Adasuve
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    Adasuve

    Loxapina

    Adasuve es un antipsicótico indicado para el control rápido de la agitación de leve a moderada en pacientes adultos con esquizofrenia o trastorno bipolar.1 Su novedosa forma de administración, la inhalación con el dispositivo Staccato®, convierte a Adasuve en una alternativa rápida, no invasiva y no coercitiva. Adasuve está aprobado por la FDA y por la EMA y está actualmente presente en algunos países de UE y América.

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    Indicaciones

    Adasuve es el antipsicótico inhalado indicado para un control rápido de la agitación de leve a moderada en pacientes adultos con esquizofrenia o trastorno bipolar. Inmediatamente después de controlar los síntomas agudos los pacientes deben recibir tratamiento regular.1

    Posología

    La dosis inicial de Adasuve es de 9,1 mg (equivalente al contenido de un dispositivo Adasuve). Se puede administrar una segunda dosis 2 horas después de la primera en caso necesario, pero no se deben administrar más de dos dosis.1

    Forma de administración

    Se extrae el producto de la bolsa (no se sacará hasta que no se vaya a utilizar el producto). Una vez retirada la pestaña aparecerá una luz verde que indica que el producto está listo para ser usado. Una vez retirada la pestaña el producto debe usarse en un plazo de 15 min. El paciente debe inhalar a través de la boquilla con una inspiración profunda y continuada. Una vez inhalado se retirará la boquilla de la boca y aguantará la respiración unos segundos. El medicamento se habrá administrado cuando la luz verde se apague.1

    INSTRUCCIONES PARA UTILIZAR ADASUVE1

    Adasuve está envasado en una bolsa sellada.

    Cuando Adasuve se extrae de la bolsa, la luz indicadora está apagada. La luz indicadora se enciende (verde) cuando se retira la pestaña. El inhalador está listo para usar. La luz indicadora se apaga automáticamente de nuevo cuando se ha inhalado el medicamento. Lea los 5 pasos siguientes antes de administrar Adasuve a un paciente.

    1. Abrir la bolsa.

    No abrir la bolsa hasta que se vaya a usar. Rasgar la bolsa de aluminio y extraer el inhalador de su embalaje.
     

    2. Tirar de  la pestaña. 

    Tirar fuerte de la pestaña de plástico desde la parte posterior del inhalador. Se encenderá la luz verde, que indica que el inhalador está listo para usar. Úselo dentro de los 15 minutos después de retirar la pestaña (o hasta que la luz verde se apague) para evitar la desactivación automática del inhalador.

    Dé instrucciones al paciente para que: 

    3. Exhale.

    Mantenga el inhalador lejos de la boca y exhale completamente para vaciar los pulmones.
     

    4. Inhale.
    Inhale a través de la boquilla con una inspiración profunda y continua.
    IMPORTANTE: compruebe que la luz verde se apaga después de la inhalación.

    5. Contenga la respiración.
    Retire la boquilla de la boca y contenga la respiración unos segundos.

     

    NOTA: Si la luz verde sigue encendida después de que el paciente haya inhalado, indique al paciente que repita los pasos de 3 a 5.

    Seguridad

    En pacientes con signos respiratorios agudos o enfermedades respiratorias activas, Adasuve puede producir broncoespasmo, por lo que se debe tener disponibilidad de un tratamiento broncodilatador con beta-agonistas de acción rápida para evitar posibles efectos adversos respiratorios. Además se debe tener precaución al asociar a benzodiacepinas, hipnosedantes u depresores respiratorios por una posible excesiva sedación. En caso de ser necesaria la medicación mencionada, se debería monitorizar al paciente1.

    Presentaciones

    Adasuve 9,1mg polvo para inhalacion (unidosis) 5 unidades (CN: 606711.6)

     

    Referencias

    1Agencia Española de Medicamentos y Productos Sanitarios. Centro de Información online de Medicamentos de la AEMPS. Ficha técnica ADASUVE® [sede web]. [Actualizado 2015; acceso noviembre 2015].

    Entrevista Dr. Javier Correas

     

    Staccato en acción

     

    Episodio agitación leve

    (Simulación con fines educativos)

     

    Episodio agitación moderado

    (Simulación con fines educativos)

     

    Episodio agitación severo

    (Simulación con fines educativos)

    El coste económico de los procedimientos de contención mecánica de origen psiquiátrico en España
    Psychomotor agitation, Costs and cost analysis, Mechanical restraint.

    La agitación de origen psiquiátrico ocurre principalmente en pacientes con trastornos psicóticos como la esquizofrenia, el trastorno esquizoafectivo y la fase maníaca del trastorno bipolar. Los métodos tradicionales para el control de los pacientes agitados incluyen la contención verbal, la contención farmacológica y la contención mecánica. En este estudio se ha estimado el coste directo sanitario asociado a la aplicación de las técnicas de contención mecánica de origen psiquiátrico en Espana. La cuantificación se realizó en función del tiempo empleado por profesional o número de visitas. La valoración de los recursos se realizó a partir de costes unitarios y datos epidemiológicos publicados. La aplicación de un procedimiento de contención mecánica a un paciente psiquiátrico supone un coste total por episodio de 513-1.160 D (considerando una duración de 4 a 12 h, respectivamente). El coste total anual se ha estimado en 27 millones de euros, considerando una duración por episodio de 4 h.

    Garrido E, Lizano-Díez I, Roset PN, Villagrán JM, Mur de Viu C.
    Psiq Biol. 2015;22(1):12–16.
    01/2015
    Health service use and costs associated with aggressiveness or agitation and containment in adult psychiatric care: a systematic review of the evidence
    Aggression, Agitation, Containment, Costs, Health services research, Inpatients, Acute psychiatric wards, Review.

    Background: Agitation and containment are frequent in psychiatric care but little is known about their costs. The aim was to evaluate the use of services and costs related to agitation and containment of adult patients admitted to a psychiatric hospital or emergency service. Methods: Systematic searches of four electronic databases covering the period January 1998-January 2014 were conducted. Manual searches were also performed. Paper selection and data extraction were performed in duplicate. Cost data were converted to euros in 2014.

    Results: Ten studies met inclusion criteria and were included in the analysis (retrospective cohorts, prospective cohorts and cost-of-illness studies). Evaluated in these studies were length of stay, readmission rates and medication. Eight studies assessed the impact of agitation on the length of stay and six showed that it was associated with longer stays. Four studies examined the impact of agitation on readmission and a statistically significant increase in the probability of readmission of agitated patients was observed. Two studies evaluated medication. One study showed that the mean medication dose was higher in agitated patients and the other found higher costs of treatment compared with non-agitated patients in the unadjusted analysis. One study estimated the costs of conflict and containment incurred in acute inpatient psychiatric care in the UK. The estimation for the year 2014 of total annual cost per ward for all conflict was €182,616 and €267,069 for containment based on updated costs from 2005.

    Conclusions: Agitation has an effect on healthcare use and costs in terms of longer length of stay, more readmissions and higher drug use. Evidence is scarce and further research is needed to estimate the burden of agitation and containment from the perspective of hospitals and the healthcare system.

    Rubio-Valera M, Luciano JV, Ortiz JM, Salvador-Carulla L, Gracia A, Serrano-Blanco A.
    BMC Psychiatry. 2015;15:35.
    01/2015
    Safety and Tolerability of Inhaled Loxapine in Subjects with Asthma and Chronic Obstructive Pulmonary Disease - Two Randomized Controlled Trials
    Inhaled loxapine, Aerosol, Asthma, COPD, Agitation, Randomized, Safety, Adasuve.

    Background: Loxapine, a first-generation antipsychotic, delivered with a novel inhalation delivery device developed for the acute treatment of agitation in patients with schizophrenia or bipolar disorder was evaluated in subjects with asthma or chronic obstructive pulmonary disease (COPD).

    Methods: Separate randomized, double-blind, parallel-arm, placebo-controlled trials compared two administrations of inhaled loxapine (10 mg) 10 hr apart with placebo in 52 subjects with asthma and in 53 subjects with COPD. A thermally-generated drug aerosol of loxapine was delivered to the deep lung for rapid systemic absorption. Controller medications were continued throughout the study, but quick-relief bronchodilators were withheld from 6–8 hr before through 34 hr after dose 1, unless indicated as rescue.

    Results: All airway adverse events (AEs) were of mild or moderate severity. Symptomatic bronchospasm occurred in 53.8% of subjects with asthma after inhaled loxapine and 11.5% after placebo; and in 19.2% of COPD subjects after inhaled loxapine and 11.1% after placebo. Subjects required inhaled albuterol as follows: asthma: 53.8% after inhaled loxapine and 11.5% after placebo; and COPD: 23.1% after inhaled loxapine and 14.8% after placebo. Respiratory signs/symptoms requiring treatment responded to rescue bronchodilator [forced expiratory volume in 1 sec (FEV1) return to within 10% of baseline] within 1 hr in 11 of 15 events in asthma subjects and four of seven events in COPD subjects, the remainder by the last spirometry.

    Conclusions: In subjects with either asthma or COPD, FEV1 decline and bronchospasm can occur following inhaled loxapine, but more frequently in asthmatic subjects. Most subjects with bronchospasm responded to rescue bronchodilator within 1 hr. No treatment-related serious AE occurred. Although inhaled loxapine is contraindicated in patients with active airways disease per the current approved US labeling, these studies demonstrated that rescue bronchodilator mitigated the symptomatic bronchospasms that may occur in case of inadvertent use.

    Gross N, Greos LS, Meltzer EO, Spangenthal S, Fishman RS, Spyker DA, Cassella JV.
    Journal of Aerosol Medicine and Pulmonary Drug Delivery. Volume 27, Number 6, 2014.
    12/2014
    Effect of Smoking on the Pharmacokinetics of Inhaled Loxapine
    Inhaled loxapine, 8-OH-loxapine, Smoking, Pharmacokinetics, Cytochrome P450 1A2.

    Background: Loxapine inhalation powder delivered by a handheld device as a thermally generated aerosol (ADASUVE) was recently approved in the United States and European Union for use in the acute treatment of agitation in patients with bipolar disorder or schizophrenia. As smokers comprise a large subpopulation of these patients, and many antipsychotic drugs require dose adjustments for smokers, the objective of this study was to compare the pharmacokinetics of inhaled loxapine administered to smokers and nonsmokers.

    Methods: Pharmacokinetics and sedation pharmacodynamics using a visual analog scale were studied in 35 male and female adult subjects (18 nonsmokers and 17 smokers) following a single dose of 10 mg of inhaled loxapine. Blood samples were drawn at predose, 30 seconds, 1, 2, 3, 10, 30, and 60 minutes, and 2, 6, 12, and 24 hours after dosing. Loxapine and 8-OH-loxapine were analyzed using reverse-phase liquid chromatography coupled with a tandem mass spectrometer. Pharmacokinetic parameters assessed included Cmax, Tmax, AUCinf, and T1/2 for loxapine and 8-OHloxapine. Geometric mean ratios (GMRs) were determined for smokers to nonsmokers.

    Results: Loxapine Cmax was similar in smokers and nonsmokers with a GMR of 99.0%. The median loxapine Tmax was 1.88 and 1.01 minutes for nonsmokers and smokers, respectively. Loxapine AUCinf and AUClast values in nonsmokers were comparable with smokers (GMRs of 85.3% and 86.7%, respectively). A slight decrease in the observed mean terminal half-life values was observed for smokers (6.52 hours for smokers and 7.30 hours for nonsmokers).

    Conclusions: Sedation profiles and visual analog scale scores at each time point were similar for nonsmokers and smokers. It was concluded that inhaled loxapine does not require dosage adjustment based on smoking behavior.

    Takahashi LH, Huie K, Spyker DA, Fishman RS, Cassella JV.
    Ther Drug Monit. Volume 36, Number 5, October 2014.
    10/2014
    Sistemas alternativos de liberación de fármacos para tratar la agitación aguda: avances realizados hasta la fecha.
    Acute Agitation, Sublingual Asenapine, Buccal Midazolam, Standard Oral Tablet, Advanced Airway Management, Mental Illness.

    La agitación psicomotriz se asocia a menudo a agresividad. Es importante identificar la agitación de forma temprana y obtener resultados de manera rápida para prevenir una conducta agresiva. Las estrategias utilizadas para ello pueden incluir técnicas de desescalada verbal, reducción de la estimulación, medicamentos o una combinación de ellas. Históricamente, los tratamientos farmacológicos para la agitación se han administrado mediante formulaciones orales e intramusculares. Aunque no ha habido cambios drásticos en los tipos de medicación disponibles, recientemente se han desarrollado formulaciones diferentes que facilitan el tratamiento de este difícil trastorno.

    En este artículo describiremos algunas de las nuevas formulaciones más novedosas que se emplean para administrar medicamentos destinados al tratamiento de la agitación. Las formulaciones que se describirán son los comprimidos bucodispersables, las formulaciones bucales e intranasales, y una formulación inhalada. Cada una de ellas tiene una finalidad particular y facilitará el tratamiento de poblaciones diferentes con distintos niveles de agitación. Es de destacar que, de las formulaciones de medicación a comentar, solamente la de loxapina inhalada ha sido autorizada por la FDA para la agitación aguda en la esquizofrenia y el trastorno bipolar, y que ninguna de las medicaciones ha sido aprobada para la “agitación” fuera del contexto de una enfermedad específica. Los comprimidos bucodispersables de olanzapina, risperidona y aripiprazol se degluten y pasan a la circulación a través del sistema portal. No tienen un inicio de acción más rápido que los comprimidos orales estándares, pero son útiles en los pacientes que, de otro modo, podrían desviar la medicación. Existen formulaciones sublinguales, bucales e intranasales de asenapina y midazolam. La absorción por esta vía es más rápida y evita el metabolismo de primer paso.

    Por último, loxapina inhalada entra en los alvéolos y aparece rápidamente en la circulación arterial. Todas estas nuevas formulaciones requieren como mínimo una cierta colaboración, pero aportan la posibilidad de evitar una escalada de las manifestaciones y mejoran la experiencia de los pacientes, y debe contemplarse su uso cuando es posible la negociación.

    Nordstrom K, Allen MH.
    Drugs. 2013 Nov;73(16):1783-92.
    10/2013
    Loxapina polvo para inhalación: revisión de su utilización en el tratamiento agudo de la agitación en pacientes con trastorno bipolar o esquizofrenia
    Acute Agitation, Bipolar Disorder, 5-HT2A Receptor, Atypical Antipsychotic, Intramuscular Aripiprazole, D2 Receptor Occupancy

    Loxapina es un fármaco antipsicótico de primera generación ampliamente utilizado. Loxapina polvo para inhalación (Adasuve®) ha sido autorizado recientemente en EEUU y la UE para el tratamiento agudo de la agitación en pacientes con trastorno bipolar o esquizofrenia. Loxapina inhalada se administra con un dispositivo de mano monodosis y de un solo uso en el que se utiliza el sistema de administración de fármacos Staccato®. Con Adasuve®, las concentraciones plasmáticas máximas de loxapina se alcanzan en una mediana de 2 min. En dos ensayos multicéntricos aleatorizados, doble ciego y controlados con placebo, loxapina inhalada 5 o 10 mg redujo de forma significativa la agitación (valorada con las puntuaciones de la Escala de los Síndromes Positivo y Negativo-Componente de Excitación) en pacientes con trastorno bipolar I o esquizofrenia, y el inicio del efecto se observó a los 10 min. de la administración. Loxapina inhalada fue por lo general bien tolerada en los ensayos en fase III (de los que se excluyó a los pacientes con enfermedad pulmonar crónica o aguda clínicamente significativa), y los acontecimientos adversos más frecuentes fueron disgeusia y sedación. Loxapina inhalada está contraindicada en pacientes con enfermedad de las vías respiratorias asociada a broncoespasmo o signos o síntomas respiratorios agudos.

    En conclusión, loxapina inhalada es una opción nueva y novedosa para el tratamiento agudo de la agitación en pacientes con trastorno bipolar o esquizofrenia que aúna un rápido inicio del efecto y una vía de administración no invasiva.

    Keating GM.
    CNS Drugs. 2013 Jun;27(6):479-89.
    01/2013
    Rapid acute treatment of agitation in patients with bipolar I disorder: a multicenter, randomized, placebo-controlled clinical trial with inhaled loxapine.
    Agitation, Bipolar I disorder, Clinical trial, Inhaled loxapina, Loxapina, Placebo-controlled, Randomized, Rapid acute treatment

    Objective: The present study evaluated inhaled loxapine for the acute treatment of agitation in patients with bipolar I disorder.

    Methods: A Phase 3, randomized, double blind, placebo-controlled, parallel group inpatient study was performed at 17 psychiatric research facilities. Agitated patients (N = 314) with bipolar I disorder (manic or mixed episodes) were randomized (1:1:1) to inhaled loxapine 5 mg or 10 mg, or inhaled placebo using the Staccato" system. Following baseline assessments, patients received Dose 1 and were evaluated for 24 hours. If required, up to two additional doses of study drug and ⁄ or lorazepam rescue medication were given. The primary efficacy endpoint was change from baseline in the Positive and Negative Syndrome Scale- Excited Component (PANSS-EC) score two hours after Dose 1. The key secondary endpoint was the Clinical Global Impression-Improvement score at two hours after Dose 1. Additional endpoints included the changes from baseline in the PANSS-EC from 10 min through 24 hours after Dose 1. Safety was assessed by adverse events, vital signs, physical examinations, and laboratory tests.

    Results: For the primary and key secondary endpoints, both doses of inhaled loxapine significantly reduced agitation compared with placebo. Reduced agitation, as reflected in PANSS-EC score, was evident 10 min after Dose 1 with both doses. Inhaled loxapine was well tolerated, and the most common adverse events were known effects of loxapine or minor oral effects common with inhaled medications (dysgeusia was reported in 17% of patients receiving active drug versus 6% receiving placebo).

    Conclusions: Inhaled loxapine provided a rapid, non-injection, welltolerated acute treatment for agitation in patients with bipolar I disorder.

    Kwentus J, Riesenberg RA, Marandi M, Manning RA, Allen MH, Fishman RS, Spyker DA, Kehne JH, Cassella JV.
    Bipolar Disord. 2012 Feb;14(1):31-40.
    01/2012
    Aerosolised antipsychotic assuages agitation: inhaled loxapine for agitation associated with schizophrenia or bipolar disorder.
    Administration, Inhalation, Aerosols, Antipsychotic agents, Pharmacology, Bipolar disorder, Loxapine

    Objective: To describe the efficacy and safety of inhaled loxapine, a new formulation of an older antipsychotic being developed for the treatment of agitation associated with schizophrenia or bipolar disorder.

    Data Sources: A literature search was conducted by querying http://www.pubmed.gov, http://www.fda.gov, http:// www.accessdata.fda.gov/scripts/cder/drugsatfda and http://www.clinicaltrials.gov for the search terms ‘loxapine’ AND ‘agitation’, ‘inhaled loxapine’, ‘staccato loxapine’. The manufacturer was asked to provide copies of posters presented at national and international meetings, and to provide any copies of papers currently in press.

    Study Selection: All available reports of studies were identified.

    Data Extraction: Descriptions of the principal results and calculation of number needed to treat (NNT) and number needed to harm (NNH) for relevant dichotomous outcomes were extracted from the study reports.

    Data Synthesis: Inhaled loxapine is delivered using a handheld device that produces a thermally generated condensation aerosol free of excipients or propellants. Time to maximum plasma concentration is approximately 2 min. In two phase III studies (one in subjects with schizophrenia, the other in subjects with bipolar disorder) inhaled loxapine 5 and 10 mg were both superior to placebo as early as 10 min after administration, as measured using the Positive and Negative Syndrome Scale excited component. Pooling together data from three efficacy studies, NNT for response for inhaled loxapine 5 or 10 mg vs. placebo were 4 (95% CI 3–5) and 3 (95% CI 3–4), respectively, with response defined as achieving a Clinical Global Impressions – Improvement score of 1 or 2 at 2 h postdose. This effect size is in the range observed for intramuscular administration of other antipsychotics for agitation associated with schizophrenia or bipolar disorder. There were no clinically relevant signals for the emergence of extra-pyramidal side effects or akathisia. The most commonly encountered adverse event appears to be dysgeusia (distorted taste sense or bad taste), with a NNH vs. placebo of 10 (95% CI 7–22) or 12 (95% CI 8–26), for loxapine 10 or 5 mg, respectively.

    Conclusions: Inhaled loxapine appears efficacious and tolerable for the treatment of agitation associated with schizophrenia or bipolar disorder. Although simple to self-administer, inhaled loxapine requires a degree of cooperation from the recipient and thus will not be a substitute for an injection during psychiatric emergencies when the patient is actively refusing medication treatment. The efficacy and safety of inhaled loxapine in elderly patients and in outpatient care settings remain to be established.

    Citrome L.
    Int J Clin Pract. 2011 Mar;65(3):330-40.
    01/2011
    Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine
    Schizophrenia, Agitation, Acute, Treatment

    BACKGROUND: There is a need for a rapid-acting, non-injection, acute treatment for agitation.

    AIMS: To evaluate inhaled loxapine for acute treatment of agitation in schizophrenia.

    METHOD: This phase III, randomised, double-blind, placebo-controlled, parallel-group study (ClinicalTrials.gov numberNCT00628589) enrolled 344 individuals who received one, two or three doses of inhaled loxapine (5 or 10 mg) or a placebo. Lorazepam rescue was permitted after dose two. The primary efficacy end-point was change from baseline in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) 2 h after dose one. The key secondary end-point was Clinical Global Impression-Improvement scale (CGI-I) score 2 h after dose one.

    RESULTS: Inhaled loxapine (5 and 10 mg) significantly reduced agitation compared with placebo as assessed by primary and key secondary end-points. Reduced PANSS-EC score was evident 10 min after dose one with both 5 and 10 mg doses. Inhaled loxapine was well tolerated, and the most common adverse events were known effects of loxapine or minor oral effects common with inhaled medications.

    CONCLUSIONS: Inhaled loxapine provided a rapid, well-tolerated acute treatment for agitation in people with schizophrenia.

    Lesem MD, Tran-Johnson TK, Riesenberg RA, Feifel D, Allen MH, Fishman R, Spyker DA, Kehne JH, Cassella JV.
    Br J Psychiatry. 2011 Jan;198(1):51-8.
    01/2011

    SEP

    Sociedad Española de Psiquiatría

    SEPB

    Sociedad Española de Psiquiatría Biológica

    SEPD

    Sociedad Española de Patología Dual

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    Última modificación: 30/03/2020