Emflaza Oral Suspension
Generic name: deflazacort
Dosage form: oral suspension, oral tablet
Drug class: Glucocorticoids
Medically reviewed by A Ras MD.
What is Emflaza?
Emflaza oral suspension is a prescription medication used for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.
Description
The active ingredient in EMFLAZA is deflazacort (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for deflazacort is C25H31NO6. The chemical name for deflazacort is (11β,16β)-21-(acetyloxy)11-hydroxy-2′-methyl-5’H-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione, and the structural formula is:
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Deflazacort is a white to off white, odorless fine powder and has a molecular weight of 441.517. Deflazacort is freely soluble in acetic acid and dichloromethane and soluble in methanol and acetone.
EMFLAZA for oral administration is available as an immediate-release tablet in strengths of 6, 18, 30 and 36 mg and an immediate-release oral suspension in a strength of 22.75 mg/mL. Each tablet contains deflazacort and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pre-gelatinized corn starch. The oral suspension contains deflazacort and the following inactive ingredients: acetic acid, aluminum magnesium silicate, benzyl alcohol, carboxymethylcellulose sodium, polysorbate 80, purified water, and sorbitol.
How should I store Emflaza?
- Store the bottle upright at room temperature between 68°F to 77°F (20°C to 25°C).
- Throw away (discard) any unused Emflaza oral suspension after 1 month of first opening the bottle.
What are the ingredients in Emflaza?
The ingredients in Emflaza oral suspension are:
Active ingredient: deflazacort
Inactive ingredients: acetic acid, aluminum magnesium silicate, benzyl alcohol, carboxymethylcellulose sodium, polysorbate 80, purified water, and sorbitol.
Instructions for use
Important information before you use Emflaza oral suspension:
- Only use the oral dispenser (see Figure A below) that comes in your Emflaza carton when using this medicine.
- Emflaza oral suspension can be taken with or without food.
- Take your dose of Emflaza oral suspension with juice or milk. Do not take Emflaza with grapefruit juice.
- Throw away (discard) any unused Emflaza oral suspension after 1 month of first opening the bottle.
- Do not stop taking Emflaza oral suspension without talking to your healthcare provider first.
Preparing for your Emflaza oral suspension dose:
You will need the following supplies: See Figure A.
- 1 Emflaza oral suspension bottle
- 1 oral dispenser (2 oral dispensers are included in the Emflaza oral suspension carton. 1 is to be used to give (administer) the product and 1 extra oral dispenser is included as a spare, if needed.)
- 1 household cup filled with 3 to 4 ounces of juice or milk
- 1 spoon
Figure A
How to prepare your dose of Emflaza oral suspension:
Step 1. Remove the Emflaza oral suspension bottle and 1 of the oral dispensers from the carton.
Step 2. Make sure the bottle cap is put on tightly and shake well before each use. See Figure B.
Figure B
Step 3. Remove the cap from the bottle by pushing down firmly on the cap and turning the cap in a counter-clockwise direction (to the left). See Figure C. Place the open bottle upright on a flat surface.
Figure C
First time use of bottle only:
Unwrap the bottle adapter.
Place the ribbed end of the bottle adapter in the bottle top.
Wrap both hands around the bottle. Press down on the bottle adapter using both thumbs. Push the ribbed end of the bottle adapter firmly into the neck of the bottle until the adapter top is even with the bottle top. See Figure D.
Do not remove the bottle adapter from the bottle after it is inserted.
Write the date that you first open the bottle on the bottle label.
Figure D
Step 4. Unwrap the oral dispenser if it is the first time you are using the oral dispenser.
Check your dose in milliliters (mL) as prescribed by your healthcare provider. Find this number on the barrel of the oral dispenser. See Figure E.
Figure E
The oral dispenser only holds 1 mL of medicine at a time. If your dose is more than 1 mL, you will need to repeat Steps 5 through 8 using the same oral dispenser until your entire dose has been drawn from the bottle.
Step 5. Push the plunger of the oral dispenser all the way down. Insert the oral dispenser into the bottle adapter. See Figure F.
Figure F
Step 6. With the oral dispenser in the bottle adapter, carefully turn the bottle upside down. Slowly pull back on the plunger until the widest part of the plunger is at the line marking on the oral dispenser of the number of mL needed for your dose. See Figure G. Do not use the narrow tip on the end of the plunger to measure the dose.
If you see air bubbles in the oral suspension, fully push in the plunger so the oral suspension flows back into the bottle. Then withdraw the dose of oral suspension that you need.
Figure G
Step 7. Leave the oral dispenser in the bottle adapter and turn the bottle to an upright position. Place the bottle onto a flat surface. Remove the oral dispenser from the bottle adapter by gently twisting the oral dispenser while pulling it straight up. See Figure H.
Figure H
Step 8. Slowly push all the way down on the plunger of the oral dispenser to add the Emflaza oral suspension dose to a household cup filled with 3 to 4 ounces of juice or milk. See Figure I.
Figure I
Step 9. Stir the Emflaza oral suspension and juice or milk with a spoon to mix well. See Figure J.
Figure J
Step 10. Immediately drink the juice or milk that is mixed with Emflaza oral suspension.
Step 11. Replace the cap tightly on the bottle by turning the cap in a clockwise direction (to the right). See Figure K.
Figure K
Step 12. Wash the oral dispenser after each use. The oral dispenser should be taken apart by pulling back on the plunger and removing it from the barrel of the oral dispenser. See Figure L.
Figure L
Step 13. After the barrel and plunger are dry, put the oral dispenser back together by pushing the plunger back into the barrel.
SRC: NLM .