Trevicta (paliperidone palmitate) is a prolonged-release suspension for intramuscular injection, used for the maintenance treatment of schizophrenia in adult patients. Because it is a long-acting formulation, it requires careful and precise administration to ensure the medication is effectively absorbed over the three-month period. This guide is for trained healthcare professionals who are responsible for administering this medication.
Patient Eligibility and Dosage Transition
Before a patient can begin treatment with Trevicta, they must be clinically stable on a monthly paliperidone palmitate injectable product (such as Invega Sustenna or Xeplion) for at least four months. The switch to Trevicta is not intended for initial treatment and must be based on a patient's stable response to the monthly injection.
When transitioning, the Trevicta dose is calculated to be 3.5 times the previous monthly paliperidone dose to ensure a comparable level of the active substance, paliperidone, is maintained in the patient's system. The first Trevicta injection is given at the time the next monthly dose would have been due, with a flexibility window of ± 7 days. Subsequent injections are then administered every three months, with a dosing window of ± 2 weeks.
Preparing the Trevicta Injection
Proper preparation is crucial to ensure the medication is effectively suspended and fully administered. The suspension must be handled according to strict guidelines, as outlined in the prescribing information.
Step-by-Step Preparation
- Gather Materials: Ensure you have the Trevicta pre-filled syringe, a new thin-walled safety needle from the pack, and a sterile alcohol swab.
- Shake Vigorously: Hold the syringe tip pointing up and shake it vigorously with a loose wrist for at least 15 seconds. This is longer and more vigorous than shaking required for the monthly formulation.
- Check Suspension: The liquid should appear uniform and milky white after shaking. The presence of small air bubbles is normal.
- Attach Needle: Twist the rubber cap off the syringe. Holding the syringe upright, attach the supplied thin-walled safety needle with a gentle twisting motion.
- Remove Air: Hold the syringe upright and tap it gently to bring any air bubbles to the top. Carefully press the plunger rod upward until a small drop of liquid appears at the needle tip, expelling the air.
- Inject Immediately: The injection must be administered within 5 minutes of shaking to prevent the medication from settling. If more than 5 minutes pass, shake vigorously again for another 15 seconds.
Administering the Intramuscular Injection
The Trevicta injection must be administered slowly and deep into a muscle. The injection site should be alternated with each subsequent dose.
Injection Site Selection
The choice of injection site and needle size depends on the patient's weight.
- Deltoid Muscle: For deltoid administration, the injection should be given into the center of the muscle. For patients weighing 90 kg or more, use the 1½-inch, 22-gauge needle. For patients weighing less than 90 kg, use the 1-inch, 22-gauge needle.
- Gluteal Muscle: For gluteal administration, use the 1½-inch, 22-gauge needle for all patients, regardless of body weight. The injection should be administered into the upper-outer quadrant of the gluteal muscle.
Injection Procedure
- Select and Prepare Site: Use a sterile alcohol swab to clean the injection site.
- Inject Slowly: Inject the entire contents of the syringe deep into the muscle in a slow, steady motion. This must be a single, uninterrupted injection.
- Secure Needle: Once the injection is complete, use your thumb or a flat surface to secure the needle into the safety device until you hear a 'click'.
- Dispose Properly: Discard the syringe and needle in an approved sharps container.
Managing Missed Doses
Adherence is crucial for the effectiveness of Trevicta. Patients can receive their injection up to two weeks before or after the three-month due date. If a patient misses the dosing window, a specific re-initiation regimen is required, which may involve re-stabilizing on the monthly formulation.
Trevicta vs. Monthly Paliperidone Administration
This table outlines the key differences in the administration procedure between Trevicta and the monthly formulation, Invega Sustenna (or Xeplion).
| Feature | Trevicta (3-Monthly) | Monthly Paliperidone (Sustenna/Xeplion) |
|---|---|---|
| Administration Frequency | Once every 3 months (± 2 weeks). | Once every month. |
| Pre-injection Shaking | Vigorously for at least 15 seconds. | Standard shaking. |
| Injection Delay Limit | Must be injected within 5 minutes of shaking. | No specific time limit mentioned, but prompt injection recommended. |
| Needle Sizes (Deltoid) | ≥90 kg: 1½-inch, 22G; <90 kg: 1-inch, 22G. | Varies by dose and weight, but often similar gauges. |
| Needle Sizes (Gluteal) | 1½-inch, 22G (regardless of weight). | 1½-inch, 22G (common). |
| Dose Conversion | Dose is 3.5 times the previous monthly dose. | Not applicable when on maintenance dose. |
Conclusion
Correct administration of Trevicta is a detailed procedure that is critical for the patient's long-term stability and treatment adherence. Healthcare professionals must follow the specific protocols for preparation, injection technique, and site selection to ensure the prolonged-release formulation works as intended. Following these guidelines ensures both patient safety and the continued efficacy of this important medication. For more detailed instructions and product information, healthcare providers should consult the official prescribing information from the European Medicines Agency.
Important Considerations
- Do not divide the dose: The entire dose must be administered in a single injection.
- Avoid blood vessels: Care must be taken to inject slowly and deep into the muscle to avoid injecting into a blood vessel.
- Incomplete injection: If an incomplete dose is administered, another dose should not be given. The patient should be monitored until the next scheduled injection.
- Regular monitoring: Continue to monitor the patient for side effects, including injection site reactions and other potential adverse effects.
