EMFLAZA ORAL SUSPENSION Rx
Generic Name and Formulations:
Deflazacort 22.75mg/mL; contains benzyl alcohol.
PTC Therapeutics, Inc.
Indications for EMFLAZA ORAL SUSPENSION:
Duchenne muscular dystrophy (DMD).
Adults and Children:
<5yrs: not recommended. Use oral dispenser. Slowly add into 3–4oz of juice or milk (avoid grapefruit juice). ≥5yrs: 0.9mg/kg once daily. Round to the nearest tenth of a milliliter (mL). Concomitant moderate or strong CYP3A4 inhibitors (eg, clarithromycin, fluconazole, diltiazem, verapamil): give ⅓ dose.
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. 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.
See Adults and Children. Live or live attenuated vaccines: not recommended; may get suboptimal response. 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).
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).
Tabs 6mg—100; 18mg, 30mg, 36mg—30; Oral susp—13mL (w. oral dispensers)