Invega

paliperidone

This is a summary of the European public assessment report (EPAR) for Invega. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Invega.

What is Invega?

Invega is a medicine that contains the active substance paliperidone. It is available as prolonged-release tablets (orange-brown: 1.5 mg; white: 3 mg; beige: 6 mg; pink: 9 mg; yellow: 12 mg). ‘Prolonged release’ means that paliperidone is released slowly from the tablet over a few hours.

What is Invega used for?

Invega is used to treat schizophrenia, a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).

Invega is also used to treat schizoaffective disorder. This is a condition in which the patient has episodes of elevated or depressed mood in addition to symptoms of schizophrenia. Invega is not effective in treating the depressive symptoms of schizoaffective disorder.

The medicine can only be obtained with a prescription.

How is Invega used?

The recommended starting dose of Invega is 6 mg once a day, taken in the morning. The tablet should be swallowed whole with a drink. Patients should take Invega either with or without food, but should not switch between taking it with food on one day and without food on another. After assessment of the symptoms, the dose of Invega can be adjusted to between 3 and 12 mg once a day in patients with schizophrenia and to between 6 and 12 mg once a day in patients with schizoaffective disorder. Patients with mild or moderate kidney problems, including some elderly patients, should start with a lower dose of Invega, but the medicine is not recommended for patients with severe kidney problems. For more information on the use of Invega, including the adjustment of doses, see the summary of product characteristics (also part of the EPAR).

How does Invega work?

The active substance in Invega, paliperidone, is an antipsychotic medicine. It is known as an ‘atypical’ antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s. Paliperidone is an active breakdown product (metabolite) of risperidone, another antipsychotic medicine that has been used in the treatment of schizophrenia since the 1990s. In the brain, it attaches to several different receptors on the surface of nerve cells. This disrupts signals transmitted between brain cells by ‘neurotransmitters’, chemicals that allow nerve cells to communicate with each other. Paliperidone acts mainly by blocking the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin), which are involved in schizophrenia. By blocking these receptors, paliperidone helps to normalise the activity of the brain and reduce symptoms.

How has Invega been studied?

Invega has been studied in three main short-term studies involving 1,692 adults with schizophrenia. In all three studies, doses of Invega between 3 and 15 mg a day were compared with placebo (a dummy treatment) and with olanzapine (another antipsychotic medicine). The main measure of effectiveness was the change in the patients’ symptoms using a standard scale for schizophrenia after six weeks. A fourth study in patients with schizophrenia looked at the long-term effects of Invega in preventing new symptoms for up to 35 weeks in 207 patients who had initially been treated over a 14-week period.

Two main studies were carried out in patients with schizoaffective disorder. A total of 614 patients were given either Invega or placebo. The main measure of effectiveness was the same as in the main schizophrenia studies: change in the patients’ symptoms after six weeks on a standard scale.

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 taking placebo had an average fall in their symptom score of 4.1 points, compared with an average fall of between 17.9 and 23.3 points in those taking Invega and of 19.9 in those taking olanzapine. Similar results were seen in the other two short-term studies. Across all three studies, higher doses of Invega were more effective than lower doses in reducing symptoms.

Invega was also more effective than placebo in preventing the occurrence of new symptoms of schizophrenia in the long-term study.

In the studies in patients with schizoaffective disorder, Invega was more effective than placebo. In the first study, patients who were given Invega had a fall in their symptom score of between 27.4 and 30.6 compared with 21.7 in patients who were given placebo. In the second study, the fall in symptom score was 20.0 in the Invega group and 10.8 in the placebo group.

What is the risk associated with Invega?

The most common side effect with 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 taken by people who may be hypersensitive (allergic) to paliperidone or any of the other ingredients, or to risperidone.

Why has Invega been approved?

The CHMP decided that Invega’s benefits are greater than its risks and recommended that it be given marketing authorisation. The CHMP noted that, although Invega is beneficial to patients with schizoaffective disorder, the medicine has not been shown to be effective in treating depressive episodes in these patients.

Other information about Invega

The European Commission granted a marketing authorisation valid throughout the European Union for Invega to Janssen-Cilag International NV on 25 June 2007. The marketing authorisation is valid for five years, after which it can be renewed.

For more information about treatment with Invega, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This EPAR was last updated on 08/12/2011 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

12/10/2011  Invega -EMEA/H/C/000746 -II/0028

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Psycholeptics

Therapeutic indication

INVEGA is indicated for the treatment of schizophrenia.

INVEGA is indicated for the treatment of psychotic or manic symptoms of schizoaffective disorder. Effect on depressive symptoms has not been demonstrated.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents