Emflaza (Deflazacort Tablets) and Food

Do not take deflazacort with grapefruit juice. Grapefruit juice may increase the blood levels of the active component of deflazacort. This may increase the risk and/or severity of side effects such as swelling, weight gain, electrolyte abnormalities, high blood pressure, high blood glucose, muscle weakness, depression, mood swings, acne, thinning skin, stretch marks, easy bruising, bone density loss, cataracts, glaucoma, menstrual irregularities, excessive growth of facial or body hair, and abnormal distribution of body fat, especially in the face, neck, back, and waist. 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 during chronic use. 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.

GENERALLY AVOID: Grapefruit juice may increase the plasma concentrations of 21-desdeflazacort, the active metabolite of deflazacort that is formed by esterases after oral administration and further metabolized by CYP450 3A4 to several inactive metabolites. The proposed mechanism is inhibition of CYP450 3A4-mediated metabolism in the gut wall by certain compounds present in grapefruit. In general, the effect of grapefruit juice is concentration-, dose- and preparation-dependent, and can vary widely among brands. Certain preparations of grapefruit juice (e.g., high dose, double strength) have sometimes demonstrated potent inhibition of CYP450 3A4, while other preparations (e.g., low dose, single strength) have typically demonstrated moderate inhibition. Increased systemic exposure to 21-desdeflazacort may increase the risk of corticosteroid adverse effects such as hypercorticism, hyperglycemia, adrenal suppression, immunosuppression, hypertension, salt and water retention, electrolyte abnormalities, behavioral and mood disturbances, posterior subcapsular cataracts, glaucoma, bone loss, and growth retardation in children and adolescents.

MANAGEMENT: Deflazacort should not be administered with grapefruit juice.