Deltyba

As part of an appropriate combination regimen for pulmonary multi-drug resistant TB (MDR-TB) in adults when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.

Adult 100 mg bd for 24 wk, administered by directly observed therapy.

Should be taken with food.

Hypersensitivity. Serum albumin <2.8 g/dL. Co-administration w/ strong CYP3A4 inducers (eg, carbamazepine).

No clinical data on the use to treat extrapulmonary TB (eg, CNS, bone); infections due to Mycobacterial species other than those of the Mycobacterium tuberculosis complex; latent infection w/ M. tuberculosis. No clinical data on the use as part of combination regimens used to treat drug-susceptible M. tuberculosis. Must only be used in an appropriate combination regimen for MDR-TB treatment as recommended by WHO to prevent development of resistance. Risk of QT prolongation. Obtain ECG before treatment initiation & mthly during the full course of treatment. Treatment should either not be started or should be discontinued if QTcF >500 ms is observed either before the 1st dose or during treatment. More frequent ECG monitoring if QTc interval duration exceeds 450/470 ms for male/female patients during treatment. Obtain serum electrolytes (eg, K) at baseline & correct if abnormal. Very frequent ECG monitoring throughout the full treatment period in patients w/ cardiac risk factors; in patients who commence treatment w/ serum albumin <3.4 g/dL or experience a fall in serum albumin into this range during treatment; if co-administration w/ any strong CYP3A4 inhibitor is considered necessary; if co-administration w/ fluoroquinolone is considered to be unavoidable. Do not initiate treatment in patients w/ cardiac risk factors unless possible benefit is considered to outweigh potential risks: known congenital prolongation of QTc interval or any clinical condition known to prolong QTc interval or QTc >500 ms; history of symptomatic cardiac arrhythmias or w/ clinically relevant bradycardia; any predisposing cardiac conditions for arrhythmia eg, severe HTN, left ventricular hypertrophy (including hypertrophic cardiomyopathy) or congestive cardiac failure accompanied by reduced left ventricle ejection fraction; electrolyte disturbances, particularly hypokalaemia, hypocalcaemia or hypomagnesaemia; taking medicinal products known to prolong QTc interval. Post-marketing reports of paradoxical drug reactions. Contains lactose. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Moderate influence on the ability to drive & use machines. Not recommended in patients w/ severe renal impairment; patients w/ moderate to severe hepatic impairment. Not recommended during pregnancy & in women of childbearing potential not using contraception. Women should not breastfeed during treatment. Safety & efficacy in childn & adolescents <18 yr have not yet been established. No data available in elderly >65 yr.

Decreased appetite; sleep disorders & disturbances; dizziness, headache; nausea, vomiting, gastritis. Hypothyroidism; psychotic disorder, anxiety, depression, hallucination; hypoaesthesia, tremor; 1st degree AV block, ventricular extrasystoles, palpitations; throat irritation; dyspepsia; muscular weakness, muscle spasms; chest pain; increased cortisol, prolonged ECG QT.

Reduced exposure w/ strong CYP3A4 inducers (eg, rifampicin). Slightly increased exposure w/ lopinavir/ritonavir. Potential to have an effect on MDR1 (P-gp), BCRP, OATP1, OATP3, OCT1, OCT2, OATP1B1, OATP1B3 & BSEP transporters. Significantly increased steady-state plasma conc of ethambutol. Co-administration w/ moxifloxacin is not recommended. Care must be taken in patients already receiving medicinal products associated w/ QTc interval prolongation eg, antiarrhythmics (eg, amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol), neuroleptics (eg, phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, thioridazine), antidepressants, certain antimicrobials (eg, erythromycin, clarithromycin, moxifloxacin, sparfloxacin, bedaquiline, triazole antifungals, pentamidine, saquinavir), certain non-sedating antihistamines (eg, terfenadine, astemizole, mizolastine), certain antimalarials w/ QT-prolonging potential (eg, halofantrine, quinine, chloroquine, artesunate/amodiaquine, dihydroartemisinin/piperaquine), cisapride, droperidol, domperidone, bepridil, diphemanil, probucol, levomethadyl, methadone, vinca alkaloids, arsenic trioxide.

Anti-TB Agents

J04AK06 - delamanid ; Belongs to the class of other drugs used in the systemic treatment of tuberculosis.

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