Drug Interactions between danicopan and Mintuss DR

Using chlorpheniramine together with dextromethorphan may increase side effects such as dizziness, drowsiness, confusion, and difficulty concentrating. Some people, especially the elderly, may also experience impairment in thinking, judgment, and motor coordination. You should avoid or limit the use of alcohol while being treated with these medications. Also avoid activities requiring mental alertness such as driving or operating hazardous machinery until you know how the medications affect you. Talk to your doctor if you have any questions or concerns. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

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MONITOR: Coadministration with danicopan may increase the plasma concentrations of drugs that are substrates of the efflux transporters breast cancer resistance protein (BCRP) and/or P-glycoprotein (P-gp). The proposed mechanism involves decreased clearance due to inhibition of BCRP and P-gp by danicopan. In clinical drug interaction studies, when subjects were coadministered the BCRP substrate rosuvastatin (single 20 mg dose) with danicopan at steady state (200 mg three times daily for 4 days), the peak plasma concentration (Cmax) and systemic exposure (AUC) of rosuvastatin increased by 3.3-fold and 2.2-fold, respectively. In addition, when the P-gp substrate fexofenadine (single 180 mg dose) was coadministered with danicopan (150 mg three times daily for 4 days), the peak plasma concentration (Cmax) and systemic exposure (AUC) of fexofenadine increased by 1.4-fold and 1.6-fold, respectively. Similarly, when subjects were coadministered the P-gp substrate tacrolimus (single 2 mg dose) with danicopan (200 mg three times daily for 5 days), the Cmax and AUC of tacrolimus increased by 1.1-fold and 1.5-fold, respectively.

MANAGEMENT: Caution and clinical monitoring are recommended if danicopan is coadministered with drugs that are substrates of the transporters BCRP and/or P-gp, particularly sensitive substrates, or those with a narrow therapeutic range. Dosage adjustments as well as closer clinical and laboratory monitoring for the development of adverse effects may be appropriate for some drugs whenever danicopan is added to or withdrawn from therapy. Individual product labeling should be consulted for further guidance.