Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A., Viale Amelia 70, 00181, Rome Italy
Latuda is indicated for the treatment of schizophrenia in adults and adolescent aged 13 years and over.
The recommended starting dose is 37 mg of lurasidone once daily. No initial dose titration is required. It is effective in a dose range of 37 to 148 mg once daily. Dose increase should be based on physician judgement and observed clinical response. The maximum daily dose should not exceed 148 mg.
Patients on doses higher than 111 mg once daily who discontinue their treatment for longer than 3 days should be restarted on 111 mg once daily and up-titrated to their optimal dose. For all other doses patients can be restarted on their previous dose without need for up-titration.
The recommended starting dose is 37 mg of lurasidone once daily. No initial dose titration is required. It is effective in a dose range of 37 to 74 mg once daily. Dose increase should be based on physician judgement and observed clinical response. The maximum daily dose should not exceed 74 mg. In children, lurasidone should be prescribed by an expert in paediatric psychiatry.
A starting dose of 18.5 mg is recommended and the maximum dose of lurasidone should not exceed 74 mg once daily in combination with moderate CYP3A4 inhibitors. Dose adjustment of lurasidone may be necessary in combination with mild and moderate CYP3A4 inducers (see section 4.5). For strong CYP3A4 inhibitors and inducers see section 4.3.
Due to different pharmacodynamic and pharmacokinetic profiles among antipsychotic medicinal products, supervision by a clinician is needed when switching to another antipsychotic product is considered medically appropriate.
Dosing recommendations for elderly patients with normal renal function (CrCl ≥80 ml/min) are the same as for adults with normal renal function. However, because elderly patients may have diminished renal function, dose adjustments may be required according to their renal function status (see “Renal impairment” below).
Limited data are available in elderly people treated with higher doses of lurasidone. No data are available in elderly people treated with 148 mg of lurasidone. Caution should be exercised when treating patients ≥65 years of age with higher doses of lurasidone.
No dose adjustment of lurasidone is required in patients with mild renal impairment. In patients with moderate (Creatinine Clearance (CrCl) ≥30 and <50 ml/min), severe renal impairment (CrCL >15 and <30 ml/min) and End Stage Renal Disease (ESRD) patients (CrCl <15 ml/min), the recommended starting dose is 18.5 mg and the maximum dose should not exceed 74 mg once daily. Lurasidone should not be used in patients with ESRD unless the potential benefits outweigh the potential risks. If used in ESRD, clinical monitoring is advised.
No dose adjustment of lurasidone is required in patients with mild hepatic impairment. Dose adjustment is recommended in moderate (Child-Pugh Class B) and severe hepatic impairment (Child-Pugh Class C) patients. The recommended starting dose is 18.5 mg. The maximum daily dose in moderate hepatic impairment patients should not exceed 74 mg and in severe hepatic impairment patients should not exceed 37 mg once daily.
Latuda film-coated tablets are for oral use, to be taken once daily together with a meal. If taken without food, it is anticipated that lurasidone exposure will be significantly lower as compared to when taken with food (see section 5.2).
Latuda tablets should be swallowed whole, in order to mask the bitter taste. Latuda tablets should be taken at the same time every day to aid compliance.
There is no specific antidote to lurasidone, therefore, appropriate supportive measures should be instituted, and close medical supervision and monitoring should continue until the patient recovers.
Cardiovascular monitoring should commence immediately, including continuous electrocardiographic monitoring for possible arrhythmias. If antiarrhythmic therapy is administered, disopyramide, procainamide, and quinidine carry a theoretical hazard of QT-prolonging effects when administered in patients with an acute overdose of lurasidone. Similarly, the alpha-blocking properties of bretylium might be additive to those of lurasidone, resulting in problematic hypotension.
Hypotension and circulatory collapse should be treated with appropriate measures. Adrenaline and dopamine should not be used, or other sympathomimetics with beta agonist activity, since beta stimulation may worsen hypotension in the setting of lurasidone-induced alpha blockade. In case of severe extrapyramidal symptoms, anticholinergic medicinal products should be administered.
Gastric lavage (after intubation if patient is unconscious) and administration of activated charcoal together with a laxative should be considered.
The possibility of obtundation, seizures, or dystonic reaction of the head and neck following overdose may create a risk of aspiration with induced emesis.
Shelf life: 5 years.
Store in the original package in order to protect from light.
Cartons contain 14 × 1, 28 × 1, 30 × 1, 56 × 1, 60 × 1, 90 × 1 or 98 × 1 tablets in aluminium/aluminium perforated unit dose blisters.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
