A UK-based resource to support the monitoring and safe use of anti-TB drugs and second-line treatment of multidrug-resistant TB

Abstract

Using the best available evidence and expert consensus, this document provides guidance for adverse effect monitoring in multidrug-resistant TB (MDR-TB). It includes recommendations for baseline tests, routine drug and toxicity monitoring guides as well as individual drug monographs for all drugs currently available in the UK to treat TB. These recommendations provide a structure through which healthcare professionals can better manage the complex drug regimens required for the treatment of MDR-TB; minimising the risk of adverse incidents and helping to improve patients’ tolerance, compliance and treatment completion.

Safety profile of antituberculosis drugs

“…Factorii de risc în dezvoltarea cardiotoxicității cu prelungirea intervalului QTc includ vârstnicii, sexul feminin, afecțiunile cardiace, inclusiv congenitale și dobândite, dezechilibru electrolitic și utilizarea concomitentă a altor medicamente cu potențial cardiotoxic. Pentru Bedaquilin rezultatele căutării sistematice au demonstrat o tolerabilitate bună, cu întreruperea administrării din cauza reacțiilor adverse în 3,4% și din cauza prelungirii intervalului QTc în 0,6% [18].…”

“…Administrarea de H poate cauza producerea anticorpilor și apariția lupusului eritematos la 1% de pacienți, de asemenea,se poate agrava lupusul eritematos preexistent. Erupțiile cutanate au fost, de asemenea, raportate și pentru medicamentele antituberculoase de linia a doua, inclusiv și cele mai noi, precum Bedaquilin (Bdq) și Delamanid (Dlm) [10,18,28,29].…”

Infant Exposure to Antituberculosis Drugs via Breast Milk and Assessment of Potential Adverse Effects in Breastfed Infants: Critical Review of Data

“…To enable an assessment of whether exposure to the external or, if available, internal exposure in the infant would raise health concerns, we consulted official sources such as approved material by a regulatory body (i.e., the official summary of product characteristics; SPC) and published material by a UK-based learned society produced by Potter et al [21], updated in 2021. The adverse effects enumerated there were assessed for whether they would be dose-dependent and whether a cut-off dose is known.…”

“…In patients treated with streptomycin, monitoring of the renal function as well as the auditory and vestibular function is essential [21] as these adverse effects are not uncommon and serious.…”

P258 Multi-Drug Resistant Tuberculosis Monitoring Guidance: Are we following the national guidelines?: Abstract P258 Table 1

“…Due to the complexity of treatment regimens used for MDR-TB, national monitoring guidelines have been developed to aid monitoring for adverse effects during treatment. 1 A previous study identified that prior to the development of these monitoring guidelines the incidence of adverse effects associated with MDR TB medicines was high. 2 Objective To establish whether national guidelines for the monitoring of MDR-TB medicines at a tertiary centre are being adhered to.…”