FAQS

Frequently asked questions

 

Get answers to frequently asked questions about INVEGA TRINZA®. Click a topic below to get started.

INVEGA TRINZA® (paliperidone palmitate) is indicated for the treatment of schizophrenia in patients after they have been adequately treated with INVEGA SUSTENNA® (paliperidone palmitate) for at least 4 months.1

93% of patients on INVEGA TRINZA® (paliperidone palmitate) remained relapse-free in a long-term maintenance trial. 7% of patients taking INVEGA TRINZA® relapsed vs 23% of patients taking placebo (P<0.001).1,2

Relapse was defined as emergence of ≥1 of the following1,2:

  • Psychiatric hospitalization
  • ≥25% increase in PANSS total score*
  • Increase in distinct PANSS item scores
  • Deliberate self-injury or violent behavior
  • Suicidal or homicidal ideation
Approved for the treatment of schizophrenia

The full constellation of symptoms and the relevant diagnostic criteria should be consulted and are available in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5®, or current version), where applicable.1,2

*Defined as a ≥25% increase for 2 consecutive assessments between 3 and 7 days apart for patients scoring >40 at randomization or a 10-point increase for patients scoring ≤40 at randomization.1,2
PANSS=Positive and Negative Syndrome Scale.

 

Due to the significant efficacy of INVEGA TRINZA® (paliperidone palmitate), the study was stopped early at the preplanned interim analysis by an Independent Data Monitoring Committee (IDMC). The study protocol planned for an interim analysis after 42 relapse events. The median time to relapse in the placebo arm of the double-blind phase was 274 days. However, in the INVEGA TRINZA® arm, the median time to relapse could not be estimated due to the low percentage of subjects with relapse. Therefore, the study was stopped early by the IDMC for efficacy.1,2

Relapse was defined as emergence of ≥1 of the following1,2:

  • Psychiatric hospitalization
  • ≥25% increase in PANSS total score*
  • Increase in distinct PANSS item scores
  • Deliberate self-injury or violent behavior
  • Suicidal or homicidal ideation
Approved for the treatment of schizophrenia

The full constellation of symptoms and the relevant diagnostic criteria should be consulted and are available in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5®, or current version), where applicable.1,2

*Defined as a ≥25% increase for 2 consecutive assessments between 3 and 7 days apart for patients scoring >40 at randomization or a 10-point increase for patients scoring ≤40 at randomization.1,2
PANSS=Positive and Negative Syndrome Scale.

 

Relapse was defined as emergence of ≥1 of the following1,2:

  • Psychiatric hospitalization
  • ≥25% increase in PANSS total score*
  • Increase in distinct PANSS item scores
  • Deliberate self-injury or violent behavior
  • Suicidal or homicidal ideation
Approved for the treatment of schizophrenia

The full constellation of symptoms and the relevant diagnostic criteria should be consulted and are available in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5®, or current version), where applicable.1,2

*Defined as a ≥25% increase for 2 consecutive assessments between 3 and 7 days apart for patients scoring >40 at randomization or a 10-point increase for patients scoring ≤40 at randomization.1,2
PANSS=Positive and Negative Syndrome Scale.

 

 

The most common adverse reactions (incidences occurring in at least 5% of patients in the open-label phase, or in the INVEGA TRINZA® [paliperidone palmitate] group and at least twice the incidence in the placebo group during the double-blind phase) of a long-term maintenance trial in subjects with schizophrenia were injection-site reaction, weight increased, headache, upper respiratory tract infection, akathisia, and parkinsonism.1

The percentage of patients who discontinued due to adverse reactions during the open-label phase of the long-term maintenance trial was 5.1%. During the double-blind phase of the trial, no INVEGA TRINZA® (paliperidone palmitate)-treated patients and 1 placebo-treated patient discontinued due to an adverse reaction.1

Weight gain1

  • Weight gain has been reported with atypical antipsychotic use. Clinical monitoring of weight is recommended
  • Relative to baseline in the double-blind (DB) phase, 9.6% of patients taking INVEGA TRINZA® (paliperidone palmitate) in the double-blind phase (DB, n=157) demonstrated a ≥7% gain in body weight vs 0.7% of patients taking placebo (DB, n=142)
  • Relative to baseline in the open-label phase (n=466), 15.2% of patients demonstrated a ≥7% gain in body weight
    –During the open-label phase, subjects received several doses of INVEGA SUSTENNA® (paliperidone palmitate) followed by a single dose of INVEGA TRINZA®

Fasting glucose1

  • Patients taking INVEGA TRINZA® (n=138) in the double-blind phase demonstrated a –1.2 mg/dL change from DB baseline in fasting glucose levels vs a –1.6 mg/dL change in patients taking placebo (n=120)
  • In the open-label phase (n=397), patients demonstrated a 1.2 mg/dL increase from baseline in fasting glucose levels

Lipid profile1

DYSLIPIDEMIA:

Undesirable alterations in lipids have been observed in patients treated with antipsychotics.1

Please see additional Important Safety Information below.

HYPERPROLACTINEMIA:

As with other drugs that antagonize dopamine D2 receptors, INVEGA TRINZA® (paliperidone palmitate) elevates prolactin levels, and the elevation persists during chronic administration.1

Paliperidone has a prolactin-elevating effect similar to risperidone, which is associated with higher levels of prolactin than other antipsychotic agents.1

Prolactin data observed: double-blind phase1

  • Treatment-emergent elevations of prolactin* in the double-blind phase were higher in males taking INVEGA TRINZA® (n=114) vs placebo (n=108) (46% vs 25%) and higher in females (n=41) taking INVEGA TRINZA® vs placebo (n=34) (32% vs 15%)
  • During the double-blind phase, 1 female (2.4%) in the INVEGA TRINZA® group (n=42) 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

 

*Prolactin level > upper limit of normal at any time during the double-blind phase, among those with levels ≤ upper limit of normal at open-label baseline. Prolactin reference range: ≤13.13 ng/mL in males and ≤26.72 ng/mL in females.1

 

Prolactin data observed: open-label phase1

  • Prior to the double-blind phase (during the 29-week open-label phase of the long-term maintenance trial), the mean (SD) serum prolactin values at baseline in males (n=368) were 17.1 (13.55) ng/mL and 51.6 (40.85) ng/mL in females (n=122)
  • 12 weeks after a single injection of INVEGA TRINZA® at the end of the open-label phase, mean (SD) prolactin values were 25.8 (13.49) ng/mL in males (n=322) and 70.6 (40.23) ng/mL in females (n=107)
  • During the open-label phase, 27% of females and 42% of males experienced elevations of prolactin above the reference range relative to baseline, and a higher proportion of females experienced potentially prolactin-related adverse reactions compared to males (7.9% vs 3.7%)
    –Amenorrhea (4.7%) and galactorrhea (3.1%) were the most commonly observed (≥3%) potentially prolactin-related adverse reactions in females
    –Among males in the open-label phase, no potentially prolactin-related adverse reaction was observed with a rate greater than 3%

     

Prolactin level > upper limit of normal at any time during the open-label phase, among those with levels ≤ upper limit of normal at open-label baseline. Prolactin reference range: ≤13.13 ng/mL in males and ≤26.72 ng/mL in females.1

 

Injection-site reactions have occurred in patients treated with INVEGA TRINZA® (paliperidone palmitate). Based on investigator ratings of the injection site, redness and swelling were observed in 2% or less of subjects in the INVEGA TRINZA® and placebo groups during the double-blind phase of the long-term maintenance study, and were mild in nature. There were no reports of induration in either group during the double-blind phase.1

EPS data observed1

  • In the double-blind (DB) phase, 8% of patients taking INVEGA TRINZA® (paliperidone palmitate) (DB, n=160) demonstrated EPS-related adverse reactions vs 3% of patients taking placebo (DB, n=145)
    –4% of patients taking INVEGA TRINZA® demonstrated an adverse reaction of parkinsonism in the DB phase, while no potential symptoms of parkinsonism were noted in the placebo group
    –1% of patients taking INVEGA TRINZA® demonstrated an adverse reaction of dystonia in the DB phase, while no potential symptoms of dystonia were noted in the placebo group

  • In the open-label phase (n=506), 10% of patients demonstrated EPS-related adverse reactions
    –4% of patients in the open-label phase demonstrated an adverse reaction of parkinsonism, and 1% of patients experienced an adverse reaction of dystonia
    –During the open-label phase, subjects received several doses of INVEGA SUSTENNA® (paliperidone palmitate) followed by a single dose of INVEGA TRINZA®

Because paliperidone palmitate is hydrolyzed to paliperidone, results from studies with oral paliperidone should be taken into consideration when assessing drug-drug interaction potential. In addition, consider the 3-month dosing interval and long half-life of INVEGA TRINZA® (paliperidone palmitate).1

References: 1. INVEGA TRINZA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; March 2016. 2. Berwaerts J, Liu Y, Gopal S, et al. Efficacy and safety of the 3-month formulation of paliperidone palmitate vs placebo for relapse prevention of schizophrenia: a randomized clinical trial. JAMA Psychiatry. 2015;72(8):830-839. Supplemental data available at: http://archpsyc.jamanetwork.com/article.aspx?articleid=2211343#tab12. Accessed March 28, 2016.