Drug Interactions between Agamree and clofazimine

Consumer information for this interaction is not currently available.

MONITOR: Coadministration with inhibitors of CYP450 3A4 may increase the plasma concentrations and pharmacologic effects of vamorolone. The proposed mechanism is inhibition of CYP450 3A4, one of the isoenzymes involved in the metabolic clearance of vamorolone. Drug interaction studies have shown that administration of vamorolone following multiple doses of the potent CYP450 3A4 inhibitor itraconazole increased the systemic exposure (AUC) and peak plasma concentration (Cmax) by 44% and 8%, respectively, compared to vamorolone administered alone. Data are not available for other, less potent CYP450 3A4 inhibitors. However, the possibility for increased risk of corticosteroid-related adverse effects should not be excluded.

MANAGEMENT: Caution is recommended with the concomitant use of vamorolone with CYP450 3A4 inhibitors. Although the manufacturer of vamorolone advises that no dosage adjustment is required when coadministered with weak to moderate CYP450 3A4 inhibitors, the possibility of increased corticosteroid effects should be considered. Patients should be monitored for corticosteroid-related adverse effects, including signs and symptoms of immunosuppression, behavioral and mood disturbances, posterior subcapsular cataracts, glaucoma, bone loss, and growth retardation (in children and adolescents). Monitoring for signs and symptoms of hypercorticism such as acne, striae, thinning of the skin, easy bruising, moon facies, dorsocervical "buffalo" hump, truncal obesity, increased appetite, acute weight gain, edema, hypertension, hirsutism, hyperhidrosis, proximal muscle wasting and weakness, glucose intolerance, exacerbation of preexisting diabetes, and depression may also be advisable. In addition, if vamorolone therapy is to be discontinued, those who have received treatment lasting longer than one week should have their dose of vamorolone gradually decreased, due to the risk of adrenal suppression. Signs and symptoms of adrenal insufficiency include anorexia, hypoglycemia, nausea, vomiting, weight loss, muscle wasting, fatigue, weakness, dizziness, postural hypotension, depression, and adrenal crisis manifested as inability to respond to stress (e.g., illness, infection, surgery, trauma).