Deltyba

Delamanid

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

Adult 100 mg bd for 24 wk (directly observed therapy).

Should be taken with food.

Hypersensitivity. Serum albumin <2.8 g/dL. Strong CYP3A inducers (eg, carbamazepine).

QT prolongation. Obtain ECG before treatment initiation & mthly during treatment. Discontinue if QTcF >500 ms before 1st dose or during treatment. More frequent ECG monitoring if QTc interval duration exceeds 450/470 ms for male/female patients during treatment. Very frequent ECG monitoring in patients who commence treatment w/ serum albumin <3.4 g/dL or experience a fall in serum albumin into this range during treatment. Caution in patients w/ known congenital prolongation of the QTc-interval or any clinical condition known to prolong the 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. Concomitant use w/ medicinal products known to prolong the QTc interval, including antiarrhythmics (eg, amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol); neuroleptics (eg, phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine), antidepressive agents; certain antimicrobial agents (eg, macrolides, moxifloxacin, sparfloxacin, triazole antifungal agents, pentamidine, saquinavir); certain non-sedating antihistamines (eg, terfenadine, astemizole, mizolastine); cisapride, droperidol, domperidone, bepridil, diphemanil, probucol, levomethadyl, methadone, vinca alkaloids, arsenic trioxide. Co-administration w/ strong CYP3A4 inhibitors (lopinavir/ritonavir) or fluoroquinolone. Contains lactose. Patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption. Do not drive or use machines in case of any adverse reaction w/ potential impact on the ability to perform activities (eg, headache & tremor). Not recommended in patients w/ moderate to severe hepatic impairment; severe renal impairment. Not recommended in pregnant women or women of childbearing potential unless using a reliable form of contraception. Do not breastfeed during treatment. Childn & adolescents <18 yr. Elderly >65 yr.

Reticulocytosis; hypokalaemia, decreased appetite, hyperuricaemia; insomnia; dizziness, headache, paraesthesia, tremor; tinnitus; palpitations; haemoptysis; vomiting, diarrhoea, nausea, upper abdominal pain; arthralgia, myalgia; asthenia; prolonged ECG QT. Anaemia, eosinophilia; hypertriglyceridaemia; psychotic disorder, agitation, anxiety & anxiety disorder, depression & depressed mood, restlessness; peripheral neuropathy, somnolence, hypoaesthesia; dry eye, photophobia; ear pain; HTN, hypotension, haematoma, hot flush; dyspnoea, cough, oropharyngeal pain, throat irritation, dry throat, rhinorrhoea; gastritis, constipation, abdominal pain, lower abdominal pain, dyspepsia, abdominal discomfort; dermatitis, urticaria, rash pruritic, pruritus, rash maculo-papular, rash, acne, hyperhidrosis; osteochondrosis, muscular weakness, musculoskeletal pain, flank pain, pain in extremity; haematuria; pyrexia, chest pain, malaise, chest discomfort, peripheral oedema; increased blood cortisol.

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. Caution in patients already receiving medicines associated w/ QT prolongation. Concomitant use w/ moxifloxacin is not recommended.

Anti-TB Agents

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

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