Emflaza Oral Suspension Generic Name & Formulations
Legal Class
Rx
General Description
Deflazacort 22.75mg/mL; contains benzyl alcohol.
Pharmacological Class
Corticosteroid.
See Also
How Supplied
Tabs 6mg—100; 18mg, 30mg, 36mg—30; Oral susp—13mL (w. oral dispensers)
Manufacturer
Generic Availability
NO
Emflaza Oral Suspension Indications
Indications
Duchenne muscular dystrophy (DMD).
Emflaza Oral Suspension Dosage and Administration
Adults and Children
<2yrs: not recommended. Use oral dispenser. Slowly add into 3–4oz of milk or juice (except grapefruit juice). ≥2yrs: 0.9mg/kg once daily. Round to the nearest tenth of a milliliter (mL). Concomitant moderate or strong CYP3A4 inhibitors: give ⅓ dose.
Emflaza Oral Suspension Contraindications
Not Applicable
Emflaza Oral Suspension Boxed Warnings
Not Applicable
Emflaza Oral Suspension Warnings/Precautions
Warnings/Precautions
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.
Emflaza Oral Suspension Pharmacokinetics
See Literature
Emflaza Oral Suspension Interactions
Interactions
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 Oral Suspension Adverse Reactions
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 Oral Suspension Clinical Trials
See Literature
Emflaza Oral Suspension Note
Not Applicable
Emflaza Oral Suspension Patient Counseling
See Literature