Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
DEFLAZACORT (UNII: KR5YZ6AE4B) (DEFLAZACORT - UNII:KR5YZ6AE4B)
Marathon Pharmaceuticals, LLC
DEFLAZACORT
DEFLAZACORT 6 mg
ORAL
PRESCRIPTION DRUG
EMFLAZA is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. EMFLAZA is contraindicated in patients with known hypersensitivity to deflazacort or to any of the inactive ingredients. Instances of hypersensitivity, including anaphylaxis, have occurred in patients receiving corticosteroid therapy [see Warnings and Precautions (5.15) and Adverse Reactions (6.2)] . Risk Summary Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. There are no adequate and well-controlled studies with EMFLAZA in pregnant women to inform drug-associated risks. Corticosteroids, including EMFLAZA, readily cross the placenta. Adverse developmental outcomes, including orofacial clefts (cleft lip, with or without cleft palate) and intrauterine growth restrictio
EMFLAZA Tablets EMFLAZA Oral Suspension Store at 20°C to 25°C (68°F to 77°F). Excursion permitted between 15°C to 30°C (59°F to 86°F). See USP controlled room temperature. Discard any unused EMFLAZA Oral Suspension remaining after 1 month of first opening the bottle.
New Drug Application
EMFLAZA- DEFLAZACORT TABLET EMFLAZA- DEFLAZACORT SUSPENSION MARATHON PHARMACEUTICALS, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION 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: 2017 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 • • DOSAGE FORMS AND STRENGTHS • • CONTRAINDICATIONS Hypersensitivity to deflazacort or any of the inactive ingredients in EMFLAZA (4) WARNINGS AND PRECAUTIONS • • • • • • • • • 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 • • ™ ™ ™ The recommended once-daily dosage is approximately 0.9 mg/kg/day administered orally (2.1) Discontinue gradually when administered for more than a few days (2.2) Tablets: 6 mg, 18 mg, 30 mg, and 36 mg (3) Oral Suspension: 22.75 mg/mL (3) _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) _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) _Alterations in Cardiovascular/Renal Function: _Monitor for elevated blood pressure and sod Les hele dokumentet