Adverse Drug Reactions due to Longer oral M/XDR-TB Regimen

The table below showcases the adverse drug events that may be caused by drugs used for longer oral Multi (M)/ Extensively Drug-resistant TB (XDR-TB) regimen. In these situations, replacement drugs are used instead of these drugs.

 

Table: Possible Adverse Drug Events in the Longer Oral M/XDR-TB Regimen

ADVERSE DRUG EVENTS

DRUGS

QT prolongation

Use of Longer Oral M/XDR-TB Regimen in Severe Forms of Extrapulmonary TB and TB Meningitis

Longer oral Multi (M)/ Extensively Drug-resistant TB (XDR-TB) regimen can be given to patients with Extrapulmonary (EP) disease. Drug adjustments may be required, depending on the specific location of the disease.

 

Treatment of Multidrug-resistant (MDR)/ Rifampicin-resistant TB (RR-TB) meningitis is best guided by Drug Susceptibility Testing (DST) of the infecting strain and by the ability of TB medicines to cross the blood-brain barrier. 

Pre-treatment Evaluation [PTE] in Longer Oral M/XDR-TB Regimen

Pre-treatment evaluation for patients on a longer oral Multi/ Extensively Drug-resistant TB (M/XDR-TB) regimen requires both clinical evaluation and laboratory-based evaluation as given below.

 

 

Clinical Evaluation

 

  • Physical examination​
  • Height​
  • Weight​
  • Psychiatric evaluation if required​
  • Ophthalmologist opinion (for Linezolid)​
  • Surgical evaluation for consideration after culture conversion is achieved​

​

Laboratory-based Evaluation​

 

Use of M/XDR-TB Regimen in People Living with HIV [PLHIV] ​

The shorter or longer oral Multi/ Extremely Drug-resistant TB (M/XDR-TB) regimens can be used in People Living with Human Immunodeficiency Virus (PLHIV), including those who are receiving Anti-retroviral Treatment (ART). 

 

The presentation of Multidrug-resistant (MDR)/ Rifampicin-resistant TB (RR-TB) in people living with HIV does not differ from that of Drug-sensitive TB (DR-TB).​ 

 

DR-TB Service Referral Linkages Scenario 5: DR-TB Patient Referred for Treatment from the Private Sector with Treatment Initiated in the Private Sector ​​

In a situation where Drug-resistant TB (DR-TB) patients may have consumed anti-TB drugs for some duration from the private sector, such prior anti-TB treatment is not likely to be uniformly reliable as far as the quality or quantity and duration of drugs consumed is concerned. 

 

Given that uncertainty, the basic principle is that the duration of the DR-TB regimen under the National Tuberculosis Elimination Programme (NTEP) need not be reduced. 

 

DR-TB Service Referral Linkages Scenario 3: DR-TB Patient Referred for Treatment from the Private Sector with Bacteriological Confirmation in the Private Sector

Many times, Drug-resistant Tuberculosis (DR-TB) patients diagnosed in the private sector will wish to avail services from the public sector. 

 

The National TB Elimination Programme (NTEP) strongly recommends bacteriological confirmation of any DR-TB patient before initiation of treatment and discourages any empirical treatment. 

 

Drug Susceptibility Testing (DST) results available from private laboratories for such patients will be considered acceptable under the following situations: 

 

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