an area where the skin is irritated, reddened, bruised, infected or scarred in any way.
Clean the injection site well with an alcohol pad.
To help minimize irritation, rotate injection sites following a pattern similar to the illustration. If you want to use the same injection site, make sure it is not the same spot on the injection site you used the last time.
8 REMOVE EXCESS AIR FROM SYRINGE
Hold the syringe upright for several seconds to allow air bubbles to rise. Remove needle cover and slowly depress the plunger to push out the excess air from the syringe (Figure 8).
If medication is seen at the needle tip, pull back slightly on the plunger to prevent medication spillage.
Due to the viscous nature of the medication, bubbles will not rise as quickly as those in an aqueous solution.
9 PINCH INJECTION SITE
Pinch the skin around the injection area. Be sure to pinch enough skin to accommodate the size of the needle (Figure 9). Lift the adipose tissue from the underlying muscle to prevent accidental intramuscular injection.
10 INJECT THE MEDICATION
Insert needle fully into the subcutaneous tissue. Inject the medication slow and steady (Figure 10).
PERSERIS is for subcutaneous administration only. Do not inject by any other route. Actual angle of injection will depend on the amount of subcutaneous tissue.
11 WITHDRAW NEEDLE
Withdraw the needle at the same angle used for insertion and release pinched skin (Figure 11).
Do not rub the injection area after the injection. If there is bleeding, apply a gauze pad or bandage but use minimal pressure.
12 LOCK THE NEEDLE GUARD AND DISPOSE OF SYRINGE
Lock the needle guard into place by pushing it against a hard surface such as a table (Figure 12).
13 INSTRUCT THE PATIENT
The patient may have a lump for several weeks that will decrease in size over time (Figure 13). It is important that the patient not rub or massage the injection site and to be aware of the placement of any belts, waistbands, sleeves, cuffs or other parts of clothing.
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