Deflazacort

Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Additional pediatric use information is approved for PTC Therapeutics, Inc.'s Emflaza™ (deflazacort) tablets. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. ( 1 )

• The recommended once-daily dosage is approximately 0.9 mg/kg/day administered orally
• Discontinue gradually when administered for more than a few days
• Assessments Prior to First Dose of Deflazacort Tablets Administer all immunizations according to immunization guidelines prior to starting deflazacort tablets
• Administer live-attenuated or live vaccines at least 4 to 6 weeks prior to starting deflazacort tablets [see Warnings and Precautions ]
• Dosing Information The recommended oral dosage of deflazacort tablets is approximately 0.9 mg/kg/day once daily
• If tablets are used, round up to the nearest possible dose
• Any combination of the four deflazacort tablet strengths can be used to achieve this dose
• Discontinuation Dosage of deflazacort tablets must be decreased gradually if the drug has been administered for more than a few days [see Warnings and Precautions ]
• Important Preparation and Administration Instructions Deflazacort tablets can be taken with or without food
• Do not administer deflazacort tablets with grapefruit juice [see Drug Interactions ]
• Deflazacort tablets can be administered whole or crushed and taken immediately after mixing with applesauce
• Dosage Modification for Use with CYP3A4 Inhibitors and Inducers CYP3A4 Inhibitors Give one third of the recommended dosage when deflazacort tablets are administered with moderate or strong CYP3A4 inhibitors. …

Deflazacort Tablets, 6 mg are white to off-white, round, uncoated tablet debossed with ‘J6’ on one side and plain on other side. Deflazacort Tablets, 18 mg are white to off-white, round, uncoated tablet debossed with ‘AC91’ on one side and plain on other side. Deflazacort Tablets, 30 mg are white to off-white, oval, uncoated tablet debossed with ‘AC92’ on one side and plain on other side. …

• The safety and effectiveness of deflazacort
• For the treatment of DMD have been established in patients 5 years of age and older. Use of deflazacort tablets
• In pediatric patients is supported by a multicenter, randomized, double-blind, placebo- and active-controlled study in 196 males 5 to 15 years of age [see Clinical Studies ]
• Safety and effectiveness
• In pediatric patients below the age of 2 years have not been established. …

DMD is largely a disease of children and young adults; therefore, there is no geriatric experience with deflazacort.

• Administration Warn patients and/or caregivers to not stop taking deflazacort tablets abruptly or without first checking with their healthcare providers as there may be a need for gradual dose reduction to decrease the risk of adrenal insufficiency [see Dosage and Administration and Warnings and Precautions ]
• Deflazacort tablets may be taken with or without food
• Do not take deflazacort tablets with grapefruit juice
• Deflazacort tablets may be taken whole or crushed and taken immediately after mixing with applesauce. …

• 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 and Adverse Reactions ]
• Hypersensitivity to deflazacort or any of the inactive ingredients in deflazacort tablets

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 rights, this drug product is not labeled with that information . 7.1 CYP3A4 Inhibitors and Inducers Moderate or Strong CYP3A4 Inhibitors The active metabolite of deflazacort, 21-desDFZ, is a substrate of CYP3A4 [see Clinical Pharmacology (12.3) ] . …

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 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: Monitor for elevated blood pressure and sodium and for decreased potassium levels. …

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 and Precautions (5.6) ] Ophthalmic Effects [see Warnings and Precautions (5.7) ] Immunizations [see Warnings and Precautions (5.8) ] Serious Skin Rashes [see Warnings and Precautions (5.9) ] Effects …

8.1 Pregnancy 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 deflazacort in pregnant women to inform drug-associated risks. …

Treatment of acute overdosage is by immediate gastric lavage or emesis followed by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of deflazacort may be reduced temporarily, or alternate day treatment may be introduced.

تناولها عندما تتذكر، إلا إذا اقترب موعد الجرعة التالية. عندها تخطَّ الجرعة المنسية. لا تتناول جرعتين معًا أبدًا للتعويض. راجع النشرة، فبعض الأدوية مختلفة.