What is Invega?
Invega is a drug containing the active substance paliperidone. It is available as prolonged-release tablets (1.5 mg, orange-brown; 3 mg, white; 6 mg beige; 9 mg pink; 12 mg yellow). The expression "prolonged release" means that paliperidone is released from the tablet slowly, within a few hours.
What is Invega used for?
Invega is indicated for the treatment of schizophrenia, a mental illness characterized by a series of symptoms, including thought and speech disorders, hallucinations (hearing or seeing things that are not there), suspiciousness and disappointments (false beliefs).
The medicine can only be obtained with a prescription.
How is Invega used?
The recommended starting dose of Invega is 6 mg, given once a day in the morning. The tablet should be swallowed whole with a liquid. Invega can be taken without food or with breakfast, but you must always take it fasting or always with breakfast and not a day on an empty stomach and a day with food. The dose of Invega can be changed after the evaluation of symptoms, up to a final dose of between 3 and 12 mg once a day. Invega should be used with caution in individuals with severe liver disorders. Patients with mild or moderate kidney problems, including some elderly patients, should start with a lower dose of Invega, while it is not recommended for patients with severe kidney problems. Invega has not been studied in patients under the age of 18 years.
How does Invega work?
The active substance in Invega, paliperidone, is an antipsychotic drug, known as an "atypical" antipsychotic, as it differs from the old antipsychotic drugs available since the 1950s. Paliperidone is a product of the active degradation (metabolite) of risperidone, a another antipsychotic drug used in the treatment of schizophrenia since the 1990s. In the brain it binds to more receptors on the surface of nerve cells. In this way the signals transmitted between the brain cells are interrupted through the "neurotransmitters", ie the chemical substances that allow nerve cells to communicate with each other. Paliperidone acts mainly by blocking receptors for dopamine and 5-hydroxytryptamine neurotransmitters (also called serotonin), implicated in schizophrenia. By inhibiting these receptors, paliperidone contributes to the normalization of brain activity and reduces symptoms.
How has Invega been studied?
The effects of Invega were first tested in experimental models before being studied in humans.
Invega has been studied in three main short-term studies involving 1 692 adult patients with schizophrenia. In all three studies, doses of Invega between 3 and 15 mg per day were compared with placebo (a dummy treatment) and with olanzapine (another antipsychotic drug). The main measure of effectiveness was the change in patients' symptoms after six weeks, measured according to a standard scale of evaluation of schizophrenia. In a further study, Invega's long-term effects in preventing new symptoms for up to 35 weeks were examined in 207 patients who had been treated initially for symptoms of schizophrenia for a period of 14 weeks.
What benefit has Invega shown during the studies?
Invega was more effective than placebo and as effective as olanzapine in reducing the symptoms of schizophrenia. In the first short-term study, patients treated with placebo had an average reduction in symptom score of 4.1 points compared to an average reduction of between 17.9 and 23.3 points recorded in subjects treated with Invega and 19, 9 points in patients taking olanzapine. Similar results also emerged in the other two short-term studies. In all three studies it has been shown that higher dosages of Invega are more effective in reducing symptoms than smaller dosages. In the long-term study, Invega was more effective than placebo in preventing new symptoms of schizophrenia.
What is the risk associated with Invega?
The most common side effect of Invega (seen in more than 1 patient in 10) is headache. For the full list of all side effects reported with Invega, see the Package Leaflet. Invega should not be used in people who may be hypersensitive (allergic) to paliperidone or any of the other substances, or to risperidone.
Why has Invega been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that, at doses between 3 and 12 mg per day, Invega's benefits outweigh its risks in the treatment of schizophrenia. The Committee also concluded that, based on the benefit / risk ratio of the different doses studied, the dose of 6 mg once a day represents a reasonable initial dose. The committee recommended that Invega be given marketing authorization.
More information on Invega:
On 25 June 2007, the European Commission granted Invega a marketing authorization valid throughout the European Union to Janssen-Cilag International NV. For the full EPAR for Invega, click here.
Last update of this summary: 02-2009.
