Annales pharmaceutiques francaises最新文献

{"title":"Pharmacological interactions between antihypertensive regimens and drugs prescribed in the emergency department.","authors":"Lilia Edith Luque Esparza, Marco Antonio Osorio García, Delgadillo Guzmán Dealmy, Irais Castillo Maldonado, Citlalli Esmeralda Corvera Aispuro","doi":"10.1016/j.pharma.2025.05.006","DOIUrl":"https://doi.org/10.1016/j.pharma.2025.05.006","url":null,"abstract":"<p><p>The risk of drug interactions in patients with HTN is aggravated when prescribing treatments for additional acute pathologies. This can favor adverse reactions to medications or make it difficult to control blood pressure during their stay in the emergency room.</p><p><strong>Objective: </strong>Identify and classify, using CDSS, the IFFs between the antihypertensive treatment regimen and the drugs prescribed in the emergency department.</p><p><strong>Material and methods: </strong>Fifty-three patients with systemic arterial hypertension were treated in the emergency department. Clinical decision support systems are used to identify and classify potential FFs.</p><p><strong>Results: </strong>IFFs were found in 96.2% of hypertensive patients in the emergency department. Those with the highest frequency were of moderate risk. The most frequent mechanism was pharmacodynamic, mainly synergistic by ad-dition.</p><p><strong>Conclusions: </strong>The correlation index between the number of drugs prescribed in the emer-gency room and the presence of IFF shows the need to carry out a scrutiny of the joint pharmaco-logical behavior used in hypertensive patients who attend emergency medical care to rationalize the use of medications reducing the probability of presenting IFF.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144141238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[PEDIAB'AIDE: A pediatric diabetes training tool for the pharmacy team].","authors":"Elise Conand, Sabine Baron, Sonia Prot-Labarthe","doi":"10.1016/j.pharma.2025.05.008","DOIUrl":"10.1016/j.pharma.2025.05.008","url":null,"abstract":"<p><strong>Introduction: </strong>In 2023, type 1 diabetes (T1DM) affected more than 31,000 young people under the age of 20 in France, with the number of new cases rising every year. The onset of the disease is acute and abrupt in children, sometimes leading to diagnosis after ketoacidosis and a stay in a pediatric intensive care unit. Healthcare professionals must be trained to diagnose the disease as soon as the first signs appear. What's more, once the diagnosis has been made, a great deal of information needs to be assimilated by the child and his or her parents, to help them cope with the disease. As the dispensing pharmacist is at the heart of the patient's health, it is vital that his or her knowledge is regularly updated.</p><p><strong>Materials and methods: </strong>The working group consisted of a pharmacy student, a hospital pharmacist and a pediatric endocrinologist. The aim was to create an e-learning program on diabetes in children, a fun learning document aimed at health students and health professionals for their continuing education. It was to contain information and best practices in line with the most common first discharge practices for newly-diagnosed diabetic children. The tool was offered to pharmacy students in order to assess the improvement in knowledge via a questionnaire before and after using it, using a Wilcoxon statistical test. They were also asked to complete a satisfaction questionnaire.</p><p><strong>Results: </strong>The tool produced is called PEDIAB'AIDE, in the form of a pdf file with links to navigate between the various slides. The tool details two prescriptions for newly-diagnosed T1DM patients: one case with a pump, the other with pen injections. The tool comprises 40 slides, diagnostic information and advice associated with the patients' discharge prescriptions. A total of 26 DFASP1 students completed the evaluation questionnaire before and after using the tool. Students' marks improved significantly, with an initial average of 13.8/20 and a final average of 16.3/20 (P<0.001). Students found the tool simple (100%), clear (100%) and appreciated its visual appeal (92%). One hundred percent appreciated its use, and 96% thought it could help train healthcare professionals. The positive elements highlighted by the students were the intuitive nature of the tool, the real-life counter situation and the explanations. They also highlighted a few areas for improvement, notably the addition of summary sheets, and access to the tool without an Internet connection.</p><p><strong>Discussion and conclusion: </strong>Delayed diagnosis of T1DM in children can have major consequences for their subsequent care. This tool helps to improve the knowledge of pharmacy students. It remains to be tested with pharmacists and disseminated further.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144131827","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lactate is a prognostic marker of acute liver failure in early identification of patients susceptible to liver transplantation following acute acetaminophen poisoning.","authors":"Masoumeh Ebrahimi Medisah, Mahdieh Sadat Badiee, Masoud Mahdavinia, Hassan Motamed, Ali Hasan Rahmani","doi":"10.1016/j.pharma.2025.05.007","DOIUrl":"https://doi.org/10.1016/j.pharma.2025.05.007","url":null,"abstract":"<p><strong>Background: </strong>Acetaminophen (APAP) is the most commonly used analgesic and antipyretic drug, and its intentional or accidental overdose can lead to acute liver failure (ALF). Rapid prognosis and the selection of appropriate patients for transplantation in ALF are crucial. Lactate is the end product of anaerobic glycolysis and an indicator for determining the oxygen status in cells. The aim of this study was to investigate the relationship between serum lactate level and the prognosis of ALF due to acute APAP poisoning in patients referred to Razi Hospital, Ahvaz.</p><p><strong>Methods: </strong>This cross-sectional and prospective study was conducted on 34 healthy individuals (as controls) and 34 patients diagnosed with acute APAP poisoning. Serum levels of APAP, lactate, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin (T.bil), direct bilirubin (D.bil), and gamma-glutamyl transferase (GGT) were measured in healthy individuals and patients with acute APAP poisoning within 24 hours of admission. The relationship between the dose of APAP consumed, the amount of N-acetylcysteine (NAC) received, and the age and gender of the patients with lactate level was also evaluated.</p><p><strong>Results: </strong>The mean dose of APAP in the patients was 10.75 gr. A total of 85% of the patients received NAC. The mean volume of NAC injection was 4.4 mmol/L. The number of women with APAP overdose was higher than men. Lactate level increased with increasing APAP doses. The mean serum lactate level significantly reduced after 24 hours compared to the initial admission, and the levels of liver markers increased significantly after 24 hours.</p><p><strong>Conclusion: </strong>In order to accept lactate as an international criterion in early identification of liver transplant candidate patients and reduce their mortality, clinical validity studies including definition and validation of clinical conditions related to lactate level and reliability tests are necessary. Therefore, early and periodic determination of serum lactate level seems to be essential as a promising biomarker for the prognosis of ALF caused by acute APAP poisoning.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144131842","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"In pursuit of software solutions for pharmaceutical regulatory affairs: Insights and trends.","authors":"Shrushti Sharma, Dyandevi Mathure, Shreyas Dingankar, Vividha Dhapte-Pawar","doi":"10.1016/j.pharma.2025.05.005","DOIUrl":"10.1016/j.pharma.2025.05.005","url":null,"abstract":"<p><p>With rapid upsurge in technology and digital tools, the existing systems including the healthcare systems, especially the pharmaceutical sector is experiencing the revolution in the flow and management of data. Use of digital tools in pharmaceutical regulatory framework and compliance has led to development of a more harmonized system globally. This has facilitated growth in pharmaceutical sector internationally along with timely availability of healthcare facilities with assured safety and efficacy. Technological solutions have upgraded the workflow in industry with the assurance of data veracity. Clinical studies demand for a huge controlled study design and data which concerns patient safety; it includes statistical interpretations and analysis. This is mostly time dependent variable and smart use of software and tools accelerate this process. Automation of the work reduces time, efforts and also streamlines timely submissions. Advanced technologies with support of machine learning, artificial intelligence would assist industry and regulatory authorities to build transparency between the documentation and data. Many regulatory agencies have come up with regulations for validation of electronic tools and data integrity to ensure ethical use of these tools. US Federal law, 21CFR is recognized and have been widely accepted. However, most of the countries have their own regulatory agency that governs these regulations. Artificial Intelligence have come up with add-on features which would overcome the lag in the systems and simplify the operations and interpretations of various studies in pharmaceutical sector. Yet, with the advancing technologies there is need for more precise regulations to evaluate it through all parameters.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144126477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Risks associated with the implementation of a nominative unit-dose dispensing robotic system: analysis after ten years of use within a hospital pharmacy department].","authors":"Thiec Julie, Malet Delphine, Colombe Anne, Debruyne Anne-Laure, Queuille Emmanuelle","doi":"10.1016/j.pharma.2025.05.003","DOIUrl":"https://doi.org/10.1016/j.pharma.2025.05.003","url":null,"abstract":"<p><strong>Objectives: </strong>Our hospital pharmaceutical department acquired an automated drug dispensive system to secure the medication management, from the dispensation to the administration process. The aim of our study was to secure the new circuit by identifying the risks associated with the implementation of the robotic system.</p><p><strong>Methods: </strong>A working-group was set-up and the use of the Failure Modes, Effects and Criticality Analysis (FMECA) method was decided. FMECA is a proactive risk assessment tool allows the identification of all potential failures. It relies on the identification of failure modes and their severity, frequency and detectability. The product of the three ratings determines the criticality of the failure mode and allows to rank the failure modes according to the criticality: from low, to intermediate and high.</p><p><strong>Results: </strong>The process was delimited from drug analysis to medication delivery to the wards. Six steps and 33 sub-steps were identified. 75 failure modes were identified, 67% of which could lead to a medication error. The working-group identified and prioritised corrective measures to implement. It was decided to focus on the failure modes with a high and intermediate criticality index.</p><p><strong>Conclusions: </strong>This analysis allowed us to highlight weaknesses is the new process created with the implementation of the robotic system. The sub-steps the more at risk are prescription analysis and pillboxes' manually addings. FMECA is an effective tool easy to implement that allows the pooling of ideas and to be exhaustive in the identification of failure modes.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144092726","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Synergistic anticonvulsant activity of oregano, chamomile, and lavender via intranasal administration: A dose-response modeling approach.","authors":"Samin Sheikholeslami, Marziyeh Amiri-Andebili, Amir Baghaei, Mohammad Mahdi Ahmadian-Attari","doi":"10.1016/j.pharma.2025.05.004","DOIUrl":"10.1016/j.pharma.2025.05.004","url":null,"abstract":"<p><strong>Background: </strong>This short communication presents an analytical approach to evaluate the synergistic anticonvulsant effects of an herbal combination containing hydroalcoholic extracts of Origanum vulgare (oregano), Matricaria chamomilla (chamomile), and Lavandula angustifolia (lavender).</p><p><strong>Objective: </strong>The study aimed to apply linear dose-response modeling to seizure score data to predict the expected outcomes of combination therapy and quantify synergy by comparing predicted and observed effects.</p><p><strong>Methods: </strong>The herbal extracts were obtained through maceration with 70% ethanol. The animal study was performed using 2 different doses of each herb, involving 36 rats in 6 groups. Building on previous in vivo findings, the study utilized linear dose-response modeling to analyze the effects of the combination therapy on seizure scores and to determine the synergistic performance at combination doses of 17mg/kg, 34mg/kg, and 68mg/kg.</p><p><strong>Results: </strong>The results highlighted the synergistic performance of the herbal combination, particularly at the dose of 34mg/kg, demonstrating the pharmacodynamic advantages of combination therapy and confirming the enhanced antiseizure effect of the herbal combination.</p><p><strong>Conclusions: </strong>This study confirms the synergistic anticonvulsant effects of the herbal combination and demonstrates its potential as a new supplementary treatment for seizures via a non-invasive intranasal administration method.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085697","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ICH-Q3D based elemental impurities study in an oral drug product: Risk assessment according to the component approach (option 2b) confirmed by the finished product analysis (option 3).","authors":"Ayoub Hamidallah, Mohamed Yafout, Ibrahim Sbai El Otmani","doi":"10.1016/j.pharma.2025.05.002","DOIUrl":"10.1016/j.pharma.2025.05.002","url":null,"abstract":"<p><strong>Background: </strong>Elemental impurities (EIs) in pharmaceutical products pose potential health risks, requiring strict regulatory control. The ICH Q3D guideline outlines two approaches for assessing EIs: the component approach, which estimates impurity levels based on supplier data, and the finished product approach, which directly quantifies EIs in the final drug product. This study compares both methods to evaluate their reliability in ensuring compliance with safety limits.</p><p><strong>Methods: </strong>A risk assessment of EIs in an oral effervescent drug product was performed using the component approach (ICH Q3D option 2b) by compiling impurity data from raw materials and packaging components. The estimated daily exposure levels were compared to permitted daily exposure (PDE) limits. To validate these findings, ICP-MS analysis (ICH Q3D option 3) was conducted on three batches of the finished product, quantifying 24 elemental impurities following USP <233> guidelines.</p><p><strong>Results: </strong>The component approach have indicated that all estimated EI levels were well below 30% of PDE, suggesting no need for additional controls. ICP-MS analysis of the finished product confirmed these findings, with actual EI concentrations consistently lower than those predicted by the component approach.</p><p><strong>Conclusion: </strong>Both the component and finished product approaches demonstrated compliance with ICH Q3D limits, confirming that no specific control strategy was required. While the finished product approach provides precise impurity quantification, the component approach offers a cost-efficient and predictive alternative, provided that data quality and supplier collaboration are ensured. This study underscores the importance of a risk-based assessment in elemental impurity control, balancing regulatory compliance with practical implementation in pharmaceutical manufacturing.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085696","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Release of chlororotetracycline hydrochloride from novel hydrogels based on crosslinked chitosan and PVA.","authors":"Mohammed Amine Zitouni, Mustapha Chabane, Chikh Melkaoui","doi":"10.1016/j.pharma.2025.05.001","DOIUrl":"10.1016/j.pharma.2025.05.001","url":null,"abstract":"<p><p>Hydrogels based on hydrochloride polyvinyl alcohol (PVA) containing chlortetracycline and crosslinked chitosan (CS) by glutaraldehyde (GLA) were prepared by the freeze-thawing method and then characterized. The swelling properties and gel fraction of these hydrogels were studied and characterized by FTIR spectroscopy, the thermal and mechanical properties were evaluated by DSC and rheology. Controlled release of chlortetracycline hydrochloride from these hydrogels was studied by UV-Visible spectroscopy. The gel fraction decreases with increase of crosslinked chitosan concentration in hydrogel but the swelling was more important due to the relaxation of the hydrogel, and the extension of macromolecular chains in the system. The crystallinity of these hydrogels increased with increasing PVA concentration. All these hydrogels exhibited a gel character with a high crosslinking degree and possessed a network structure. The release of chlortetracycline hydrochloride from these hydrogels was occurred by fickian diffusion, faster at 37°C than at 25°C because hydrogels were more swollen at 37°C and their network densities were decreased to perfect the release of drugs from hydrogels.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143960817","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Theobromine as a multi-target therapeutic agent: Analgesic, anti-inflammatory, and anti-arthritic potential with network pharmacology insights.","authors":"Hafiza-Sara Afzal, Ambreen-Malik Uttra, Sumera Qasim, Abdul Malik, Aisha Mobashar","doi":"10.1016/j.pharma.2025.04.007","DOIUrl":"10.1016/j.pharma.2025.04.007","url":null,"abstract":"<p><strong>Objective: </strong>Inflammatory disorders, including rheumatoid arthritis (RA) and osteoarthritis, contribute significantly to global health burdens. Theobromine, a xanthine alkaloid present in cocoa, has pharmacological properties with potential therapeutic benefits in inflammatory conditions. Nonetheless, its analgesic and anti-inflammatory attributes remained underexplored.</p><p><strong>Materials and methods: </strong>Analgesic, anti-arthritic and anti-inflammatory efficacy of theobromine was evaluated via experimental models, alongside network pharmacology to understand its molecular mechanisms. Theobromine's effects were assessed in multiple models: acetic acid-induced writhing, tail immersion, and formalin tests to evaluate analgesia; carrageenan- and egg albumin-induced paw edema models for anti-inflammatory activity; and protein denaturation and human red blood cell (HRBC) membrane stabilization for anti-arthritic effects. Network pharmacology was utilized to identify molecular targets and pathways, including KEGG pathway enrichment analysis.</p><p><strong>Results: </strong>Theobromine exhibited significant analgesic effects, reducing writhing behavior by 42.71% at 200mg/kg, and increasing tail-flick latency. Theobromine significantly lowered pain during both early as well as late phase of formalin test. Inflammation was notably reduced in both egg albumin and carrageenan inflammatory models. Theobromine also demonstrated anti-arthritic properties, inhibiting protein denaturation and stabilizing HRBC membranes. Network pharmacology revealed key targets such as COX-2, TNF-α, and NF-kB, implicated in inflammation and immune responses.</p><p><strong>Conclusion: </strong>Theobromine exhibits significant analgesic, anti-inflammatory, and anti-arthritic effects. Network pharmacology provides insights into its molecular mechanisms, suggesting its promise as a therapeutic modality for inflammatory disorders.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143953200","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Immunosubstitution of patients with refractory multiple myeloma treated with teclistamab, a bispecific antibody].","authors":"Ariane Bros, Stéphanie Harel, Bertrand Arnulf, Isabelle Madelaine, Laure Deville","doi":"10.1016/j.pharma.2025.04.008","DOIUrl":"10.1016/j.pharma.2025.04.008","url":null,"abstract":"&lt;p&gt;&lt;p&gt;Multiple myeloma (MM) is the 2&lt;sup&gt;nd&lt;/sup&gt; most common haematological malignancy in France, and its treatment has been improved in recent years by the arrival of new therapies such as CAR-T cells and bispecific antibodies. Among the latter, teclistamab, indicated as a 4&lt;sup&gt;th&lt;/sup&gt;-line treatment for relapsed or refractory MM patients, targets the CD3 antigen on the surface of T lymphocytes and the BCMA antigen on the surface of malignant plasma cells. The adverse reactions to teclistamab described in the summary of product characteristics (SPC) mention hypogammaglobulinemia, leading to recurrent infections. Immunosubstitution with normal human immunoglobulin (HN-Ig) is often necessary. However, these drugs are regularly in short supply, and are subject to prioritisation recommendations. Until now, immunosubstitution in myeloma has been a \"non-priority\" indication, to be assessed according to the criteria of the French National Agency for the Safety of Medicines and Health Products (ANSM). The aim of this study was to analyse the management of hypogammaglobulinaemia in the context of teclistamab treatment in our institution over a one-year period during post-marketing authorisation (MA) early access (AP2). Patient characteristics and clinical data related to treatment with teclistamab and HN-Ig (dose, route of administration, frequency, and time to post-teclistamab initiation for HN-Ig, first infection and its type prior to immunosubstitution and its time to onset relative to teclistamab initiation) were extracted from patient records. In order to analyse compliance with the recommendations for prioritisation of HN Ig indications, blood Ig G levels were recorded (at the time of teclistamab initiation, one month later, 3 months later, and 6 months after the start of teclistamab treatment). The quantities in total grams of Ig HN consumed in hospital and aftercare as part of teclistamab treatment and in all DIS indications combined were also investigated. Among the 35 patients treated with teclistamab, 24 received HN Ig as a replacement after an average of 1 month of treatment. At least one infection occurred in 13 of these patients approximately 1 month after initiation of teclistamab. Bacterial infections accounted for 75 % of these infections, mainly pneumonia, bronchitis and urinary tract infections. In 96 % of patients, HN Ig was administered intravenously at a dose of 0.4g/kg each month. Only one patient was treated with weekly subcutaneous Ig HN at a dose of 0.1g/kg. Only 50 % of patients treated with HN Ig met the prioritisation criteria defined by the ANSM (latest recommendations April 2019). Despite immunosubstitution, IgG levels remained relatively stable over time, with a median of 2.6g/L at the start of teclistamab treatment. The time to initiation of immunosubstitution only shortened over time, from 3 months at the start of the study to 0 months, and then to systematic initiation of IS from the start of teclistamab. In terms of","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143963348","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}