ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
medimedia.ir

Deflazacort: Drug information

Deflazacort: Drug information
(For additional information see "Deflazacort: Patient drug information" and see "Deflazacort: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Emflaza
Pharmacologic Category
  • Corticosteroid, Systemic
Dosing: Adult
Duchenne muscular dystrophy

Duchenne muscular dystrophy: Oral: Usual dose: 0.9 mg/kg once daily; may decrease dose by 25% to 33% in patients who experience intolerable adverse effects (Ref). Note: Round up to nearest possible dose when using tablets; round up to nearest tenth of a mL when using suspension.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

No dosage adjustment necessary; use with caution.

Dosing: Hepatic Impairment: Adult

Mild to moderate impairment: No dosage adjustment necessary.

Severe impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Deflazacort: Pediatric drug information")

Note: Vaccinate patients based on current immunization schedules prior to therapy initiation; any live-attenuated or live vaccines should be administered at least 4 to 6 weeks prior to starting deflazacort.

Duchenne muscular dystrophy

Duchenne muscular dystrophy (DMD): Children ≥2 years and Adolescents: Oral: ~0.9 mg/kg/dose once daily; doses should be rounded based on product formulation: Oral suspension: Round dose up to nearest 0.1 mL (tenth of a mL), Tablets: Round up to the nearest possible dose based on tablet strengths using any combination of available tablet strengths. Note: DMD primarily affects males, and rarely females; therefore, clinical trial experience is limited to the male population.

Discontinuation of therapy: It is necessary to gradually decrease deflazacort if administered for more than few days.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Children ≥2 years and Adolescents: No dosage adjustment necessary.

Dosing: Hepatic Impairment: Pediatric

Children ≥2 years and Adolescents:

Mild to moderate impairment: No dosage adjustment necessary.

Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Dermatologic: Erythema (8% to 28%)

Endocrine & metabolic: Cushingoid appearance (33% to 60%), hirsutism (10% to 35%), weight gain (20% to 28%), obesity (central, 10% to 25%)

Gastrointestinal: Abdominal pain (including upper abdominal pain: 18%), increased appetite (14%)

Genitourinary: Pollakiuria (12% to 15%)

Respiratory: Cough (12%), upper respiratory tract infection (12%)

1% to 10%:

Cardiovascular: Cardiac arrhythmia (≥1%)

Central nervous system: Irritability (8% to 10%), abnormal behavior (9%), psychomotor agitation (6%), aggressive behavior (≥1%), depression (≥1%), dizziness (≥1%), emotional disturbance (≥1%), emotional lability (≥1%), heat exhaustion (≥1%), hypertonia (≥1%, hypertonic bladder), insomnia (≥1%), mood changes (≥1%), sleep disorder (≥1%)

Dermatologic: Skin rash (7%), atrophic striae (6%), acneiform eruption (≥1%), acne vulgaris (≥1%), alopecia (≥1%), impetigo (≥1%)

Endocrine & metabolic: Glycosuria (≥1%), hot flash (≥1%), increased thirst (≥1%)

Gastrointestinal: Constipation (10%), abdominal distress (6%), nausea (6%), dyspepsia (≥1%), gastrointestinal disease (≥1%)

Genitourinary: Dysuria (≥1%), testicular pain (≥1%), urinary tract infection (≥1%), urine discoloration (≥1%)

Hematologic & oncologic: Bruise (6%)

Infection: Influenza (≥1%), tooth abscess (≥1%), viral infection (≥1%)

Neuromuscular & skeletal: Back pain (7%), back injury (≥1%), limb pain (≥1%), muscle spasm (≥1%), myalgia (≥1%), neck pain (≥1%)

Ophthalmic: Hordeolum (≥1%), increased lacrimation (≥1%)

Otic: Otitis externa (≥1%)

Respiratory: Nasopharyngitis (10%), rhinorrhea (8%), epistaxis (6%), hypoventilation (≥1%), pharyngitis (≥1%)

Miscellaneous: Fever (9%), accidental injury (≥1%, face), mass (≥1%, neck)

Frequency not defined.

Central nervous system: Myasthenia (associated with long-term use)

Neuromuscular & skeletal: Bone fracture (long bones including the fibula as well as greenstick fractures), decreased bone mineral density, osteopenia (associated with long-term use), tendinopathy (associated with long-term use)

<1%, postmarketing, and/or case reports: Abnormal serum calcium (negative calcium balance), acute pancreatitis (especially in children), acute peptic ulcer with hemorrhage and perforation, amyotrophy, anaphylaxis, anxiety, avascular necrosis of bones, carbohydrate intolerance, change in serum protein (negative protein balance), chorioretinitis, cognitive dysfunction (including confusion, amnesia, delusions, hallucinations, mania, or suicidal thoughts), corneal thinning, decreased serum potassium, edema, exacerbation of epilepsy, hemorrhage, hypersensitivity, hypokalemic alkalosis, increased intracranial pressure (with papilledema in children), leukocytosis, negative nitrogen balance, peptic ulcer, pseudotumor cerebri, scleral thinning, thromboembolism (especially in patients with underlying conditions associated with increased thrombotic tendency), toxic epidermal necrolysis, vertebral compression fracture, vertigo, wound healing impairment

Contraindications

Hypersensitivity to deflazacort or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully.

• Anaphylaxis: Rare cases of anaphylaxis have occurred in patients receiving corticosteroids.

• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection, cause activation of latent infections, mask acute infection (including fungal infections), prolong or exacerbate existing infections, or limit response to killed or inactivated vaccines. Exposure to chickenpox or measles should be avoided. Vaccinate patients based on current immunization schedules prior to therapy initiation; any live-attenuated or live vaccines should be administered at least 4 to 6 weeks prior to starting deflazacort. Close observation is required in patients with tuberculosis (TB) infection (latent TB) and/or TB reactivity; restrict use in TB disease (active TB) (only in conjunction with antituberculosis treatment). Avoid use in patients with active ocular herpes simplex. Hepatitis B reactivation can occur in patients who are hepatitis B carriers. Amebiasis should be ruled out in any patient with recent travel to tropic climates or unexplained diarrhea prior to initiation of corticosteroids. Use with extreme caution in patients with Strongyloides infections; hyperinfection, dissemination and fatalities have occurred.

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).

• Myopathy: Acute myopathy has been reported with high dose corticosteroids, usually in patients with neuromuscular transmission disorders; may involve ocular and/or respiratory muscles; monitor creatinine kinase; recovery may be delayed.

• Ocular effects: Prolonged use may cause posterior subcapsular cataracts, glaucoma (with possible nerve damage), and increased intraocular pressure. Consider routine eye exams in chronic users.

• Psychiatric disturbances: Corticosteroid use may cause psychiatric disturbances, including depression, euphoria, insomnia, mood swings, and personality changes. Preexisting psychiatric conditions may be exacerbated by corticosteroid use.

• Skin reactions: Toxic epidermal necrolysis has been reported within 8 weeks of starting treatment; discontinue at first sign of rash, unless rash is clearly not drug-related.

• Thromboembolic events: Higher cumulative doses of corticosteroids have been associated with an increased risk of thromboembolism. Use caution in patients with a history of or at increased risk for thromboembolic disorders.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with heart failure and/or hypertension; use has been associated with fluid retention, electrolyte disturbances, and hypertension. Use with caution following acute MI; corticosteroids have been associated with myocardial rupture.

• Diabetes: Use with caution in patients with diabetes mellitus; may alter glucose production/regulation leading to hyperglycemia.

• Gastrointestinal disease: Use with caution in patients with GI diseases (diverticulitis, fresh intestinal anastomoses, ulcerative colitis, active or latent peptic ulcer, abscess or other pyogenic infections) due to perforation risk. Avoid use if there is a probability of impending perforation, abscess, or other pyogenic infection.

• Hepatic impairment: Use with caution in patients with severe hepatic impairment.

• Myasthenia gravis: Use may cause transient worsening of myasthenia gravis (MG) (eg, within first 2 weeks of treatment); monitor for worsening MG (AAN [Narayanaswami 2021]).

• Osteoporosis: Use with caution in patients with or who are at risk for osteoporosis; high doses and/or long-term use of corticosteroids have been associated with increased bone loss, osteoporotic fractures, and avascular necrosis.

• Pheochromocytoma: Use with caution in patients with pheochromocytoma; cases of pheochromocytoma crisis, which can be fatal, have been reported with corticosteroids.

• Renal impairment: Use with caution in renal impairment; fluid retention may occur.

• Seizure disorders: Use with caution in patients with a history of seizure disorder.

• Systemic sclerosis: Use with caution in patients with systemic sclerosis; an increase in scleroderma renal crisis incidence has been observed with corticosteroid use. Monitor BP and renal function in patients with systemic sclerosis treated with corticosteroids (EULAR [Kowal-Bielecka 2017]).

• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroid ones.

Special populations:

• Pediatric: May affect growth velocity; growth should be routinely monitored in pediatric patients.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP 1997; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer's labeling.

Other warnings/precautions:

• Discontinuation of therapy: Withdraw therapy with gradual tapering of dose.

• Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Complete necessary immunizations ≥4 to 6 weeks prior to initiating therapy; live vaccines should not be given concurrently with deflazacort.

• Stress: Patients may require higher doses when subject to stress (ie, trauma, surgery, severe infection).

Warnings: Additional Pediatric Considerations

May cause osteoporosis (at any age) or inhibition of bone growth in pediatric patients. Use with caution in patients with osteoporosis. In a population-based study of children, risk of fracture was shown to be increased with >4 courses of corticosteroids; underlying clinical condition may also impact bone health and osteoporotic effect of corticosteroids (Leonard 2007). Increased IOP may occur, especially with prolonged use; in children, increased IOP has been shown to be dose dependent and produce a greater IOP in children <6 years than older children treated with ophthalmic dexamethasone (Lam 2005). Data suggest higher incidence of cataracts with deflazacort compared to prednisone in DMD patients (AAN [Gloss 2016]). Corticosteroids have been associated with myocardial rupture; hypertrophic cardiomyopathy has been reported in premature neonates.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Oral:

Emflaza: 22.75 mg/mL (13 mL) [contains polysorbate 80]

Tablet, Oral:

Emflaza: 6 mg, 18 mg, 30 mg, 36 mg [contains corn starch]

Generic Equivalent Available: US

No

Pricing: US

Suspension (Emflaza Oral)

22.75 mg/mL (per mL): $622.22

Tablets (Emflaza Oral)

6 mg (per each): $122.78

18 mg (per each): $368.36

30 mg (per each): $613.97

36 mg (per each): $710.73

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Oral: Administer with or without food.

Tablets: Administer whole or may crush and mix with applesauce (administer applesauce mixture immediately).

Suspension: Shake well; measure prescribed dose with provided dispenser, mix thoroughly with 3 to 4 ounces of juice or milk and administer immediately. Do not mix or administer with grapefruit juice.

Administration: Pediatric

Oral: May administer without regard to food

Oral suspension: Shake well before use; measure prescribed dose with provided dispenser; add dose to 3 to 4 ounces of juice (not grapefruit) or milk, mix thoroughly and administer immediately

Tablet: May administer whole or crush and mix with applesauce (administer applesauce mixture immediately)

Use: Labeled Indications

Duchenne muscular dystrophy: Treatment of Duchenne muscular dystrophy (DMD) in patients ≥2 years of age.

Metabolism/Transport Effects

Substrate of CYP3A4 (major), P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Abrocitinib: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Abrocitinib. Management: The use of abrocitinib in combination with other immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider therapy modification

Acetylcholinesterase Inhibitors: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Risk C: Monitor therapy

Aldesleukin: Corticosteroids (Systemic) may diminish the therapeutic effect of Aldesleukin. Risk X: Avoid combination

Amphotericin B: Corticosteroids (Systemic) may enhance the hypokalemic effect of Amphotericin B. Risk C: Monitor therapy

Androgens: Corticosteroids (Systemic) may enhance the fluid-retaining effect of Androgens. Risk C: Monitor therapy

Antacids: May decrease the bioavailability of Corticosteroids (Oral). Management: Consider separating doses by 2 or more hours. Budesonide enteric coated tablets could dissolve prematurely if given with drugs that lower gastric acid, with unknown impact on budesonide therapeutic effects. Risk D: Consider therapy modification

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Antithymocyte Globulin (Equine): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of systemic corticosteroid is reduced. Corticosteroids (Systemic) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy

Baricitinib: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Baricitinib. Management: The use of baricitinib in combination with potent immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider therapy modification

BCG Products: Corticosteroids (Systemic) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination

Bile Acid Sequestrants: May decrease the absorption of Corticosteroids (Oral). Risk C: Monitor therapy

Brincidofovir: Corticosteroids (Systemic) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy

Brivudine: May enhance the adverse/toxic effect of Corticosteroids (Systemic). Risk X: Avoid combination

Calcitriol (Systemic): Corticosteroids (Systemic) may diminish the therapeutic effect of Calcitriol (Systemic). Risk C: Monitor therapy

CAR-T Cell Immunotherapy: Corticosteroids (Systemic) may enhance the adverse/toxic effect of CAR-T Cell Immunotherapy. Specifically, the severity and duration of neurologic toxicities may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of CAR-T Cell Immunotherapy. Management: Avoid use of corticosteroids as premedication before treatment with CAR-T cell immunotherapy agents. Corticosteroids are indicated and may be required for treatment of toxicities such as cytokine release syndrome or neurologic toxicity. Risk D: Consider therapy modification

Chikungunya Vaccine (Live): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination

Cladribine: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Coccidioides immitis Skin Test: Corticosteroids (Systemic) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing systemic corticosteroids (dosed at 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks) several weeks prior to coccidioides immitis skin antigen testing. Risk D: Consider therapy modification

Corticorelin: Corticosteroids (Systemic) may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Risk C: Monitor therapy

Cosyntropin: Corticosteroids (Systemic) may diminish the diagnostic effect of Cosyntropin. Risk C: Monitor therapy

COVID-19 Vaccine (Adenovirus Vector): Corticosteroids (Systemic) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters) Risk D: Consider therapy modification

COVID-19 Vaccine (Inactivated Virus): Corticosteroids (Systemic) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy

COVID-19 Vaccine (mRNA): Corticosteroids (Systemic) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification

COVID-19 Vaccine (Subunit): Corticosteroids (Systemic) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy

COVID-19 Vaccine (Virus-like Particles): Corticosteroids (Systemic) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy

CYP3A4 Inducers (Moderate): May decrease serum concentrations of the active metabolite(s) of Deflazacort. Risk X: Avoid combination

CYP3A4 Inducers (Strong): May decrease serum concentrations of the active metabolite(s) of Deflazacort. Risk X: Avoid combination

CYP3A4 Inhibitors (Moderate): May increase serum concentrations of the active metabolite(s) of Deflazacort. Management: Administer one third of the recommended deflazacort dose when used together with a strong or moderate CYP3A4 inhibitor. Risk D: Consider therapy modification

CYP3A4 Inhibitors (Strong): May increase serum concentrations of the active metabolite(s) of Deflazacort. Management: Administer one third of the recommended deflazacort dose when used together with a strong or moderate CYP3A4 inhibitor. Risk D: Consider therapy modification

Deferasirox: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor therapy

Dengue Tetravalent Vaccine (Live): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination

Denosumab: May enhance the immunosuppressive effect of Corticosteroids (Systemic). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and systemic corticosteroids. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider therapy modification

Desirudin: Corticosteroids (Systemic) may enhance the anticoagulant effect of Desirudin. More specifically, corticosteroids may increase hemorrhagic risk during desirudin treatment. Management: Discontinue treatment with systemic corticosteroids prior to desirudin initiation. If concomitant use cannot be avoided, monitor patients receiving these combinations closely for clinical and laboratory evidence of excessive anticoagulation. Risk D: Consider therapy modification

Desmopressin: Corticosteroids (Systemic) may enhance the hyponatremic effect of Desmopressin. Risk X: Avoid combination

Deucravacitinib: May enhance the immunosuppressive effect of Corticosteroids (Systemic). Management: The use of deucravacitinib in combination with potent immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider therapy modification

Estrogen Derivatives: May increase the serum concentration of Corticosteroids (Systemic). Risk C: Monitor therapy

Etrasimod: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Etrasimod. Risk C: Monitor therapy

Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Filgotinib: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Filgotinib. Management: Coadministration of filgotinib with systemic corticosteroids at doses equivalent to greater than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks is not recommended. Risk D: Consider therapy modification

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Gallium Ga 68 Dotatate: Corticosteroids (Systemic) may diminish the diagnostic effect of Gallium Ga 68 Dotatate. Risk C: Monitor therapy

Grapefruit Juice: May increase the serum concentration of Deflazacort. Risk X: Avoid combination

Growth Hormone Analogs: Corticosteroids (Systemic) may diminish the therapeutic effect of Growth Hormone Analogs. Growth Hormone Analogs may decrease serum concentrations of the active metabolite(s) of Corticosteroids (Systemic). Risk C: Monitor therapy

Hyaluronidase: Corticosteroids (Systemic) may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Risk D: Consider therapy modification

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Corticosteroids (Systemic) may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Management: Carefully consider the need for corticosteroids, at doses of a prednisone-equivalent of 10 mg or more per day, during the initiation of immune checkpoint inhibitor therapy. Use of corticosteroids to treat immune related adverse events is still recommended Risk D: Consider therapy modification

Indium 111 Capromab Pendetide: Corticosteroids (Systemic) may diminish the diagnostic effect of Indium 111 Capromab Pendetide. Risk X: Avoid combination

Inebilizumab: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy

Influenza Virus Vaccines: Corticosteroids (Systemic) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiation of systemic corticosteroids at immunosuppressive doses. Influenza vaccines administered less than 14 days prior to or during such therapy should be repeated 3 months after therapy. Risk D: Consider therapy modification

Isoniazid: Corticosteroids (Systemic) may decrease the serum concentration of Isoniazid. Risk C: Monitor therapy

Leflunomide: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as systemic corticosteroids. Risk D: Consider therapy modification

Licorice: May increase the serum concentration of Corticosteroids (Systemic). Risk C: Monitor therapy

Loop Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Loop Diuretics. Risk C: Monitor therapy

Lutetium Lu 177 Dotatate: Corticosteroids (Systemic) may diminish the therapeutic effect of Lutetium Lu 177 Dotatate. Management: Avoid repeated use of high-doses of corticosteroids during treatment with lutetium Lu 177 dotatate. Use of corticosteroids is still permitted for the treatment of neuroendocrine hormonal crisis. The effects of lower corticosteroid doses is unknown. Risk D: Consider therapy modification

Macimorelin: Corticosteroids (Systemic) may diminish the diagnostic effect of Macimorelin. Risk X: Avoid combination

MetyraPONE: Corticosteroids (Systemic) may diminish the diagnostic effect of MetyraPONE. Management: Consider alternatives to the use of the metyrapone test in patients taking systemic corticosteroids. Risk D: Consider therapy modification

Mifamurtide: Corticosteroids (Systemic) may diminish the therapeutic effect of Mifamurtide. Risk X: Avoid combination

MiFEPRIStone: May diminish the therapeutic effect of Corticosteroids (Systemic). MiFEPRIStone may increase the serum concentration of Corticosteroids (Systemic). Management: Avoid mifepristone in patients who require long-term corticosteroid treatment of serious illnesses or conditions (eg, for immunosuppression following transplantation). Corticosteroid effects may be reduced by mifepristone treatment. Risk X: Avoid combination

Mumps- Rubella- or Varicella-Containing Live Vaccines: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

Nadofaragene Firadenovec: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination

Natalizumab: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination

Neuromuscular-Blocking Agents (Nondepolarizing): May enhance the adverse neuromuscular effect of Corticosteroids (Systemic). Increased muscle weakness, possibly progressing to polyneuropathies and myopathies, may occur. Management: If concomitant therapy is required, use the lowest dose for the shortest duration to limit the risk of myopathy or neuropathy. Monitor for new onset or worsening muscle weakness, reduction or loss of deep tendon reflexes, and peripheral sensory decriments Risk D: Consider therapy modification

Nicorandil: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nicorandil. Gastrointestinal perforation has been reported in association with this combination. Risk C: Monitor therapy

Nirmatrelvir and Ritonavir: May increase serum concentrations of the active metabolite(s) of Deflazacort. Management: Consider reducing the deflazacort dose to one-third the recommended dose during coadministration with nirmatrelvir and ritonavir. Risk D: Consider therapy modification

Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective). Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Nonselective): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Topical): May enhance the adverse/toxic effect of Corticosteroids (Systemic). Specifically, the risk of gastrointestinal bleeding, ulceration, and perforation may be increased. Risk C: Monitor therapy

Ocrelizumab: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy

Ofatumumab: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy

Ozanimod: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Ozanimod. Risk C: Monitor therapy

Pidotimod: Corticosteroids (Systemic) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: May enhance the immunosuppressive effect of Corticosteroids (Systemic). Risk X: Avoid combination

Pneumococcal Vaccines: Corticosteroids (Systemic) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

Poliovirus Vaccine (Live/Trivalent/Oral): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination

Polymethylmethacrylate: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Polymethylmethacrylate. Specifically, the risk for hypersensitivity or implant clearance may be increased. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification

Quinolones: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Quinolones. Specifically, the risk of tendonitis and tendon rupture may be increased. Risk C: Monitor therapy

Rabies Vaccine: Corticosteroids (Systemic) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification

Ritlecitinib: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination

Ritodrine: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Ritodrine. Risk C: Monitor therapy

Ruxolitinib (Topical): Corticosteroids (Systemic) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination

Salicylates: May enhance the adverse/toxic effect of Corticosteroids (Systemic). These specifically include gastrointestinal ulceration and bleeding. Corticosteroids (Systemic) may decrease the serum concentration of Salicylates. Withdrawal of corticosteroids may result in salicylate toxicity. Risk C: Monitor therapy

Sargramostim: Corticosteroids (Systemic) may enhance the therapeutic effect of Sargramostim. Specifically, corticosteroids may enhance the myeloproliferative effects of sargramostim. Risk C: Monitor therapy

Sipuleucel-T: Corticosteroids (Systemic) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing immunosuppressants, such as systemic corticosteroids, prior to initiating sipuleucel-T therapy. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone given for 2 or more weeks are immunosuppressive. Risk D: Consider therapy modification

Sodium Benzoate: Corticosteroids (Systemic) may diminish the therapeutic effect of Sodium Benzoate. Risk C: Monitor therapy

Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Corticosteroids (Systemic). Risk C: Monitor therapy

Succinylcholine: Corticosteroids (Systemic) may enhance the neuromuscular-blocking effect of Succinylcholine. Risk C: Monitor therapy

Tacrolimus (Systemic): Corticosteroids (Systemic) may decrease the serum concentration of Tacrolimus (Systemic). Conversely, when discontinuing corticosteroid therapy, tacrolimus concentrations may increase. Risk C: Monitor therapy

Tacrolimus (Topical): Corticosteroids (Systemic) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination

Talimogene Laherparepvec: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination

Tertomotide: Corticosteroids (Systemic) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination

Thiazide and Thiazide-Like Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Tofacitinib: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider therapy modification

Typhoid Vaccine: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination

Ublituximab: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy

Upadacitinib: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Upadacitinib. Management: Coadministration of upadacitinib with systemic corticosteroids at doses equivalent to greater than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks is not recommended. Risk D: Consider therapy modification

Urea Cycle Disorder Agents: Corticosteroids (Systemic) may diminish the therapeutic effect of Urea Cycle Disorder Agents. More specifically, Corticosteroids (Systemic) may increase protein catabolism and plasma ammonia concentrations, thereby increasing the doses of Urea Cycle Disorder Agents needed to maintain these concentrations in the target range. Risk C: Monitor therapy

Vaccines (Inactivated/Non-Replicating): Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to immunosuppressive corticosteroids if possible. If patients are vaccinated less than 14 days prior to or during such therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Corticosteroids (Systemic) may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy

Yellow Fever Vaccine: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination

Food Interactions

Grapefruit juice may increase total exposure to the active metabolite of deflazacort.

Management: Do not administer with grapefruit juice.

Pregnancy Considerations

Deflazacort crosses the placenta. Orofacial clefts, intrauterine growth restriction, and decreased birth weight have been reported following maternal use. Hypoadrenalism may occur in newborns following maternal use of corticosteroids in pregnancy; monitor.

Breastfeeding Considerations

Corticosteroids are excreted in breast milk. Information specific to deflazacort has not been located. According to the manufacturer, the decision to continue or discontinue breast-feeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Dietary Considerations

Grapefruit juice increases the total exposure to the active metabolite of deflazacort.

Monitoring Parameters

Blood pressure, blood glucose, electrolytes

Following prolonged use: Bone mass density, assess HPA axis suppression (eg, ACTH stimulation test, morning plasma cortisol test, urinary free cortisol test), growth in children, signs and symptoms of infection, cataract formation, intraocular pressure.

Mechanism of Action

Deflazacort is a corticosteroid prodrug; its active metabolite, 21-desDFZ, acts on the glucocorticoid receptor to exert anti-inflammatory and immunosuppressive effects. The precise mechanism by which deflazacort exerts its therapeutic effects in patients with Duchenne muscular dystrophy is unknown.

Pharmacokinetics (Adult Data Unless Noted)

Protein binding: ~40%

Metabolism: Rapidly converted by esterases to 21-desDFZ (active metabolite); 21-desDFZ metabolized by CYP3A4 to several metabolites (inactive)

Time to peak, serum: 1 hour (range: 0.25 to 2 hours); delayed by 1 hour with a high-fat meal

Excretion: Urine (~68%; 18% as 21-desDFZ)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Defal;
  • (AR) Argentina: Azacortid | Calcort | Defas | Flamirex | Zamen;
  • (BD) Bangladesh: Cortiflo | Cortimax | Deflacort | Deflazit | Defzort | Dezacot | Flacort | Imucort | Nuvicort | Refla | Xalcort | Zodef;
  • (BF) Burkina Faso: Defal;
  • (BR) Brazil: Calcort | Cortax | Deflaimmun | Deflanil | Deflazacorte | Denacen | Flaz-cort | Flazal;
  • (CH) Switzerland: Calcort;
  • (CI) Côte d'Ivoire: Defal;
  • (CL) Chile: Arrumal | Azacortid | Dezartal | Disflax;
  • (CO) Colombia: Avantium | Clobak | Cortidexan | Defal | Deflacort | Dezartal | Landacort | Lantadin;
  • (DE) Germany: Calcort;
  • (DO) Dominican Republic: Aflazacort | Avalor | Avexa | Calcort | Defal | Deflarin | Flezacor | Numival | Zamen;
  • (EC) Ecuador: Aflazacort | Calcort | Decortan | Defal | Defladol | Deflazacort mk | Flezacor | Landacort;
  • (EE) Estonia: Calcort;
  • (EG) Egypt: Flacort | Flantadin | Flazacor;
  • (ES) Spain: Deflazacort alter | Deflazacort cantabria | Deflazacort Cinfa | Deflazacort Faes | Deflazacort Kern pharma | Deflazacort Normon | Deflazacort pensa | Deflazacort ranbaxy | Deflazacort sandoz | Deflazacort tarbis | Deflazacort vir | Dezacor | Zamene;
  • (FI) Finland: Deflazacort vital pharma nordic;
  • (GB) United Kingdom: Calcort;
  • (GR) Greece: Deflan | Zamene;
  • (IE) Ireland: Calcort;
  • (IN) India: Advacort | Aerodef | Aflaze | Alvicort | Alzcort | Ambicort | Asteride | Brifcort | Caflacort | Coecortt | Cordef | Corset | Cortafin | Cortazone | Cortezar | Cortiflaz | Cortihope | Cortimax | Cortipure | Cortisa | Cortisure | Cortiza | Cortosept | Cozadef | D flator | Decdan next | Decort | Decotaz | Defagem | Defalone | Defcort | Defjoy | Defla | Deflachek | Deflacin | Deflafit | Deflamax | Deflaris | Deflawal | Deflawin | Deflaz | Deflazen | Deflex | Defley | Deflocare | Deflograf | Deflokem | Deflonem | Defloset | Defluv | Defnalone | Defnet | Defocad | Defol | Defolt | Defort | Defortin dz | Defpro | Defshield | Defsix | Defsone | Defstar | Defstead | Defsure | Defza | Defzart | Defzil | Defzo | Defzoc | Defzona | Delacort | Delzy | Desacort | Desthama | Detloc 6 | Dezacor | Dezacortin | Dezert | Dezocort | Dezomac | Dfz | Didef | Diplocort xt | Dlc | Dracort | Ducort | Dz cort | Dzcot | Eldocort | Emsolone d | Endcort | Enzocort | Eticort | Evacort | Ezacort | Fastcort | Flacort | Flamcor | Flazassil | Flozastar | G cort | Gladcort | Gracecort | Inflacort | Laza | Ldcort | Lecort | Lezatis | Mahacort dz | Man cort | Maxcort | Mdcort | Medcort | Mediflaza | Microcort | Monocortil d | Nestacort | New premisol | Nilo cort | Nusone m | Orthocort | Pancort | Pecort | Ronicort | Rzcort | Samliza | Solo d | Stemin dfl | Stercort | Syncort | Tenflay | Tyzocort | Vincort | Vozocart | Zacdef | Zacort | Zaflart | Zecort | Zedcort | Zeed | Zefcort | Zoket;
  • (IT) Italy: Deflan | Deflazacort EG | Deflazacort Fg | Deflazacort Ipso pharma | Deflazacort Pharmeg | Flantadin | Surrenol;
  • (JO) Jordan: Defal;
  • (KE) Kenya: Defcian | Deflacort | Deflaz | Deflozed | Dynacort | Safecort | Yescort;
  • (KR) Korea, Republic of: Calcort | Decort | Defla | Prandin | Telacort | Teracort;
  • (LB) Lebanon: Defal;
  • (LT) Lithuania: Calcort | Defneed | Defrut;
  • (LU) Luxembourg: Calcort;
  • (LV) Latvia: Calcort | Deflazacort West Pharma Cinfa | Dezacor | Zamene;
  • (MA) Morocco: Deflazacorte | Deflazacorte farmoz;
  • (MX) Mexico: Calcort | Cariden | Carzoflep | Cormocor | Danzafhal | Deflazacort teva | Frewer | Kisika | Levedesa | Misoneflo | Setatrep | Tovadart;
  • (NL) Netherlands: Deflazacort vital pharma nordic;
  • (NO) Norway: Calcort | Deflazacort vital pharma nordic | Flantadin;
  • (NZ) New Zealand: Calcort;
  • (PE) Peru: Aflazacort | Calcort | Corflat | Cortflat | Defal | Deflazix | Farmacortix | Flacort | Flacortex;
  • (PL) Poland: Calcort;
  • (PR) Puerto Rico: Emflaza;
  • (PT) Portugal: Deflazacorte | Deflazacorte almus | Deflazacorte APceuticals | Deflazacorte tecnicina | Desay | Rosilan;
  • (PY) Paraguay: Artrisona | Azacortid;
  • (QA) Qatar: Defal;
  • (RU) Russian Federation: Deflazacort sandoz;
  • (SE) Sweden: Calcort | Deflazacort vital pharma nordic;
  • (SI) Slovenia: Calcort;
  • (TR) Turkey: Flantadin;
  • (TW) Taiwan: Calcort;
  • (UY) Uruguay: Azacortid | Dispercort | Servicor;
  • (VE) Venezuela, Bolivarian Republic of: Calcort | Deflarin
  1. Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319. [PubMed 11487763]
  2. Birnkrant DJ, Bushby K, Bann CM, et al; DMD Care Considerations Working Group. Diagnosis and management of Duchenne muscular dystrophy, part 1: diagnosis, and neuromuscular, rehabilitation, endocrine, and gastrointestinal and nutritional management. Lancet Neurol. 2018;17(3):251-267. doi:10.1016/S1474-4422(18)30024-3 [PubMed 29395989]
  3. Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm. [PubMed 6810084]
  4. Emflaza (deflazacort) [prescribing information]. South Plainfield, NJ: PTC Therapeutics Inc; June 2021.
  5. Gloss D, Moxley RT, Ashwal S, Oskoui M. Practice guideline update summary: corticosteroid treatment of Duchenne muscular dystrophy. American Academy of Neurology. 2016. Available at http://www.neurology.org/content/86/5/465.full.pdf+html.com
  6. Goedert JJ, Vitale F, Lauria C, et al; Classical Kaposi's Sarcoma Working Group. Risk factors for classical Kaposi's sarcoma. J Natl Cancer Inst. 2002;94(22):1712-1718. [PubMed 12441327]
  7. "Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics Committee on Drugs. Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  8. Kowal-Bielecka O, Fransen J, Avouac J, et al; EUSTAR Coauthors. Update of EULAR recommendations for the treatment of systemic sclerosis. Ann Rheum Dis. 2017;76(8):1327-1339. doi: 10.1136/annrheumdis-2016-209909. [PubMed 27941129]
  9. Lam DS, Fan DS, Ng JS, et al, "Ocular Hypertensive and Anti-Inflammatory Responses to Different Dosages of Topical Dexamethasone in Children: A Randomized Trial," Clin Experiment Ophthalmol, 2005, 33(3):252-8. [PubMed 15932528]
  10. Leonard MB, "Glucocorticoid-Induced Osteoporosis in Children: Impact of the Underlying Disease," Pediatrics, 2007, 119 Suppl 2:S166-74. [PubMed 17332238]
  11. Narayanaswami P, Sanders DB, Wolfe G, et al. International consensus guidance for management of myasthenia gravis: 2020 update. Neurology. 2021;96(3):114-122. doi:10.1212/WNL.0000000000011124 [PubMed 33144515]
Topic 111930 Version 177.0

آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟