Lurasidone should be administered orally with food (> 350 calories). Studies have shown that when lurasidone is taken with food, absorption increases.
Lurasidone is FDA approved for the treatment of schizophrenia and depressive episodes associated with bipolar I disorder. It has received regulatory approval in the UK in September 2014. It received EMA approval on January 24, 2014. It was launched in Canada for the treatment of schizophrenia in September 2012, Health Canada giving their Summary Basis of Decision (SBD) as favourable on October 15, 2012. European Commission has granted a marketing authorization for once-daily oral lurasidone for the treatment of schizophrenia in adults. It's approved for use in the EU.
In July 2013 lurasidone received approval for bipolar I depression. Few available atypical antipsychotics are known to possess antidepressant efficacy in bipolar disorder (with the notable exceptions being quetiapine,olanzapine and possibly asenapine) as a monotherapy, even though the majority of atypical antipsychotics are known to possess significant antimanic activity, which is yet to be clearly demonstrated for lurasidone.
Lurasidone has completed phase III clinical trial for extended use study in India, although it is not yet approved in India. Lurasidone is not approved by the Food and Drug Administration (FDA) for the treatment of behavior disorders in older adults with dementia.
As with other atypical neuroleptics, lurasidone should be used with caution in the elderly because it puts them at an increased risk for a stroke or transient ischemic attack; however, these risks are not likely to be greater than those associated with antipsychotics of other classes. Similarly, lurasidone should not be used to treat dementia-related psychosis, as evidence has shown increased mortality with antipsychotic use.
Lurasidone is metabolized in the liver via the enzymeCYP3A4. This means that its plasma concentrations may be increased when combined with CYP3A4 inhibitors like ketoconazole or grapefruit juice, possibly leading to more side effects. Co-administration of CYP3A4 inducers like rifampicin or St. John's wort can reduce plasma levels and consequently decrease the effects of the drug.
Lurasidone is contraindicated in individuals who are taking strong CYP3A4 inhibitors (ketoconazole, clarithromycin, ritonavir, etc.) or inducers (carbamazepine, St. John's wort, phenytoin, rifampicin etc.). The use of lurasidone in pregnant women has not been studied and is not recommended. Excretion in breast milk is also unknown; lurasidone is not recommended for breastfeeding women. Additionally and as with other antidepressants, lurasidone increases the risk of suicidal thinking and behavior in patients 18 to 24 years old. In the United States it is not indicated for use in children.
^Meyer, Jonathan M; Loebel, Antony D; Schweizer, Edward (2009). "Lurasidone: A new drug in development for schizophrenia". Expert Opinion on Investigational Drugs18 (11): 1715–26. doi:10.1517/13543780903286388. PMID19780705.
^Young, Allan H.; McElroy, Susan L.; Bauer, Michael; Philips, Nabil; Chang, William; Olausson, Bengt; Paulsson, Björn; Brecher, Martin; EMBOLDEN I (Trial 001) Investigators (2010). "A Double-Blind, Placebo-Controlled Study of Quetiapine and Lithium Monotherapy in Adults in the Acute Phase of Bipolar Depression (EMBOLDEN I)". The Journal of Clinical Psychiatry71 (2): 150–62. doi:10.4088/JCP.08m04995gre. PMID20122369.
^Suppes, Trisha; Datto, Catherine; Minkwitz, Margaret; Nordenhem, Arvid; Walker, Chris; Darko, Denis (2010). "Effectiveness of the extended release formulation of quetiapine as monotherapy for the treatment of acute bipolar depression". Journal of Affective Disorders121 (1–2): 106–15. doi:10.1016/j.jad.2009.10.007. PMID19903574.
^Tohen, Mauricio; Vieta, E; Calabrese, J; Ketter, TA; Sachs, G; Bowden, C; Mitchell, PB; Centorrino, F; Risser, R; Baker, RW; Evans, AR; Beymer, K; Dube, S; Tollefson, GD; Breier, A (2003). "Efficacy of Olanzapine and Olanzapine-Fluoxetine Combination in the Treatment of Bipolar I Depression". Archives of General Psychiatry60 (11): 1079–88. doi:10.1001/archpsyc.60.11.1079. PMID14609883.
^Tohen, M.; Katagiri, H.; Fujikoshi, S.; Kanba, S. (2013). "Efficacy of olanzapine monotherapy in acute bipolar depression: A pooled analysis of controlled studies". Journal of Affective Disorders149 (1–3): 196–201. doi:10.1016/j.jad.2013.01.022. PMID23485111.
^Corya, Sara A.; Perlis, Roy H.; Keck Jr, Paul E.; Lin, Daniel Y.; Case, Michael G.; Williamson, Doug J.; Tohen, Mauricio F. (2006). "A 24-Week Open-Label Extension Study of Olanzapine-Fluoxetine Combination and Olanzapine Monotherapy in the Treatment of Bipolar Depression". The Journal of Clinical Psychiatry67 (5): 798–806. doi:10.4088/JCP.v67n0514. PMID16841630.
^Azorin, J.M.; Sapin, C.; Weiller, E. (2013). "Effect of asenapine on manic and depressive symptoms in bipolar I patients with mixed episodes: Results from post hoc analyses". Journal of Affective Disorders145 (1): 62–9. doi:10.1016/j.jad.2012.07.013. PMID22868059.
^Cipriani, Andrea; Barbui, Corrado; Salanti, Georgia; Rendell, Jennifer; Brown, Rachel; Stockton, Sarah; Purgato, Marianna; Spineli, Loukia M; Goodwin, Guy M; Geddes, John R (2011). "Comparative efficacy and acceptability of antimanic drugs in acute mania: A multiple-treatments meta-analysis". The Lancet378 (9799): 1306–15. doi:10.1016/S0140-6736(11)60873-8. PMID21851976.
^ abcdefIshiyama, Takeo; Tokuda, Kumiko; Ishibashi, Tadashi; Ito, Akira; Toma, Satoko; Ohno, Yukihiro (2007). "Lurasidone (SM-13496), a novel atypical antipsychotic drug, reverses MK-801-induced impairment of learning and memory in the rat passive-avoidance test". European Journal of Pharmacology572 (2–3): 160–70. doi:10.1016/j.ejphar.2007.06.058. PMID17662268.
^Enomoto, T; Ishibashi, T; Tokuda, K; Ishiyama, T; Toma, S; Ito, A (2008). "Lurasidone reverses MK-801-induced impairment of learning and memory in the Morris water maze and radial-arm maze tests in rats". Behavioural Brain Research186 (2): 197–207. doi:10.1016/j.bbr.2007.08.012. PMID17881065.