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  • Management of TB in special situations

    Learning Objectives

    There are special situation where modification of drugs and drugs dosages is required, and early identificaiton of ADR through stringent monitoring

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The treatment for TB is demanding in terms of duration of treatment, adverse drug reactions, the requirement of prolonged adherence by patients and catastrophic expenditures. The presence of a special condition added on by a TB diagnosis makes it even more challenging.

To improve the outcomes for such challenging situations, the programme recommends certain modifications in the regimen, which are listed in the table below.

Table: Management of TB in Special Situations

Pregnancy and lactation Pregnant women with TB should be jointly managed by an obstetrician/ gynaecologist and pulmonologist/ physician.
The shorter oral Bedaquiline-containing Multidrug-resistant (MDR)/Rifampicin-resistant (RR)-TB regimen should not be administered in pregnant women before 32 weeks due to Ethionamide (Eto) led to potential teratogenicity in first trimester and risk of hypothyroidism in the infant in second trimester.
Beyond 32 weeks, the choice of regimen needs to be a consultative decision between the obstetrician and physician at the Nodal/District Drug-resistant TB Centre (N/DDR-TBC).
In pregnant women diagnosed with DR-TB, if the duration of pregnancy is <20 weeks*, the patient should be advised to opt for Medical Termination of Pregnancy (MTP) in view of the potential severe risk to both mother and foetus.
Bedaquiline (Bdq) and Delamanid (Dlm) both should not be recommended during the lactating period unless the mother is willing to replace breastfeeding with formula feed.
Breastfeeding must be continued and after ruling out active TB, the baby should be given 6 months of isoniazid preventive therapy, The mother should be advised about cough hygiene measures such as covering the nose and mouth while coughing, sneezing or any act which can produce sputum droplets.
Mothers receiving INH and their breastfed infants should be supplemented with vitamin B6 (pyridoxine), recommended dose of Pyridoxine in infants is 5 mg/day and for mother is 10mg/day.
Renal impairment In the presence of mild to moderate renal impairment dosage of Ethambutol (E) and Levofloxacin (Lfx) should be adjusted.
In the presence of severe renal impairment, Lfx can be replaced with a normal dose of Moxifloxacin (Mfx) (200/400 mg based on the patients’ weight).
In case of patients undergoing dialysis, medicine should be given either 4-6 hours before dialysis or immediately after dialysis
Pre-existing liver disease MDR/ RR-TB patients having deranged Liver Function Test (LFT) during pre-treatment evaluation should be strictly monitored as clinically indicated while on treatment.
In patients with pre-existing liver disease with persistently abnormal liver function tests, a shorter oral MDR/ RR-TB regimen should be avoided due to presence of High-dose Isoniazid (H(h)), Eto and Pyrazinamide (Z).

If the serum alanine aminotransferase level is more than 3 times normal before the initiation of treatment, the following regimens should be considered: –

  1. Containing two hepatotoxic drugs:

- 9 months of isoniazid and rifampicin, plus ethambutol (until or unless isoniazid susceptibility is documented) - 9HRE

- 2 months of isoniazid, rifampicin, streptomycin and ethambutol, followed by 7 months of isoniazid and rifampicin-2SHR/ 7HR

- 6–9 months of rifampicin, pyrazinamide and ethambutol-(6-9 RZE)

  1. Containing one hepatotoxic drug: 2 months of isoniazid, ethambutol and streptomycin, followed by 10 months of isoniazid and ethambutol (2SHE/10 HE)
  2. Containing no hepatotoxic drugs: 18–24 months of streptomycin, ethambutol and fluoroquinolone. (18-24 SLE)
Seizure disorders Patients should be evaluated to check if seizures are under control and verify if the patient is taking anti-seizure medication.
Since Eto, Fluoroquinolones (FQ), and high dose Isoniazid are associated with seizures they should be used carefully/ avoided amongst MDR/RR-TB patients with a history of seizures.
Though the seizure is not common with Bdq, it should also be considered while assessing the causality assessment.
The prophylactic use of oral pyridoxine (vitamin B6) up to 5-25 mg/day can be used in patients with seizure disorders to protect against the neurological adverse effects of isoniazid or cycloserine.
Serum levels of anti-epileptic drugs should be monitored closely to identify any drug interactions.

Management of Adverse Drug Reactions (ADRs) in Special Situations

  • The actual management of ADR begins during the treatment initiation counselling, where the patient should be instructed in detail about potential adverse effects due to the prescribed drug regimen and when they occur, to notify a healthcare provider.
  • Treatment Supporter (TS) should be trained to closely monitor the patient for any signs of ADR (especially, since drug-drug interaction could happen) daily so that they can be recognized and managed quickly.
  • The TS should also be trained to identify ADR as major and minor.
  • A symptom-based approach should be followed to manage minor ADR where the patient is usually able to tolerate anti-TB drugs and continue medication with symptomatic treatment. Appropriate referrals should be made for all major ADRs that may require hospitalization of the patient.
  • If the adverse effect is mild and not serious the treatment regimen must be continued with the help of ancillary drugs, if needed.
  • For most second-line drugs related ADR, reducing the dosage/ terminating the offending drug can be considered and should be decided by the Nodal/District Drug-resistant TB Centre (N/DD- TBC) committee.
  • Psychosocial support, patient education and motivation through TS and other patient support groups are also effective ways to manage the ADRs.

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Assessment

Question Answer 1 Answer 2 Answer 3 Answer 4 Correct answer Correct explanation Page id Part of Pre-test Part of Post-test
The shorter oral Bdq-containing regimen should not be administered to pregnant women until how many weeks? 20 22 30 32 4 The shorter oral Bedaquiline-containing MDR/RR-TB regimen should not be administered in pregnant women before 32 weeks as it can cause Ethionamide (Eto)-led potential teratogenicity in the first trimester and risk of hypothyroidism in infants in the second trimester.   Yes Yes

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