What should clinicians know about Invega Hafyera (paliperidone palmitate 6-month LAI)?

Invega Hafyera is a long-acting injectable (LAI) formulation of Paliperidone. It is the first available antipsychotic LAI that provides coverage for 6 months. It is FDA-indicated to treat adults with schizophrenia.

Establishing Efficacy and Tolerability

Prior to initiating Invega Hafyera, treat the patient with either:

• Invega Sustenna (1 month formulation of Paliperidone palmitate) for at least four months (4 injections of Sustenna) or
• Invega Trinza (3 month formulation of Paliperidone palmitate) for at least one three month cycle (1 injection of Trinza)

Dosing

• Once every 6 months gluteal intramuscular injection by a healthcare professional. It cannot be administered by any other route.
• Available as single-dose prefilled syringes of the following doses:
  • 1,092 mg (injection volume of 3.5 ml)
  • 1,560 mg (injection volume of 5 ml)

    Paliperidone Conversion from Oral to LAI Formulations
    PO Dose	LAI/Invega Sustenna Dose	LAI/Invega Trinza*	LAI/Invega Hafyera**
    <3 mg Paliperidone	39 mg Invega Sustenna every 4 weeks	N/A	N/A
    3 mg Paliperidone	78 mg Invega Sustenna every 4 weeks	273 mg Invega Trinza every 12 weeks	N/A
    6 mg Paliperidone	117 mg Invega Sustenna every 4 weeks	410 mg Invega Trinza every 12 weeks	N/A
    9 mg Paliperidone	156 mg Invega Sustenna every 4 weeks	546 mg Invega Trinza every 12 weeks	1,092 mg Invega Hafyera every 6 months
    12 mg Paliperidone	234 mg Invega Sustenna every 4 weeks	819 mg Invega Trinza every 12 weeks	1,560 mg Invega Hafyera every 6 months
    *Stabilization with at least four months (4 injections) of Invega Sustenna required prior to initiation of Invega Trinza. **Stabilization with at least four months (4 injections) of Invega Sustenna or at least one three month cycle (1 injection) of Invega Trinza prior to initiation of Invega Hafyera.  If administering a strong CYP3A4/P-glycoprotein inducer, considering managing the patient using Paliperidone extended-release tablet.  References: 1.  Stahl, S.M. (2017).  The prescribers guide: Stahl’s essential psychopharmacology (6th ed.). New York: Cambridge University Press. 2.  American Psychiatric Association. (2020). The American Psychiatric Association Practice Guideline for the Treatment of Patients with Schizophrenia.  American Psychiatric Association Publishing.   https://doi.org/10.71176/appi.books.9780890424841  3.  INVEGA SUSTENNA USPI, Section 2.8: Instructions for Use; Section 17: How Supplied/Storage and Handling 4.  INVEGA TRINZA USPI, Section 2.2: Schizophrenia 5.  INVEGA HAFYERA USPI, Section 2.4: Instruction for Preparation and Administration

• A stable patient who has demonstrated response to a particular dose of Sustenna or Trinza would be a patient to consider for use of Invega Hafyera.
• No loading dose or oral supplementation recommended because steady state plasma levels have been achieved by 4 months of Invega Sustenna or at least one Invega Trinza.
• To avoid a missed maintenance dose of Invega Hafyera, patients may be given the injection up to 2 weeks before or 3 weeks after the scheduled 6-month dose.

Practical Issues (including administration)

• Store Invega Sustenna at room temperature.
• Medication should be shipped and stored in a horizontal position.
• The thin-walled needles included in the Invega Hafyera kit must be used for the injection.
• Invega Hafyera requires longer and faster shaking than once-a-month Sustenna. Shake the pre-filled syringe very fast for at least 15 seconds, rest briefly, and then shake again for another full 15 seconds. The shaking must be short, very fast in an up and down motion. Administer the injection within 5 minutes of shaking.
• Invega Hafyera must be administered via gluteal injection. The injection should be administered slowly with firm, consistent pressure. The injection itself should take approximately 30 seconds.

FDA Medication Label

Information on this topic is found in the FDA medication label. Prescribing should always be informed by the FDA medication label. Medication labels can be found searching Drugs@FDA at the FDA website. Labels are available using the Drugs@FDA app for Apple or Android devices.

Labels change over time, and the current label should always be consulted. Here is the most recent label, at time of writing.

Administration/Dosing Guide

More information about administration (including a detailed video) and dosing can be found here.

REFERENCES

• Invega Hafyera USPI, Section 2.4: Instruction for Preparation and Administration; Section 16: How Supplied/Storage and Handling

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