Pronunciation:

dee-FLAYZ-a-kort

Brand Names:

• Emflaza

Dosage Forms:

• Tablet
• Suspension

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Adrenal Glucocorticoid

Uses of This Medicine:

Deflazacort is used to treat Duchenne muscular dystrophy (DMD). DMD is a rare, inherited muscle disease that occurs usually in children and young adults and is caused by an absence of a protein called dystrophin, which helps keep muscle cells intact. Deflazacort is corticosteroid (cortisone-like medicine or steroid).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of deflazacort in children 2 years of age and older. Safety and efficacy have been established. However, because of deflazacort oral suspension containing benzyl alcohol, use in children younger than 2 years of age is not recommended.

Older adults—

No information is available on the relationship of age to the effects of deflazacort in geriatric patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Adenovirus Vaccine, Live
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Desmopressin
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Aldesleukin
• Amtolmetin Guacil
• Aprepitant
• Aspirin
• Atazanavir
• Balofloxacin
• Bemiparin
• Besifloxacin
• Boceprevir
• Bosentan
• Bromfenac
• Bufexamac
• Bupropion
• Carbamazepine
• Celecoxib
• Choline Salicylate
• Ciprofloxacin
• Clarithromycin
• Clonixin
• Cobicistat
• Conivaptan
• Cosyntropin
• Crizotinib
• Cyclosporine
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Diltiazem
• Dipyrone
• Dronedarone
• Droxicam
• Efavirenz
• Enoxacin
• Enzalutamide
• Erythromycin
• Etodolac
• Etofenamate
• Etoricoxib
• Etravirine
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Fleroxacin
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Flumequine
• Flurbiprofen
• Fluvoxamine
• Fosphenytoin
• Gatifloxacin
• Gemifloxacin
• Ibuprofen
• Idelalisib
• Imatinib
• Indinavir
• Indomethacin
• Itraconazole
• Ketoconazole
• Ketoprofen
• Ketorolac
• Letermovir
• Levofloxacin
• Lomefloxacin
• Lopinavir
• Lornoxicam
• Loxoprofen
• Lumacaftor
• Lumiracoxib
• Lutetium Lu 177 Dotatate
• Macimorelin
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Mitotane
• Modafinil
• Morniflumate
• Moxifloxacin
• Nabumetone
• Nadifloxacin
• Nadroparin
• Nafcillin
• Naproxen
• Nefazodone
• Nelfinavir
• Nepafenac
• Niflumic Acid
• Nilotinib
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Norfloxacin
• Ofloxacin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Pazufloxacin
• Pefloxacin
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Piketoprofen
• Piroxicam
• Posaconazole
• Pranoprofen
• Primidone
• Proglumetacin
• Propyphenazone
• Proquazone
• Prulifloxacin
• Rifampin
• Ritonavir
• Rofecoxib
• Rufloxacin
• Salicylic Acid
• Salsalate
• Saquinavir
• Sargramostim
• Sodium Salicylate
• Somatrogon-ghla
• Sparfloxacin
• St John's Wort
• Sulindac
• Telaprevir
• Telithromycin
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Tosufloxacin
• Valdecoxib
• Verapamil
• Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Auranofin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Adrenal problems or
• Amebiasis, inactive or
• Blood clotting problems or
• Cataracts or
• Congestive heart failure or
• Cushing's syndrome (adrenal gland problem) or
• Diabetes or
• Glaucoma or
• Heart attack, recent or
• Hepatitis B infection or
• Hyperglycemia (high blood sugar) or
• Hypertension (high blood pressure) or
• Infection (eg, bacterial, virus, or fungal) or
• Intraocular pressure (high pressure in the eyes), increased or
• Kidney disease, severe or
• Mood changes, including depression or
• Myasthenia gravis (severe muscle weakness) or
• Osteoporosis (weak bones) or
• Peptic ulcer, active or history of or
• Personality changes or
• Pheochromocytoma (adrenal tumor) or
• Stomach or bowel problems (eg, diverticulitis, ulcerative colitis) or
• Thyroid problems or
• Tuberculosis, inactive or
• Weak immune system (eg, Kaposi sarcoma)—Use with caution. May make these conditions worse.

• Eye infection (eg, herpes infection in the eyes) or
• Fungal infections—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for unwanted effects.

This medicine should come with patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

You may swallow the tablet whole. You may also crush and mix it with applesauce. Take the mixture right away.

Shake well the oral suspension before each use. Measure the dose with the oral dispenser that comes with it. Add your dose with 3 or 4 ounces of juice or milk, mix well, and take it right away.

Do not drink grapefruit juice while you are using this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (suspension and tablets):
  • For treatment of Duchenne muscular dystrophy
    • Adults and children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.9 milligram (mg) per kilogram (kg) of body weight once a day.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away any unused oral suspension after 1 month of first opening the bottle.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood or urine tests may be needed to check for unwanted effects.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor right away if you have more than one of these symptoms while you are using this medicine: blurred vision, dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.

This medicine may cause you to get more infections than usual. Avoid people who are sick or have infections and wash your hands often. If you are exposed to chickenpox or measles, tell your doctor right away. If you start to have a fever, chills, sore throat, or any other sign of an infection, call your doctor right away.

While you are being treated with deflazacort, do not have any live or live-attenuated immunizations (vaccines) at least 4 to 6 weeks before starting this medicine without your doctor's approval. Deflazacort may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

If you use this medicine for a long time, do not suddenly stop using it without checking first with your doctor. You may need to slowly decrease your dose before stopping it completely.

Using this medicine may increase the risk of stomach or bowel perforation. It usually occurs in patients with stomach ulcers or other digestive problems. Tell your doctor right away if you have severe abdominal or stomach pain, cramping, or burning, bloody, black, or tarry stools, or vomiting of material that looks like coffee grounds, severe and continuing.

This medicine may cause changes in mood or behavior, including thoughts of suicide for some patients. Tell your doctor right away if you have depression, mood swings, a false or unusual sense of well-being, trouble with sleeping, thoughts of killing oneself, or personality changes while using this medicine.

This medicine may cause thinning of the bones (osteoporosis), loss of blood supply, or slow growth in children if used for a long time. Tell your doctor if you have any bone or joint pain or if you have an increased risk for osteoporosis. If your child is using this medicine, tell the doctor if you think your child is not growing properly.

Check with your doctor right away if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. Your doctor may want your eyes to be checked by an ophthalmologist (eye doctor).

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

This medicine may increase your risk for cancer, including Kaposi's sarcoma. Tell your doctor right away if you have flat, painless spots that are red or purple on white skin and bluish, brownish, or black on dark skin.

This medicine may increase your risk of developing blood clots. Check with your doctor right away if you or your child have swelling and pain in your arms, legs, or stomach, chest pain, shortness of breath, loss of sensation, confusion, or problems with muscle control or speech.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Backache

blurred vision

body aches or pain

chills

cough

difficulty with breathing

ear congestion

facial hair growth in females

fever

fractures

full or round face, neck, or trunk

headache

increased hair growth, especially on the face

increased thirst or urination

irritability

loss of sexual desire or ability

loss of voice

menstrual irregularities

muscle aches or wasting

sneezing

sore throat

stuffy or runny nose

unusual tiredness or weakness

weight gain

Less common

Bladder pain

bloody or cloudy urine

diarrhea

difficult, burning, or painful urination

difficulty with moving

frequent urge to urinate

general feeling of discomfort or illness

joint pain

loss of appetite

lower back or side pain

muscle pains or stiffness

nausea

shivering

sweating

swollen joints

trouble sleeping

vomiting

Rare

Difficulty with swallowing

dizziness

fast heartbeat

hives, itching, or rash

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Incidence not known

Blindness

blistering, peeling, loosening of the skin

changes in behavior

decreased vision

depression

dry mouth

eye pain

false or unusual sense of well-being

flushed, dry skin

fruit-like breath odor

increased hunger

indigestion

loss of sexual desire or ability

muscular pain, tenderness, wasting, or weakness

pain in the bones

pain in the chest, groin, or legs, especially the calves

pounding in the ears

red skin lesions, often with a purple center

red, irritated eyes

severe abdominal pain, cramping, or burning

severe, sudden headache

slow or fast heartbeat

slurred speech

sores, ulcers, or white spots in the mouth or on the lips

stomach pain

sudden loss of coordination

sudden, severe weakness or numbness in the arm or leg

tearing

thoughts of killing oneself

unexplained weight loss

vision changes

vomiting of material that looks like coffee grounds, severe and continuing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Flushing or redness of the skin

increase appetite

stomach discomfort

unusually warm skin

Less common

Belching

blemishes on the skin

hair loss or thinning of the hair

pimples

stomach upset or pain

watering of the eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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