bremelanotide
Fuentes regulatorias consultadas
Indicaciones aprobadas
- Trastorno del deseo sexual hipoactivo adquirido y generalizado en mujeres premenopáusicas, no explicado por otra afección, la relación ni un medicamento.
Contraindicaciones
Absolutas
- Hipertensión no controlada o enfermedad cardiovascular conocida.
Advertencias clínicas
- Advertencia mayor · Aumenta transitoriamente la presión arterial y reduce la frecuencia cardiaca tras cada dosis; valorar el riesgo cardiovascular y comprobar que la presión esté controlada. — DailyMed, VYLEESI, set ID f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf
- Advertencia mayor · Puede causar hiperpigmentación focal, incluida cara, encías y mamas, que puede ser permanente; el riesgo aumenta con dosis mensuales frecuentes. — DailyMed, VYLEESI, set ID f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf
- Advertencia mayor · Se notificaron náuseas en el 40 % de las pacientes que recibieron hasta 8 dosis mensuales; el 13 % necesitó tratamiento antiemético y el 8 % suspendió prematuramente. Considerar suspender bremelanotida o iniciar un antiemético si las náuseas son persistentes o graves. — DailyMed, VYLEESI, set ID f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf
Interacciones medicamentosas
- ModeradaMedicamentos orales, especialmente naltrexona oral
Mecanismo: Retrasa el vaciamiento gástrico y puede reducir la absorción de medicamentos orales; puede reducir de forma importante la exposición a naltrexona.
Recomendación: Evitar naltrexona oral para dependencia y revisar medicamentos orales críticos.
DailyMed, VYLEESI, set ID f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcfhttps://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf
Eventos adversos
Comunes (≥1%)
Náuseas · Rubor · Reacciones en el lugar de inyección · Cefalea · Vómitos
Raros pero graves
Hipertensión marcada o reacción cardiovascular · Hiperpigmentación persistente
Embarazo y lactancia
Puede causar daño fetal; suspender si se sospecha embarazo y usar anticoncepción eficaz durante el tratamiento. No hay datos sobre leche humana ni efectos en el lactante.
Bibliografía reciente (PubMed)
Nearly half of women in the United States report problems with sexual function. Many health care providers do not ask about sexual concerns during routine clinical encounters because of personal discomfort, lack of familiarity with treatment, or the belief that they lack adequate time to address this complex issue. This may be especially true for hypoactive sexual desire disorder (HSDD), the most commonly identified sexual problem among women. HSDD is characterized by a deficiency of sexual thoughts, feelings, or receptiveness to sexual stimulation that has been present for at least 6 months, causes personal distress, and is not due to another medical condition. This is an up-to-date overview of HSDD for clinicians, discussing its physiology, assessment, diagnosis, and treatment strategies. Although a definitive physiology of HSDD is still unknown, multiple hormones and neurotransmitters likely participate in a dual-control model to balance excitation and inhibition of sexual desire. For assessment and diagnosis, validated screening tools are discussed, and the importance of a biopsychosocial assessment is emphasized, with guidance on how this can be implemented in clinical encounters. The 2 recently approved medications for HSDD, flibanserin and bremelanotide, are reviewed as well as off-label treatments. Overall, HSDD represents a common yet likely underrecognized disorder that midwives and other health care providers who care for women across the life span are in a unique position to address.
To conduct a systematic review and meta-analysis of treatments for female sexual desire, arousal, and orgasmic dysfunction in patients without sexual pain conditions. MEDLINE, Embase, Web of Science, Cochrane Library, PsycINFO, and ClinicalTrials.gov. Following the initial search in December 2024, a total of 8994 abstracts were screened, 278 full-text articles were reviewed, and 36 studies met criteria for data abstraction including a patient population with female sexual dysfunction (FSD) of desire, arousal, and/or orgasm (DAO) and outcome measures including the Female Sexual Function Index (FSFI), its DAO subscales, and the Female Sexual Distress Scale (FSDS). Studies including patients with sexual pain conditions were excluded. Two reviewers independently conducted each phase. Of the 36 studies, 26 were RCTs and 10 were single-arm trials. Ten studies evaluated cognitive behavioral therapy (CBT), 24 investigated medication therapy, and 2 investigated devices. Meta-analyses were conducted for mindfulness-based CBT, flibanserin, and bremelanotide. Mindfulness-based CBT significantly improved total FSFI and subscales of desire, arousal, and orgasm. Conversely, flibanserin improved total FSFI and desire while bremelanotide improved total FSFI and its desire and arousal subscales. No studies directly compared CBT to pharmacotherapy. In this systematic review of treatments of females with sexual DAO dysfunctions without pain, we found that CBT improves DAO; flibanserin improves desire; and bremelanotide improves both desire and arousal; and all 3 treatments reduce distress. Our findings align with previous literature and expand upon it to include multiple treatment modalities. This broader perspective offers a starting point for clinicians, including gynecologists, who frequently serve as the first point of care for FSD. Conclusions regarding most other treatments could not be drawn due to limited numbers of studies of FSD excluding pain, heterogeneous terminology for D
Female sexual dysfunction (FSD) comprises multiple overlapping sexual disorders with a multifaceted cause within the frame of the biopsychosocial model. Health care providers can screen for FSD according to their level of expertise and deliver at least basic counseling before eventually referring to sexual medicine specialists for specific care. The therapeutic algorithm comprises a multidisciplinary approach, including pharmacologic and nonpharmacologic management. Flibanserin and bremelanotide are psychoactive agents indicated for the treatment of generalized acquired hypoactive sexual desire disorder (HSDD) in premenopausal women, whereas transdermal testosterone is effective on HSDD in postmenopausal women. Menopause hormone therapy (systemic and local) is the mainstay for individualized management of women at midlife.