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INVEGA HAFYERA

PALIPERIDONE PALMITATE

Manufacturer: Janssen Pharmaceuticals, Inc

Score: 144.0

Quick Summary

INVEGA TRINZA is a 3-month injection indicated for the treatment of schizophrenia in patients after they have been adequately treated with the 1-month paliperidone palmitate extended-release injectable suspension for at least four months. The drug has a unique mechanism of action, with paliperidone acting as an antagonist at central dopamine Type 2 and serotonin Type 2 receptors. Important safety information includes a boxed warning for increased mortality in elderly patients with dementia-related psychosis, and the drug is contraindicated in patients with a known hypersensitivity to paliperidone or risperidone. The recommended dosage is 273-819 mg every 3 months, with dose adjustments based on individual patient tolerability and efficacy. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use, with specific recommendations and precautions for each group.

Key Clinical Findings and Indications

  • INVEGA TRINZA is indicated for the treatment of schizophrenia in patients after they have been adequately treated with the 1-month paliperidone palmitate extended-release injectable suspension for at least four months
  • The drug has a unique mechanism of action, with paliperidone acting as an antagonist at central dopamine Type 2 and serotonin Type 2 receptors
  • INVEGA TRINZA is designed to deliver paliperidone over a 3-month period

Important Safety Information

Warning

Increased mortality in elderly patients with dementia-related psychosis

Contraindications

  • Known hypersensitivity to paliperidone or risperidone

Adverse Reactions

  • Injection site reaction
  • Weight increased
  • Headache
  • Upper respiratory tract infection
  • Akathisia
  • Parkinsonism

Dosing Recommendations

General Guidance

Dose adjustments can be made every 3 months in increments within the range of 273 mg to 819 mg based on individual patient tolerability and/or efficacy

Schizophrenia

Adult Dose

273-819 mg every 3 months

Pediatric Dose

Not recommended for pediatric patients

Special Population Considerations

Pregnancy

  • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including INVEGA TRINZA, during pregnancy
  • Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery

Nursing Mothers

  • It is not known whether INVEGA TRINZA is excreted in human breast milk

Pediatric Use

  • Safety and effectiveness of INVEGA TRINZA in patients less than 18 years of age have not been established
  • Use of INVEGA TRINZA is not recommended in pediatric patients because of the potential longer duration of an adverse event compared to shorter-acting products

Geriatric Use

  • Clinical studies of INVEGA TRINZA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects
  • This drug is known to be substantially excreted by the kidney and clearance is decreased in patients with renal impairment

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