Some information presented within this Center of Excellence was created in collaboration with the California Department of State Hospitals (DSH). This includes that the content has been specifically aligned to the DSH’s medication guidelines (DSH Psychotropic Medication Operational Procedures, appended to DSH Policy Directive 3400). These medication guidelines are applicable only to the DSH settings and inclusion within this resource does not indicate that they must be followed in any non-DSH settings. The medication guidelines included in this resource are those of DSH and do not necessarily represent the views, policy(ies), and/or position(s) of the American Psychiatric Association (APA).
Invega Hafyera | |
Indication(s) | Schizophrenia |
Dosing available as prefilled syringes | 1,092 mg (injection volume of 3.5 ml) |
Recommended starting and maintenance dose | Prior to initiating Invega Hafyera, treat the patient with either: Invega Sustenna (4 week formulation of Paliperidone palmitate) for at least 17 weeks (4 injections of Sustenna) or Invega Trinza (13 week formulation of Paliperidone palmitate) for at least one 13 week cycle (1 injection of Trinza) |
Drug Metabolizing Enzyme | CYP3A4 |
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 17 weeks (with the last 2 doses being 156 mg or 234 mg) or Invega Trinza for at least one 13-week 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 (4 week formulation of Paliperidone palmitate) for at least 17 weeks (4 injections of Sustenna) or Invega Trinza (13 week formulation of Paliperidone palmitate) for at least one 13 week cycle (1 injection of Trinza) |
Storage | Room temperature in a horizontal position |
Reconstitution or mixing | Invega Hafyera requires longer and faster shaking than once every 4 weeks 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 26 weeks |
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 every four weeks 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. |
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 26 week dose. See this tip for more information. |
REMS | No |
Paliperidone Conversion from Oral to LAI Formulations | |||
Oral Dose | LAI/Invega Sustenna Dose | LAI/Invega Trinza* | LAI/Invega Hafyera** |
Paliperidone <3 mg | Invega Sustenna 39 mg every 4 weeks | N/A | N/A |
Paliperidone 3 mg | Invega Sustenna 78 mg every 4 weeks | Invega Trinza 273 mg every 12 weeks | N/A |
Paliperidone 6 mg | Invega Sustenna 117 mg every 4 weeks | Invega Trinza 410 mg every 12 weeks | N/A |
Paliperidone 9 mg | Invega Sustenna 156 mg every 4 weeks | Invega Trinza 546 mg every 12 weeks | Invega Hafyera 1,092 mg every 6 months |
Paliperidone 12 mg | Invega Sustenna 234 mg every 4 weeks | Invega Trinza 819 mg every 12 weeks | Invega Hafyera 1,560 mg 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 6. California Department of State Hospitals Psychotropic Medication Operational Procedures. | |||
FDA Medication Label
Information on this topic is found in the FDA medication label. Not all information in the FDA medication label is included here, and clinicians should read the entire FDA medication label before making treatment decisions.
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.
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