Deltyba Drug Interactions

The complete metabolic profile and mode of elimination of delamanid has not yet been fully elucidated (see Pharmacology: Pharmacokinetics under Actions, and Precautions).
Effects of other medicinal products on deltyba: Cytochrome P450 3A4 inducers: Clinical drug-drug interactions studies in healthy subjects indicated a reduced exposure to delamanid, of up to 45% following 15 days of concomitant administration of the strong inducer of cytochrome P450 (CYP) 3A4 (Rifampicin 300 mg daily) with delamanid (200 mg daily). No clinically relevant reduction in delamanid exposure was observed with the weak inducer efavirenz when administered at a dose of 600 mg daily for 10 days in combination with delamanid 100 mg twice daily.
Anti-HIV medicines: In clinical drug-drug interaction studies in healthy subjects, delamanid was administered alone (100 mg twice daily) and with tenofovir (300 mg daily) or lopinavir/ritonavir (400/100 mg daily) for 14 days and with efavirenz for 10 days (600 mg daily). Delamanid exposure remained unchanged (<25% difference) with anti-HIV medicines tenofovir and efavirenz but was slightly increased with the combination anti-HIV medicine containing lopinavir/ritonavir.
Effects of Deltyba on other medicinal products: In-vitro studies showed that delamanid did not inhibit CYP450 isozymes.
In-vitro studies showed that delamanid and metabolites did not have any effect on the transporters MDR1(p-gp), BCRP, OATP1, OATP3, OCT1, OCT2, OATP1B1, OATP1B3 and BSEP, at concentrations of approximately 5 to 20 fold greater than the C_max at steady state. However, since the concentrations in the gut can potentially be much greater than these multiples of the C_max, there is a potential for delamanid to have an effect on these transporters.
Anti-Tuberculosis medicines: In a clinical drug-drug interaction study in healthy subjects, delamanid was administered alone (200 mg daily) and with rifampicin/isoniazid/pyrazinamide (300/720/1800 mg daily) or ethambutol (1100 mg daily) for 15 days. Exposure of concomitant anti-TB drugs [rifampicin (R)/isoniazid (H)/pyrazinamide (Z)] was not affected. Co-administration with delamanid significantly increased steady state plasma concentrations of ethambutol by approximately 25%, the clinical relevance is unknown.
Anti-HIV medicines: In a clinical drug-drug interaction study in healthy subjects, delamanid was administered alone (100 mg twice daily) and tenofovir (300 mg), lopinavir/ritonavir (400/100 mg) for 14 days and with efavirenz for 10 days (600 mg daily). Delamanid given in combination with the anti-HIV-medicines, tenofovir, lopinavir/ritonavir and efavirenz, did not affect the exposure to these medicinal products.
Medicinal products with the potential to prolong QTc: Care must be taken in using delamanid in patients already receiving medicines associated with QT prolongation (see Precautions). Co-administration of moxifloxacin and delamanid in MDR-TB patients has not been studied. Moxifloxacin is not recommended for use in patients treated with delamanid.