What is Trevicta and its Primary Use?
Trevicta is the brand name for a long-acting injectable (LAI) formulation of paliperidone palmitate. It is classified as an atypical antipsychotic, a class of drugs that are effective in treating the symptoms of psychotic disorders like schizophrenia. The primary and specific use of Trevicta is for the maintenance treatment of schizophrenia in adults. This means it is not typically used for initial or acute treatment. Instead, it is prescribed for individuals who have already been successfully treated and stabilized on a once-monthly paliperidone palmitate injection (also known by brand names like Xeplion or Invega Sustenna in different regions).
The symptoms of schizophrenia, which Trevicta helps to manage long-term, can be divided into "positive" and "negative" categories. Positive symptoms include delusions, hallucinations, and disorganized thinking or speech, which are present in excess compared to the general population. Negative symptoms involve a lack of behaviors or emotions typically present in others, such as withdrawal or a flattened affect. By providing a steady, prolonged release of medication, Trevicta helps to alleviate these symptoms and, most importantly, reduces the risk of relapse.
Understanding the Indication for Schizophrenia
The use of Trevicta is based on a specific clinical pathway. Before a patient can be switched to the 3-monthly injection, they must be adequately treated and clinically stable on the 1-monthly paliperidone palmitate injection for a minimum of four months. This staged approach ensures the patient tolerates the active ingredient, paliperidone, and confirms the monthly formulation has effectively managed their symptoms. Once this prerequisite is met, a healthcare professional can initiate Trevicta, with the dosing calculated based on the previous monthly dose.
How Does Trevicta Work?
The active ingredient in Trevicta, paliperidone, is a major active metabolite of the older antipsychotic risperidone. The mechanism of action is primarily based on its activity in the brain, where it influences the signaling of certain neurotransmitters, namely dopamine and serotonin.
- Dopamine D2 Receptor Antagonism: By blocking dopamine Type 2 (D2) receptors, paliperidone helps reduce the overactivity of dopamine in specific areas of the brain, which is thought to be a key factor in the positive symptoms of schizophrenia, such as hallucinations and delusions.
- Serotonin 5-HT2A Receptor Antagonism: Paliperidone also acts on serotonin Type 2 (5-HT2A) receptors. The combination of dopamine and serotonin antagonism is believed to contribute to a better management of both positive and negative symptoms, while also potentially leading to a lower risk of extrapyramidal side effects compared to older antipsychotics.
To create a long-acting formulation like Trevicta, the paliperidone is attached to a fatty acid, or palmitate ester, which allows it to be released slowly and consistently over three months after a single intramuscular injection. This prolonged-release system maintains stable therapeutic drug levels in the bloodstream, preventing the fluctuations that can occur with daily oral medication and reducing the risk of relapse.
Who is Trevicta For? Patient Selection and Administration
As a maintenance treatment, Trevicta is for adult patients with schizophrenia who meet specific criteria. Its suitability is determined by a mental healthcare provider based on the patient's history of response to the monthly paliperidone injection.
The Switch from Monthly Injections
The transition to Trevicta is a key part of the treatment process. Patients must be clinically stable on the 1-monthly paliperidone palmitate injection for at least four months before making the switch. This stability ensures that the patient's symptoms are well-controlled and that they tolerate the medication. During this period, the patient should be closely monitored by their healthcare team.
How Trevicta is Administered
Trevicta is administered by a healthcare professional as a slow injection into the upper part of the shoulder (deltoid muscle) or the buttocks. The dosage is determined by a calculation based on the patient's previous monthly dose. The 3-monthly schedule offers a significant advantage over daily oral medication or monthly injections, potentially reducing the logistical and psychological burden of frequent medical visits.
Key Benefits of a Long-Acting Injection
The use of a long-acting injectable for schizophrenia offers several advantages, especially for long-term management.
- Improved Adherence: Missing daily doses is a common challenge for individuals with schizophrenia. The 3-monthly injection schedule significantly reduces the opportunity for missed doses, helping to ensure consistent medication levels and therapeutic effects.
- Reduced Relapse Risk: Consistent medication is a crucial factor in preventing psychotic relapse. By providing stable drug levels over a longer period, Trevicta has been shown to be effective in delaying and reducing relapse rates in clinical trials.
- Increased Freedom: With less frequent dosing, patients may feel a greater sense of freedom and less focused on their treatment regimen, allowing them to better engage in other aspects of their lives.
Potential Side Effects and Risks
Like all medications, Trevicta can cause side effects. Awareness and discussion with a healthcare provider are important for managing any adverse reactions.
Common side effects (seen in at least 5% of patients) include:
- Increased weight
- Upper respiratory tract infection
- Anxiety
- Headache
- Insomnia
- Injection site reaction
Other reported side effects can include:
- Nausea and vomiting
- Constipation
- Muscle pains or stiffness
- Dry mouth
- Increased heart rate
- Drowsiness
- For a full list of potential side effects, refer to the package leaflet.
Serious but less common risks include:
- Neuroleptic Malignant Syndrome (NMS): A rare but severe reaction characterized by high fever, muscle rigidity, and altered mental status.
- Tardive Dyskinesia: A movement disorder involving involuntary movements of the face and body.
- Orthostatic Hypotension: Dizziness or fainting upon standing due to a drop in blood pressure.
- Changes in Metabolism: Such as high blood sugar or cholesterol levels.
Trevicta Compared to Other Treatments
While Trevicta is a valuable option, it is one of several antipsychotic treatments. The choice of medication depends on the individual patient's needs and their response to previous treatments.
| Feature | Trevicta (Paliperidone Palmitate 3-monthly) | Paliperidone Palmitate (1-monthly) | Oral Antipsychotics (e.g., Paliperidone tablets) |
|---|---|---|---|
| Dosing Frequency | Every 3 months (Intramuscular injection) | Every 1 month (Intramuscular injection) | Daily (Oral tablets) |
| Pre-treatment Required | Yes, stable on 1-monthly injection for $\geq$ 4 months | None for initiation | None |
| Adherence Support | High; requires only 4 administrations per year | Good; requires 12 administrations per year | Potentially low due to daily effort required |
| Onset of Effect | Not for initiation; maintains effect after stabilization | Used for both acute and maintenance | Used for acute and maintenance, daily administration |
| Cost | Considered more expensive per administration, but similar annual cost to monthly LAI | More expensive per dose than oral, similar annual cost to Trevicta | Typically less expensive, but depends on adherence |
Comparative studies have shown that Trevicta is non-inferior to the 1-monthly paliperidone palmitate injection in preventing relapse. The primary benefit of the longer interval is the potential for improved adherence and convenience for the patient.
Conclusion
In summary, the drug Trevicta is a long-acting injectable formulation of paliperidone palmitate used for the maintenance treatment of schizophrenia in adult patients who have been clinically stabilized on a monthly injection. Its extended 3-monthly dosing schedule provides a significant advantage for promoting medication adherence and reducing the risk of relapse compared to more frequent dosing options. While offering clear benefits for patient convenience, it is important to be aware of potential side effects and for the medication to be prescribed and administered under the careful supervision of a mental healthcare professional. For individuals who have a positive response to the monthly paliperidone injection, Trevicta presents an effective and less burdensome long-term management strategy.
For more detailed product information, consult the European Medicines Agency's EPAR for Trevicta, available here.
