Deflazacort

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

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

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

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

You can take deflazacort with or without food.

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

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

Shake the oral suspension (liquid) before measuring a dose. Use only the dosing syringe that comes with the medicine (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 may change if you gain or lose weight.

Deflazacort can weaken (suppress) your immune system, making you more likely to get an infection. You may need regular 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 some parts of the world, and you may have been exposed during your travel.

If you have ever had hepatitis B or are a carrier of hepatitis B, using deflazacort can cause this virus to become active or worsen. You may need regular liver function tests.

If you need surgery, inform the surgeon ahead of time that you are taking deflazacort.

Store at room temperature, away from moisture and heat.

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

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

Follow all instructions on your medicine label and package. Inform all of your healthcare providers about all your medical conditions, allergies, and all medicines you are taking.

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.

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

Deflazacort may lead to serious side effects. Contact your doctor immediately if you experience:

• fever, chills, sore throat, weakness;
• severe or ongoing diarrhea;
• any skin rash, regardless of 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, changes in menstrual cycle, 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 feeling limp.

Deflazacort can impact growth in children. Inform your doctor if your child is not growing at a normal rate while taking this medicine.

Common side effects of deflazacort may include:

• increased appetite;
• weight gain;
• increased growth of body hair;
• sleep problems;
• cold symptoms like stuffy nose, sneezing, sore throat, cough;
• frequent urge to urinate; or
• changes in the shape or distribution of body fat (especially in your face and back).

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

Usual Adult Dose for Muscular Dystrophy:

Approximately 0.9 mg/kg orally once a dayComments:-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 dayComments:-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

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

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

Grapefruit and grapefruit juice may interact with deflazacort and cause unwanted side effects. Avoid using 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 may include measles, mumps, rubella (MMR), varicella (chickenpox), nasal flu vaccine, and others.
• 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.

Sometimes it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medications less effective.

When you begin or stop taking deflazacort, your doctor may need to change the doses of any other medicines you regularly take.

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