deflazacort

Contraindicated in:

Hypersensitivity;
Active untreated infections.

Use Cautiously in:

Hypopituitarism, primary adrenal insufficiency, congenital adrenal hyperplasia, thyroid dysfunction, or pheochromocytoma (↑ risk of endocrine abnormalities);
HF, hypertension, recent MI, or renal impairment;
Peptic ulcer disease, diverticulitis, recent intestinal anastomoses, or ulcerative colitis (↑ risk of GI perforation);
Myasthenia gravis (↑ risk of myopathy);
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risks to infant;
Pedi: Children <2 yr (safety and effectiveness not established); oral suspension contains benzyl alcohol, which can cause gasping syndrome in premature neonates and low-birth-weight infants.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypertension, peripheral edema, THROMBOEMBOLIC EVENTS

Derm: acne, hirsutism, erythema, rash, skin striae, TOXIC EPIDERMAL NECROLYSIS (TEN)

EENT: cataracts, epistaxis, glaucoma, rhinorrhea

Endo: Cushingoid appearance, ↓bone density, ↓growth (children), adrenal suppression, hyperglycemia

GI: abdominal pain, constipation, nausea, PEPTIC ULCERATION

Metab: ↑appetite, weight gain

MS: avascular necrosis of joints, back pain, myopathy

Neuro: headache, depression, euphoria, insomnia, irritability, mood swings

Resp: cough

Misc: fever, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), INFECTION, KAPOSI SARCOMA

Interactions ⬆ ⬇

Drug-drug:

May ↑ requirement for insulins or oral hypoglycemic agents.
May ↓ antibody response to and ↑ the risk of adverse reactions from live-virus vaccines.
Neuromuscular blocking agents may ↑ risk of acute myopathy.
Moderate CYP3A4 inhibitors and strong CYP3A4 inhibitors, including clarithromycin, fluconazole, diltiazem, or verapamil may ↑ levels of active metabolite and risk of toxicity; ↓ deflazacort dose.
Moderate CYP3A4 inducers and strong CYP3A4 inducers, including rifampin, efavirenz, carbamazepine, or phenytoin, may ↓ levels of active metabolite and therapeutic effect; avoid concurrent use.

Drug-Food:

Grapefruit juice may ↑ levels of active metabolite and risk of toxicity; ↓ deflazacort dose.

Availability ⬆ ⬇

(Generic available)

Oral suspension: 22.75 mg/mL
Tablets: 6 mg; 18 mg; 30 mg; 36 mg

Route/Dosage ⬆ ⬇

PO (Adults and Children ≥2 yr): 0.9 mg/kg once daily. Concurrent use of moderate or strong CYP3A4 inhibitors: Give ⅓ the recommended dose.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Exerts anti-inflammatory and immunosuppressive effects. Mechanism for therapeutic effect in DMD not fully known.

Therapeutic effects:

Improved muscle strength.

Classifications ⬆ ⬇

Therapeutic Classification: anti-inflammatories, Immunosuppressant agents, none assigned

Pharmacologic Classification: corticosteroids

Pharmacokinetics ⬆ ⬇

Absorption: Rapidly absorbed.

Distribution: Unknown.

Metabolism/Excretion: Parent drug (prodrug) is rapidly metabolized by esterases to active metabolite (21-desDFZ), which is then further metabolized by the CYP3A4 isoenzyme to inactive metabolites. Primarily excreted in urine.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	1 hr	unknown

Patient/Family Teaching ⬆ ⬇

Educate patient on reason for deflazacort and side effects. Instruct patient and parents to take as directed. Do not stop taking without consulting health care professional; must be discontinued gradually. Take missed doses as soon as remembered unless almost time for next dose. Do not double doses. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
Stopping the medication suddenly may result in adrenal insufficiency (anorexia, nausea, weakness, fatigue, dyspnea, hypotension, hypoglycemia), which can be life-threatening. If these signs appear, notify health care professional immediately.
Caution patient to avoid vaccinations without first consulting health care professional. Advise patient to avoid live-virus vaccines during therapy.
Instruct patient to notify health care professional if signs and symptoms of infection, ↑ BP or fluid retention, behavioral or mood disturbances (manic or depressive symptoms), or rash occur. Instruct patient to notify health care professional immediately if exposed to chickenpox or measles.
Corticosteroids cause immunosuppression and may mask symptoms of infection; may worsen existing TB; fungal, bacterial, viral, or parasitic infections or ocular herpes simplex.
Advise patient to notify health care professional of signs and symptoms of hypercorticism (acne; thicker or more hair on body and face; bruising easily; fatty pad or hump between shoulders [buffalo hump]; rounding of face [moon face]; pink or purple stretch marks on skin of abdomen, thighs, breasts, and arms; ankle swelling), adrenal suppression (tiredness, weakness, nausea and vomiting, low BP), worsening of allergies (eczema, rhinitis), or infection (fever, chills, pain, feeling tired, aches, nausea and vomiting).
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Advise patient to avoid grapefruit juice during therapy.
Inform patient of need for periodic bone mineral density and ophthalmalogic exams.
Pedi: Advise parents that use may cause shortened stature.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Deflazacort readily crosses the placenta. Adverse developmental outcomes (including cleft lip, with or without cleft palate; intrauterine growth restriction) and ↓ birth weight have occurred with maternal use of corticosteroids (including this drug) during pregnancy. Hypoadrenalism may occur in infants born to mothers receiving corticosteroids during pregnancy. Observe infant for signs of hypoadrenalism (poor feeding, irritability, weakness, vomiting).

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

42998- Marathon Pharmaceuticals, LLC
- 42998-501- EMFLAZA
  - 42998-501-01- 100 TABLET in 1 BOTTLE (42998-501-01)

42998- Marathon Pharmaceuticals, LLC
- 42998-502- EMFLAZA
  - 42998-502-03- 30 TABLET in 1 BOTTLE (42998-502-03)

42998- Marathon Pharmaceuticals, LLC
- 42998-503- EMFLAZA
  - 42998-503-03- 30 TABLET in 1 BOTTLE (42998-503-03)

42998- Marathon Pharmaceuticals, LLC
- 42998-504- EMFLAZA
  - 42998-504-03- 30 TABLET in 1 BOTTLE (42998-504-03)

42998- Marathon Pharmaceuticals, LLC
- 42998-505- EMFLAZA
  - 42998-505-21- 13 mL in 1 BOTTLE (42998-505-21)

52856- PTC Therapeutics, Inc.
- 52856-501- EMFLAZA
  - 52856-501-01- 100 TABLET in 1 BOTTLE (52856-501-01)

52856- PTC Therapeutics, Inc.
- 52856-502- EMFLAZA
  - 52856-502-03- 30 TABLET in 1 BOTTLE (52856-502-03)

52856- PTC Therapeutics, Inc.
- 52856-503- EMFLAZA
  - 52856-503-03- 30 TABLET in 1 BOTTLE (52856-503-03)

52856- PTC Therapeutics, Inc.
- 52856-504- EMFLAZA
  - 52856-504-03- 30 TABLET in 1 BOTTLE (52856-504-03)

52856- PTC Therapeutics, Inc.
- 52856-505- EMFLAZA
  - 52856-505-21- 13 mL in 1 BOTTLE (52856-505-21)

52856- PTC Therapeutics, Inc.
- 52856-505- EMFLAZA
  - 52856-505-22- 13 mL in 1 BOTTLE (52856-505-22)

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇