EMFLAZA- deflazacort tablet EMFLAZA- deflazacort suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PTC Therapeutics, Inc.

INN (International Name):

DEFLAZACORT

Composition:

DEFLAZACORT 6 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

EMFLAZA is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 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

Product summary:

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.

Authorization status:

New Drug Application

Summary of Product characteristics

EMFLAZA- DEFLAZACORT TABLET
EMFLAZA- DEFLAZACORT SUSPENSION
PTC THERAPEUTICS, INC.
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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 2 years of age and older (1)
DOSAGE AND ADMINISTRATION
The recommended once-daily dosage is approximately 0.9 mg/kg/day
administered orally (2.2)
Discontinue gradually when administered for more than a few days (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 6 mg, 18 mg, 30 mg, and 36 mg (3)
Oral Suspension: 22.75 mg/mL (3)
CONTRAINDICATIONS
Hypersensitivity to deflazacort or any of the inactive ingredients in
EMFLAZA (4)
WARNINGS AND PRECAUTIONS
_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 (2.3, 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 sodium, and for
decreased potassium levels (5.3)
_Gastrointestinal Perforation:_ Increased risk in patients with
certain GI disorders; Signs and symptoms
may be masked (5.4)
_Behavioral and Mood Disturbances:_ May include euphoria, insomnia,
mood swings, personality
changes, severe depression, and psychosis (5.5)
_Effects on Bones:_ Monitor for decreases in bone mineral density with
chronic use of EMFLAZA (5.6)
_Ophthalmic Effects:_ May include cataracts, infections, and glaucoma;
Monitor intraocular pressure if
EMFLAZA is continued for more than