Lurace Uses

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How do you administer this medicine?

What is Lurace?

Lurace (Lurace) is an antipsychotic medicine. It works by changing the effects of chemicals in the brain.

Lurace is used to treat schizophrenia in adults.

Lurace is also used to treat episodes of depression in people with bipolar disorder (manic depression).

Lurace indications

infoAn indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Schizophrenia

Lurace is indicated for the treatment of patients with schizophrenia.

The efficacy of Lurace in schizophrenia was established in five 6-week controlled studies of adult patients with schizophrenia.

The effectiveness of Lurace for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use Lurace for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Depressive Episodes Associated with Bipolar I Disorder

Monotherapy: Lurace is indicated as monotherapy for the treatment of patients with major depressive episodes associated with bipolar I disorder (bipolar depression). The efficacy of Lurace was established in a 6-week monotherapy study in adult patients with bipolar depression.

Adjunctive Therapy with Lithium or Valproate: Lurace is indicated as adjunctive therapy with either lithium or valproate for the treatment of patients with major depressive episodes associated with bipolar I disorder (bipolar depression). The efficacy of Lurace as adjunctive therapy was established in a 6-week study in adult patients with bipolar depression who were treated with lithium or valproate.

The effectiveness of Lurace for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use Lurace for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

The efficacy of Lurace in the treatment of mania associated with bipolar disorder has not been established.

How should I use Lurace?

Use Lurace as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Lurace comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Lurace refilled.
  • Take Lurace by mouth with food (at least 350 calories).
  • Swallow Lurace whole. Do not split, crush, or chew before swallowing.
  • Do not eat grapefruit or drink grapefruit juice while you use Lurace.
  • Do not suddenly stop taking Lurace without checking with your doctor. You may have an increased risk of side effects. If you need to stop Lurace, your doctor may need to gradually lower your dose.
  • Take Lurace on a regular schedule to get the most benefit from it. Taking Lurace at the same time each day will help you remember to take it.
  • Continue to take Lurace even if you feel well. Do not miss any doses.
  • If you miss a dose of Lurace, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once unless your doctor tells you to. If you are not sure what to do, call your doctor.

Ask your health care provider any questions you may have about how to use Lurace.

Uses of Lurace in details

infoThere are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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This medication is used to treat certain mental/mood disorders (such as schizophrenia, depression associated with bipolar disorder). Lurace helps you to think more clearly, feel less nervous, and take part in everyday life. It may also help to decrease hallucinations (hearing/seeing things that are not there). In addition, this medication may improve your mood, sleep, appetite, and energy level. Lurace is a psychiatric medication that belongs to the class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.

How to use Lurace

Read the Medication Guide provided by your pharmacist before you start taking Lurace and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with food as directed by your doctor, usually once daily. Dosage is based on your medical condition, kidney/liver function, other drugs you are taking, and your response to treatment.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Continue taking this medication exactly as prescribed, even if you are feeling better and thinking more clearly. Do not increase your dose or take this drug more often than prescribed. Your symptoms will not improve any faster, and your risk of side effects will increase. Do not stop taking this medication without consulting your doctor.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Tell your doctor if your condition does not improve or if it worsens. It may take several weeks before you feel the full benefit of this medication.

Lurace description

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Lurace is an atypical antipsychotic developed by Dainippon Sumitomo Pharma. It was approved by the U.S. Food and Drug Administration (FDA) for treatment of schizophrenia on October 29, 2010 and is currently pending approval for the treatment of bipolar disorder in the United States. (Wikipedia)

Lurace dosage

Schizophrenia

The recommended starting dose of Lurace is 40 mg once daily. Initial dose titration is not required. Lurace has been shown to be effective in a dose range of 40 mg per day to 160 mg per day. The maximum recommended dose is 160 mg per day.

Depressive Episodes Associated with Bipolar I Disorder

The recommended starting dose of Lurace is 20 mg given once daily as monotherapy or as adjunctive therapy with lithium or valproate. Initial dose titration is not required. Lurace 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. 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 (14.2).

Administration Instructions

Lurace should be taken with food (at least 350 calories). Administration with food substantially increases the absorption of Lurace. Administration with food increases the AUC approximately 2-fold and increases the Cmax approximately 3-fold. In the clinical studies, Lurace was administered with food.

Dose Modifications in Special Populations

Renal Impairment

Dose adjustment is recommended in moderate (creatinine clearance: 30 to <50 mL/min) and severe renal impairment (creatinine clearance <30 mL/min) patients. The recommended starting dose is 20 mg per day. The dose in these patients should not exceed 80 mg per day.

Hepatic Impairment

Dose adjustment is recommended in moderate (Child-Pugh Score = 7 to 9) and severe hepatic impairment (Child-Pugh Score = 10 to 15) patients. The recommended starting dose is 20 mg per day. The dose in moderate hepatic impairment patients should not exceed 80 mg per day and the dose in severe hepatic impairment patients should not exceed 40 mg/day.

Dose Modifications Due to Drug Interactions

Concomitant Use with CYP3A4 Inhibitors

Lurace should not be used concomitantly with a strong CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.).

If Lurace is being prescribed and a moderate CYP3A4 inhibitor (e.g. diltiazem, atazanavir, erythromycin, fluconazole, verapamil etc.) is added to the therapy, the Lurace dose should be reduced to half of the original dose level. Similarly, if a moderate CYP3A4 inhibitor is being prescribed and Lurace is added to the therapy, the recommended starting dose of Lurace is 20 mg per day, and the maximum recommended dose of Lurace is 80 mg per day.

Grapefruit and grapefruit juice should be avoided in patients taking Lurace, since these may inhibit CYP3A4 and alter Lurace concentrations.

Concomitant Use with CYP3A4 Inducers

Lurace should not be used concomitantly with a strong CYP3A4 inducer (e.g., rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine, etc.). If Lurace is used concomitantly with a moderate CYP3A4 inducer, it may be necessary to increase the Lurace dose after chronic treatment (7 days or more) with the CYP3A4 inducer.

Lurace interactions

See also:
What other drugs will affect Lurace?

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Potential for Other Drugs to Affect Lurace

Lurace is predominantly metabolized by CYP3A4. Lurace should not be used concomitantly with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) or strong CYP3A4 inducers (e.g., rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine, etc.). The Lurace dose should be reduced to half of the original level when used concomitantly with moderate inhibitors of CYP3A4 (e.g., diltiazem, atazanavir, erythromycin, fluconazole, verapamil, etc.). If Lurace is used concomitantly with a moderate CYP3A4 inducer, it may be necessary to increase the Lurace dose.

Lithium: It is not necessary to adjust the Lurace dose when used concomitantly with lithium (Figure 1).

Valproate: It is not necessary to adjust the Lurace dose when used concomitantly with valproate. A dedicated drug-drug interaction study has not been conducted with valproate and Lurace. Based on pharmacokinetic data from the bipolar depression studies valproate levels were not affected by Lurace, and Lurace concentrations were not affected by valproate.

Grapefruit: Grapefruit and grapefruit juice should be avoided in patients taking Lurace, since these may inhibit CYP3A4 and alter Lurace concentrations.

Figure 1: Impact of Other Drugs on Lurace Pharmacokinetics

Potential for Lurace to Affect Other Drugs

No dose adjustment is needed for lithium, substrates of P-gp, CYP3A4 (Figure 2) or valproate when coadministered with Lurace. ).

Figure 2: Impact of Lurace on Other Drugs

Drug Abuse And Dependence

Controlled Substance

Lurace is not a controlled substance.

Abuse

Lurace has not been systematically studied in humans for its potential for abuse or physical dependence or its ability to induce tolerance. While clinical studies with Lurace did not reveal any tendency for drug-seeking behavior, these observations were not systematic and it is not possible to predict the extent to which a CNS-active drug will be misused, diverted and/or abused once it is marketed. Patients should be evaluated carefully for a history of drug abuse, and such patients should be observed carefully for signs of Lurace misuse or abuse (e.g., development of tolerance, drug-seeking behavior, increases in dose).

Lurace side effects

See also:
What are the possible side effects of Lurace?

The following adverse reactions are discussed in more detail in other sections of the labeling:

  • Increased Mortality in Elderly Patients with Dementia-Related Psychosis
  • Suicidal Thoughts and Behaviors
  • Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-related Psychosis
  • Neuroleptic Malignant Syndrome
  • Tardive Dyskinesia
  • Metabolic Changes (Hyperglycemia and Diabetes Mellitus, Dyslipidemia, and Weight Gain)
  • Hyperprolactinemia
  • Leukopenia, Neutropenia, and Agranulocytosis
  • Orthostatic Hypotension and Syncope
  • Seizures
  • Potential for Cognitive and Motor Impairment
  • Body Temperature Dysregulation
  • Suicide
  • Activation of Mania/Hypomania
  • Dysphagia
  • Neurological Adverse Reactions in Patients with Parkinson's Disease or Dementia with Lewy Bodies

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The information below is derived from an integrated clinical study database for Lurace consisting of 3799 patients exposed to one or more doses of Lurace for the treatment of schizophrenia and bipolar depression in placebo-controlled studies. This experience corresponds with a total experience of 1250.9 patient-years. A total of 1106 Lurace-treated patients had at least 24 weeks and 371 Lurace-treated patients had at least 52 weeks of exposure.

Adverse events during exposure to study treatment were obtained by general inquiry and voluntarily reported adverse experiences, as well as results from physical examinations, vital signs, ECGs, weights and laboratory investigations. Adverse experiences were recorded by clinical investigators using their own terminology. In order to provide a meaningful estimate of the proportion of individuals experiencing adverse events, events were grouped in standardized categories using MedDRA terminology.

Schizophrenia

The following findings are based on the short-term, placebo-controlled premarketing studies for schizophrenia in which Lurace was administered at daily doses ranging from 20 to 160 mg (n=1508).

Commonly Observed Adverse Reactions

The most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo) in patients treated with Lurace were somnolence, akathisia, extrapyramidal symptoms, and nausea.

Adverse Reactions Associated with Discontinuation of Treatment

A total of 9.5% (143/1508) Lurace-treated patients and 9.3% (66/708) of placebo-treated patients discontinued due to adverse reactions. There were no adverse reactions associated with discontinuation in subjects treated with Lurace that were at least 2% and at least twice the placebo rate.

Adverse Reactions Occurring at an Incidence of 2% or More in Lurace-Treated Patients

Adverse reactions associated with the use of Lurace (incidence of 2% or greater, rounded to the nearest percent and Lurace incidence greater than placebo) that occurred during acute therapy (up to 6 weeks in patients with schizophrenia) are shown in Table 15.

Table 15: Adverse Reactions in 2% or More of Lurace-Treated Patients and That Occurred at Greater Incidence than in the Placebo-Treated Patients in Short-term Schizophrenia Studies

Body System or Organ Class Percentage of Patients Reporting Reaction
Placebo

(N=708)

(%)

Lurace
20 mg/day

(N=71)

(%)

40 mg/day

(N=487)

(%)

80 mg/day

(N=538)

(%)

120 mg/day

(N=291)

(%)

160 mg/day

(N=121)

(%)

All Lurace

(N=1508)

(%)

Gastrointestinal Disorders
Nausea 5 11 10 9 13 7 10
Vomiting 6 7 6 9 9 7 8
Dyspepsia 5 11 6 5 8 6 6
Salivary Hypersecretion < 1 1 1 2 4 2 2
Musculoskeletal and Connective Tissue Disorders
Back Pain 2 0 4 3 4 0 3
Nervous System Disorders
Somnolence* 7 15 16 15 26 8 17
Akathisia 3 6 11 12 22 7 13
Extrapyramidal Disorder** 6 6 11 12 22 13 14
Dizziness 2 6 4 4 5 6 4
Psychiatric Disorders
Insomnia 8 8 10 11 9 7 10
Agitation 4 10 7 3 6 5 5
Anxiety 4 3 6 4 7 3 5
Restlessness 1 1 3 1 3 2 2
Note: Figures rounded to the nearest integer

* Somnolence includes adverse event terms: hypersomnia, hypersomnolence, sedation, and somnolence

** Extrapyramidal symptoms includes adverse event terms: bradykinesia, cogwheel rigidity, drooling, dystonia, extrapyramidal disorder, hypokinesia, muscle rigidity, oculogyric crisis, oromandibular dystonia, parkinsonism, psychomotor retardation, tongue spasm, torticollis, tremor, and trismus

Dose-Related Adverse Reactions in the Schizophrenia Studies

Akathisia and extrapyramidal symptoms were dose-related. The frequency of akathisia increased with dose up to 120 mg/day (5.6% for Lurace 20 mg, 10.7% for Lurace 40 mg, 12.3% for Lurace 80 mg, and 22.0% for Lurace 120 mg). Akathisia was reported by 7.4% (9/121) of patients receiving 160 mg/day. Akathisia occurred in 3.0% of subjects receiving placebo. The frequency of extrapyramidal symptoms increased with dose up to 120 mg/day (5.6% for Lurace 20 mg, 11.5% for Lurace 40 mg, 11.9% for Lurace 80 mg, and 22.0% for Lurace 120 mg).

Bipolar Depression (Monotherapy)

The following findings are based on the short-term, placebo-controlled premarketing study for bipolar depression in which Lurace was administered at daily doses ranging from 20 to 120 mg (n=331).

Commonly Observed Adverse Reactions

The most common adverse reactions (incidence ≥ 5%, in either dose group, and at least twice the rate of placebo) in patients treated with Lurace were akathisia, extrapyramidal symptoms, somnolence, nausea, vomiting, diarrhea, and anxiety.

Adverse Reactions Associated with Discontinuation of Treatment

A total of 6.0% (20/331) Lurace-treated patients and 5.4% (9/168) of placebo-treated patients discontinued due to adverse reactions. There were no adverse reactions associated with discontinuation in subjects treated with Lurace that were at least 2% and at least twice the placebo rate.

Adverse Reactions Occurring at an Incidence of 2% or More in Lurace-Treated Patients

Adverse reactions associated with the use of Lurace (incidence of 2% or greater, rounded to the nearest percent and Lurace incidence greater than placebo) that occurred during acute therapy (up to 6 weeks in patients with bipolar depression) are shown in Table 16.

Table 16: Adverse Reactions in 2% or More of Lurace-Treated Patients and That Occurred at Greater Incidence than in the Placebo-Treated Patients in a Short-term Monotherapy Bipolar Depression Study

Body System or Organ Class Dictionary-derived Term Percentage of Patients Reporting Reaction
Placebo (N=168) (%) Lurace 20-60 mg/day (N=164) (%) Lurace 80-120 mg/day (N=167) (%) All Lurace (N=331) (%)
Gastrointestinal Disorders
Nausea 8 10 17 14
Dry Mouth 4 6 4 5
Vomiting 2 2 6 4
Diarrhea 2 5 3 4
Infections and Infestations
Nasopharyngitis 1 4 4 4
Influenza 1 < 1 2 2
Urinary Tract Infection < 1 2 1 2
Musculoskeletal and Connective TissueDisorders
Back Pain < 1 3 < 1 2
Nervous System Disorders
Extrapyramidal Symptoms* 2 5 9 7
Akathisia 2 8 11 9
Somnolence** 7 7 14 11
Psychiatric Disorders
Anxiety 1 4 5 4
Note: Figures rounded to the nearest integer

*Extrapyramidal symptoms includes adverse event terms: bradykinesia, cogwheel rigidity, drooling, dystonia, extrapyramidal disorder, glabellar reflex abnormal, hypokinesia, muscle rigidity, oculogyric crisis, oromandibular dystonia, parkinsonism, psychomotor retardation, tongue spasm, torticollis, tremor, and trismus

** Somnolence includes adverse event terms: hypersomnia, hypersomnolence, sedation, and somnolence

Dose-Related Adverse Reactions in the Monotherapy Study

In the short-term, placebo-controlled study (involving lower and higher Lurace dose ranges) the adverse reactions that occurred with a greater than 5% incidence in the patients treated with Lurace in any dose group and greater than placebo in both groups were nausea (10.4%, 17.4%), somnolence (7.3%, 13.8%), akathisia (7.9%, 10.8%), and extrapyramidal symptoms (4.9%, 9.0%) for Lurace 20 to 60 mg/day and Lurace 80 to 120 mg/day, respectively.

Bipolar Depression

Adjunctive Therapy with Lithium or Valproate

The following findings are based on two short-term, placebo-controlled premarketing studies for bipolar depression in which Lurace was administered at daily doses ranging from 20 to 120 mg as adjunctive therapy with lithium or valproate (n=360).

Commonly Observed Adverse Reactions

The most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo) in subjects treated with Lurace were akathisia and somnolence.

Adverse Reactions Associated with Discontinuation of Treatment

A total of 5.8% (21/360) Lurace-treated patients and 4.8% (16/334) of placebo-treated patients discontinued due to adverse reactions. There were no adverse reactions associated with discontinuation in subjects treated with Lurace that were at least 2% and at least twice the placebo rate.

Adverse Reactions Occurring at an Incidence of 2% or More in Lurace-Treated Patients

Adverse reactions associated with the use of Lurace (incidence of 2% or greater, rounded to the nearest percent and Lurace incidence greater than placebo) that occurred during acute therapy (up to 6 weeks in patients with bipolar depression) are shown in Table 17.

Table 17: Adverse Reactions in 2% or More of Lurace-Treated Patients and That Occurred at Greater Incidence than in the Placebo-Treated Patients in the Short-term Adjunctive Therapy Bipolar Depression Studies

Body System or Organ Class Dictionary-derived Term Percentage of Patients Reporting Reaction
Placebo

(N=334)

(%)

LATUDA20 to 120 mg/day

(N=360)

(%)

Gastrointestinal Disorders
Nausea 10 14
Vomiting 1 4
General Disorders
Fatigue 1 3
Infections and Infestations
Nasopharyngitis 2 4
Investigations
Weight Increased < 1 3
Metabolism and Nutrition Disorders
Increased Appetite 1 3
Nervous System Disorders
Extrapyramidal Symptoms* 9 14
Somnolence** 5 11
Akathisia 5 11
Psychiatric Disorders
Restlessness < 1 4
Note: Figures rounded to the nearest integer

*Extrapyramidal symptoms includes adverse event terms: bradykinesia, cogwheel rigidity, drooling, dystonia, extrapyramidal disorder, glabellar reflex abnormal, hypokinesia, muscle rigidity, oculogyric crisis, oromandibular dystonia, parkinsonism, psychomotor retardation, tongue spasm, torticollis, tremor, and trismus

** Somnolence includes adverse event terms: hypersomnia, hypersomnolence, sedation, and somnolence

Extrapyramidal Symptoms

Schizophrenia

In the short-term, placebo-controlled schizophrenia studies, for Lurace-treated patients, the incidence of reported events related to extrapyramidal symptoms (EPS), excluding akathisia and restlessness, was 13.5% versus 5.8% for placebo-treated patients. The incidence of akathisia for Lurace-treated patients was 12.9% versus 3.0% for placebo-treated patients. Incidence of EPS by dose is provided in Table 18.

Table 18: Incidence of EPS Compared to Placebo in Schizophrenia Studies

Adverse Event Term Placebo

(N=708)

(%)

Lurace
20 mg/day

(N=71)

(%)

40 mg/day

(N=487)

(%)

80 mg/day

(N=538)

(%)

120 mg/day

(N=291)

(%)

160 mg/day

(N=121)

(%)

All EPS events 9 10 21 23 39 20
All EPS events, excluding Akathisia/ Restlessness 6 6 11 12 22 13
Akathisia 3 6 11 12 22 7
Dystonia* < 1 0 4 5 7 2
Parkinsonism** 5 6 9 8 17 11
Restlessness 1 1 3 1 3 2
Note: Figures rounded to the nearest integer

* Dystonia includes adverse event terms: dystonia, oculogyric crisis, oromandibular dystonia, tongue spasm, torticollis, and trismus

** Parkinsonism includes adverse event terms: bradykinesia, cogwheel rigidity, drooling, extrapyramidal disorder, hypokinesia, muscle rigidity, parkinsonism, psychomotor retardation, and tremor

Bipolar Depression

Monotherapy

In the short-term, placebo-controlled monotherapy bipolar depression study, for Lurace-treated patients, the incidence of reported events related to EPS, excluding akathisia and restlessness was 6.9% versus 2.4% for placebo-treated patients. The incidence of akathisia for Lurace-treated patients was 9.4% versus 2.4% for placebo-treated patients. Incidence of EPS by dose groups is provided in Table 19.

Table 19: Incidence of EPS Compared to Placebo in the Monotherapy Bipolar Depression Study

Adverse Event Term Placebo

(N=168)

(%)

Lurace
20 to 60 mg/day

(N=164)

(%)

80 to 120 mg/day

(N=167)

(%)

All EPS events 5 12 20
All EPS events, excluding Akathisia/Restlessness 2 5 9
Akathisia 2 8 11
Dystonia* 0 0 2
Parkinsonism** 2 5 8
Restlessness <1 0 3
Note: Figures rounded to the nearest integer

* Dystonia includes adverse event terms: dystonia, oculogyric crisis, oromandibular dystonia, tongue spasm, torticollis, and trismus

** Parkinsonism includes adverse event terms: bradykinesia, cogwheel rigidity, drooling, extrapyramidal disorder, glabellar reflex abnormal, hypokinesia, muscle rigidity, parkinsonism, psychomotor retardation, and tremor

Adjunctive Therapy with Lithium or Valproate

In the short-term, placebo-controlled adjunctive therapy bipolar depression studies, for Lurace-treated patients, the incidence of EPS, excluding akathisia and restlessness, was 13.9% versus 8.7% for placebo. The incidence of akathisia for Lurace-treated patients was 10.8% versus 4.8% for placebo-treated patients. Incidence of EPS is provided in Table 20.

Table 20: Incidence of EPS Compared to Placebo in the Adjunctive Therapy Bipolar Depression Studies

Adverse Event Term Placebo

(N=334)

(%)

Lurace 20 to 120 mg/day

(N=360)

(%)

All EPS events 13 24
All EPS events, excluding Akathisia/Restlessness 9 14
Akathisia 5 11
Dystonia* < 1 1
Parkinsonism** 8 13
Restlessness < 1 4
Note: Figures rounded to the nearest integer

* Dystonia includes adverse event terms: dystonia, oculogyric crisis, oromandibular dystonia, tongue spasm, torticollis, and trismus

** Parkinsonism includes adverse event terms: bradykinesia, cogwheel rigidity, drooling, extrapyramidal disorder, glabellar reflex abnormal, hypokinesia, muscle rigidity, parkinsonism, psychomotor retardation, and tremor

In the short-term, placebo-controlled schizophrenia and bipolar depression studies, data was objectively collected on the Simpson Angus Rating Scale (SAS) for extrapyramidal symptoms (EPS), the Barnes Akathisia Scale (BAS) for akathisia and the Abnormal Involuntary Movement Scale (AIMS) for dyskinesias.

Schizophrenia

The mean change from baseline for Lurace-treated patients for the SAS, BAS and AIMS was comparable to placebo-treated patients, with the exception of the Barnes Akathisia Scale global score (Lurace, 0.1; placebo, 0.0). The percentage of patients who shifted from normal to abnormal was greater in Lurace-treated patients versus placebo for the BAS (Lurace, 14.4%; placebo, 7.1%), the SAS (Lurace, 5.0%; placebo, 2.3%) and the AIMS (Lurace, 7.4%; placebo, 5.8%).

Bipolar Depression

Monotherapy

The mean change from baseline for Lurace-treated patients for the SAS, BAS and AIMS was comparable to placebo-treated patients. The percentage of patients who shifted from normal to abnormal was greater in Lurace-treated patients versus placebo for the BAS (Lurace, 8.4%; placebo, 5.6%), the SAS (Lurace, 3.7%; placebo, 1.9%) and the AIMS (Lurace, 3.4%; placebo, 1.2%).

Adjunctive Therapy with Lithium or Valproate

The mean change from baseline for Lurace-treated patients for the SAS, BAS and AIMS was comparable to placebo-treated patients. The percentage of patients who shifted from normal to abnormal was greater in Lurace-treated patients versus placebo for the BAS (Lurace, 8.7%; placebo, 2.1%), the SAS (Lurace, 2.8%; placebo, 2.1%) and the AIMS (Lurace, 2.8%; placebo, 0.6%).

Dystonia

Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first-generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Schizophrenia

In the short-term, placebo-controlled schizophrenia clinical studies, dystonia occurred in 4.2% of Lurace-treated subjects (0.0% Lurace 20 mg, 3.5% Lurace 40 mg, 4.5% Lurace 80 mg, 6.5% Lurace 120 mg and 2.5% Lurace 160 mg) compared to 0.8% of subjects receiving placebo. Seven subjects (0.5%, 7/1508) discontinued clinical trials due to dystonic events – four were receiving Lurace 80 mg/day and three were receiving Lurace 120 mg/day.

Bipolar Depression

Monotherapy

In the short-term, flexible-dose, placebo-controlled monotherapy bipolar depression study, dystonia occurred in 0.9% of Lurace-treated subjects (0.0% and 1.8% for Lurace 20 to 60 mg/day and Lurace 80 to 120 mg/day, respectively) compared to 0.0% of subjects receiving placebo. No subject discontinued the clinical study due to dystonic events.

Adjunctive Therapy with Lithium or Valproate

In the short-term, flexible-dose, placebo-controlled adjunctive therapy bipolar depression studies, dystonia occurred in 1.1% of Lurace-treated subjects (20 to 120 mg) compared to 0.6% of subjects receiving placebo. No subject discontinued the clinical study due to dystonic events.

Other Adverse Reactions Observed During the Premarketing Evaluation of Lurace

Following is a list of adverse reactions reported by patients treated with Lurace at multiple doses of ≥ 20 mg once daily within the premarketing database of 2905 patients with schizophrenia. The reactions listed are those that could be of clinical importance, as well as reactions that are plausibly drug-related on pharmacologic or other grounds. Reactions listed in Table 15 or those that appear elsewhere in the Lurace label are not included. Although the reactions reported occurred during treatment with Lurace, they were not necessarily caused by it.

Reactions are further categorized by organ class and listed in order of decreasing frequency according to the following definitions: those occurring in at least 1/100 patients (frequent) (only those not already listed in the tabulated results from placebo-controlled studies appear in this listing); those occurring in 1/100 to 1/1000 patients (infrequent); and those occurring in fewer than 1/1000 patients (rare).

Blood and Lymphatic System Disorders: Infrequent: anemia

Cardiac Disorders: Frequent: tachycardia; Infrequent: AV block 1st degree, angina pectoris, bradycardia

Ear and Labyrinth Disorders: Infrequent: vertigo

Eye Disorders: Frequent: blurred vision

Gastrointestinal Disorders: Frequent: abdominal pain, diarrhea; Infrequent: gastritis

General Disorders and Administrative Site Conditions: Rare: sudden death

Investigations: Frequent: CPK increased

Metabolism and Nutritional System Disorders: Frequent: decreased appetite

Musculoskeletal and Connective Tissue Disorders: Rare: rhabdomyolysis

Nervous System Disorders: Infrequent: cerebrovascular accident, dysarthria

Psychiatric Disorders: Infrequent: abnormal dreams, panic attack, sleep disorder

Renal and Urinary Disorders: Infrequent: dysuria; Rare: renal failure

Reproductive System and Breast Disorders: Infrequent: amenorrhea, dysmenorrhea; Rare: breast enlargement, breast pain, galactorrhea, erectile dysfunction

Skin and Subcutaneous Tissue Disorders: Frequent: rash, pruritus; Rare: angioedema

Vascular Disorders: Frequent: hypertension

Clinical Laboratory Changes

Schizophrenia

Serum Creatinine: In short-term, placebo-controlled trials, the mean change from Baseline in serum creatinine was +0.05 mg/dL for Lurace-treated patients compared to +0.02 mg/dL for placebo-treated patients. A creatinine shift from normal to high occurred in 3.0% (43/1453) of Lurace-treated patients and 1.6% (11/681) on placebo. The threshold for high creatinine value varied from > 0.79 to > 1.3 mg/dL based on the centralized laboratory definition for each study (Table 21).

Table 21: Serum Creatinine Shifts from Normal at Baseline to High at Study End-Point in Schizophrenia Studies

Laboratory Parameter Placebo

(N=708)

Lurace 20 mg/day

(N=71)

Lurace 40 mg/day

(N=487)

Lurace 80 mg/day

(N=538)

Lurace 120 mg/day

(N=291)

Lurace 160 mg/day

(N=121)

Serum Creatinine Elevated 2% 1% 2% 2% 5% 7%

Bipolar Depression

Monotherapy

Serum Creatinine: In the short-term, flexible-dose, placebo-controlled monotherapy bipolar depression study, the mean change from Baseline in serum creatinine was +0.01 mg/dL for Lurace-treated patients compared to -0.02 mg/dL for placebo-treated patients. A creatinine shift from normal to high occurred in 2.8% (9/322) of Lurace-treated patients and 0.6% (1/162) on placebo (Table 22).

Table 22: Serum Creatinine Shifts from Normal at Baseline to High at Study End-Point in a Monotherapy Bipolar Depression Study

Laboratory Parameter Placebo

(N=168)

Lurace 20 to 60 mg/day

(N=164)

Lurace 80 to 120 mg/day

(N=167)

Serum Creatinine Elevated < 1% 2% 4%

Adjunctive Therapy with Lithium or Valproate

Serum Creatinine: In short-term, placebo-controlled premarketing adjunctive studies for bipolar depression, the mean change from Baseline in serum creatinine was +0.04 mg/dL for Lurace-treated patients compared to -0.01 mg/dL for placebo-treated patients. A creatinine shift from normal to high occurred in 4.3% (15/360) of Lurace-treated patients and 1.6% (5/334) on placebo (Table 23).

Table 23: Serum Creatinine Shifts from Normal at Baseline to High at Study End-Point in the Adjunctive Therapy Bipolar Depression Studies

Laboratory Parameter Placebo

(N=334)

Lurace 20 to 120 mg/day

(N=360)

Serum Creatinine Elevated 2% 4%

Lurace contraindications

See also:
What is the most important information I should know about Lurace?

Lurace is not for use in psychotic conditions related to dementia. Lurace may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

You should not use this medication if you are allergic to Lurace, or if you are also using ketoconazole (Extina, Ketozole, Nizoral, Xolegal) or rifampin (Rifater, Rifadin, Rifamate).

Before you take Lurace, tell your doctor if you have liver disease, kidney disease, heart disease, high blood pressure, heart rhythm problems, a history of heart attack or stroke, high cholesterol or triglycerides, low white blood cell (WBC) counts, seizures, diabetes, Parkinson's disease, trouble swallowing, or a history of breast cancer or suicidal thoughts.

While you are taking Lurace, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking Lurace.

Lurace may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase certain side effects of Lurace.

Stop using Lurace and call your doctor at once if you have very stiff (rigid) muscles, high fever, sweating, confusion, fast or pounding heartbeats, feeling like you might pass out, tremors, or twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs.

There are many other drugs that can interact with Lurace. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.



Active ingredient matches for Lurace:

Lurasidone


Unit description / dosage (Manufacturer)Price, USD
Lurace 40mg Tablet (Icon Life Sciences)$ 0.25

List of Lurace substitutes (brand and generic names):

ALSIVA 40MG TABLET 1 strip / 10 tablets each (Alembic Pharmaceuticals Ltd)$ 2.54
ALSIVA 80MG TABLET 1 strip / 10 tablets each (Alembic Pharmaceuticals Ltd)$ 4.73
Alsiva 80mg Tablet (Alembic Pharmaceuticals Ltd)$ 0.47
ATLURA 40MG TABLET 1 strip / 10 tablets each (Torrent Pharmaceuticals Ltd)$ 2.59
ATLURA 80MG TABLET 1 strip / 10 tablets each (Torrent Pharmaceuticals Ltd)$ 4.84
Atlura 80mg Tablet (Torrent Pharmaceuticals Ltd)$ 0.48
Emsidon 40mg Tablet (Emcure Pharmaceuticals Ltd)$ 0.29
Latuda tablet 80 mg (Sunovion Pharmaceuticals Canada Inc (Canada))
Latuda tablet, film coated 20 mg/1 (Sunovion Pharmaceuticals Inc. (US))
Latuda tablet, film coated 120 mg/1 (Sunovion Pharmaceuticals Inc. (US))
Latuda tablet 120 mg (Sunovion Pharmaceuticals Canada Inc (Canada))
Latuda tablet, film coated 40 mg/1 (Sunovion Pharmaceuticals Inc. (US))
Latuda tablet 60 mg (Sunovion Pharmaceuticals Canada Inc (Canada))
Latuda tablet, film coated 60 mg/1 (Sunovion Pharmaceuticals Inc. (US))
Latuda tablet 40 mg (Sunovion Pharmaceuticals Canada Inc (Canada))
Latuda tablet 20 mg (Sunovion Pharmaceuticals Canada Inc (Canada))
Latuda tablet, film coated 80 mg/1 (Sunovion Pharmaceuticals Inc. (US))
Lurafic 40mg Tablet (Lupin Ltd)$ 0.28
Lurafore 40mg Tablet (Zydus Cadila)$ 0.25
Lurakem 40mg Tablet (Alkem Laboratories Ltd)$ 0.28
Luramax 40mg Tablet (Sun Pharma Laboratories Ltd)$ 0.28
Lurasid 40mg Tablet (Intas Pharmaceuticals Ltd)$ 0.28
Lurastar 40mg Tablet (Linux Laboratories)$ 0.26
Lurastar 80mg Tablet (Linux Laboratories)$ 0.48
Lurata 40mg Tablet (MSN Laboratories)$ 0.25
Luratrend 40mg Tablet (Abbott India Ltd)$ 0.25
Tablura 40mg Tablet (Cipla Ltd)$ 0.25
Unisidon 40mg Tablet (Unichem Laboratories Ltd)$ 0.25

References

  1. DailyMed. "LURASIDONE HYDROCHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "Lurasidone". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "Lurasidone". http://www.drugbank.ca/drugs/DB08815 (accessed September 17, 2018).

Reviews

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