baloxavir marboxil
Fuentes regulatorias consultadas
Indicaciones aprobadas
- Tratamiento de la gripe no complicada dentro de las 48 horas del inicio y profilaxis posexposición en personas de al menos 20 kg que puedan recibir el comprimido de 40 mg. Para pesos inferiores se requiere otra formulación.
Contraindicaciones
Absolutas
- Hipersensibilidad a baloxavir marboxilo.
Interacciones medicamentosas
- SeveraProductos con calcio, hierro, magnesio, selenio o zinc
Mecanismo: Los cationes polivalentes reducen la absorción.
Recomendación: No administres simultáneamente.
CIMA/AEMPS, ficha técnica 1201500004
Eventos adversos
Comunes (≥1%)
Diarrea y vómitos
Raros pero graves
Anafilaxia o reacción anafiláctica, urticaria, angioedema y colitis isquémica
Embarazo y lactancia
Es preferible evitar durante el embarazo. Decide sobre la lactancia tras valorar el beneficio para la madre y el riesgo para el lactante.
Bibliografía reciente (PubMed)
Baloxavir marboxil (baloxavir) rapidly reduces influenza virus shedding, which suggests that it may reduce transmission. Studies of treatment with neuraminidase inhibitors have not shown sufficient evidence that they prevent transmission to contacts. We conducted a multicountry, phase 3b trial to assess the efficacy of single-dose baloxavir treatment to reduce influenza transmission from index patients to household contacts. Influenza-positive index patients 5 to 64 years of age were randomly assigned in a 1:1 ratio to receive baloxavir or placebo within 48 hours after symptom onset. The primary end point was transmission of influenza virus from an index patient to a household contact by day 5. The first secondary end point was transmission of influenza virus by day 5 that resulted in symptoms. Overall, 1457 index patients and 2681 household contacts were enrolled across the 2019-2024 influenza seasons; 726 index patients were assigned to the baloxavir group, and 731 to the placebo group. By day 5, transmission of laboratory-confirmed influenza was significantly lower with baloxavir than with placebo (adjusted incidence, 9.5% vs. 13.4%; adjusted odds ratio, 0.68; 95.38% confidence interval [CI], 0.50 to 0.93; P = 0.01), with an adjusted relative risk reduction of 29% (95.38% CI, 12 to 45). The adjusted incidence of transmission of influenza virus by day 5 that resulted in symptoms was 5.8% with baloxavir and 7.6% with placebo; however, the difference was not significant (adjusted odds ratio, 0.75; 95.38% CI, 0.50 to 1.12; P = 0.16). Emergence of drug-resistant viruses during the follow-up period occurred in 7.2% (95% CI, 4.1 to 11.6) of the index patients in the baloxavir group; no resistant viruses were detected in household contacts. No new safety signals were identified. Treatment with a single oral dose of baloxavir led to a lower incidence of transmission of influenza virus to close contacts than placebo. (Funded by F. Hoffmann-La Roche and others; CENTERSTONE
Flu is a serious health, medical, and economic problem, but no therapy is yet available that has satisfactory results and reduces the occurrence of these problems. Nearly 20 years after the registration of the previous therapy, baloxavir marboxil, a drug with a new mechanism of action, recently appeared on the market. This is a promising step in the fight against the influenza virus. This article presents the possibilities of using all available antiviral drugs specific for influenza A and B. We compare all currently recommended anti-influenza medications, considering their mechanisms of action, administration, indications, target groups, effectiveness, and safety profiles. We demonstrate that baloxavir marboxil presents a similar safety and efficacy profile to those of drugs already used in the treatment of influenza. Further research on combination therapy is highly recommended and may have promising results.
Influenza remains a significant public health concern, particularly among children. This comprehensive review focuses on pathophysiology, epidemiology, clinical presentation, treatment, and vaccines for pediatric influenza. Key genetic and immune-related factors, as well as excessive neutrophil activation, contribute to severe disease and outcomes. Epidemiologically, influenza affects 8% to 10% of children in the United States annually, with higher hospitalization rates among children who are Black, Hispanic, Native American and Alaska Native, and Asian and Pacific Islander. Clinically, children exhibit more severe symptoms and higher rates of gastrointestinal manifestations compared with adults. Treatment primarily involves neuraminidase inhibitors, like oseltamivir; although, therapies, such as baloxavir marboxil, are also effective. Vaccination remains the cornerstone of prevention, yet declining rates of uptake and increasing vaccine hesitancy pose challenges for population immunity. Universal influenza vaccine research offers hope for broader protection. This review aims to inform evidence-based practices in managing pediatric influenza and highlights areas for future research. [Pediatr Ann. 2025;54(5):e174-e178.].
Baloxavir marboxil (BXM), a newly developed cap-dependent endonuclease inhibitor, is widely used to treat influenza virus infections in inpatients and outpatients. A previous meta-analysis included only outpatients and patients suspected of having an influenza virus infection based on clinical symptoms. However, whether BXM or oseltamivir is safer and more effective for inpatients remains controversial. Therefore, we conducted a systematic review and meta-analysis validating the effectiveness and safety of BXM versus oseltamivir in inpatients with influenza virus. The Scopus, EMBASE, PubMed, Ichushi, and CINAHL databases were systematically searched for articles published until January 2023. The outcomes were mortality, hospitalization period, incidence of BXM- or oseltamivir-related adverse events, illness duration, and changes of virus titers and viral RNA load in patients with influenza virus infections. Two randomized controlled trials with 1624 outpatients and two retrospective studies with 874 inpatients were enrolled. No deaths occurred in outpatients treated with BXM or oseltamivir. Among inpatients, BXM reduced mortality (p = 0.06) and significantly shortened hospitalization period (p = 0.01) compared to oseltamivir. In outpatients, BXM had a significantly lower incidence of adverse events (p = 0.03), reductions in influenza virus titers (p < 0.001) and viral RNA loads (p < 0.001), and a tendency to be a shorter illness duration compared with that of oseltamivir (p = 0.27). Our meta-analysis showed that BXM was safer and more effective in patients than oseltamivir; thus, supporting the use of BXM for the initial treatment of patients with proven influenza virus infection.
Comparing the clinical efficacy and safety of baloxavir marboxil and oseltamivir against influenza viruses in children, to provide theoretical references for clinical practice. A systematic search of PubMed, Embase, Web of Science, Cochrane Library, Epistemonikos, CNKI, Wipu.com, Wan Fang Database, and China Biomedical Literature Database for articles published up to December 25th, 2024, was conducted. After literature screening, data extraction, and quality evaluation, descriptive analysis was performed. Eight papers were included, comprising three randomized controlled studies and Five cohort studies, involving 3141 patients (1745 in the baloxavir marboxil group and 1396 in the oseltamivir group). Meta-analysis revealed no significant differences in time to remission of influenza symptoms and duration of fever between the two groups. However, baloxavir marboxil demonstrated a significantly greater reduction in influenza virus titer and RNA load. Additionally, the incidence of adverse events was significantly lower with baloxavir marboxil (p = 0.03). Baloxavir marboxil appears more effective than oseltamivir in reducing viral load and is associated with fewer adverse events in children with influenza, while both drugs yield comparable effects in relieving symptoms. Given the limited number of included studies and absence of subgroup analyses, further well-designed trials are needed to corroborate these findings. PROSPERO Registration Number: CRD42024565338.