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Invega Hafyera FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 2, 2021.

FDA Approved: Yes (First approved August 30, 2021)
Brand name: Invega Hafyera
Generic name: paliperidone palmitate
Dosage form: Extended-Release Injectable Suspension
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Schizophrenia

Invega Hafyera (paliperidone palmitate) is a long-acting injectable atypical antipsychotic for the twice-yearly treatment of schizophrenia in adults.

  • Before transitioning to Invega Hafyera (6-month paliperidone palmitate), patients must be adequately treated with Invega Sustenna (1-month paliperidone palmitate) for at least four months, or Invega Trinza (3-month paliperidone palmitate) for at least one 3-month injection cycle.
  • The FDA approval of Invega Hafyera was based on the results of a 12-month, randomized, double-blind, non-inferiority Phase 3 global study that showed 92.5 percent of patients treated with Invega Hafyera were relapse-free at 12 months, compared to 95 percent of patients treated with Invega Trinza. 
  • Invega Hafyera is administered by gluteal intramuscular injection once every 6 months by a healthcare professional.
  • Invega Hafyera can cause serious adverse reactions including cerebrovascular adverse reactions in elderly patients with dementia-related psychosis, neuroleptic malignant syndrome, QT prolongation, tardive dyskinesia, metabolic changes, orthostatic hypotension and syncope, leukopenia, neutropenia, agranulocytosis, hyperprolactinemia, potential for cognitive and motor impairment, and seizures. The Invega Hafyera product label carries a Boxed Warning for increased mortality in elderly patients with dementia-related psychosis.
  • Common adverse reactions include upper respiratory tract infection, injection site reaction, weight increased, headache, and parkinsonism.

Development timeline for Invega Hafyera

DateArticle
Sep  1, 2021Approval FDA Approves Invega Hafyera (paliperidone palmitate) for Twice-Yearly Treatment for Adults with Schizophrenia

Further information

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