Emflaza 18mg Tablets

Deflazacort is a corticosteroid that acts as an anti-inflammatory and immunosuppressant agent. It binds to glucocorticoid receptors, modulating gene expression to produce its effects. This includes inhibition of inflammatory mediators, suppression of immune cell function, and stabilization of lysosomal membranes.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or a wound that won't heal.
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing.
Signs of adrenal gland problems: severe nausea or vomiting, extreme dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of electrolyte imbalance: mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, balance problems, abnormal heartbeat, seizures, loss of appetite, or severe nausea or vomiting.
Shortness of breath, sudden weight gain, or swelling in the arms or legs.
Skin changes: acne, stretch marks, slow healing, or excessive hair growth.
Changes in vision.
Bone or joint pain.
Black, tarry, or bloody stools.
Vomiting blood or coffee ground-like material.
New or worsening mental, mood, or behavioral changes.
Purple, red, blue, brown, or black bumps or patches on the skin or in the mouth.
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, or difficulty speaking or swallowing.
A severe skin reaction (toxic epidermal necrolysis) may occur, causing serious health problems or even death. Seek immediate medical attention if you experience: red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you're concerned about any of the following side effects or if they persist, contact your doctor:

Weight gain.
Increased appetite.
Common cold symptoms.
Nose and throat irritation.
Frequent urination.
Stomach pain.
Constipation.
Back pain.
Upset stomach.
* Headache.

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
The presence of any infection, including bacterial, viral, or fungal infections, such as:
+ Amoeba infection (e.g., traveler's diarrhea)
+ Herpes infection of the eye
+ Malaria infection in the brain
+ Threadworm infestation
+ Any other type of infection
Certain health conditions, including:
+ Diverticulitis
+ Hole in the gastrointestinal (GI) tract
+ Stomach or bowel infection
+ Ulcers
Recent stomach or bowel surgery
* Any medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as some may interact with this medication. Specifically, inform your doctor about:
+ Certain HIV medications
+ Infection treatments
+ Seizure medications
+ Other medications that may interact with this drug

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all your medications and health conditions with your doctor and pharmacist. Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Monitoring and Tests

Your doctor will monitor your blood work regularly. Additionally, if you take this medication for an extended period, you may need to undergo eye pressure and bone density tests to assess potential long-term effects.

Potential Risks and Side Effects

Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor. Furthermore, prolonged use may lead to weak bones (osteoporosis). Consult your doctor to determine if you are at a higher risk or have any questions.

High blood pressure has been reported in patients taking this medication. Regular blood pressure checks are crucial, as directed by your doctor. If you have diabetes, it is vital to closely monitor your blood sugar levels.

You may need to reduce your salt intake and take potassium supplements. Consult your doctor for personalized advice. Avoid consuming grapefruit and grapefruit juice while taking this medication.

Vaccinations and Infections

If you are not up to date with all recommended vaccines, discuss your vaccination status with your doctor. You may need to receive certain vaccines before starting treatment with this medication. However, some vaccines may not be effective or may increase the risk of infection when taken with this medication. Consult your doctor before receiving any vaccines.

If you have not had chickenpox or measles, avoid close contact with individuals who have these infections. If you have been exposed to chickenpox or measles, inform your doctor immediately. Steroid medications like this one can increase the risk of infection, which can be severe or even life-threatening. Wash your hands frequently, avoid people with infections, and report any signs of infection to your doctor.

Reactivation of Infections

In some cases, this medication can reactivate latent infections, such as tuberculosis or hepatitis B. Inform your doctor if you have a history of these infections.

Adrenal Insufficiency and Stress

This medication may decrease the natural production of steroids in your body. If you experience a fever, infection, surgery, or injury, consult your doctor, as you may require additional oral steroids to help your body cope with stress. Carry a warning card indicating that you may need extra steroids in certain situations.

Rare but Serious Side Effects

Long-term use of this medication can lead to rare but serious health problems, including changes in adrenal gland function and the development of a tumor on the adrenal gland (pheochromocytoma). Discuss these potential risks with your doctor.

Blood clots have been reported in patients taking this medication. Inform your doctor if you have a history of blood clots. Additionally, long-term use of this medication has been associated with an increased risk of Kaposi's sarcoma, a type of cancer.

Discontinuation and Missed Doses

Do not stop taking this medication abruptly without consulting your doctor, as this may increase the risk of side effects. If you need to discontinue this medication, your doctor will provide guidance on gradually tapering off the dose. If you have missed a dose or recently stopped taking this medication and experience symptoms such as fatigue, weakness, shakiness, fast heartbeat, confusion, sweating, or dizziness, inform your doctor.

Pediatric and Adolescent Use

This medication may affect growth in children and adolescents. Regular growth checks may be necessary. Discuss this potential risk with your doctor.

Pregnancy and Breastfeeding

If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the benefits and risks of this medication to you and your baby.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir): May significantly increase deflazacort exposure, requiring dose reduction of deflazacort.
• Live or live attenuated vaccines: Risk of severe or fatal infection due to immunosuppression.

• CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital): May decrease deflazacort exposure, potentially reducing efficacy.
• Antidiabetics (e.g., insulin, oral hypoglycemics): Deflazacort may increase blood glucose, requiring adjustment of antidiabetic therapy.
• Anticoagulants (e.g., warfarin): May alter anticoagulant effects (either increase or decrease), requiring close INR monitoring.
• NSAIDs: Increased risk of gastrointestinal ulceration and bleeding.
• Potassium-depleting agents (e.g., thiazide diuretics, loop diuretics, amphotericin B): Increased risk of hypokalemia.
• Cardiac glycosides (e.g., digoxin): Increased risk of toxicity due to hypokalemia.

• Antacids: May reduce absorption of deflazacort (separate administration).

• Signs of infection (fever, chills, sore throat, cough, unusual fatigue)
• Changes in mood or behavior (irritability, anxiety, depression, insomnia)
• Swelling in ankles or feet
• Unusual weight gain
• Increased thirst or urination
• Muscle weakness or pain
• Vision changes
• Stomach pain or black/tarry stools
• Easy bruising or thinning skin
• Delayed wound healing

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Corticosteroids can cross the placenta and may cause fetal harm, including adrenal insufficiency, cleft palate, and intrauterine growth restriction.

Deflazacort and its active metabolite are excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., growth suppression, interference with endogenous corticosteroid production), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Emflaza is indicated for the treatment of Duchenne muscular dystrophy in patients 2 years of age and older. Long-term corticosteroid use in children can cause growth suppression, bone mineral density loss, and other systemic adverse effects. Growth should be monitored regularly.

Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients may be at increased risk for adverse reactions common to corticosteroids, such as osteoporosis and fluid retention.

• Deflazacort is a corticosteroid with a unique pharmacokinetic profile, being a prodrug that is rapidly converted to an active metabolite.
• It is crucial to taper the dose gradually when discontinuing Emflaza to prevent adrenal insufficiency.
• Patients on Emflaza are at increased risk of infection; educate patients and caregivers on signs of infection and the importance of prompt medical attention.
• Regular monitoring of growth, bone health, blood pressure, and blood glucose is essential, especially in pediatric patients.
• Emflaza can cause behavioral and mood changes; caregivers should be aware of these potential side effects.
• Due to the high cost, patient assistance programs are often necessary and available through the manufacturer.

• Prednisone (another corticosteroid used off-label for DMD)
• Prednisolone (another corticosteroid used off-label for DMD)
• Eteplirsen (Exondys 51, for DMD patients amenable to exon 51 skipping)
• Golodirsen (Vyondys 53, for DMD patients amenable to exon 53 skipping)
• Viltolarsen (Viltepso, for DMD patients amenable to exon 53 skipping)
• Casimersen (Amondys 45, for DMD patients amenable to exon 45 skipping)
• Ataluren (Translarna, for nonsense mutation DMD, approved in some regions but not FDA approved in US)
• Gene therapy (e.g., Elevidys, for DMD patients 4-5 years old with confirmed DMD mutation)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.