Invega Trinza

Invega Trinza Adverse Reactions

paliperidone

Manufacturer:

Johnson & Johnson
Full Prescribing Info
Adverse Reactions
Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of paliperidone palmitate based on the comprehensive assessment of the available adverse event information. A causal relationship with paliperidone palmitate cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Clinical Trial Data: The data described in this section include data from 3 clinical trials. One was a long-term relapse-prevention/randomized withdrawal trial, in which 506 subjects with schizophrenia received the 1-month paliperidone palmitate injectable product during the open-label phase, of which 379 subjects continued to receive a single injection of INVEGA TRINZA during the open-label phase, and 160 subjects were subsequently randomized to receive at least one dose of INVEGA TRINZA and 145 subjects received placebo during the double-blind placebo-controlled phase. The mean (Standard Deviation [SD]) duration of exposure during the double-blind phase was 150 (79) days in the placebo group and 175 (90) days in the INVEGA TRINZA group.
The second trial was a long-term double-blind, active-controlled noninferiority study, in which 1429 acutely ill subjects were enrolled into the open-label phase and treated with the 1 month paliperidone palmitate injectable product. Subjects who met the randomization criteria were randomized in a ratio to continue on monthly injections of the 1-month paliperidone palmitate injectable product (n=512) or to switch to INVEGA TRINZA (n=504) for 48 weeks. The mean (SD) duration of exposure during the double-blind phase was 295 (88) days in the INVEGA TRINZA group and 287 (96) days in the 1-month paliperidone palmitate injectable product group.
The third trial was a Phase 1 study, in which 308 subjects with schizophrenia or schizoaffective disorder received a single injection of INVEGA TRINZA concomitantly with other oral antipsychotics.
The majority of adverse reactions were mild to moderate in severity.
Adverse reactions reported in the long-term relapse-prevention trial are shown in Table 5. (See Table 5 and Table 6.)


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Other clinical trial data: Paliperidone palmitate is hydrolyzed to paliperidone. Paliperidone is the active metabolite of risperidone, therefore, the adverse reaction profiles of these compounds (including both the oral and injectable formulations) are relevant to one another. This subsection includes additional adverse reactions reported with paliperidone and/or risperidone in clinical trials.
Additional adverse reactions reported in clinical trials of INVEGA TRINZA, not included in Table 5 and Table 6, are shown in Table 7. (See Table 7.)


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Additional adverse reactions reported in other clinical trials of paliperidone and risperidone are shown in Table 8. (See Table 8.)


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Events of particular interest to the class: Extrapyramidal symptoms (EPS): Data from the double-blind placebo-controlled phase of the long-term relapse prevention trial (see Pharmacology: Pharmacodynamics: Clinical efficacy under Actions) showed that the incidence of EPS-related AES was higher in the INVEGA TRINZA group (13 subjects [8.1%]) than in the placebo group (5 subjects [3.4%]). Evaluation of EPS included a pooled analysis of the following EPS groups: dyskinesia, dystonia, hyperkinesia, parkinsonism, and tremor.
Weight gain: In the double-blind placebo-controlled phase of the long-term relapse prevention trial, abnormal increases of ≥7% in body weight from double-blind baseline to double-blind end point were reported for 15 subjects (10%) in the INVEGA TRINZA group and 1 subject (1%) in the placebo group. Conversely, abnormal decreases in body weight (≥7%) from double-blind baseline to double blind end point were reported for 2 subjects (1%) in the INVEGA TRINZA group and 12 subjects (8%) in the placebo group. The mean changes in body weight from double-blind baseline to double-blind end point were +0.94 kg and 1.28 kg for the INVEGA TRINZA and placebo groups, respectively.
Laboratory tests: serum prolactin: During the double-blind placebo-controlled phase of the long-term relapse prevention trial, elevations of prolactin to above the reference range (>13.13 ng/mL in males and >26.72 ng/mL in females) were noted in a higher percentage of males and females in the INVEGA TRINZA group than in the placebo group (9% vs. 3% and 5% vs. 3%, respectively). In the INVEGA TRINZA group, the mean change from double-blind baseline to double blind end point was +2.90 ng/mL for males (vs. 10.26 ng/mL in the placebo group) and +7.48 ng/mL for females (vs. -32.93 ng/mL in the placebo group). One female (2.4%) in the INVEGA TRINZA group experienced an adverse reaction of amenorrhea, while no potentially prolactin-related adverse reactions were noted among females in the placebo group. There were no potentially prolactin-related adverse reactions among males in either group.
Postmarketing data: In addition to the adverse reactions reported during clinical studies and listed previously, the following adverse reactions have been reported during postmarketing experience with paliperidone and/or risperidone (Table 9). In each table, the frequencies are provided according to the following convention: Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1000 and <1/100; Rare ≥1/10000 and <1/1000; Very rare <1/10000, including isolated reports.
In Table 9, adverse reactions are presented by frequency category based on spontaneous reporting rates. (See Table 9.)


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Very rarely, cases of anaphylactic reaction after administration of the 1-month paliperidone palmitate injectable product have been reported during postmarketing experience in patients who have previously tolerated oral risperidone or oral paliperidone.
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