Emflaza 36mg Tablets

Deflazacort is a glucocorticoid. It acts by binding to glucocorticoid receptors, modulating gene expression to produce anti-inflammatory and immunosuppressive effects. In Duchenne muscular dystrophy (DMD), its exact mechanism is not fully understood but is thought to involve anti-inflammatory and immunomodulatory effects that help preserve muscle function and slow disease progression.

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:

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.
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.
High Blood Sugar: Confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Cushing's Syndrome: Weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing.
Adrenal Gland Problems: Severe nausea or vomiting, extreme dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss.
High Blood Pressure: Severe headache or dizziness, fainting, or changes in vision.
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.
Respiratory Issues: Shortness of breath, significant weight gain, or swelling in the arms or legs.
Skin Changes: Acne, stretch marks, slow healing, or excessive hair growth.
Vision Changes: Changes in eyesight.
Musculoskeletal Issues: Bone or joint pain.
Gastrointestinal Issues: Black, tarry, or bloody stools, or vomiting blood or coffee ground-like material.
Mental Health Changes: New or worsening mental, mood, or behavioral changes.
Skin Lesions: Purple, red, blue, brown, or black bumps or patches on the skin or in the mouth.
Blood Clots: 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.
Severe Skin Reaction (Toxic Epidermal Necrolysis): Red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in the mouth, throat, nose, or eyes.

Other Possible Side Effects

While many people may not experience side effects or may only have mild ones, it's essential to be aware of the following:

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

If any of these side effects or others bother you or persist, contact your doctor for guidance. 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
The presence of any infection, such as bacterial, viral, or fungal infections, including:
+ Amoeba infections (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. It is crucial to discuss all your medications and health conditions with your doctor and pharmacist to ensure safe treatment. Do not start, stop, or change the dose of any medication without consulting your doctor first.

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.

Regular blood tests, as directed by your doctor, are crucial to monitor your health. If you are taking this medication long-term, you may also need to have your eye pressure and bone density checked.

Long-term Use Risks

Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this with your doctor to understand the potential risks. Additionally, long-term use may cause weak bones (osteoporosis). Consult your doctor to determine if you are at a higher risk or have any questions.

Blood Pressure and Sugar Monitoring

This medication may cause high blood pressure. Regular blood pressure checks, as advised by your doctor, are necessary. If you have diabetes, it is crucial to closely monitor your blood sugar levels.

Dietary Considerations and Vaccine Precautions

You may need to reduce your salt intake and increase your potassium consumption. Consult your doctor for personalized advice. Avoid consuming grapefruit and grapefruit juice. If you are not up to date with all recommended vaccines, discuss this 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.

Infection Risks

If you have not had chickenpox or measles, avoid close contact with anyone who has these infections. If you have been exposed, inform your doctor immediately. Steroid medications like this one can increase the risk of infection, which can be severe or even life-threatening. The risk of infection is higher with higher doses of steroids. To minimize the risk, wash your hands frequently, avoid people with infections, colds, or flu, and report any signs of infection to your doctor.

Reactivation of Infections

In some cases, this medication may 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 lower your body's natural steroid production. If you experience a fever, infection, surgery, or injury, consult your doctor, as you may need additional oral steroids to help your body cope with stress. Carry a warning card indicating that you may require extra steroids in certain situations.

Rare but Serious Risks

Long-term use of this medication, especially at high doses, 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 risks with your doctor.

Blood Clots and Cancer Risks

Blood clots have been reported in people 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 a type of cancer called Kaposi's sarcoma. Discuss this risk with your doctor.

Stopping the Medication

Do not stop taking this medication abruptly without consulting your doctor, as this may increase the risk of side effects. If you need to stop taking this medication, your doctor will advise you on how to gradually taper 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.

Effects on Growth and Pregnancy

This medication may affect growth in children and teenagers. Regular growth checks may be necessary. Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the benefits and risks of this medication to you and your baby.

• Live attenuated vaccines (during immunosuppressive doses of deflazacort)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin): May significantly increase deflazacort exposure; consider deflazacort dose reduction.
• Strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital): May significantly decrease deflazacort exposure; consider deflazacort dose increase.
• Anticoagulants (e.g., warfarin): May alter anticoagulant effect (increase or decrease); monitor INR closely.
• NSAIDs (Nonsteroidal Anti-inflammatory Drugs): Increased risk of gastrointestinal ulceration and bleeding.
• Diuretics (e.g., thiazide, loop diuretics): Increased risk of hypokalemia.
• Antidiabetics (e.g., insulin, oral hypoglycemics): May increase blood glucose levels, requiring adjustment of antidiabetic medication doses.

• Oral contraceptives: May increase corticosteroid effects.
• Cyclosporine: May increase levels of both deflazacort and cyclosporine.
• Digoxin: Increased risk of digitalis toxicity with hypokalemia (due to diuretic use with deflazacort).
• Antacids: May decrease deflazacort absorption; separate administration times.

• Not many specific minor interactions beyond general corticosteroid interactions.

• Signs of infection (fever, chills, sore throat, unusual fatigue, localized pain/redness)
• Symptoms of hyperglycemia (increased thirst, increased urination, blurred vision)
• Signs of adrenal insufficiency (severe fatigue, weakness, nausea, vomiting, dizziness, hypotension upon withdrawal)
• Cushingoid features (moon face, buffalo hump, central obesity, thin skin, striae)
• Mood changes (irritability, anxiety, depression, euphoria)
• Sleep disturbances (insomnia)
• Gastrointestinal upset (stomach pain, indigestion, black/tarry stools)
• Muscle weakness or pain (beyond DMD progression)
• Vision changes (blurred vision, halos around lights)
• Swelling in ankles or feet
• Unusual weight gain

There are no adequate and well-controlled studies of Emflaza in pregnant women. Based on animal reproduction studies, Emflaza may cause fetal harm when administered to a pregnant woman. Use only if the potential benefit justifies the potential risk to the fetus.

Deflazacort and its active metabolite are excreted in human milk. Monitor breastfed infants for adverse reactions such as growth suppression, feeding difficulties, and signs of adrenal suppression. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for Emflaza, and any potential adverse effects on the breastfed infant from Emflaza or from the underlying maternal condition.

Emflaza is approved for patients 2 years of age and older. Pediatric patients are at increased risk for certain adverse effects of corticosteroids, including growth suppression, cataracts, glaucoma, and bone effects (e.g., osteoporosis). Close monitoring of growth and development is essential.

No specific dose adjustment is needed based on age. However, geriatric patients may have an increased incidence of comorbidities (e.g., osteoporosis, diabetes, hypertension) that are exacerbated by corticosteroids, requiring careful monitoring.

• Deflazacort is a unique corticosteroid specifically approved for Duchenne muscular dystrophy (DMD) in the US, distinguishing it from other corticosteroids used off-label for this condition.
• It has a relatively lower mineralocorticoid activity compared to prednisone, which may lead to less fluid retention and hypertension.
• Patients should never abruptly discontinue Emflaza due to the risk of adrenal insufficiency; doses must be tapered gradually.
• Due to its immunosuppressive effects, patients should avoid live attenuated vaccines while on Emflaza and report any signs of infection promptly.
• Comprehensive monitoring for typical corticosteroid side effects (e.g., growth, bone health, blood glucose, blood pressure, eye health) is crucial during treatment.

• Prednisone (another corticosteroid, often used off-label for DMD)
• Prednisolone (another corticosteroid, often used off-label for DMD)
• Eteplirsen (Exondys 51® - exon-skipping therapy for DMD)
• Golodirsen (Vyondys 53® - exon-skipping therapy for DMD)
• Viltolarsen (Viltepso® - exon-skipping therapy for DMD)
• Casimersen (Amondys 45® - exon-skipping therapy for DMD)
• Delandistrogene moxeparvovec (Elevidys® - gene therapy for DMD)
• Supportive care (physical therapy, occupational therapy, respiratory support, cardiac management)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.