LATUDA TABLET 80MG

BUSHU PHARMACEUTICALS LTD (KAWAGOE FACTORY) - JAPANOLIC (THAILAND) LTD (PRIMARY AND SECONDARY PACKAGER) (THAILAND)🇸🇬 Health Sciences Authority

Approval Date: Sep 14, 2016
Approval ID: 5a7202a0adbd169f
Company: BUSHU PHARMACEUTICALS LTD (KAWAGOE FACTORY) - JAPANOLIC (THAILAND) LTD (PRIMARY AND SECONDARY PACKAGER) (THAILAND)
Type: Therapeutic

Approval Details

Approval Id: 5a7202a0adbd169f
Drug Name: LATUDA TABLET 80MG
Product Name: LATUDA TABLET 80MG
Approval Number: SIN15089P
Approval Date: 2016-09-14
Registrant: MARUBENI PHARMACEUTICALS ASIA PACIFIC PTE. LTD.
Licence Holder: MARUBENI PHARMACEUTICALS ASIA PACIFIC PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, COATED
Dosage: 14 DOSAGE AND ADMINISTRATION 14.1 Schizophrenia Adults The efficacy of LATUDA has been established at doses of 40, 80, 120 and 160 mg/day. The recommended starting dose of LATUDA is 40 mg once daily. Initial dose titration is not required. Patients should be treated with the lowest effective dose that provides optimal clinical response and tolerability, which is expected to be 40 mg or 80 mg once daily for most patients. Dose increase should be based on physician judgement and observed clinical response. In the six week controlled trials, there was no suggestion of added benefit with the 120 mg/day dose compared to 40 and 80 mg/day. In the pooled analyses, added benefit occurred at 160 mg/day compared to lower doses. Doses above 80 mg may be considered for certain patients based on individual clinical judgement. The maximum recommended dose is 160 mg/day. LATUDA should be taken with food (at least 350 calories). Patients who have been receiving LATUDA for the treatment of schizophrenia, may continue maintenance therapy at the same dose. Adolescents The recommended starting dose of LATUDA is 40 mg/day. In a placebo-controlled clinical trial, LATUDA has been shown to be effective at doses of 40mg/day and 80mg/day. The maximum recommended dose is 80mg/day. Patients should be treated with the lowest effective dose that provides optimal clinical response and tolerability. In the placebo-controlled clinical trial, no additional benefit was demonstrated for 80mg over 40mg. LATUDA should be taken with food. Switching Antipsychotics There are no systematically collected data to specifically address switching patients from other antipsychotics to LATUDA or concerning concomitant administration with other antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. 14.2 Depressive Episodes Associated with Bipolar I Disorder Adults The recommended starting dose of LATUDA is 20 mg given once daily as monotherapy or as adjunctive therapy with lithium or valproate. Initial dose titration is not required. LATUDA has been shown to be effective in a dose range of 20 mg per day to 120 mg per day as monotherapy or as adjunctive therapy with lithium or valproate [see Clinical Studies (5.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. The maximum recommended dose, as monotherapy or as adjunctive therapy with lithium or valproate, is 120 mg per day. In the monotherapy study, the higher dose range (80 mg to 120 mg per day) did not provide additional efficacy, on average, compared to the lower dose range (20 to 60 mg per day) [see Clinical Studies (5.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. As the incidence of certain adverse events increase with dose [see Adverse Reactions (11) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information] patients should be treated with the lowest effective dose of LATUDA. Pediatric Patients (13 – 17 years) The recommended starting dose of LATUDA is 20 mg given once daily as monotherapy. Initial dose titration is not required. The dose may be increased after one week based on clinical response. LATUDA has been shown to be effective in a dose range of 20 mg per day to 80 mg per day as monotherapy. At the end of the clinical study, most of the patients (67%) received 20 mg or 40 mg once daily [see Clinical Studies (5.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. The maximum recommended dose is 80 mg per day. The efficacy of LATUDA in the treatment of mania associated with bipolar disorder has not been established. 14.3 Administration Instructions Administration with food substantially increases the absorption of LATUDA. Administration with food increases the AUC approximately 2-fold and increases the Cmax approximately 3-fold. In the clinical studies, LATUDA was administered with food. 14.4 Dose Modifications in Special Populations Renal Impairment After administration of a single dose of 40 mg to patients with mild, moderate and severe renal impairment, mean Cmax increased by 40%, 92%, and 54%, respectively and mean AUC(0-∞) increased by 53%, 91% and 2-times, respectively compared to healthy matched subjects. Dose adjustment is recommended in moderate (creatinine clearance: 30 to <50 mL/min) and severe renal impairment (creatinine clearance <30 mL/min) patients. Caution should be exercised when starting LATUDA in patients with renal impairment. The recommended starting dose is 20 mg. Patients should be treated with the lowest effective dose that provides optimal clinical response and tolerability, which is expected to be 20–40 mg once daily for most patients with moderate or severe renal function impairment. The dose in these patients should not exceed 80 mg/day. Hepatic Impairment In a single-dose study of 20 mg, LATUDA mean AUC (0–last) was 1.5-times higher in subjects with mild hepatic impairment (Child-Pugh Class A), 1.7-times higher in subjects with moderate hepatic impairment (Child-Pugh class B) and 3-times higher in subjects with severe hepatic impairment (Child-Pugh Class C) compared to the values for healthy matched subjects. Mean Cmax was 1.3, 1.2, and 1.3-times higher for mild, moderate and severe hepatic impaired patients, respectively, compared to the values for healthy matched subjects. Dose adjustment is recommended in moderate (Child-Pugh Score = 7 to 9) and severe hepatic impairment (Child-Pugh Score = 10 to 15) patients. Caution should be exercised when starting LATUDA in patients with hepatic impairment. The recommended starting dose is 20 mg. Patients should be treated with the lowest effective dose that provides optimal clinical response and tolerability, which is expected to be 20–40 mg once daily for most patients with moderate or severe hepatic impairment (Child Pugh Class B and C). The dose in moderate hepatic impaired patients should not exceed 80 mg/day and the dose in severe hepatic impaired patients should not exceed 40 mg/day. 14.5 Dose Modifications Due to Drug Interactions Concomitant Use with CYP3A4 Inhibitors LATUDA should not be used in combination with a strong CYP3A4 inhibitor (e.g. ketoconazole) [see Contraindications]. If LATUDA is being prescribed and a moderate CYP3A4 inhibitor (e.g., diltiazem, atazanavir, erythromycin, fluconazole, verapamil etc.) is added to the therapy, the LATUDA dose should be reduced to half of the original dose level. Similarly, if a moderate CYP3A4 inhibitor is being prescribed and LATUDA is added to therapy, the recommended starting dose of LATUDA is 20 mg per day, the maximum recommended dose of LATUDA is 80 mg/day. Grapefruit and grapefruit juice should be avoided in patients taking LATUDA, since these may inhibit CYP3A4 and alter LATUDA concentrations. Concomitant Use with CYP3A4 Inducers LATUDA should not be used concomitantly with a strong CYP3A4 inducer (e.g., rifampin, avasimibe, St. John’s wort, phenytoin, carbamazepine, etc.) [see Contraindications]. If LATUDA is used concomitantly with a moderate CYP3A4 inducer, it may be necessary to increase the LATUDA dose after chronic treatment (7 days or more) with the CYP3A4 inducer.
Route Of Administration: ORAL
Indication Info: 6 INDICATIONS AND USAGE LATUDA is indicated for: <ul> <li>Treatment of adult and adolescent patients age 13 to 17 years with schizophrenia.</li> <li>Monotherapy treatment of adult and pediatric patients (13 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression).</li> <li>Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression).</li> </ul>
Contraindications: 7 CONTRAINDICATIONS LATUDA is contraindicated in any patient with a known hypersensitivity to lurasidone HCl or any components in the formulation. LATUDA is contraindicated with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, and voriconazole) and strong CYP3A4 inducers (e.g., rifampin, St. John’s wort, phenytoin, and carbamazepine).
Atc Code: N05AE05
Atc Item Name: lurasidone
Pharma Manufacturer Name: SUMITOMO PHARMA ASIA PACIFIC PTE. LTD.

Active Ingredients

Lurasidone hydrochloride

80 mg

Lurasidone hydrochloride

80 mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Sep 14, 2016

Approval ID

5a7202a0adbd169f

Type

Therapeutic

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