latuda presentation
DESCRIPTION
Case study on Latuda for Graduate Psychology ProgramTRANSCRIPT
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LATUDA (lurasidone)Melissa Atkinson, Monica Castro, Claudia Chandler,
Brocha Choen, Justin Do, Erika Ober
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DRUG HISTORYMelissa Atkinson
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FDA APPROVAL HISTORY Jul 1, 2013: Sunovion Pharmaceuticals Inc. Announces
FDA Approval of Latuda (lurasidone HCl) as Monotherapy and Adjunctive Therapy in Adult Patients with Bipolar Depression
Oct 28, 2010: FDA approves Latuda to treat schizophrenia in adults
Mar 10, 2010: Dainippon Sumitomo Pharma America Announces FDA Acceptance of Lurasidone New Drug Application for Treatment of Schizophrenia
Jan 6, 2010: Dainippon Sumitomo Pharma America Announces the NDA Submission of Lurasidone to the FDA for the Treatment of Schizophrenia
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APPROVAL HISTORYFDA approved: Yes (First approved October 28th,
2010)Brand name: LatudaGeneric name: lurasidoneCompany: Dainippon Sumitomo Pharma
America, Inc.Treatment for: Schizophrenia, Bipolar Disorder
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BACKGROUND HISTORY Approved for the treatment of schizophrenia and Depressive
episodes in Bipolar 1 Disorder. → Not yet received regulatory approval in the UK.
It was launched in Canada for the treatment of schizophrenia in September 2012.
Switzerland is the first and only European country so far where lurasidone is approved for schizophrenia
It acts as a stronger block on the 5HT7 receptor, which may give it more of an advantage in treating the negative symptoms, as well as improve cognitive and depressive symptoms associated with schizophrenia.
The average price for a 30-day supply of lurasidone is $ 475.98
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RESEARCHJustin Do
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RESEARCH EXPERIMENT4 6-week controlled studies on adult patients
with schizophrenia Recommended starting dose is 40mg/day; -
(without titration)Maximum recommended does 80mg Brief Psychiatric Rating Scale Derived (BPRSD)Positive And Negative Symptom Scale (PANSS)
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RESULTSStudy 1: placebo controlled study (N=145)Fixed dose of 40mg or 120mgBoth doses were significant superior to the
placebo (40mg -9.4 vs -3.8, p=0.018)Study 2: placebo controlled study (N=180)(-8.9 vs -4.2, respectively; P=0.0118).
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RESULTS IIStudy 3: placebo controlled study in conjunction
to Olanzapine (Zyprexa) (N=473)96.6 for LATUDA, 40 mg/day, 97.9 for LATUDA,
120 mg/day, 96.3 for olanzapine, 15 mg/day, and 95.8 for placebo
40mg (-25.7 vs -16.0,respectively; adjusted P=0.002)
20mg (-23.6 vs -16.0, respectively; adjusted P=0.022)
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RESULTS IIIStudy 4: placebo controlled
study (N=489)Only 80mg was significant ( -23.4 vs -17.0, respectively;
adjusted P=0.034)
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AVERSIVE REACTIONSWeight gain Recommend monitoring for symptoms of
hyperglycemia, polydipsia, polyuria, polyphagia, and weakness
EPS 14.7% compared to control 5.1%
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DRUG USESErika Ober
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WHAT IS LATUDA?Latuda is an atypical antipsychotic.
Similar to other aytpical antipsychotics, Latuda is an antagonist for the dopamine D2 and serotonin 5-HT2A receptors.
Latuda is also an antagonist for the Serotonin 5-HT7 receptor which can have an impact on depression and cognition.
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FDA APPROVED USESSchizophrenia (2010)The efficacy of Latuda in schizophrenia was
established in five 6-week controlled studies of
adult patients with schizophrenia The effectiveness of Latuda for longer-term
use, has not been established in controlled studies.
Major Depressive episodes associated with Bipolar I Disorder Latuda has been approved for both
monotherapy and adjunctive therapy with either lithium or valproate
The efficacy of Latuda in the treatment of mania associated with bipolar disorder has not been established.
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DOSAGE AND ADMINISTRATION
Schizophrenia
The recommended starting dose of Latuda is 40 mg once daily. The maximum recommended dose is 160 mg per day.
Depressive Episodes Associated with Bipolar I Disorder
The recommended dose of Latuda ranges from 20 mg to 120mg given once daily as monotherapy or as adjunctive therapy with lithium or valproate.
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COMMON SIDE EFFECTSClaudia Chandler
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COMMON SIDE EFFECTS
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COMPARIATIVE SIDE EFFECTS
At higher than the recommended dose (120 mg to 160 mg), anxiety, insomnia, agitation, and fatigue predominate.
Dystonia and extrapyramidal side effects are dose-dependent, and are comparable to risperidone, olanzapine, and ziprasidone. There are no significant increases vs placebo in triglycerides, cholesterol, or fasting glucose
(Newcomer J et al, poster presentation at: International Congress on Schizophrenia Research, 2011, Colorado Spring, CO
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COMPARISONS WITH OTHER ANTIPSYCHOTICS
Lurasidone advantages:
Once-daily dosing Initial dose is therapeutic Minimal weight gain Minimal increase in lipids,
cholesterol, and fasting glucose
Minimal QTc prolongation
Lurasidone disadvantages:
Sedation Akathisia and other EPS No track record of safe use,
therefore possibility of rare post-marketing side effects
No IM or sublingual formulation Expensive Must be taken with food Potential for 3A4 drug
interactions
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SERIOUS SIDE EFFECTSIncreased risk of death in elderly people who are
confused, have memory loss and have lost touch with reality (dementia-related psychosis)
Increased risk of suicidal thoughts or actions (antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions)
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CALL YOUR DOCTOR IF…Thoughts of
SuicideDepressionAnxietyAgitatedInsomnia
Irritability/Aggression
ImpulsivityMania/Mood
Changes
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CONTRAINDICATIONSMonica Castro
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CONTRAINDICATIONS• Latuda should not be taken along with a strong
CYP3A4 inhibitor or inducer• If Latuda is being taken with a moderate CYP3A4
inhibitor the dosage should be half the amount
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CONTRAINDICATIONS
• If Latuda is being used with a moderate CYP3A4 inducer.
• The dosage may need to be increased after chronic treatment (7days).
• Grapefruit and grapefruit juice should also be avoided
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CASE EXAMPLEBrocha Cohen
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CASE STUDYBipolar II Disorder
“After about two weeks of taking Latuda it began
to help my depression.”
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REFERENCES Lurasidone. (n.d.). In Wikipedia. Retrieved July 22,
2014, from http://en.wikipedia.org/wiki/LurasidoneNolan, F. S., & Roman, M. W. (2012). Lurasidone
(Latuda): An Atypical Antipsychotic. Issues in Mental Health Nursing, 33, 342-343.
N.A (2014). Latuda Approval History, retrieved from http://www.drugs.com/history/latuda.html
Risbood, V., Lee, J.R., Roche-Desllets, J., & Fuller, M.A. (2012). Lurasidone: an atypical antipsychotic. The Annals of Pharmacotherapy, 46, 1033-46. doi: 10.1345/aph.1M721.)