EMFLAZA- deflazacort tablet EMFLAZA- deflazacort suspension

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

DEFLAZACORT (UNII: KR5YZ6AE4B) (DEFLAZACORT - UNII:KR5YZ6AE4B)

থেকে পাওয়া:

Marathon Pharmaceuticals, LLC

INN (International Name):

DEFLAZACORT

রচনা:

DEFLAZACORT 6 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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

পণ্য সারাংশ:

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.

অনুমোদন অবস্থা:

New Drug Application

পণ্য বৈশিষ্ট্য

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
[e-mail] 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