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Deflazacort: Drug information

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

For abbreviations, symbols, and age group definitions 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: Liver 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: Adjustment for Toxicity: Adult

Infection: Consider dosage reduction or discontinuing deflazacort as needed.

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: Liver 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: Corticosteroids suppress the immune system and increase risk of infection with any pathogen, including bacterial, fungal, helminthic, protozoan, or viral; severe and sometimes fatal corticosteroid-associated infections have occurred. Corticosteroids may reduce resistance to new infections, exacerbate existing infections, increase the risk of disseminated infections, increase the risk of reactivation or exacerbation of latent infections, or mask some signs of infection. Avoid exposure to varicella or measles; if exposure occurs, prophylaxis with an appropriate immunoglobulin may be indicated; antiviral treatment may be considered if varicella infection occurs. Tuberculosis reactivation may occur when treating patients with latent tuberculosis or tuberculin reactivity; administer chemoprophylaxis in patients with latent tuberculosis or tuberculin reactivity during prolonged use of deflazacort. Avoid use in patients with active ocular herpes simplex. Hepatitis B reactivation can occur (infrequently) in patients who are hepatitis B carriers. For patients who show evidence of hepatitis B infection, consult an infectious disease specialist regarding monitoring and treatment options before initiating deflazacort. May exacerbate systemic fungal infections. Amebiasis reactivation may occur. Use with extreme caution in patients with Strongyloides infections; hyperinfection, dissemination and fatalities have occurred. Avoid use in patients with cerebral malaria.

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma; clinical improvement may occur with deflazacort discontinuation.

• 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]

Generic: 22.75 mg/mL (13 mL)

Tablet, Oral:

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

Generic: 6 mg, 18 mg, 30 mg, 36 mg

Generic Equivalent Available: US

Yes

Pricing: US

Suspension (Deflazacort Oral)

22.75 mg/mL (per mL): $583.33

Suspension (Emflaza Oral)

22.75 mg/mL (per mL): $622.22

Tablets (Deflazacort Oral)

6 mg (per each): $98.23 - $110.50

18 mg (per each): $294.69 - $331.52

30 mg (per each): $491.17 - $552.56

36 mg (per each): $568.59 - $639.65

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.

Medication Safety Issues
International issues:

Prandin [South Korea] may be confused with Avandia brand name for rosiglitazone [US, Canada, and multiple international markets]

Prandin brand name for deflazacort [South Korea], but also brand name for repaglinide [multiple international markets]

Metabolism/Transport Effects

Substrate of CYP3A4 (Major), P-glycoprotein (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 drug interactions program by clicking on the “Launch drug interactions program” link above.

Abrocitinib: Corticosteroids (Systemic) may increase immunosuppressive effects 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 increase adverse/toxic effects of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Risk C: Monitor

Aldesleukin: Corticosteroids (Systemic) may decrease therapeutic effects of Aldesleukin. Risk X: Avoid

Amphotericin B: Corticosteroids (Systemic) may increase hypokalemic effects of Amphotericin B. Risk C: Monitor

Androgens: Corticosteroids (Systemic) may increase fluid-retaining effects of Androgens. Risk C: Monitor

Antacids: May decrease 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 decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor

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

Baricitinib: Corticosteroids (Systemic) may increase immunosuppressive effects 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 decrease therapeutic effects of BCG Products. Corticosteroids (Systemic) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

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

Brincidofovir: Corticosteroids (Systemic) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Corticosteroids (Systemic). Risk X: Avoid

Calcitriol (Systemic): Corticosteroids (Systemic) may decrease therapeutic effects of Calcitriol (Systemic). Risk C: Monitor

CAR-T Cell Immunotherapy: Corticosteroids (Systemic) may decrease therapeutic effects of CAR-T Cell Immunotherapy. Corticosteroids (Systemic) may increase adverse/toxic effects of CAR-T Cell Immunotherapy. Specifically, the severity and duration of neurologic toxicities may be increased. 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

Cardiac Glycosides: Corticosteroids (Systemic) may increase adverse/toxic effects of Cardiac Glycosides. Risk C: Monitor

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

Cladribine: Corticosteroids (Systemic) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

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

Coccidioides immitis Skin Test: Coadministration of Corticosteroids (Systemic) and Coccidioides immitis Skin Test may alter diagnostic results. 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 decrease therapeutic effects of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Risk C: Monitor

Cosyntropin: Coadministration of Corticosteroids (Systemic) and Cosyntropin may alter diagnostic results. Risk C: Monitor

COVID-19 Vaccine (Inactivated Virus): Corticosteroids (Systemic) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Corticosteroids (Systemic) may decrease therapeutic effects 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 decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

CYP3A4 Inducers (Moderate): May decrease active metabolite exposure of Deflazacort. Risk X: Avoid

CYP3A4 Inducers (Strong): May decrease active metabolite exposure of Deflazacort. Risk X: Avoid

CYP3A4 Inhibitors (Moderate): May increase active metabolite exposure 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 active metabolite exposure 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 increase adverse/toxic effects of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor

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

Denosumab: May increase immunosuppressive effects 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 increase anticoagulant effects 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 increase hyponatremic effects of Desmopressin. Risk X: Avoid

Deucravacitinib: May increase immunosuppressive effects 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

Dinutuximab Beta: Corticosteroids (Systemic) may increase immunosuppressive effects of Dinutuximab Beta. Management: Corticosteroids are not recommended for 2 weeks prior to dinutuximab beta, during therapy and for 1 week after treatment. Doses equivalent to over 2 mg/kg or 20 mg/day of prednisone (persons over 10 kg) for 2 or more weeks are considered immunosuppressive Risk D: Consider Therapy Modification

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

Etrasimod: Corticosteroids (Systemic) may increase immunosuppressive effects of Etrasimod. Risk C: Monitor

Filgotinib: Corticosteroids (Systemic) may increase immunosuppressive effects 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 serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification

Gallium Ga 68 Dotatate: Coadministration of Corticosteroids (Systemic) and Gallium Ga 68 Dotatate may alter diagnostic results. Risk C: Monitor

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

Growth Hormone Analogs: Corticosteroids (Systemic) may decrease therapeutic effects of Growth Hormone Analogs. Growth Hormone Analogs may decrease active metabolite exposure of Corticosteroids (Systemic). Risk C: Monitor

Hyaluronidase: Corticosteroids (Systemic) may decrease therapeutic effects 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 decrease therapeutic effects 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: Coadministration of Corticosteroids (Systemic) and Indium 111 Capromab Pendetide may alter diagnostic results. Risk X: Avoid

Inebilizumab: Corticosteroids (Systemic) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

Influenza Virus Vaccines: Corticosteroids (Systemic) may decrease therapeutic effects 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 serum concentration of Isoniazid. Risk C: Monitor

Leflunomide: Corticosteroids (Systemic) may increase immunosuppressive effects 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 serum concentration of Corticosteroids (Systemic). Risk C: Monitor

Loop Diuretics: Corticosteroids (Systemic) may increase hypokalemic effects of Loop Diuretics. Risk C: Monitor

Lutetium Lu 177 Dotatate: Corticosteroids (Systemic) may decrease therapeutic effects 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: Coadministration of Corticosteroids (Systemic) and Macimorelin may alter diagnostic results. Risk X: Avoid

MetyraPONE: Coadministration of Corticosteroids (Systemic) and MetyraPONE may alter diagnostic results. Management: Consider alternatives to the use of the metyrapone test in patients taking systemic corticosteroids. Risk D: Consider Therapy Modification

Mifamurtide: Corticosteroids (Systemic) may decrease therapeutic effects of Mifamurtide. Risk X: Avoid

MiFEPRIStone: May decrease therapeutic effects of Corticosteroids (Systemic). MiFEPRIStone may increase 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

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

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

Natalizumab: Corticosteroids (Systemic) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Neuromuscular-Blocking Agents (Nondepolarizing): May increase adverse neuromuscular effects 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 increase adverse/toxic effects of Nicorandil. Gastrointestinal perforation has been reported in association with this combination. Risk C: Monitor

Nirmatrelvir and Ritonavir: May increase active metabolite exposure 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 increase adverse/toxic effects of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective). Risk C: Monitor

Nonsteroidal Anti-Inflammatory Agents (Nonselective): Corticosteroids (Systemic) may increase adverse/toxic effects of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Risk C: Monitor

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

Ocrelizumab: Corticosteroids (Systemic) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Corticosteroids (Systemic) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Ozanimod: Corticosteroids (Systemic) may increase immunosuppressive effects of Ozanimod. Risk C: Monitor

Pidotimod: Corticosteroids (Systemic) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: May increase immunosuppressive effects of Corticosteroids (Systemic). Risk X: Avoid

Pneumococcal Vaccines: Corticosteroids (Systemic) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

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

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

Rabies Vaccine: Corticosteroids (Systemic) may decrease therapeutic effects 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 increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Ritodrine: Corticosteroids (Systemic) may increase adverse/toxic effects of Ritodrine. Risk C: Monitor

Ruxolitinib (Topical): Corticosteroids (Systemic) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

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

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

Sipuleucel-T: Corticosteroids (Systemic) may decrease therapeutic effects 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

Sitafloxacin: Corticosteroids (Systemic) may increase adverse/toxic effects of Sitafloxacin. Specifically, the risk of tendonitis and tendon rupture may be increased. Management: Consider alternatives to coadministration of corticosteroids and sitafloxacin unless the benefits of coadministration outweigh the risk of tendon disorders. Risk D: Consider Therapy Modification

Sodium Benzoate: Corticosteroids (Systemic) may decrease therapeutic effects of Sodium Benzoate. Risk C: Monitor

Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Corticosteroids (Systemic). Risk C: Monitor

Succinylcholine: Corticosteroids (Systemic) may increase neuromuscular-blocking effects of Succinylcholine. Risk C: Monitor

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

Tacrolimus (Topical): Corticosteroids (Systemic) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Corticosteroids (Systemic) may increase adverse/toxic effects 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

Tertomotide: Corticosteroids (Systemic) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Thiazide and Thiazide-Like Diuretics: Corticosteroids (Systemic) may increase hypokalemic effects of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor

Tofacitinib: Corticosteroids (Systemic) may increase immunosuppressive effects 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 decrease therapeutic effects of Typhoid Vaccine. Corticosteroids (Systemic) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Corticosteroids (Systemic) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Corticosteroids (Systemic) may increase immunosuppressive effects 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 decrease therapeutic effects 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

Vaccines (Non-Live/Inactivated/Non-Replicating): Corticosteroids (Systemic) may decrease therapeutic effects of Vaccines (Non-Live/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: Corticosteroids (Systemic) may increase anticoagulant effects of Vitamin K Antagonists. Risk C: Monitor

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

Zoster Vaccine (Live/Attenuated): Corticosteroids (Systemic) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

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

BP; blood glucose, electrolytes; screen for hepatitis B prior to initiation; latent or active amebiasis prior to initiation in patients who have spent time in tropical climates or have unexplained diarrhea.

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; reactivation of tuberculosis in patients with latent tuberculosis or tuberculin reactivity; cataract formation and 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: Cordef | Cortiflo | Cortimax | Defcort | Deflacort | Deflaxen | 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 | Flacort | 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;
  • (FR) France: Deflazacort alter;
  • (GB) United Kingdom: Calcort;
  • (GR) Greece: Deflan | Zamene;
  • (IE) Ireland: Calcort;
  • (IN) India: Actroid | Advacort | Aerodef | Aflaze | Alnacort | Alvicort | Alzcort | Ambicort | Apcort | Asteride | Averdef | Brifcort | Caflacort | Cartivent | Coecortt | Cordef | Corset | Cortafin | Cortazone | Cortezar | Cortiflaz | Cortihope | Cortimax | Cortipure | Cortisa | Cortisure | Cortiza | Cortosept | Cozadef | Cygna cort 6 | D flator | Daxicort | Decdan next | Decort | Decotaz | Defagem | Defalone | Defcade | Defcor | Defcort | Defdoze | Defjoy | Defla | Deflacet | Deflachek | Deflacin | Deflafit | Deflamax | Deflaris | Deflatis | 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 | Deltacort | Delzy | Desacort | Desthama | Detloc 6 | Dewfladew | Dezacor | Dezacortin | Dezert | Dezocort | Dezomac | Dfz | Diascort | 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 | Indacort | Inflacort | Laza | Ldcort | Lecort | Lezatis | Mahacort dz | Man cort | Maxcort | Mdcort | Medcort | Mediflaza | Microcort | Moaid | Monocortil d | Nestacort | New premisol | Nilo cort | Nusone m | Orthocort | Osmocort | Pancort | Pecort | Predicort d | Realcort | Ronicort | Rzcort | Safcot | Samliza | Sencort | Solme | 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 | Edemacort | Famacort | 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 | Dezacor | Flantadin;
  • (RU) Russian Federation: Deflan | Deflazacort EG | Deflazacort sandoz | Defza | Flantadin;
  • (SE) Sweden: Calcort | Deflazacort vital pharma nordic;
  • (SI) Slovenia: Calcort;
  • (TR) Turkey: Flantadin;
  • (TW) Taiwan: Calcort;
  • (UG) Uganda: Defal | Deflagen;
  • (UY) Uruguay: Azacortid | Dispercort | Servicor;
  • (VE) Venezuela, Bolivarian Republic of: Bioflazacort | Calcort | Deflarin;
  • (VN) Viet Nam: Basmetin | Dezfast | Flazacort | Tamdeflo
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