These highlights do not include all the information needed to use EMFLAZA ™ safely and effectively. See full prescribing information for EMFLAZA.
EMFLAZA ™ (deflazacort) tablets, for oral use
EMFLAZA ™ (deflazacort) oral suspension
Initial U.S. Approval: 201 7
INDICATIONS AND USAGE
EMFLAZA is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older (
1)
DOSAGE AND ADMINISTRATION
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The recommended once-daily dosage is approximately 0.9 mg/kg/day administered orally (2.1)
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Discontinue gradually when administered for more than a few days (2.2)
DOSAGE FORMS AND STRENGTHS
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Tablets: 6 mg, 18 mg, 30 mg, and 36 mg (3)
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Oral Suspension: 22.75 mg/mL (3)
CONTRAINDICATIONS
Hypersensitivity to deflazacort or any of the inactive ingredients in EMFLAZA (4)
WARNINGS AND PRECAUTIONS
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Alterations in Endocrine Function: Hypothalamic-pituitary-adrenal axis suppression, Cushing’s syndrome, and hyperglycemia can occur; Monitor patients for these conditions with chronic use of EMFLAZA (2.2, 5.1)
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Immunosuppression and Increased Risk of Infection: Increased risk of new, exacerbation, dissemination, or reactivation of latent infections, which can be severe and at times fatal; Signs and symptoms of infection may be masked (5.2)
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Alterations in Cardiovascular/Renal Function: Monitor for elevated blood pressure and sodium, and for decreased potassium levels (5.3)
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Gastrointestinal Perforation: Increased risk in patients with certain GI disorders; Signs and symptoms may be masked (5.4)
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Behavioral and Mood Disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis (5.5)
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Effects on Bones: Monitor for decreases in bone mineral density with chronic use of EMFLAZA (5.6)
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Ophthalmic Effects: May include cataracts, infections, and glaucoma; Monitor intraocular pressure if EMFLAZA is continued for more than 6 weeks (5.7)
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Vaccination: Do not administer live or live attenuated vaccines to patients receiving immunosuppressive doses of corticosteroids (5.8)
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Serious Skin Rashes: Discontinue at the first sign of rash, unless the rash is clearly not drug related (5.9)
ADVERSE REACTIONS
The most common adverse reactions (≥ 10% for EMFLAZA and greater than placebo) are Cushingoid appearance, weight increased, increased appetite, upper respiratory tract infection, cough, pollakiuria, hirsutism, central obesity, and nasopharyngitis (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Marathon Pharmaceuticals, LLC at 1-866-562-4620 or DrugSafety@propharmagroup.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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Moderate or strong CYP3A4 inhibitors: Give one third of the recommended dosage of EMFLAZA (7.1)
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Avoid use of moderate or strong CYP3A4 inducers with EMFLAZA, as they may reduce efficacy (7.1)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 2/2017
