Deflazacort

(dee flayz' a kort)

Brand Name(s): Emflaza^®

WHY is this medicine prescribed?

Deflazacort is used to treat Duchenne muscular dystrophy (DMD; a progressive disease in which the muscles do not function properly) in adults and children 2 years of age and older. Deflazacort is in a class of medications called corticosteroids. It works by reducing inflammation (swelling) and by changing the way the immune system works.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Deflazacort comes as a tablet and a suspension (liquid) to take by mouth. It is usually taken once a day with or without food. Take deflazacort at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take deflazacort exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you cannot swallow the tablet whole, you may crush the tablet and mix with applesauce. The mixture should be taken immediately.

Shake the suspension well before each use to mix the medication evenly. Use the measuring device to measure the dose of deflazacort and slowly add the dose to 3 to 4 ounces (90 to 120 mL) of milk or fruit juice and take immediately. Do not mix deflazacort suspension with grapefruit juice.

Your doctor may need to change your dose of deflazacort if you experience unusual stress on your body such as surgery, illness, or infection. Tell your doctor if your symptoms improve or get worse or if you get sick or have any changes in your health during your treatment.

Do not stop taking deflazacort without talking to your doctor. Stopping the drug abruptly may cause symptoms such as loss of appetite, an upset stomach, vomiting, drowsiness, confusion, headache, fever, joint and muscle pain, peeling skin, and weight loss. Your doctor will probably decrease your dose gradually to allow your body to adjust before stopping the drug completely. Watch for these side effects if you are gradually decreasing your dose and after you stop taking the tablets or oral suspension. If these problems occur, call your doctor immediately.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking deflazacort,

• tell your doctor and pharmacist if you are allergic to deflazacort, any other medications, or any of the ingredients in deflazacort tablets or suspension. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn), carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), clarithromycin (Biaxin, in Prevpac), efavirenz (Sustiva, in Atripla), fluconazole (Diflucan), diltiazem (Cardizem, Cartia, Diltzac, Taztia), medications for diabetes including insulin, phenytoin (Dilantin, Phenytek), rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), thyroid medications, and verapamil (Calan, in Tarka, Verelan). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with deflazacort, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have or have ever had hepatitis B (HBV, a virus that infects the liver and may cause severe liver damage); herpes eye infection (a type of eye infection that causes a sore on the eyelid or eye surface); cataracts (clouding of the lens of the eye); glaucoma (an eye disease); high blood pressure; heart failure; a recent heart attack; diabetes; emotional problems, depression, or other types of mental illness; myasthenia gravis (a condition in which the muscles become weak); osteoporosis (condition in which the bones become weak and fragile and can break easily); pheochromocytoma (tumor on a small gland near the kidneys); ulcers; a blood clot in your legs, lungs, or eyes; or liver, kidney, heart, intestinal, adrenal, or thyroid disease. Also tell your doctor if you have any type of untreated bacterial, fungal, parasitic, or viral infection anywhere in your body.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking deflazacort, call your doctor.

• check with your doctor to see if you need to receive any vaccinations. It is important to have all vaccines appropriate for your age before beginning your treatment with deflazacort. Do not have any vaccinations during your treatment without talking to your doctor.

• you should know that deflazacort may decrease your ability to fight infection and may prevent you from developing symptoms if you get an infection. Stay away from people who are sick and wash your hands often while you are taking this medication. Be sure to avoid people who have chicken pox or measles. Call your doctor immediately if you think you may have been around someone who had chicken pox or measles.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Deflazacort may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• thin, fragile skin
• red or purple blotches or lines under the skin
• increased hair growth
• acne
• bulging eyes
• irregular or absent menstrual periods
• slowed healing of cuts and bruises
• changes in the way fat is spread around the body
• weak muscles
• joint pain
• frequent urination during the daytime
• dizziness
• difficulty falling asleep or staying asleep
• increased appetite
• upset stomach
• back pain
• heartburn

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• sore throat, fever, chills, cough, or other signs of infection
• seizures
• eye pain, redness, or tearing
• changes in vision
• swelling of the eyes, face, lips, tongue, throat, arms, hands, feet, ankles, or lower legs
• difficulty breathing or swallowing
• shortness of breath
• sudden weight gain
• rash
• hives
• itching
• peeling or blistering skin
• stomach pain
• confusion
• extreme changes in mood changes in personality
• inappropriate happiness
• depression
• ongoing pain that begins in the stomach area, but may spread to the back

Deflazacort may slow growth and development in children. Your child's doctor will watch his or her growth carefully. Talk to your child's doctor about the risks of giving deflazacort to your child.

People who use deflazacort for a long time may develop glaucoma or cataracts. Talk to your doctor about the risks of using deflazacort and how often you should have your eyes examined during your treatment.

Deflazacort may increase your risk of developing osteoporosis. Talk to your doctor about the risks of using this medication.

Deflazacort may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

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.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: September 15, 2019.