LET YOUR PATIENTS KNOW ABOUT THE CONVENIENT ONCE-A-DAY DOSING OF EMFLAZA

Below you will find helpful information about how to administer EMFLAZA, dosing considerations, and potential drug interactions.1


EMFLAZA® (deflazacort) is available in 2 formulations that can be taken with or without food. Recommended dosing (approximately 0.9 mg/kg/day) for both formulations.1

Available in 4 tablet strengths1
image of emflaza tablets
Tablets not shown at actual size.
Oral suspension1
image of emflaza oral suspension
Bottle not shown at actual size.

Tablets

  • Round up to the nearest possible dose (any combination of the 4 tablet strengths can be used to achieve this dose)

  • Tablets can be administered whole or crushed and taken immediately after mixing in applesauce

Oral Suspension

  • Round up to the nearest tenth of a milliliter (mL)

  • Supplied as 13 mL bottle copackaged with oral dispensers

  • Add oral suspension to 3-4 oz. juice or milk, mix well, and administer immediately

  • EMFLAZA should not be taken with grapefruit or grapefruit juice

  • Replace cap tightly on bottle and clean oral dispenser after each use

  • Discard any unused EMFLAZA oral suspension remaining after 1 month of first opening the bottle


EMFLAZA is dosed at approximately 0.9 mg/kg/day by weight1

Recommended Dose for Tablets (mg)
Weight
kg (lb)
Dose (mg) 36
mg
tablet
30
mg
tablet
18
mg
tablet
6
mg
tablet
10 kg – 13 kg
(22 lb – 29 lb)
9 mg – 11.7 mg 0 0 0 2
14 kg – 20 kg
(31 lb – 44 lb)
12.6 mg – 18 mg 0 0 1 0
21 kg – 26 kg
(46 lb – 57 lb)
18.9 mg – 23.4 mg 0 0 1 1
27 kg – 33 kg
(60 lb – 73 lb)
24.3 mg – 29.7 mg 0 1 0 0
34 kg – 40 kg
(75 lb – 88 lb)
30.6 mg – 36 mg 1 0 0 0
41 kg – 46 kg
(90 lb – 101 lb)
36.9 mg – 41.4 mg 1 0 0 1
47 kg – 53 kg
(104 lb – 117 lb)
42.3 mg – 47.7 mg 0 1 1 0
54 kg – 60 kg
(119 lb – 132 lb)
48.6 mg – 54 mg 1 0 1 0
61 kg – 66 kg
(134 lb – 146 lb)
54.9 mg – 59.4 mg 0 2 0 0
67 kg – 73kg
(148 lb – 161 lb)
60.3 mg – 65.7 mg 1 1 0 0
74 kg – 80 kg
(163 lb – 176 lb)
66.6 mg – 72 mg 2 0 0 0
81 kg – 86 kg
(179 lb – 190 lb)
72.9 mg – 77.4 mg 2 0 0 1
87 kg – 93 kg
(192 lb – 205 lb)
78.3 mg – 83.7 mg 2 0 0 2
94 kg – 100 kg
(207 lb – 220 lb)
84.6 mg – 90 mg 0 3 0 0
Recommended Dose for Oral Suspension (mL)
Weight
kg (lb)
Dose (mL)
10 kg – 15 kg
(22 lb – 33 lb)
0.4 mL – 0.6 mL
16 kg – 22 kg
(35 lb – 49 lb)
0.7 mL – 0.9 mL
23 kg – 30 kg
(51 lb – 66 lb)
1 mL – 1.2 mL
31 kg – 40 kg
(68 lb – 88 lb)
1.3 mL – 1.6 mL
41 kg – 48 kg
(90 lb – 106 lb)
1.7 mL – 1.9 mL
49 kg – 58 kg
(90 lb – 101 lb)
2 mL – 2.3 mL
59 kg – 68 kg
(130 lb – 150 lb)
2.4 mL – 2.7 mL
69 kg – 73 kg
(152 lb – 161 lb)
2.8 mL – 2.9 mL
74 kg – 78 kg
(163 lb – 172 lb)
3 mL – 3.1 mL
79 kg – 85 kg
(174 lb – 187 lb)
3.2 mL – 3.4 mL
86 kg – 93 kg
(190 lb – 205 lb)
3 mL – 3.2 mL
94 kg – 100 kg
(207 lb – 220 lb)
3.8 mL – 4 mL

DISCUSS THE IMPORTANT DOSING CONSIDERATIONS OF EMFLAZA WITH YOUR PATIENTS

  • Patients should not stop taking EMFLAZA abruptly or without first checking with their healthcare provider as there may be a need for gradual dose reduction to decrease the risk of adrenal insufficiency

  • Dosage of EMFLAZA must be decreased gradually if the drug has been administered for more than a few days

  • Weight gain should be reassessed by a physician to determine appropriate dosing


Let your patients know about any potential drug interactions associated with EMFLAZA1

  • If patient is also taking a moderate or strong CYP3A4 inhibitor, give one third of the recommended dosage of EMFLAZA

  • Avoid use of strong or moderate CYP3A4 inducers with EMFLAZA, as they may reduce efficacy

  • Patients receiving corticosteroids, including EMFLAZA and concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium), may be at increased risk of developing an acute myopathy


If you are interested in more information about EMFLAZA, sign up to receive updates as they become available.


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Get your patients started on EMFLAZA

1. EMFLAZA (deflazacort) [package insert]. South Plainfield, NJ: PTC Therapeutics, Inc.

INDICATION & IMPORTANT SAFETY INFORMATION FOR EMFLAZA® (deflazacort)

INDICATION

EMFLAZA® is a corticosteroid indicated for the treatment of patients with Duchenne muscular dystrophy (DMD) in patients 5 years of age or older.

IMPORTANT SAFETY INFORMATION

Contraindications: EMFLAZA is contraindicated in patients with a hypersensitivity to deflazacort or any of the inactive ingredients in EMFLAZA

Warnings & Precautions

Alterations in Endocrine Function: Corticosteroids, such as EMFLAZA, can cause serious and life-threatening alterations in endocrine function, especially with chronic use. Monitor patients receiving EMFLAZA for Cushing’s syndrome, hyperglycemia, and adrenal insufficiency after EMFLAZA 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. Acute adrenal insufficiency or “withdrawal syndrome” can occur if corticosteroids are withdrawn abruptly, and can be fatal. The risk is reduced by gradually tapering the corticosteroid dose when withdrawing treatment. During times of medical stress, corticosteroid dosage may need to be increased.

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. Tell patients and/or caregivers to inform their healthcare provider if the patient has had recent or ongoing infections or if they have recently received a vaccine. Warn patients who are on corticosteroids who have not had chickenpox or measles to avoid exposure to chickenpox or measles and to alert their healthcare provider immediately if they are exposed.

Alterations in Cardiovascular/Renal Function: Monitor for elevated blood pressure. Dietary salt restriction and potassium supplementation may be needed.

Gastrointestinal Perforation: Increased risk of gastrointestinal perforation during corticosteroid use in patients with certain gastrointestinal disorders such as active or latent peptic ulcers, diverticulitis, recent intestinal anastomoses, and inflammatory bowel disease. Signs and symptoms may be masked.

Behavioral and Mood Disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis. Encourage patients to seek medical attention if symptoms develop or worsen.

Effects on Bones: The risk of osteoporosis increases with prolonged use of EMFLAZA, which can predispose patients to vertebral and long bone fractures. Monitor for decreases in bone density with chronic use of EMFLAZA.

Ophthalmic Effects: May include cataract formation, ocular infections, and glaucoma. If treatment with corticosteroids, including EMFLAZA, are continued for more than 6 weeks, monitor intraocular pressure.

Vaccination: Do not administer live or live attenuated vaccines to patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered, but the responses cannot be predicted.

Serious Skin Rashes: Toxic epidermal necrolysis has been reported with the use of deflazacort. Discontinue at the first sign of rash, unless the rash is clearly not drug related.

Effects on Growth and Development: Long-term use of corticosteroids, including EMFLAZA, may slow growth and development in children.

Thromboembolic Events: Observational studies have shown an increased risk of thromboembolism. Use EMFLAZA with caution in patients who have or may be predisposed to thromboembolic disorders.

Adverse Reactions: The most common adverse reactions (≥10% for EMFLAZA and greater than placebo) are Cushingoid appearance, weight increased, increased appetite, upper respiratory tract infection, cough, pollakiuria, hirsutism, central obesity, and nasopharyngitis.

Drug Interactions: Give one third of the recommended dose of EMFLAZA when EMFLAZA is administered with strong or moderate CYP3A4 inhibitors. Avoid use of strong or moderate CYP3A4 inducers with EMFLAZA, as they may reduce efficacy.

Please see the accompanying full Prescribing Information

For medical information, product complaints, or to report an adverse event, please call 1‑866‑562‑4620 or email at usmedinfo@ptcbio.com.

You may also report adverse events directly to FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.