Emflaza

Generic name: Deflazacort
Dosage form: oral suspension, oral tablet
Drug class: Glucocorticoids

Usage of Emflaza

Emflaza (deflazacort) is a corticosteroid medication used to treat a rare genetic disorder called Duchenne muscular dystrophy.

Duchenne muscular dystrophy is a severe form of muscular dystrophy, which is caused by an abnormal gene that results in low levels of a protein called dystrophin. Dystrophin helps to keep muscle cells intact. A lack of this protein leads to muscle weakness and wasting (atrophy). Other signs of Duchenne muscular dystrophy include chronic inflammation and activation of the immune system.

Emflaza acts as an anti-inflammatory and immunosuppresive agent. Emflaza is a pro-drug that is converted by the body into an active metabolite called 21-desDFZ. It is this active form of the drug that helps to decrease inflammation and suppress the immune system.

Emglaza was approved by the US Food and Drug Administration (FDA) in 2017.

Emflaza side effects

Emflaza can cause serious side effect. See 'Important Information" above.

The most common side effects of Emflaza include:

facial puffiness or Cushingoid appearance

weight increased

increased appetite

upper respiratory tract infection

cough

frequent daytime urination

unwanted hair growth

central obesity

colds

These are not all of the possible side effects. Call your doctor for medical advice about side effects.

To report an adverse event, please call 1‑866‑562‑4620 or email at [email protected]. You may also report side effects to FDA at 1‑800‑FDA‑1088 or at www.fda.gov/medwatch.

Before taking Emflaza

Tell your doctor if you are pregnant or planning to become pregnant. Emflaza can harm your unborn baby. It should only be used during pregnancy if the potential benefits justify the risk to the fetus. Use of corticosteroid like Emflaza during pregnancy may result in cleft lip with our without cleft palate, intrauterine growth restriction and decreased birth weight.

Tell your doctor if you are breastfeeding or plan to breastfeed. Emflaza may appear in breastmilk and could affect a nursing child. Talk to your doctor about the best way to feed your baby while taking this medication.

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How to use Emflaza

The recommended dose of Emflaza is approximately 0.9 mg/kg/day administered orally once a day.

Warnings

Emflaza can cause serious side effects including:

Changes in endocrine function. Do not stop taking Emflaza, or change the amount you are taking, without first checking with your healthcare provider, as there may be a need for gradual dose reduction to decrease the risk of adrenal insufficiency and steroid “withdrawal syndrome”. Acute adrenal insufficiency can occur if corticosteroids are withdrawn abruptly, and can be fatal. A steroid “withdrawal syndrome,” seemingly unrelated to adrenocortical insufficiency, may also occur following abrupt discontinuance of corticosteroids. For patients already taking corticosteroids during times of stress, the dosage may need to be increased.

An increased risk of infection. Tell the healthcare provider if the patient has had recent or ongoing infections or if they have recently received a vaccine. Medical advice should be sought immediately if the patient develops fever or other signs of infection. Patients and/or caregivers should be made aware that some infections can potentially be severe and fatal. Warn patients who are on corticosteroids to avoid exposure to chickenpox or measles and to alert their healthcare provider immediately if they are exposed.

An increase in blood pressure and water retention. If this occurs, dietary salt restriction and potassium supplementation may be needed.

An increased risk of developing a hole in the stomach or intestines in patients with certain stomach or intestine disorders.

Severe behavioral and mood changes. Seek medical attention from the health care provider if any behavioral or mood changes develop.

A risk of osteoporosis with prolonged use, which can lead to vertebral and long bone fractures.

Cataracts or glaucoma. A health care provider should monitor for these conditions if corticosteroid therapy is continued for more than 6 weeks.

Serious skin rashes. Seek medical attention at the first sign of a rash.

Anaphylaxis. In rare instances anaphylaxis has occurred in patients receiving corticosteroid therapy, including Emflaza.

Immunizations should be up-to-date according to immunization guidelines prior to starting therapy with Emflaza. Live‑atTenuated or live vaccines should be administered at least 4 to 6 weeks prior to starting this medication. Live‑attenuated or live vaccines should not be used in patients taking Emflaza.

What other drugs will affect Emflaza

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines (such as insulin, aspirin or other NSAIDS), vitamins, and herbal supplements.

Especially tell your doctor if you take:

Clarithromycin

Fluconazole

Diltiazem

Verapamil

Rifampin

Efavirenz

Carbamazepine

Phenytoin

Alternate treatment, dosage adjustment, and/or special test(s) may be needed during the treatment.

The list above is not a complete list of medications that may interact with Emflaza.

Emflaza also interacts with grapefruit juice. Do not& take with grapefruit juice.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.