Longer Oral M/XDR-TB: Regimen and Duration
ContentLonger oral Multi (M)/ Extensive Drug-resistant (XDR) -TB treatment is specified with a definite regime and duration.
Regimen: (18-20) Levofloxacin (Lfx), Bedaquiline (Bdq) (6 months or longer), Linezolid# (Lzd), Clofazimine (Cfz), Cycloserine (Cs) (# dose of Lzd will be tapered to 300 mg after the initial 6–8 months of treatment)
- Duration: 18-20 months
- No separate Intensive Phase (IP) and Continuation Phase (CP).
- Bdq will be given for 6 months and extended beyond 6 months as an exception.
- Pyridoxine should be given to all Drug-resistant TB (DR-TB) patients as per the weight bands.
- For Extensively Drug-resistant TB (XDR-TB) patients, the duration of a longer oral XDR-TB regimen would be for 20 months.
Resources
- Guidelines for Programmatic Management of Drug-Resistant Tuberculosis in India, March 2021.
- WHO Consolidated Guidelines on Tuberculosis: Module 4 – Treatment: Drug-resistant TB Treatment, 2020.
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Treatment Extension in Longer Oral M/XDR-TB Regimen
ContentThe total duration of a longer oral Multidrug/ Extensively drug-resistant TB (M/XDR-TB) regimen is 18–20 months.
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Figure: Protocol for Treatment Extension in Longer Oral M/XDR-TB Treatment Regimen
Extension of Bedaquiline (Bdq) beyond 6 months is to be considered in patients in whom an effective regimen cannot otherwise be designed.
- If any additional resistance to Group A, B or C drugs in use is detected, the patient needs to be reassessed at the Nodal/ District Drug-resistant Tuberculosis Centre (N/DDR-TBC) for modification of a longer oral M/XDR-TB regimen immediately on receiving the report.
- A treatment duration of 15–17 months after culture conversion is suggested for most patients. The duration may be modified according to the patient’s response to treatment.
Resources
- Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.
- WHO Consolidated Guidelines on Tuberculosis: Module 4 – Treatment: Drug-resistant TB Treatment, 2020.
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Adverse Drug Reactions due to Longer oral M/XDR-TB Regimen
ContentThe 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
Bedaquiline (Bdq), Fluoroquinolone (FQ), Clofazimine (Cfz) Rash, allergic reaction and anaphylaxis Any drug
Gastrointestinal symptoms
Ethionamide (Eto), P-Aminosalicylic Acid (PAS), Pyrazinamide (Z), Ethambutol (E), Bdq, Cfz, Linezolid (Lzd), FQs Diarrhoea and/or flatulence
PAS, Eto
Hepatitis
Z, Eto, PAS, Bdq
Giddiness
Amikacin (Am), Eto, FQ and/or Z
Haematological abnormalities
Lzd
Hypothyroidism
Eto, PAS
Arthralgia
Z, FQ, Bdq
Peripheral neuropathy
Lzd, Cycloserine (Cs), Am, FQ, rarely Eto, E
Headache
Bdq, Cs
Depression
Cs, FQ, Eto
Psychotic symptoms
Cs, Isoniazid (H), FQ
Suicidal ideation
Cs, Eto
Seizures
Cs, H, FQ
Tendonitis and tendon rupture
FQ
Nephrotoxicity (renal toxicity)
Am
Vestibular toxicity (tinnitus and dizziness
Am, Cs, FQs, Eto, Lzd
Hearing loss
Am Optic neuritis
E, Lzd, Eto, Cfz
Metallic taste
Eto, FQs
Electrolyte disturbances (Hypokalaemia and Hypomagnesaemia
Am
Gynaecomastia
Eto
Alopecia
Eto
Superficial fungal infection and thrush
FQ
Lactic acidosis
Lzd
Dysglycaemia and Hyperglycaemia
Eto
Resources
- Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.
- WHO Consolidated Guidelines on Tuberculosis: Module 4 - Treatment: Drug Resistant TB Treatment, 2020.
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Dosages of M/XDR-TB Drugs for Adult in Longer Oral M/XDR-TB Regimen
ContentIt is important to know the dosages of Multi (M)/ Extensively Drug-resistant TB (XDR-TB) drugs for adults on a longer oral M/XDR-TB regimen.
The table below shows the M/XDR-TB regimen drugs for adults weight band-wise, used in longer oral M/XDR-TB regimen customized for India by national experts.
Table: Dosages of M/XDR-TB Drugs for Adults in Longer Oral M/XDR-TB Regimen Sr.No
Drugs
16-29 kg
30-45 kg
46-70 kg
>70 kg
1
Levofloxacin (Lfx)
250 mg
750 mg
1000 mg
1000 mg
2
Moxifloxacin (Mfx)
200 mg
400 mg
400 mg
400 mg
3
High dose Mfx (Mfxh)
400 mg
600 mg
600 mg
600 mg
4
Bedaquiline (Bdq)
Week 0–2: Bdq 400 mg daily
Week 3–24: Bdq 200 mg 3 times per week
5
Clofazimine (Cfz)
50 mg
100 mg
100 mg
200 mg
6
Cycloserine (Cs)3
250 mg
500 mg
750 mg
1000 mg
7
Linezolid (Lzd)
300 mg
600 mg
600 mg
600 mg
8
Delamanid (Dlm)
50 mg twice daily (100 mg) for 24 weeks in 6-11 years of age
100 mg twice daily (200 mg) for 24 weeks for ≥12 years of age
9
Amikacin (Am)1
500 mg
750 mg
750 mg
1000 mg
10
Pyrazinamide (Z)
750 mg
1250 mg
1750 mg
2000 mg
11
Ethionamide (Eto)3
375 mg
500 mg
750 mg
1000 mg
12
Na - PAS (60% weight/ vol)2,3
10 gm
14 gm
16 gm
22 gm
13
Ethambutol (E)
400 mg
800 mg
1200 mg
1600 mg
14
Imipenem-Cilastatin (Imp-Cln)3
2 vials (1g + 1g) bd (to be used with Clavulanic acid)
15
Meropenems (Mpm)3
1000 mg three times daily (alternative dosing is 2000 mg twice daily) (to be used with Clavulanic acid)
16
Amoxicillin-Clavulanate (Amx-Clv) (to be given with Carbapenems only)
875/125 mg bd
875/125 mg bd
875/125 mg bd
875/125 mg bd
17
Pyridoxine (Pdx)
50 mg
100 mg
100 mg
100 mg
1For adults more than 60 years of age, the dose of Second-line Injectable (SLI) should be reduced to 10 mg/kg (max up to 750 mg).
2In patients of Para Amino Salicylic Acid (PAS) with 80% weight/ volume the dose will be changed to 7.5 gm (16-29 kg); 10 gm (30-45 Kg); 12 gm (46-70 kg) and 16 gm (>70 kg).
3Drugs can be given in divided doses in a day in the event of intolerance.
Resources
- Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.
- WHO Consolidated Guidelines on Tuberculosis: Module 4 – Treatment: Drug-resistant TB Treatment, 2020.
Kindly provide your valuable feedback on the page to the link provided HERE
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