Emflaza Generic Name & Formulations
Deflazacort 6mg, 18mg, 30mg, 36mg; tabs.
Tabs 6mg—100; 18mg, 30mg, 36mg—30; Oral susp—13mL (w. oral dispensers)
Duchenne muscular dystrophy (DMD).
Emflaza Dosage and Administration
Adults and Children
<2yrs: not established. Swallow tabs whole or may crush and mix with applesauce. ≥2yrs: 0.9mg/kg once daily. Round up to the nearest possible dose. Concomitant moderate or strong CYP3A4 inhibitors: give ⅓ dose.
Emflaza Boxed Warnings
Increased risk of infection (eg, viral, bacterial, fungal, protozoan, helminthic) and may mask signs/symptoms. If exposed to chickenpox or measles, consider prophylactic passive immune therapy. Concomitant systemic fungal infections, active ocular herpes simplex: not recommended. Hepatitis B virus reactivation. Latent or acute amebiasis. Strongyloides infestation. Cushing’s syndrome. Hyperglycemia. Thyroid disorders. Hypopituitarism. Adrenal insufficiency. Congenital adrenal hyperplasia. Pheochromocytoma. Supplement with additional steroids during physiologic stress. CHF. Hypertension. Recent MI. Renal insufficiency. Peptic ulcers. Diverticulitis. Intestinal anastomoses. Ulcerative colitis. Psychotic tendencies. Myasthenia gravis. Thromboembolic disorders. Risk of osteoporosis; monitor bone mineral density with long-term therapy. Administer all immunizations according to guidelines prior to initiation. Discontinue at the first sign of rash. Avoid abrupt cessation. Monitor weight, growth, BP, fluid, electrolyte balance, blood glucose, and intraocular pressure (w. therapy >6weeks). Oral susp: neonates/infants (gasping syndrome). Pregnancy. Nursing mothers.
Potentiated by moderate or strong CYP3A4 inhibitors (eg, clarithromycin, fluconazole, diltiazem, verapamil, grapefruit juice); see Adults and Children. Live or live attenuated vaccines: administer at least 4–6 weeks prior to initiation. Avoid concomitant moderate or strong CYP3A4 inducers (eg, efavirenz, carbamazepine, phenytoin). Concomitant levothyroxine: give corticosteroid first. May need to adjust dose of antidiabetic agents. Increased risk of acute myopathy with concomitant neuromuscular blockers (eg, pancuronium).
Emflaza Adverse Reactions
Cushingoid appearance, weight increase, increased appetite, upper respiratory tract infection, cough, pollakiuria, hirsutism, central obesity, nasopharyngitis; HPA axis suppression, steroid withdrawal syndrome, avascular necrosis, GI perforation, behavioral/mood changes, glaucoma, cataracts, myopathy, Kaposi's sarcoma, anaphylaxis, negative growth/development effects (in children).
Emflaza Clinical Trials
Emflaza Patient Counseling