Cost, side effects, dosage, etc.

Emflaza can cause mild or severe side effects. The following lists contain some of the main side effects that can occur when taking Emflaza. These lists do not include all possible side effects.

For more information about the possible side effects of Emflaza, talk to your doctor or pharmacist. They can give you advice on how to deal with side effects that may be concerning or bothersome.

To note: The Food and Drug Administration (FDA) tracks the side effects of drugs it has approved. If you would like to notify the FDA about a side effect you have had with Emflaza, you can do so via MedWatch.

Mild side effects

Mild side effects* of Emflaza may include:

Most of these side effects may disappear within a few days or weeks. However, if they get worse or don’t go away, talk to your doctor or pharmacist.

*This is a partial list of mild Emflaza side effects. For more information about other mild side effects, talk to your doctor or pharmacist, or see the Package Leaflet for Emflaza. prescribing information.
† For more information on this side effect, see “Details of side effects” below.

Serious side effects

Serious side effects from Emflaza are not common. However, they can happen. Call your doctor right away if you experience any serious side effects. Call 911 or your local emergency number if your symptoms are life-threatening or you think you have a medical emergency.

Serious side effects and their symptoms may include:

  • Blood clots. Symptoms vary depending on where the blood clot occurs. They may include:
    • warmth, pain, or swelling in the arms or legs
  • Eye problems such as eye infection, cataracts or glaucoma. Symptoms vary depending on the exact eye problem. They may include:
    • difficulty seeing in the dark
  • Bone loss. Symptoms can include:
  • High blood sugar. Symptoms can include:
    • increased hunger or thirst
    • urinating more often than usual
  • Kaposi’s sarcoma (a rare type of cancer). Symptoms can include:
    • skin nodules (bumps), plaques, or plaques, usually on the face or legs
    • red, purple, brown, or discolored patches of skin
  • Changes in mood or behavior. Symptoms can include:
    • euphoria (feeling high)
    • mania (moments of extremely high energy and excitement)
  • High blood pressure. Symptoms may not appear unless the condition is severe. They may include:
  • Allergic reaction.*
  • Cushing’s Syndrome.*
  • Serious infection.*
  • Severe rash.*

* For more information on this side effect, see ‘Details of side effects’ below.

Side effects in children

Emflaza is approved to treat Duchenne muscular dystrophy in children aged 2 years and older.

It is expected that most side effects of Emflaza in children will be the same as in adults. (For details, see “Mild Side Effects” and “Severe Side Effects” above.)

Also, long-term treatment with corticosteroids can slow growth in children. (Emflaza is a type of corticosteroid.) However, this side effect has not been reported in clinical tests from Emflaza. Your child’s doctor will recommend how long your child can safely take the medicine.

If you have any questions about how Emflaza may affect your child, talk to their doctor.

Details of side effects

Here are some details about some side effects that this drug can cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Emflaza.

Cushing’s syndrome

Cushing’s syndrome is the most common side effect of Emflaza. This condition is caused by a high level of cortisol in the blood. Cortisol is a hormone that your body produces naturally. However, corticosteroids (such as Emflaza) also mimic cortisol activity in your body.

Over time, high levels of cortisol in the blood can lead to Cushing’s syndrome. Symptoms of this condition include:

  • weight gain
  • The face of the moon (puffiness that makes your face puffy and round)
  • bison hump (accumulation of fat on the back of the shoulders and neck)
  • skin thinning
  • bruising more easily than usual

what you can do

If you are concerned about Cushing’s syndrome while taking Emflaza, talk to your doctor. They can recommend ways to reduce your risk of this side effect, such as taking the medicine for only a short time.

Infection

Emflaza can decrease the activity of the immune system, which could increase your risk of infection.

The most frequently reported infections in clinical tests of Emflaza were upper respiratory tract infections. An example of an upper respiratory tract infection is the common cold.

Examples of less common mild infections reported in trials include urinary tract infections, influenza and ear infections.

The exact symptoms you experience will depend on the specific infection you may have. However, common symptoms of infection include:

In rare cases, Emflaza can cause more serious cases of certain infections. Examples include chickenpox and measles.

what you can do

Talk to your doctor about your risk of Emflaza infection. Be sure to tell them if you’ve been around anyone with an infection, especially chicken pox or measles. Also let them know if you have hepatitis B virus (HBV) or have had it in the past. Taking Emflaza can make HBV worse or cause it to come back.

Your doctor will monitor you closely for any symptoms of infection while you are taking Emflaza.

severe rash

A severe rash is a rare side effect of Emflaza.

Keep in mind that a severe rash can be a symptom of toxic epidermal necrolysis (TEN). TEN is a rare, potentially fatal disease. With TEN, you may have a rash with painful blistering or peeling of the skin. You may also have flu-like symptoms such as body aches, fever, or runny nose.

In people who developed TEN in clinical testssymptoms usually appeared within the first 8 weeks of starting Emflaza treatment.

what you can do

If you develop a rash with Emflaza, stop taking the drug and tell your doctor right away. It’s especially important to tell them if you have other symptoms of TEN besides a rash.

Your doctor can advise you if you can have TEN. If they find out that’s the case, they’ll probably send you to the hospital right away for treatment.

Allergic reaction

As with most medicines, some people may have an allergic reaction after taking Emflaza. This side effect was not reported when first clinical tests drug. However, an allergic reaction was reported after Emflaza became available by prescription.

Symptoms of a mild allergic reaction may include:

A more serious allergic reaction is rare. However, it is possible. Symptoms of a severe allergic reaction may include:

  • swelling under the skin, usually in the eyelids, lips, hands, or feet
  • swelling of the tongue, mouth or throat
  • difficulty breathing

Call your doctor right away if you have an allergic reaction to Emflaza, as the reaction could become serious. Call 911 or your local emergency number if your symptoms are life-threatening or you think you have a medical emergency.

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