Deflazacort is a steroid that is used to treat Duchenne muscular dystrophy in adults and children at least 2 years old.

Deflazacort is not a cure for muscular dystrophy, but deflazacort may improve muscle strength and slow the progression of disability.

Deflazacort may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take deflazacort with or without food.

You may need to take multiple tablets of different strengths to make up your correct dose. Follow your doctor's dosing instructions very carefully.

If you cannot swallow a tablet whole, crush it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture right away without chewing. Do not save it for later use.

Shake the oral suspension (liquid) before you measure a dose. Use only the dosing syringe provided (not a kitchen spoon) to measure your dose. Mix your measured dose with 3 to 4 ounces of milk or fruit juice (but not grapefruit juice). Drink this mixture right away and do not save it for later.

Deflazacort doses are based on weight (especially in children and teenagers). Your dose needs may change if you gain or lose weight.

Deflazacort can weaken (suppress) your immune system, and you may get an infection more easily. You may need frequent medical tests. Your vision and bone mineral density may also need to be checked.

Tell your doctor if you have recently traveled. Certain infections are more common in certain parts of the world, and you may have been exposed during travel.

If you've ever had hepatitis B or if you are a carrier of hepatitis B, using deflazacort can cause this virus to become active or get worse. You may need frequent liver function tests.

If you need surgery, tell the surgeon ahead of time that you are using deflazacort.

Store at room temperature away from moisture and heat.

Throw away any deflazacort liquid that has not been used within 1 month after you first opened the bottle.

You should not stop using deflazacort suddenly. Follow your doctor's instructions about tapering your dose. You may need to restart deflazacort if you are under stress or if you have a medical emergency.

Usual Adult Dose for Muscular Dystrophy:

Approximately 0.9 mg/kg orally once a day

Comments:
-If tablets are used, rounding up to the nearest possible dose is recommended.
-If the oral suspension is used, rounding up to the nearest tenth of a mL is recommended.
-If this drug has been administered for more than a few days, the dosage should be decreased gradually.

Use: For the treatment of Duchenne muscular dystrophy (DMD)

Usual Pediatric Dose for Muscular Dystrophy:

2 years or older: Approximately 0.9 mg/kg orally once a day

Comments:
-If tablets are used, rounding up to the nearest possible dose is recommended.
-If the oral suspension is used, rounding up to the nearest tenth of a mL is recommended.
-If this drug has been administered for more than a few days, the dosage should be decreased gradually.

Use: For the treatment of DMD

You should not use deflazacort if you are allergic to it.

Deflazacort should not be given to a child younger than 2 years old. Deflazacort oral suspension (liquid) contains an ingredient that can cause serious side effects or death in very young or premature babies.

Tell your doctor if you have ever had:

• any type of bacterial, fungal, viral, or parasite infection;

• heart problems, high blood pressure;

• a stroke or blood clot;

• fluid retention;

• kidney disease;

• liver disease (especially hepatitis B);

• a stomach or intestinal disorder;

• a colostomy or ileostomy;

• cataracts, glaucoma, or herpes infection of the eyes;

• diabetes;

• a nerve-muscle disorder, such as myasthenia gravis;

• low bone mineral density; or

• a problem with your thyroid, pituitary gland, or adrenal gland.

You should be current on all vaccines. Tell your doctor if you have recently received a vaccine or if you are scheduled for a booster dose.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis.

Taking deflazacort during early pregnancy may increase the risk of cleft lip and palate in a newborn. Tell your doctor if you are pregnant or plan to become pregnant.

Taking deflazacort at any time during pregnancy may affect adrenal gland hormones in the newborn baby. Tell your doctor if your baby has symptoms such as dry skin, weakness, feeding problems, or vomiting.

It may not be safe to breastfeed while using deflazacort. Ask your doctor about any risk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Dispose of any unused suspension (liquid) after 1 month.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Do not eat of grapefruit or drink grapefruit juice while taking this medication.

Grapefruit and grapefruit juice may interact with deflazacort and lead to unwanted side effects. Avoid the use of grapefruit products while taking deflazacort.

While taking deflazacort and for at least 4 to 6 weeks before you start taking it: Do not receive a "live" vaccine or you could develop a serious infection.

• Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

• You may still be able to receive a yearly flu shot, or an "inactivated" vaccine to prevent diseases such as hepatitis, meningitis, pneumonia, shingles, HPV, or whooping cough.

• Ask your doctor before getting any vaccine.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using steroid medicine.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Deflazacort may cause serious side effects. Call your doctor at once if you have:

• fever, chills, sore throat, weakness;

• severe or ongoing diarrhea;

• any skin rash, no matter how mild;

• blurred vision, tunnel vision, eye pain, or seeing halos around lights;

• swelling in your hands, feet, or lower legs;

• severe muscle weakness;

• decreased adrenal gland hormones--weakness, diarrhea, nausea, menstrual changes, skin discoloration, craving salty foods, and feeling light-headed;

• increased adrenal gland hormones--weight gain in your face and upper back, slow wound healing, skin discoloration, acne, thinning skin, increased body hair, tiredness, mood changes, menstrual changes, sexual changes;

• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or

• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Deflazacort can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects of deflazacort may include:

• increased appetite;

• weight gain;

• increased growth of body hair;

• sleep problems;

• cold symptoms such as stuffy nose, sneezing, sore throat, cough;

• frequent urge to urinate; or

• changes in the shape or location of body fat (especially in your face and back).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

When you start or stop taking deflazacort, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Many drugs can affect deflazacort. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor will check your blood pressure regularly and order certain lab tests to check your body's response to deflazacort.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking deflazacort.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Deflazacort won’t cure muscular dystrophy; it will only help improve symptoms and slow the progression of disability.

Let your doctor know if you experience any severe or unusual side effects while using this medicine.

Don’t stop taking deflazacort without first discussing it with your healthcare provider.

Your dosage will be based on your age, medical condition, and other factors.

Follow your doctor’s instructions carefully when using this medicine.

Deflazacort may be used to treat other medical conditions, including asthma, rheumatoid arthritis, and chronic obstructive pulmonary disease (COPD).