Drug Interactions between azelastine / fluticasone nasal and berotralstat

Consumer information for this interaction is not currently available.

MONITOR: Coadministration with berotralstat may increase the plasma concentrations and effects of drugs that are substrates of CYP450 3A4 and/or 2D6. The mechanism is decreased clearance due to inhibition of CYP450 3A4 and 2D6 activity by berotralstat. Berotralstat is considered a moderate inhibitor of CYP450 3A4 and 2D6. In drug interaction studies, berotralstat reportedly increased the peak plasma concentration (Cmax) and systemic exposure (AUC) of the sensitive CYP450 3A4 substrate midazolam by approximately 1.5-fold and 2.25-fold, respectively, and the CYP450 3A4 substrate amlodipine by approximately 1.5-fold and 1.75-fold, respectively. It increased the Cmax and AUC of the sensitive CYP450 2D6 substrate dextromethorphan by approximately 2.9-fold and 2.7-fold, respectively, and the CYP450 2D6 substrate desipramine by 1.7-fold and 1.9-fold, respectively. Clinical data are not available.

MANAGEMENT: Caution is advised when berotralstat is coadministered with drugs that are substrates of CYP450 3A4 and/or 2D6, particularly those with a narrow therapeutic index. Clinical and laboratory monitoring are recommended following the initiation of berotralstat, and the individual dosages of the concomitant agents adjusted as needed.

Berotralstat may significantly increase the absorption of fluticasone nasal into the blood stream. You may be more likely to experience side effects such as swelling, weight gain, high blood pressure, high blood glucose, muscle weakness, depression, acne, thinning skin, stretch marks, easy bruising, bone density loss, cataracts, menstrual irregularities, excessive growth of facial or body hair, and abnormal distribution of body fat, especially in the face, neck, back, and waist. Talk to your doctor if you have any questions or concerns. Your doctor may be able to prescribe alternatives that do not interact, or you may need a dose adjustment or more frequent monitoring by your doctor to safely use both medications. Other side effects that may occur include decreased ability to fight infections, increased risk of developing infections, and inadequate response to stress such as infection, surgery, trauma, or a severe asthma attack. Children may experience a reduced growth rate due to excessive effects of fluticasone nasal. 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.