ation/swelling and erythema) was none or mild for most subjects receiving PERSERIS.
Most subjects (≥ 79%) reported no tenderness and most who had tenderness reported mild severity. Less than 1% of subjects had moderate tenderness at any time point and 1 subject at Injections 1, 2, and 5 had severe tenderness. At each time point, most subjects (≥ 75%) reported no pain on injection. Of subjects who did have pain on injection, almost all of these were mild at each time point; only 1 or 2 subjects at Injections 1, 2, 7, and 12 had moderate pain on injection. At least 92% of subjects reported no erythema on each injection. All reports of erythema were of mild severity except for 2 cases of moderate erythema on Injection 1. Inflammation/swelling had a similar profile, with at least 88% of subjects reporting no inflammation/swelling and only mild symptoms except for 1 case of moderate severity on Injection 1.
6.2 Postmarketing Experience
The following adverse reactions have been identified during post approval use of oral risperidone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions include: alopecia, anaphylactic reaction, angioedema, atrial fibrillation, cardiopulmonary arrest, diabetic ketoacidosis in patients with impaired glucose metabolism, dysgeusia, hypoglycemia, hypothermia, ileus, inappropriate antidiuretic hormone secretion, intestinal obstruction, jaundice, mania, pancreatitis, pituitary adenoma, precocious puberty, pulmonary embolism, QT prolongation, sleep apnea syndrome, sudden death, thrombocytopenia, thrombotic thrombocytopenic purpura, urinary retention, and water intoxication.
7 DRUG INTERACTIONS
The interactions of PERSERIS with co-administration of other drugs have not been studied. The drug interaction data provided in this section is based on studies with oral risperidone.
7.1 Drugs Having Clinically Important Interactions with PERSERIS
TABLE 5 includes clinically significant drug interactions with PERSERIS.
Table 5: Clinically Important Drug Interactions with PERSERIS
Strong CYP2D6 Inhibitors
Clinical Impact: Concomitant use of PERSERIS with strong CYP2D6 inhibitors may increase the plasma exposure of risperidone and lower the plasma exposure of a major active metabolite, 9-hydroxyrisperidone [see Clinical Pharmacology (12.3)].
Intervention: When initiation of strong CYP2D6 inhibitors is considered, patients may be placed on the lowest dose (90 mg) of PERSERIS between 2 to 4 weeks before the planned start of strong CYP2D6 inhibitors to adjust for the expected increase in plasma concentrations of risperidone. When strong CYP2D6 inhibitors 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. The effects of discontinuation of strong CYP2D6 inhibitors on the pharmacokinetics of risperidone and 9-hydroxyrisperidone have not been studied [see Clinical Pharmacology (12.3)].
Examples: paroxetine, fluoxetine, quinidine
Strong CYP3A4 Inducers
Clinical Impact: Concomitant use of PERSERIS and a strong CYP3A4 inducer may cause decreases in the combined plasma concentrations of risperidone and 9-hydroxyrisperidone which could lead to decreased effica |
