What is Latuda - lurasidone and what is it 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 range of symptoms, including thought and speech disturbances, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
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 daily; the tablets should be taken with food at approximately the same time. Depending on the patient's response and the treating physician's judgment, the dose may be increased up to a maximum daily dose of 148 mg. Patients with renal or hepatic insufficiency of moderate or severe degrees and patients treated with certain other medicines that can affect the concentration of Latuda in the blood should take reduced doses, see the package leaflet for more information.
How does Latuda work - lurasidone?
The active substance in Latuda, lurasidone, is an antipsychotic medicine. In the brain, it binds to various neurotransmitter receptors found on the surface of nerve cells, interfering with their functioning. Neurotransmitters are chemicals that allow communication between nerve cells. Lurasidone works mainly by blocking the receptors for the neurotransmitters dopamine, 5-hydroxytryptamine (also called “serotonin”) and noradrenaline. Since dopamine, 5-hydroxytryptamine and noradrenaline contribute to the onset 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 in a total of 1,466 patients. The main measure of effectiveness was the change in patients' symptoms, as measured by a standard schizophrenia rating scale called the 'positive and negative syndrome scale' (PANSS). In these studies, different doses of Latuda were shown to be more efficacy of placebo, resulting in a reduction of the PANSS score up to a maximum of 16 points more than placebo; this effect, however, was not consistently demonstrated for each dose, as well as a dose-to-dose relationship could not be observed. consistent response. The company conducted further analysis of the results, which confirmed the short-term benefits of treatment with Latuda. One of the short-term studies was extended for up to 12 months (extension study) to evaluate the maintenance of "Latuda effect in 292 subjects compared to quetiapine; two other studies, involving 914 patients, looked at the long-term effects of Latuda compared to both another medicine used in the treatment of schizophrenia, risperidone, and placebo. In these long-term studies, the efficacy of Latuda was measured by the proportion of patients in whom relapse and symptoms of schizophrenia were observed during therapy. In the extension study, 21% of patients treated with Latuda had relapsed within a year compared with 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 available data show a long-term benefit. The latest study found that 30% of patients treated with Latuda had a relapse within one year compared with 41% of patients treated with placebo
What is the risk associated with Latuda - lurasidone?
The most common side effects with Latuda (which may affect more than 1 in 10 people) are akathisia (a state of motor restlessness) and sleepiness. 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 'strong CYP3A4 inhibitors' or 'strong CYP3A4 inducers', which may interfere with blood levels. of lurasidone in the blood. For the full list of restrictions, 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 Latuda's short- and long-term efficacy was adequately demonstrated, the CHMP noted that in the short-term studies it was "moderate efficacy. In terms of safety, the side effects of Latuda were considered to be similar to those of other medicines of the same kind, except for the effects apparently more limited on the body metabolism (for example, on blood sugar and fat concentrations, and on body weight) and for a presumed more limited effect on cardiac activity than 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 added to the summary of product characteristics and package leaflet for Latuda, including the appropriate precautions to be followed by healthcare professionals and patients. Further information can be found 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 about Latuda therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist. This summary was last updated 03-2014.
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