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.

Invega Hafyera

Indication(s)

Schizophrenia

Dosing available as prefilled syringes

1,092 mg (injection volume of 3.5 ml)
1,560 mg (injection volume of 5 ml)

Recommended starting and maintenance dose

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 exclusions

Doses less than 9mg oral Paliperidone do not have Invega Hafyera equivalents.

Loading dose

Used only after adequate treatment has been established with Invega Sustenna for at least 4 months (with the last 2 doses being 156 mg or 234 mg) or Invega Trinza for at least one 3-month injection cycle (at doses of 546 mg or 819 mg)
To establish a consistent maintenance dose, it is recommended that the last 2 doses of Invega Sustenna be the same dosage strength before starting Invega Hafyera

Oral overlap

Not required

Establishing 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)

Storage

Room temperature in a horizontal position

Reconsititution or mixing

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.

Injection site

Gluteal intramuscular

Injection interval

Every 6 months

Preparation

With the syringe tip pointing up, shake vigorously with a loose wrist, using a very fast up and down motion, for at least 15 seconds.  Rest briefly, then shake again for 15 seconds.  If more than 5 minutes pass before injection, shake the syringe very fast with the tip cap pointing up again for at least 30 seconds to re-suspend the medication.  Priming the syringe is recommended.

Administration 

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.

The injection should be administered slowly with firm, consistent pressure. The injection itself should take approximately 30 seconds.

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

When a dose is missed

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. See this tip for more information.

REMS

No

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

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

If you would like more information on this topic, or would like to provide any feedback, please send us a message using our consultation system. Be sure to let us know about which tip you are writing. We would love to hear from you, and the consultation system is free to use and confidential. Thank you!

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