What is Latuda - lurasidone used for?
Latuda is a medicine that contains the active substance lurasidone . It is indicated for the treatment of adult patients with schizophrenia, a mental illness characterized by a series of symptoms, including thought and speech disorders, hallucinations (hearing or seeing non-existent things), suspiciousness and fixations (false convictions).
How is Latuda used - lurasidone?
Latuda is available as tablets (18.5, 37 and 74 mg) and can only be obtained with a prescription. The recommended starting dose is 37 mg once a day; the tablets should be taken with food at about the same time. Depending on the patient's response and the attending physician's judgment, the dose may be increased up to a maximum daily dose of 148 mg. Patients with moderate or severe renal or hepatic impairment and patients treated with certain other medicines that can alter the concentration of Latuda in the blood should take reduced doses. For more information, see the package leaflet.
How does Latuda - lurasidone work?
The active substance in Latuda, lurasidone, is an antipsychotic medicine. In the brain it binds to various receptors for neurotransmitters that are on the surface of nerve cells, interfering with their functioning. Neurotransmitters are chemicals that allow communication between nerve cells. Lurasidone acts mainly by blocking receptors for neurotransmitters dopamine, 5-hydroxytryptamine (also called "serotonin") and noradrenaline. Since dopamine, 5-hydroxytryptamine and norepinephrine contribute to the manifestation of schizophrenia, by inhibiting these receptors, lurasidone contributes to the normalization of brain activity and reduces symptoms.
What benefit has Latuda - lurasidone shown during the studies?
Latuda has been studied in six main studies. Three short-term studies compared Latuda with placebo (a dummy treatment) over six weeks out of a total of 1 466 patients. The main measure of effectiveness was the change in patients' symptoms, measured on the basis of a standard scale of evaluation of schizophrenia called "positive and negative syndrome scale" (PANSS). In these studies, different doses of Latuda were more effective than placebo, leading to a reduction in the PANSS score up to a maximum of 16 points more than placebo; however, this effect was not consistently demonstrated for each dose, nor was a consistent dose-response relationship observed. The company conducted further analysis of the results, which confirmed the benefits of the treatment with Latuda in the short term. One of the short-term studies was extended up to 12 months (extension study) in order to evaluate the maintenance of the effect of Latuda in 292 subjects compared to quetiapine; two other studies, involving 914 patients, examined the effects of Latuda over the long term compared to both another medicine used to treat schizophrenia, risperidone, and placebo. In these long-term studies, the effectiveness of Latuda was measured by the percentage of patients in whom schizophrenia relapses and symptoms were observed during therapy. In the extension study, 21% of patients treated with Latuda had a relapse within a year compared to 27% of subjects treated with quetiapine, which suggests that Latuda was at least as effective as quetiapine. Latuda was not as effective as risperidone in the second study, although the available data showed a long-term benefit. The latest study showed that 30% of patients treated with Latuda had a relapse within a year compared to 41% of patients treated with placebo
What is the risk associated with Latuda - lurasidone?
The most common side effects of Latuda (which may affect more than 1 in 10 people) are akathisia (a state of motor restlessness) and drowsiness. For the full list of all side effects reported with Latuda, see the package leaflet. Latuda should not be used in combination with medicines known as "potent CYP3A4 inhibitors" or "potent CYP3A4 inducers" which may interfere with blood lurasidone levels. For the full list of limitations, see the package leaflet.
Why has Latuda - lurasidone been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Latuda's benefits are greater than its risks and recommended that it be approved for use in the EU. Although the efficacy of Latuda in the short and long term has been adequately demonstrated, the CHMP noted that in short-term studies it was a moderate efficacy. As for safety, the undesirable effects of Latuda were considered similar to those of other medicines of the same kind, except for the apparently more limited effects on the body's metabolism (for example, on blood concentrations of sugar and fat, and on weight body) and for a presumed more limited effect on cardiac activity compared to other available treatments.
What measures are being taken to ensure the safe and effective use of Latuda - lurasidone?
A risk management plan has been developed to ensure that Latuda is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Latuda, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information about Latuda - lurasidone
On 21 March 2014, the European Commission issued a marketing authorization for Latuda, valid throughout the European Union. For more information on Latuda therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 03-2014.
