cutaneous injection. Do not administer more than one dose (90 mg or 120 mg total) per month.
Based on average plasma concentrations (Cavg) of risperidone and total active moiety, PERSERIS 90 mg corresponds to 3 mg/day oral risperidone and PERSERIS 120 mg corresponds to 4 mg/day oral risperidone. Patients who are on stable oral risperidone doses lower than 3 mg/day or higher than 4 mg/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. A patient who misses a dose should receive the next dose as soon as possible.
2.2 Dosage Recommendations for Patients with Renal or Hepatic Impairment
PERSERIS has not been studied in patients with renal or hepatic impairment and should be used with caution in these special populations. Prior to initiating treatment with PERSERIS in these patients, it is advisable that patients be carefully titrated up to at least 3 mg daily of oral risperidone. If patients can tolerate 3 mg of oral risperidone and are psychiatrically stable, a dose of PERSERIS 90 mg may be considered [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
When initiation of fluoxetine or paroxetine is considered, patients may be placed on the lowest dose (90 mg) of PERSERIS 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 PERSERIS 90 mg, it is recommended to continue treatment with 90 mg unless clinical judgment necessitates interruption of PERSERIS treatment [see Drug Interactions (7.1)].
Co-administration with Strong CYP3A4 Inducers
At the initiation of therapy with carbamazepine or other known hepatic enzyme inducers, patients should be closely monitored during the first 4 to 8 weeks. In patients receiving PERSERIS 90 mg, consider increasing the dose to 120 mg. In patients receiving PERSERIS 120 mg, additional oral risperidone therapy may need to be considered.
On discontinuation of carbamazepine or other strong CYP3A4 hepatic enzyme inducers, the dosage of PERSERIS or any additional oral risperidone therapy should be re-eva luated and, if necessary, decreased to adjust for the expected increase in plasma concentration of risperidone.
For patients treated with PERSERIS 90 mg and discontinuing from carbamazepine or other strong CYP3A4 enzyme inducers, it is recommended to continue treatment with the 90 mg dose unless clinical judgment necessitates interruption of PERSERIS treatment [see Drug Interactions (7.1)].
2.4 Instructions for Use
Important Information
For abdominal subcutaneous injection, only. Do not administer by any other route.
To be administered by a healthcare professional only.
Please read the instructions carefully before handling this product.
Allow package to come to room temperature for at least 15 minutes prior to preparation.
Only prepare medication when you are ready to administer the dose.
As a universal precaution, always wear gloves.
1 CHECK CONTENTS
See FIGURE 1
One Liquid Syringe (Figure
) prefilled with the delivery system. Inspect liquid solution for foreign particles. This is the syringe you will u |
