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Deflazacort is a brand name for Deflazacort. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Additional pediatric use information is approved for PTC Therapeutics, Inc.'s Emflaza™ (deflazacort) tablets. However, due to PTC Therapeutics, Inc.'s marketing…
Verbatim from this product's FDA label. Tap a section to expand.
9 mg/kg/day administered orally. 2 ) Discontinue gradually when administered for more than a few days. 1 Assessments Prior to First Dose of Deflazacort Tablets Administer all immunizations according to immunization guidelines prior to starting deflazacort tablets.
8) ]. 9 mg/kg/day once daily. If tablets are used, round up to the nearest possible dose. Any combination of the four deflazacort tablet strengths can be used to achieve this dose. 1) ] . 4 Important Preparation and Administration Instructions Deflazacort tablets can be taken with or without food.
1) ]. Deflazacort tablets can be administered whole or crushed and taken immediately after mixing with applesauce. 5 Dosage Modification for Use with CYP3A4 Inhibitors and Inducers CYP3A4 Inhibitors Give one third of the recommended dosage when deflazacort tablets are administered with moderate or strong CYP3A4 inhibitors.
3) ]. 3) ].
15) ] The most common adverse reactions (≥ 10% for deflazacort and greater than placebo) are Cushingoid appearance, weight increased, increased appetite, upper respiratory tract infection, cough, pollakiuria, hirsutism, central obesity and nasopharyngitis.
gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In Study 1 [see Clinical Studies ( 14) ], the adverse reactions that were associated with deflazacort treatment discontinuation, in decreasing order of frequency, were weight increased, obesity, cataract and sleep disorder. 9 mg/kg/day deflazacort-treated group and that occurred more frequently than in placebo patients in Study 1, which included patients with DMD between the ages of 5 and 15 years.
9 mg/kg/d (N=51) % at 12 weeks Placebo (N=50) % at 12 weeks 1 Cushingoid appearance 33 12 Weight increased 20 6 Increased appetite 14 2 Upper respiratory tract infection 12 10 Cough 12 6 Pollakiuria 12 2 Nasopharyngitis 10 6 Hirsutism 10 2 Central obesity 10 4 Erythema 8 6 Irritability 8 4 Rhinorrhea 8 0 Abdominal discomfort 6 2 1 At 12 weeks placebo patients were re-randomized to receive either deflazacort or an active comparator.
9 mg/kg/day in the 12-week placebo-controlled phase of the trial include Cushingoid appearance (60%), hirsutism (35%), weight increased (28%), erythema (28%), central obesity (25%), abdominal pain/abdominal pain upper (18% combined), pollakiuria (15%), constipation (10%), irritability (10%), abnormal behavior (9%), pyrexia (9%), back pain (7%), rash (7%), contusion (6%), nausea (6%), psychomotor hyperactivity (6%), epistaxis (6%) and skin striae (6%).
5 WARNINGS AND PRECAUTIONS Alterations in Endocrine Function: Hypothalamic-pituitary-adrenal axis suppression, Cushing’s syndrome and hyperglycemia can occur; Monitor patients for these conditions with chronic use of deflazacort. 1 ) Immunosuppression and Increased Risk of Infection : Increased risk of new, exacerbation, dissemination, or reactivation of latent infections, which can be severe and at times fatal; Signs and symptoms of infection may be masked.
2 ) Alterations in Cardiovascular/Renal Function: Monitor for elevated blood pressure and sodium and for decreased potassium levels. 3 ) Gastrointestinal Perforation: Increased risk in patients with certain GI disorders; Signs and symptoms may be masked.
4 ) Behavioral and Mood Disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression and psychosis. 5 ) Effects on Bones: Monitor for decreases in bone mineral density with chronic use of deflazacort.
6 ) Ophthalmic Effects: May include cataracts, infections and glaucoma; Monitor intraocular pressure if deflazacort is continued for more than 6 weeks. 7 ) Vaccination: Do not administer live or live attenuated vaccines to patients receiving immunosuppressive doses of corticosteroids.
Administer live-attenuated or live vaccines at least 4 to 6 weeks prior to starting deflazacort. 8 ) Serious Skin Rashes: Discontinue at the first sign of rash, unless the rash is clearly not drug related. 1 Alterations in Endocrine Function Corticosteroids, such as deflazacort, can cause serious and life-threatening alterations in endocrine function, especially with chronic use.
Monitor patients receiving deflazacort for Cushing’s syndrome, hyperglycemia and adrenal insufficiency after deflazacort withdrawal. In addition, patients with hypopituitarism, primary adrenal insufficiency or congenital adrenal hyperplasia, altered thyroid function, or pheochromocytoma may be at increased risk for adverse endocrine events.
4 CONTRAINDICATIONS Deflazacort tablet is contraindicated in patients with known hypersensitivity to deflazacort or to any of the inactive ingredients. 2) ] . Hypersensitivity to deflazacort or any of the inactive ingredients in deflazacort tablets.
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2 mg/kg/day). 2 mg/kg/day over 52 weeks was associated with a higher incidence of certain adverse reactions, including Cushingoid appearance (69%), erythema (49%), hirsutism (37%), headache (34%), weight increased (32%), constipation (15%), abdominal pain upper (14%), skin striae (11%), acne (11%) and abdominal discomfort (8%).
2) ]. In an additional clinical study of two years duration with extended follow-up (Study 2), many of the same adverse reactions were observed. In addition, musculoskeletal events associated with long-term steroid use were also observed, including muscle weakness, tendon disorder and osteopenia.
Less Common Adverse Reactions Observed in Clinical Studies Other adverse reactions (≥ 1% frequency in any deflazacort treatment group and greater than placebo) that were observed during the 12-week placebo-controlled phase of Study 1 are shown below.
2 Post-marketing Experience The following adverse reactions have been reported during post-approval use of deflazacort worldwide or during post-approval use of other corticosteroids. These reactions are reported voluntarily from a population of uncertain size; therefore, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders:
Leukocytosis Cardiac Disorder: Heart failure Eye Disorders: Chorioretinopathy, corneal or scleral thinning Gastrointestinal Disorders: Acute pancreatitis (especially in children), hemorrhage, peptic ulceration, perforation of peptic ulcer General Disorders and Administration Site Conditions: Edema, impaired healing Immune System Disorders: Hypersensitivity including anaphylaxis Metabolism and Nutrition Disorders: Impaired carbohydrate tolerance with increased requirement for anti-diabetic therapy, negative protein and calcium balance, potassium loss and hypokalemic alkalosis when co-administered with beta 2-agonist and xanthines Musculoskeletal and Connective Tissue Disorders: Avascular necrosis, muscle wasting, negative nitrogen balance, tendonitis and tendon rupture when co-administered with quinolones, vertebral and long bone fractures Nervous System Disorders: Aggravation of epilepsy, increased intra-cranial pressure with papilledema in children (pseudotumor cerebri) usually after treatment withdrawal, vertigo Psychiatric Disorders: Anxiety, cognitive dysfunction including confusion and amnesia, delusions, hallucinations, mania, suicidal thoughts Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis Vascular Disorders: Thromboembolism, in particular in patients with underlying conditions associated with increased thrombotic tendency, benign intracranial hypertension
Risk of Adrenal Insufficiency Following Corticosteroid Withdrawal Corticosteroids produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, with the potential for the development of secondary adrenal insufficiency after withdrawal of corticosteroid treatment.
Acute adrenal insufficiency can occur if corticosteroids are withdrawn abruptly and can be fatal. The degree and duration of adrenocortical insufficiency produced is variable among patients and depends on the dose, frequency and duration of corticosteroid therapy.
The risk is reduced by gradually tapering the corticosteroid dose when withdrawing treatment. This insufficiency may persist, however, for months after discontinuation of prolonged therapy; therefore, in any situation of stress occurring during that period of discontinuation, corticosteroid therapy should be reinstituted.
For patients already taking corticosteroids during times of stress, the dosage may need to be increased. A steroid “withdrawal syndrome”, seemingly unrelated to adrenocortical insufficiency, may also occur following abrupt discontinuance of corticosteroids.
This syndrome includes symptoms such as anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, desquamation, myalgia and/or weight loss. These effects are thought to be due to the sudden change in corticosteroid concentration rather than to low corticosteroid levels.
Cushing’s Syndrome Cushing’s syndrome (hypercortisolism) occurs with prolonged exposure to exogenous corticosteroids, including deflazacort. Symptoms include hypertension, truncal obesity and thinning of the limbs, purple striae, facial rounding, facial plethora, muscle weakness, easy and frequent bruising with thin fragile skin, posterior neck fat deposition, osteopenia, acne, amenorrhea, hirsutism and psychiatric abnormalities.
Hyperglycemia Corticosteroids can increase blood glucose, worsen pre-existing diabetes, predispose those on long-term therapy to diabetes mellitus and may reduce the effect of anti-diabetic drugs. Monitor blood glucose at regular intervals.
For patients with hyperglycemia, anti-diabetic treatment should be initiated or adjusted accordingly. Considerations for Use in Patients with Altered Thyroid Function Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients.
Changes in thyroid status of the patient may necessitate a dose adjustment of the corticosteroid. When concomitant administration of corticosteroids and levothyroxine is required, administration of corticosteroid should precede the initiation of levothyroxine therapy to reduce the risk of adrenal crisis.
Pheochromocytoma Crisis There have been reports of pheochromocytoma crisis, which can be fatal, after administration of systemic corticosteroids. In patients with suspected or identified pheochromocytoma, consider the risk of pheochromocytoma crisis prior to administering corticosteroids.
2 Immunosuppression and Increased Risk of Infection Corticosteroids, including deflazacort, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens.
Corticosteroids can:
Reduce resistance to new infections Exacerbate existing infections Increase the risk of disseminated infections Increase the risk of reactivation or exacerbation of latent infections Mask some signs of infections Corticosteroid-associated infections can be mild but can be severe and at times fatal.
The rate of infectious complications increases with increasing corticosteroid dosages. Monitor for the development of infection and consider deflazacort withdrawal or dosage reduction as needed. Tuberculosis If deflazacort is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of tuberculosis may occur.
Closely monitor such patients for reactivation. During prolonged deflazacort therapy, patients with latent tuberculosis or tuberculin reactivity should receive chemoprophylaxis. Varicella Zoster and Measles Viral Infections Varicella and measles can have a serious or even fatal course in non-immune patients taking corticosteroids, including deflazacort.
In corticosteroid-treated patients who have not had these diseases or are non-immune, particular care should be taken to avoid exposure to varicella and measles. If an deflazacort-treated patient is exposed to varicella, prophylaxis with varicella zoster immunoglobulin may be indicated.
If varicella develops, treatment with antiviral agents may be considered. If an deflazacort-treated patient is exposed to measles, prophylaxis with immunoglobulin may be indicated. Hepatitis B Virus Reactivation Hepatitis B virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteroids, including deflazacort.
Reactivation can also occur infrequently in corticosteroid-treated patients who appear to have resolved hepatitis B infection. , prolonged) treatment with deflazacort. For patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy.
Fungal Infections Corticosteroids, including deflazacort, may exacerbate systemic fungal infections; therefore, avoid deflazacort use in the presence of such infections unless deflazacort is needed to control drug reactions. For patients on chronic deflazacort therapy who develop systemic fungal infections, deflazacort withdrawal or dose reduction is recommended.
Amebiasis Corticosteroids, including deflazacort, may activate latent amebiasis. Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating deflazacort in patients who have spent time in the tropics or patients with unexplained diarrhea.
Strongyloides Infestation Corticosteroids, including deflazacort, should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.
Cerebral Malaria Avoid corticosteroids, including deflazacort, in patients with cerebral malaria. 3 Alterations in Cardiovascular/Renal Function Corticosteroids, including deflazacort, can cause elevation of blood pressure, salt and water retention and increased excretion of potassium and calcium.
Monitor blood pressure and assess for signs and symptoms of volume overload. Monitor serum potassium levels. Dietary salt restriction and potassium supplementation may be necessary. Deflazacort should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.
Literature reports suggest an association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with deflazacort should be used with great caution in these patients.
4 Gastrointestinal Perforation There is an increased risk of gastrointestinal perforation during corticosteroid use in patients with certain gastrointestinal disorders such as active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses and non-specific ulcerative colitis.
Signs of gastrointestinal perforation, such as peritoneal irritation, may be masked in patients receiving corticosteroids. Avoid corticosteroids if there is a probability of impending perforation, abscess, or other pyogenic infections; diverticulitis; fresh intestinal anastomoses; or active or latent peptic ulcer.
5 Behavioral and Mood Disturbances Potentially severe psychiatric adverse reactions may occur with systemic corticosteroids, including deflazacort . Symptoms typically emerge within a few days or weeks of starting treatment and may be dose-related.
These reactions may improve after either dose reduction or withdrawal, although pharmacologic treatment may be necessary. , euphoria, insomnia, mood swings) during treatment and depressive episodes after discontinuation of treatment.
Inform patients or caregivers of the potential for behavioral and mood changes and encourage them to seek medical attention if psychiatric symptoms develop, especially if depressed mood or suicidal ideation is suspected. , decreasing absorption and increasing excretion) and inhibition of osteoblast function.
This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of bone loss at any age.
Bone loss can predispose patients to vertebral and long bone fractures. Consider a patient’s risk of osteoporosis before initiating corticosteroid therapy. Monitor bone mineral density in patients on long-term treatment with deflazacort.
Avascular Necrosis Corticosteroids, including deflazacort, may cause avascular necrosis. 7 Ophthalmic Effects Use of corticosteroids, including deflazacort, may produce posterior subcapsular cataracts. Corticosteroids may also cause glaucoma with possible damage to the optic nerves and may increase the risk of secondary ocular infections caused by bacteria, fungi, or viruses.
Corticosteroids are not recommended for patients with active ocular herpes simplex. Intraocular pressure may become elevated in some patients taking corticosteroids. If treatment with deflazacort is continued for more than 6 weeks, monitor intraocular pressure.
8 Immunizations Administer all immunizations according to immunization guidelines prior to starting deflazacort. Administer live-attenuated or live vaccines at least 4 to 6 weeks prior to starting deflazacort. Patients on deflazacort may receive concurrent vaccinations, except for live-attenuated or live vaccines.
9 Serious Skin Rashes Toxic epidermal necrolysis has been reported with the use of deflazacort with symptoms beginning within 8 weeks of starting treatment. Discontinue at the first sign of rash, unless the rash is clearly not drug related.
10 Effects on Growth and Development Long-term use of corticosteroids, including deflazacort, can have negative effects on growth and development in children. , myasthenia gravis) may be at increased risk of developing acute myopathy.
This acute myopathy is generalized, may involve ocular and respiratory muscles and may result in quadriparesis. Elevation of creatine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years.
12 Kaposi’s Sarcoma Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement of Kaposi’s sarcoma.
14 Thromboembolic Events Observational studies have shown an increased risk of thromboembolism (including venous thromboembolism) particularly with higher cumulative doses of corticosteroids. It is unclear if risk differs by daily dose or duration of use.
Use deflazacort with caution in patients who have or may be predisposed to thromboembolic disorders. 15 Anaphylaxis Rare instances of anaphylaxis have occurred in patients receiving corticosteroid therapy, including deflazacort.