spillage.
Due to the viscous nature of the medication, bubbles will not rise as quickly as those in an aqueous solution.
Figure 8
Figure 8
9 PINCH INJECTION SITE
See FIGURE 9
Pinch the skin around the injection area. Be sure to pinch enough skin to accommodate the size of the needle. Lift the adipose tissue from the underlying muscle to prevent accidental intramuscular injection.
Figure 9
Figure 9
10 INJECT THE MEDICATION
See FIGURE 10
Insert needle fully into the subcutaneous tissue.
Inject the medication slow and steady.
PERSERIS is for subcutaneous administration only. Do not inject by any other route.
NOTE: Actual angle of injection will depend on the amount of subcutaneous tissue.
Figure 10
Figure 10
11 WITHDRAW NEEDLE
See FIGURE 11
Withdraw the needle at the same angle used for insertion and release pinched skin.
Do not rub the injection area after the injection. If there is bleeding, apply a gauze pad or bandage but use minimal pressure.
Figure 11
Figure 11
12 LOCK THE NEEDLE GUARD AND DISPOSE OF SYRINGE
See FIGURE 12
Lock the needle guard into place by pushing it against a hard surface such as a table.
Dispose of all syringe components in a secure sharps disposal container.
Figure 12
Figure 12
13 INSTRUCT THE PATIENT
See FIGURE 13
Advise the patient that they may have a lump for several weeks that will decrease in size over time. It is important that the patient not rub or massage the injection site and to be aware of the placement of any belts or clothing waistbands.
Figure 13
Figure 13
3 DOSAGE FORMS AND STRENGTHS
PERSERISTM (risperidone) for extended-release injectable suspension for subcutaneous use is available in strengths of 90 mg and 120 mg.
Each strength is provided as a kit which includes: one pre-filled syringe containing a white to yellow risperidone powder in a sealed pouch, one pre-filled syringe containing a colorless to yellow delivery system in a sealed pouch, and one 18-gauge, 5/8-inch needle.
4 CONTRAINDICATIONS
PERSERIS is contraindicated in patients with a known hypersensitivity to risperidone, its metabolite, paliperidone, or to any of its components. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone or paliperidone.
5 WARNINGS AND PRECAUTIONS
5.1 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. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients 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 no |
