Deflazacort (dee-FLAYZ-a-kort)

Treats Duchenne muscular dystrophy. This medicine is a corticosteroid.

Brand Name(s):

Emflaza

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Tablet: Swallow the tablet whole. You may also crush and mix it with applesauce. Take the mixture right away.
• Oral liquid:
  • Shake the bottle well before each use. Remove the cap by pushing down on the cap and turn it to the left (counter-clockwise).
  • If you are using the medicine for the first time, place the ribbed end of the bottle adapter in the bottle top. Wrap both hands around the bottle. Press down on the bottle adapter with both thumbs. Firmly push the ribbed end of the bottle adapter into the neck of the bottle until the adapter top is even with the bottle top.
  • Hold the syringe and push the plunger all the way down. Insert the syringe into the bottle adapter. Slowly turn the bottle upside down.
  • Slowly pull back on the plunger until you reach the prescribed dose. If you see air bubbles, push in the plunger so the oral liquid flows back into the bottle. Then, pull back on the plunger again until you reach your prescribed dose.
  • Keep the plunger in the same position, turn the bottle upright, and place it on a flat surface. Remove the oral syringe by gently twisting and pulling it straight up.
  • Slowly push the plunger all the way down to add the oral liquid into a household cup filled with 3 to 4 ounces of juice or milk. Stir the mixture with a spoon. Drink the mixture right away.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Throw away any unused oral liquid after 1 month of first opening the bottle.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how deflazacort works. Tell your doctor if you are using any of the following:
  • Carbamazepine, clarithromycin, diltiazem, efavirenz, fluconazole, phenytoin, rifampin, verapamil
  • Insulin or diabetes medicine
  • Muscle relaxer (including pancuronium)
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should receive live or live-attenuated vaccines at least 4 to 6 weeks before starting this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, blood clotting problems, congestive heart failure, adrenal gland problems, pituitary gland problems, diabetes, high blood pressure, depression or mental health problems, stomach or bowel problems (including ulcers, ulcerative colitis, or diverticulitis), myasthenia gravis, osteoporosis, pheochromocytoma (adrenal tumor), thyroid problems, or a recent heart attack.
• This medicine may cause the following problems:
  • Increased risk of infections
  • Adrenal gland problems, which may be life-threatening
  • High blood sugar levels
  • High blood pressure
  • Increased risk of stomach or bowel perforation (tear or hole)
  • Unusual mood or behavior, including thoughts of suicide
  • Bone problems (including loss of bone density, loss of blood supply to the bone)
  • Cataracts or glaucoma
  • Serious skin reactions, including toxic epidermal necrolysis
  • Slow growth in children
  • Increased risk for cancer (including Kaposi's sarcoma)
  • Increased risk of blood clots
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Bloody, black, tarry stools, vomiting of material that looks like coffee grounds, severe stomach pain
• Bone, joint, or muscle pain, slow growth
• Color changes on the skin, dark freckles, easy bruising, muscle weakness, round puffy face
• Depression, mood swings, trouble sleeping, unusual mood or behavior, thoughts of killing oneself
• Dizziness, lightheadedness, or fainting
• Dry mouth, muscle cramps, nausea, vomiting, uneven heartbeat
• Eye pain, blurred vision or other vision changes
• Fast, slow, or pounding heartbeat
• Fever, chills, cough, sore throat, body aches
• Increased thirst, hunger, or urination, weight loss
• Numbness or weakness in your arm or leg, or on one side of your body, sudden or severe headache, problems with vision, speech, or walking

If you notice these less serious side effects, talk with your doctor:

• Constipation
• Headache
• Increased appetite or weight
• Increased hair growth

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088