SUMMARY

• A literature search did not identify any information related to safety concerns of using INVEGA SUSTENNA, INVEGA TRINZA, or INVEGA HAFYERA for patients with schizophrenia who are also diagnosed with active coronavirus (COVID-19).
• For patients with schizophrenia who have been diagnosed with COVID-19 and are currently receiving INVEGA SUSTENNA, INVEGA TRINZA, or INVEGA HAFYERA treatment, clinicians should use clinical judgment to decide whether to delay treatment until the patient is recovered or to continue treatment with INVEGA SUSTENNA, INVEGA TRINZA, or INVEGA HAFYERA as scheduled. It will be important to evaluate the risk benefit of continued treatment based on the patient’s clinical status in terms of schizophrenia symptoms versus the severity of symptoms from COVID-19.¹
• The American Psychiatric Association (APA) issued a COVID-19 Pandemic Guidance Document recommending that COVID-19 vaccinations be prioritized for people with serious mental illness due to factors such as comorbidities and other health and social risk factors, which lead to higher rates of infection and severe morbidity and mortality.
• A cohort study conducted in a Northeast US health system demonstrated that patients hospitalized with COVID-19 and a psychiatric diagnosis had a significantly higher 2-week mortality (35.7% vs 14.7%; P<0.01) and 3-week mortality (40.9% vs 22.2%; P<0.001) rate compared to those without a psychiatric diagnosis.²
• In a retrospective cohort study of a New York health system evaluating the association between psychiatric disorders and mortality in patients with laboratory-confirmed COVID-19, schizophrenia spectrum disorder was associated with an increased risk of mortality (odds ratio [OR], 2.67; 95% CI, 1.48-4.80) after adjustment for demographic and medical risk factors.³
• During the COVID-19 Public Health Emergency, the APA encourages hospitals and other facilities to continue the use of long-acting injectables (LAIs) for patients with high-risk chronic illness as a necessary procedure.⁴
• An article by Chepke (2020)⁵ provides considerations for the administration of LAIs as a drive-up service during the COVID-19 pandemic.
• Barnett et al (2023)⁶ conducted a real-world, observational study evaluating the experience of switching from INVEGA SUSTENNA to INVEGA TRINZA in 46 patients with schizophrenia and schizoaffective disorders, found that 93.5% of the patients reported feeling safer receiving INVEGA TRINZA during the COVID-19 pandemic.
• Appropriate precautions should be taken to minimize the potential for spread of infection. Please see the latest information on the CDC website for the latest infection prevention and control recommendations for treating patients with suspected or confirmed coronavirus disease (COVID-19) in healthcare settings.⁷

Considerations for the use of LAis

Increased Risk in Patients with Psychiatric Disorders

Patients with serious mental illness have an increased risk of comorbidities, overcrowded living conditions, and risk factors including smoking and reduced access to medical care, which may lead to higher rates of infection as well as severe morbidity and mortality due to COVID-19.¹ The Committee on Psychiatric Dimensions of Disaster & COVID-19 recommends that COVID-19 vaccinations should be prioritized for people with substance use disorders and serious mental illness due to these health and social risk factors. In a cohort study conducted in a Northeast US health system, patients hospitalized with COVID-19 and a psychiatric diagnosis had a significantly higher mortality rate compared to those without a psychiatric diagnosis for 2-week mortality (35.7% vs 14.7%; P<0.01) and 3-week mortality (40.9% vs 22.2%; P<0.001).² A retrospective cohort study of a New York health system evaluated the association between psychiatric disorders and mortality, defined as death or discharge to hospice within 45 days, among adults with COVID-19 (N=7,348).³ Patients categorized into 3 mutually exclusive psychiatric diagnoses (schizophrenia spectrum disorders, mood disorders, and anxiety disorders) were compared to a reference group of patients without psychiatric disorders. Patients with schizophrenia spectrum disorders had an increased risk in 45-day mortality after adjustment for age, sex, and race (OR, 2.87; 95% CI, 1.62-5.08) and medical risk factors (OR, 2.67; 95% CI, 1.48-4.80).

Guidance and Reports of LAI Use During the COVID-19 Pandemic

The Committee on Psychiatric Dimensions of Disaster & COVID-19 provides guidance for the use of LAIs during the COVID-19 pandemic.⁴ The guidance recommends that the use of LAIs is a clinically necessary treatment and should be continued for patients with chronic mental illness.

Individuals with serious mental illness remain at a much higher risk of morbidity and mortality despite continuous treatment.⁴ In consideration of the pandemic, risks of physical and psychiatric decompensations are increased due to reduced natural supports, reduced access to outpatient treatment, and risk of exposure to the coronavirus with increased contacts.

The benefits of LAIs, especially in a pandemic, for those with severe and chronic mental illness may include reduced personal suffering and distress; reduced disorganized or impulsive behaviors that increase risk of physical injury, aggression, ER admission, or incarceration; and ensured adequate level of functioning and cognitive processing needed to adhere to social distancing measures.⁴

This guidance recommends continued LAI use for individuals who may experience an adverse outcome with a transition to oral medication, those who have a history of decompensation due to LAI discontinuation, or those who have barriers in accessing oral medication in order to avoid non-urgent office visits/procedures during the COVID-19 crisis.

MacLaurin et al (2021)⁸ reported their approach to managing patients on LAI treatment at their clinic by determining which patients could be: 1) switched to an LAI with a longer dosing interval, 2) switched to oral antipsychotics, or 3) administered the LAI at home. Among the patients who continued to receive their LAI at the clinic, 15% were switched to the longer-acting formulation of the LAI they were receiving. The authors reported that careful planning with the patient, communication with community support, and use of precautions led to the continuation of psychiatric care while mitigating the risk of infection. No patients required psychiatric hospitalization or experienced increased symptoms due to missed injections or medication switches.

Chepke (2020)⁵ reported the utilization of drive-up administration of LAIs during COVID-19. For patients who receive LAIs that are injected into the deltoid muscle, injections were administered without patients leaving the car. If appropriate, patients receiving a monthly deltoid injection were transitioned to an equivalent quarterly deltoid injection.

As gluteal injections may be inappropriate for drive-up administration due to safety and privacy concerns, patients receiving gluteal injections were converted to an equivalent deltoid injection if appropriate.

Barnett et al (2023)⁶ conducted a cross-sectional, multicenter, real-world, observational study in London from April to June 2020 in patients primarily diagnosed with schizophrenia to evaluate their experience of switching from INVEGA SUSTENNA to INVEGA TRINZA, including the feeling of safety during the COVID-19 pandemic. The experience of switching from INVEGA SUSTENNA to INVEGA TRINZA was recorded via a 4-part questionnaire co-developed by 2 psychiatrists that included satisfaction, feeling of safety during the COVID-19 pandemic, advantages, and disadvantages.

The study included 46 patients (male, n=31; average age, 48.5 years; age range, 23-78 years) with a diagnosis of schizophrenia (84.8%) or schizoaffective disorder (15.2%). INVEGA TRINZA is not indicated for use with schizoaffective disorder in the United States. The mean treatment length with INVEGA SUSTENNA before switching to INVEGA TRINZA was 47.0 months. Regarding the feeling of safety during the COVID-19 pandemic after switching to INVEGA TRINZA, 26 (56.5%) patients responded, “strongly agreed”; 17 (37%), “agreed”; 3 (6.5%), “neither agreed nor disagreed”; and none, “disagreed” or “strongly disagreed”.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 11 June 2024.