Paliperidone palmitate label adds more dosing options, warnings

Paliperidone palmitate (Invega Sustenna), a monthly extended-release injectable suspension atypical antipsychotic for the treatment of schizophrenia, has a new updated product label that describes greater flexibility and dosing options for healthcare providers as well as additional warnings and precautions, according to its manufacturer, Janssen Pharmaceuticals.

After the first dose of paliperidone palmitate, a second dose is administered 1 week later. Then maintenance doses are given once a month. Additional instructions for dosings have been developed to help avoid a missed dose, according to the Janssen release issued on September 26.

Patients can receive the second dose 4 days before or after the 1-week time period, instead of 2 days before or after the 1-week time point as outlined in the original label. If the second dose is completed missed, the recommended re-initiation depends on the length of time that has elapsed since the patient’s first injection.

Dosage adjustment instructions have also been added when paliperidone palmitate is coadministered with a strong CYP3A4 inducer, recommending a higher dose of paliperidone palmitate.

In the boxed warning section, an increased risk of mortality in elderly with dementia-related psychosis was noted with the use of antipsychotic drugs and states that paliperidone palmitate is NOT approved for the treatment of patients with dementia-related psychosis. In analyses of 17 placebo-controlled trials lasting approximately 10 weeks, patients who were mostly taking atypical antipsychotic drugs had a 1.6 to 1.7 times increased risk of death compared with the placebo-controlled group. The rate of death in a typical 10-week controlled trial for the drug-treated group was 4.5%, while the placebo-controlled group was only 2.6%. The causes of death were due either cardiovascular or infectious disease. In addition, observational studies also suggest that the use of conventional antipsychotic drugs may increase mortality.

Additional information about the product’s use in specific populations, such as nursing women, individuals with Parkinson’s disease or Lewy Body Dementia, is now available.