DEFLAZACORT

AbsorptionAfter oral administration in the fasted state, the median T max with deflazacort tablet is about 1 hour (range 0.25 to 2 hours). Food Effect: Co-administration of deflazacort tablets with a high-fat meal reduced C max by about 30% and delayed T max by one hour, relative to administration under fasting conditions, but there was no effect on the overall systemic absorption as measured by AUC. The bioavailability of deflazacort tablets was similar to that of the oral suspension. The admi...

The effectiveness of deflazacort for the treatment of DMD was established in Study 1, a multicenter, randomized, double-blind, placebo-controlled, 52-week study conducted in the U.S. and Canada. The study population consisted of 196 male pediatric patients 5 to 15 years of age with documented mutation of the dystrophin gene, onset of weakness before 5 years of age and serum creatinine kinase activity at least 10 times the upper limit of normal (ULN) at some stage in their illness. Patients were randomized to therapy with deflazacort (0.9 or 1.2 mg/kg/day), an active comparator, or placebo. A c...

The following serious adverse reactions are discussed in more detail in other sections: Alterations in Endocrine Function [see Warnings and Precautions ( 5.1) ] Immunosuppression and Increased Risk of Infection [see Warnings and Precautions (5.2) ] Alterations in Cardiovascular/Renal Function [see Warnings and Precautions (5.3) ] Gastrointestinal Perforation [see Warnings and Precautions (5.4) ] Behavioral and Mood Disturbances [see Warnings and Precautions (5.5) ] Effects on Bones [see Warnings...

Deflazacort tablet 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) ] . Hypersensitivity to deflazacort or any of the inactive ingredients in deflazacort tab...

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 deflazacort. ( 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: ...

7 DRUG INTERACTIONS Moderate or strong CYP3A4 inhibitors: Give one third of the recommended dosage of deflazacort. ( 7.1 ) Avoid use of moderate or strong CYP3A4 inducers with deflazacort, as they may reduce efficacy. ( 7.1 ) Additional pediatric use information is approved for PTC Therapeutics, Inc.'s Emflaza™ (deflazacort) tablets. However, due to PTC Therapeutics, Inc.'s marketing exclusivity r...