New drug formulation – Trevicta® (paliperidone) three-monthly injection

 In Medicines Management Processes, Mental Health, Pharmacy Information, Regulations and Standards

Janssen-MedInfo has launched Trevicta® which is a very long-acting antipsychotic depot injection containing paliperidone palmitate and is administered every three months. Trevicta® is licensed for the maintenance treatment of schizophrenia in adult patients who are clinically stable on one-monthly paliperidone palmitate injectable product (Xeplion®).

Trevicta® is available in four doses and is supplied as pre-filled injections. Patients who are adequately treated with one monthly paliperidone injections, preferably for more than four months, can be switched to Trevicta® providing they don’t require dosage adjustment.

Switching from other antipsychotics, whether oral or long-acting injections, is not recommended.

Method of administration

Trevicta® must only be given by the intramuscular route using the full dose in the pre-filled syringe. It should be administered slowly deep into the deltoid or gluteal muscle using the special thin-walled needles provided. There are different needles available depending on the weight of the patient and the injection site.

The injection must be shaken for at least 15 seconds before use and must be re-shaken if not given within five minutes.

If needed, subsequent dose adjustment of Trevicta® can be made every three months in increments within the range of 175mg to 525mg based on individual patient tolerability and/or efficacy. Due to the long-acting nature of Trevicta®, the patient’s response to an adjusted dose may not be apparent for several months.

As with all medications, some patients may experience side effects. The most frequently observed adverse drug reactions reported in ≥ 5% of patients in the two double-blind controlled clinical trials of the paliperidone palmitate three-monthly injection were: increased weight, upper respiratory tract infection, anxiety, headache, insomnia and injection site reaction.

For further information on Trevicta®, such as indications, dosage, administration, contraindications, etc., please see the Summary of Product Characteristics, which can be accessed by the following link: http://www.medicines.org.uk/emc/medicine/32050

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