Latuda

Posology Adult population 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.

Paediatric population 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 3 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. 5 mg is recommended and the maximum dose of lurasidone should not exceed 74 mg once daily in combination with moderate CYP3A4 inhibitors.

5). For strong CYP3A4 inhibitors and inducers see section

5 -148 mg in clinical studies in patients with schizophrenia treated for up to 52 weeks and in the post-marketing setting. The most common adverse drug reactions (ADRs) (≥ 10%) were akathisia, nausea and insomnia. Tabulated summary of adverse reactions Adverse drug reactions (ADRs) based upon pooled data are shown by system, organ class and by preferred term are listed in Table 1 below.

The incidence of ADRs reported in clinical trials is tabulated by frequency category. The following terms and frequencies are applied: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (<1 /10,000) and not known (cannot be estimated from the available data).

6) Reproductive system and breast disorders Blood prolactin increased Erectile dysfunction Amenorrhoea Dysmenorrhoea Breast pain Galactorrhoea Breast enlargement*** * General disorders and administration site conditions Fatigue Gait disturbance Sudden death 10 System Organ Class Very Commo n Common Uncommon Rare Frequency not known Investigations Blood creatinine phosphokinase increased *Somnolence includes adverse reaction terms: hypersomnia, hypersomnolence, sedation, and somnolence **Parkinsonism includes adverse reaction terms: bradykinesia, cogwheel rigidity, drooling, extrapyramidal disorder, hypokinesia, muscle rigidity, parkinsonism, psychomotor retardation, and tremor ***Dystonia includes adverse reaction terms: dystonia, oculogyric crisis, oromandibular dystonia, tongue spasm, torticollis, and trismus.

****ADRs noted in Phase 2 and 3 controlled and uncontrolled studies; however, the incidence of occurrence for these are too low to estimate frequencies.

Table 2:

Adverse Drug Reactions (ADRs) for Adolescents System Organ Class Very Common Common Uncommon Rare Frequency not known Infections and infestations Nasopharyngitis Rhinitis Upper respiratory tract infection Blood and lymphatic system disorders Neutropenia Immune System Disorders Hypersensitivity Endocrine disorders Hyperprolactinaemia (including blood prolactin increased) Autoimmune thyroiditis Hyperandrogenism Hypothyroidism Metabolism and nutrition disorders Decreased appetite Increased appetite Hyperinsulinemia Psychiatric Disorders Abnormal dreams Agitation Anxiety Depression Insomnia Psychotic disorder Schizophrenia Tension Aggression Apathy Confusional state Depressed mood Dissociation Hallucination (auditory) Hallucination (visual) Homicidal ideation Impulsive behaviour Initial insomnia Libido decreased Libido increased Listlessness Mental status changes Obsessive thoughts 11 System Organ Class Very Common Common Uncommon Rare Frequency not known Panic Attack Psychomotor hyperactivity Restlessness Sleep disorder Suicidal ideation Terminal insomnia Thinking abnormal Nervous System Disorders Akathisia Headache Somnolence* Disturbance in attention Dizziness Dyskinesia Dystonia*** Parkinsonism** Dizziness postural Dysgeusia Hyperkinesia Memory impairment Migraine Paraesthesia Psychomotor hyperactivity Restless legs syndrome Tardive dyskinesia Tension headache Eye Disorders Accommodation disorder Vision blurred Ear and labyrinth disorders Hyperacusis Cardiac disorders Tachycardia Palpitations Supraventricular extrasystoles Vascular disorders Orthostatic hypotension Hypertension Respiratory, thoracic and mediastinal disorders Oropharyngeal pain Dyspnoea Gastrointestinal disorders Nausea Constipation Dry mouth Salivary hypersecretion Vomiting Abdominal discomfort Abdominal pain upper Aptyalism Diarrhoea Dyspepsia Lip dry Toothache Skin and subcutaneous tissue disorders Hyperhidrosis Alopecia Hair growth abnormal Rash Urticaria 12 System Organ Class Very Common Common Uncommon Rare Frequency not known Musculoskeletal and connective tissue disorders Muscle rigidity Arthralgia Muscle tightness Musculoskeletal stiffness Myalgia Pain in extremity Pain in jaw Renal and urinary disorders Bilirubinuria Dysuria Micturition disorder Polyuria Proteinuria Renal disorder Reproductive system and breast disorders Erectile dysfunction Amenorrhoea Breast pain Ejaculation disorder Galactorrhoea Gynaecomastia Menstruation […]

During antipsychotic treatment, improvement in the patient's clinical condition may take a few days to some weeks. Patients should be closely monitored during this period. Suicidality The occurrence of suicidal behaviour is inherent in psychotic illnesses and in some cases has been reported early after initiation or switch of antipsychotic therapy.

Close supervision of high-risk patients should accompany antipsychotic therapy. Parkinson’s disease If prescribed to patients with Parkinson’s disease, antipsychotic medicinal products may exacerbate the underlying parkinsonism symptoms.

Physicians should therefore weigh the risks versus the benefits when prescribing lurasidone to patients with Parkinson’s disease. Extrapyramidal symptoms (EPS) Medicinal products with dopamine receptor antagonistic properties have been associated with extrapyramidal adverse reactions including rigidity, tremors, mask-like face, dystonias, drooling of saliva, drooped posture and abnormal gait.

In placebo controlled clinical studies in adult patients with schizophrenia there was an increased occurrence of EPS following treatment with lurasidone compared to placebo. Tardive dyskinesia Medicinal products with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical involuntary movements, predominantly of the tongue and/or face.

If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics, including lurasidone, should be considered. Cardiovascular disorders/QT prolongation Caution should be exercised when lurasidone is prescribed in patients with known cardiovascular disease or family history of QT prolongation, hypokalaemia, and in concomitant use with other medicinal products thought to prolong the QT interval.

Seizures Lurasidone should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold. Neuroleptic malignant syndrome (NMS) Neuroleptic Malignant Syndrome, characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels, has been reported to occur with lurasidone.

3. Switching between antipsychotic medicinal products 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.

Elderly people 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.

Renal impairment No dose adjustment of lurasidone is required in patients with mild renal impairment. 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. Hepatic impairment 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.

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. Method of administration Latuda film-coated tablets are for oral use, to be taken once daily together with a meal.

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. 1. g. g. 5). 4