Emflaza

Emflaza is a prescription medication used to treat Duchenne muscular dystrophy (DMD).

Emflaza belongs to a group of drugs called corticosteroids. These work on the glucocorticoid receptor to decrease inflammation (swelling) and change the immune system.

This medication comes in tablet form and as an oral suspension. Emflaza is taken once daily with or without food. Emflaza suspension should be taken with 3 to 4 ounces of juice or milk. 

Common side effects include cushingoid appearance (round moon face), weight gain, and increased appetite .

Emflaza is a prescription medication used to treat Duchenne muscular dystrophy (DMD). Duchenne muscular dystrophy is a genetic disorder where your muscles deteriorate over time and you grow weaker. 

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

Serious side effects have been reported with Emflaza. See the “Emflaza Precautions” section.

Common side effects of Emflaza include the following:

• cushingoid appearance (round, moon-shaped face)
• hair growth on face, chest, or back
• weight increased
• erythema (redness)
• abdominal pain
• increased number of times you go to the bathroom during the day
• constipation
• irritability

This is not a complete list of Emflaza side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effects that bother you or that do not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort
• medications that decrease the activity of the enzyme CYP3A4 such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone
• neuromuscular blocking drugs such as pancuronium (Pavulon) or rocuronium (Zemuron)
• NSAID medications such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn)

This is not a complete list of Emflaza drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Emflaza including the following:

Changes in Endocrine Function. Emflaza can change how your body regulates hormones. Contact your doctor if you experience any of the following disorders or symptoms: 

• withdrawal symptoms. Acute adrenal insufficiency can occur if Emflaza is stopped abruptly. When stopping Emflaza, the dose should be decreased slowly over time. 
• cushings syndrome. Abnormal fat deposites around the face and neck. Symptoms can include high blood pressure, obesity around chest and stomach, thin arms and legs, moon-shaped face, and easy or frequent bruising
• hyperglycemia. Blood glucose levels can increase. 

Immunosuppression and Increased Risk of Infection. Emflaza can decrease your body's immune response and increase your risk of infection. Contact your doctor if you experience any of the following disorders or symptoms:

• chicken pox or measles exposure
• hepatitis B exposure
• fungal infection
• amebiasis (an ameba is a single cell organism commonly found in tropical places)
• strongyloides infestation (a type of threadworm that can cause GI problems including diarrhea, vomitting, and abdominal pain)
• fever is often one of the most common and earliest signs of infection. Follow your doctor's instructions about how often to take your temperature. If you have a fever, tell your doctor or nurse right away.

Alterations in Cardiovascular/Renal Function. Emflaza may cause high blood pressure, changes in salt levels in your blood and kidneys. Frequent blood monitoring may be required. Tell your doctor if you have any of the folllowing heart conditions:

• congestive heart failure (CHF)
• hypertension (high blood pressure)
• kidney diseaese

Gastrointestinal Perforation. Emflaza can cause a GI rupture in patients with previous GI disorders. Tell your doctor if you have any of the following before you start Emflaza treatment:

• peptic ulcers
• diverticulitis
• recent surgery on your intestines
• ulcerative colitis 

Behavioral and Mood Disturbances. Contact your doctor if you experience any of the following symptoms:

• euphoria
• insomnia
• mood swings
• depression
• suicidal thoughts 

Effects on Bones. Emflaza can decrease your bone mineral density causing your bones to become weaker. This can lead to falls and fractures. Keep all appointments with your doctor so they can monitor your bone mineral density while on Emflaza treatment.

Ophthalmic Effects. Emflaza may cause cataracts (cloudy vision) or glaucoma (symptoms that lead to vision loss). Your doctor will monitor the pressure in your eye regularly to assess the risk of these eye problems. Keep all appointments with your eye doctor during Emflaza treatment. 

Vaccination. Emflaza can decrease your immune response and increase your risk of infection, so you should not recieve any live vaccines such as the chicken pox or shingles vaccinations. These vaccines have weakened real viruses that could cause infections since your immune system isn't as strong with Emflaza. 

Serious Skin Rashes. Emflaza may cause a skin condition called Toxic Epidermal Necrolysis (TEN). If you experience any of the following symptoms, stop Emflaza immediately and contact your doctor: 

• flu like symptoms
• small purple spotted rash 
• fever
• mouth ulcers 
• skin peeling

Effects on Growth and Development. Emflaza may cause growth delays if used long term in children. Caution should be used with monitoring for children on Emflaza treatment. 

Myopathy. Emflaza can cause severe muscle pain and spasms. Contact your doctor if you experience any of the following symptoms:

• localized muscle pain
• fever
• chills
• joint pain
• fatigue 

Kaposi’s Sarcoma. Emflaza can cause a rare cancer called Kaposi's Saroma that can look like red, purple, or brown skin blotches. Emflaza should be discontinued immediately after Kaposi's Sarcoma is confirmed. 

Risk of Serious Adverse Reactions in Infants because of Benzyl Alcohol Preservative. Emflaza can cause gasping syndrome in infants due to the ingredient benzyl alcohol. Emflaza should not be used in patients less than 5 years old.

Thromboembolic Events. Emflaza may cause clots. Keep all appointments with your doctor so they can monitor your blood while on Emflaza treatment.

Hypersensitivity. Emflaza may cause a sever allergic reaction. Do not take Emflaza if you are allergic to Emflaza or any of its ingredients. Tell your healthcare provider about any signs or symptoms of hypersensitivity, which include the following:

• chest pain
• swelling of the face, eyes, lips, tongue, arms, or legs
• difficulty breathing or swallowing
• rash

Grapefruit and grapefruit juice may interact with Emflaza and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Emflaza, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Emflaza or to any of its ingredients
• have or have had hepatitis B
• cataracts or glaucoma
• have heart problems
• have mental illness
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• if you are having surgery while taking Emflaza
• need any vaccinations, do not get any vaccinations during Emflaza without talking to your doctor first

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

No studies have been done in animals, but it has been shown that use of Emflaza in pregnant women caused some babies to be born with problems. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Emflaza has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Emflaza, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take Emflaza exactly as prescribed.

Emflaza Tablets:

Emflaza comes as a tablet and is taken once every day with or without food. Tablets can be swallowed whole or crushed and mixed with applesauce. If crushed, Emflaza should be taken immediately after mixing.

Emflaza Oral Suspension:

Emflaza comes as a oral suspension and is taken once every day with 3-4 ounces of juice or milk. Shake well before withdrawing using dispenser. Dose should be mixed with juice (no grapefruit juice) or milk, then taken immediately after mixing. 

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Emflaza at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Emflaza is dosed based on your weight. The recommended dose of Emflaza is approximately 0.9 mg/kg once daily.

If you take too much Emflaza, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store Emflaza tablets and oral suspension at room temperature. Throw away any unused Emflaza oral suspension 1 month after opening the bottle. 

Keep Emflaza and any medication out of the reach of children.