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) |
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 |
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 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) |
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 |
Reconstitution 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. 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.
REFERENCES
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