Deflazacort 36mg Tablets

Deflazacort is a corticosteroid that acts as a glucocorticoid receptor agonist. It exerts its anti-inflammatory and immunosuppressive effects by binding to intracellular glucocorticoid receptors, leading to changes in gene expression. This results in the inhibition of pro-inflammatory mediators (e.g., cytokines, prostaglandins, leukotrienes) and the upregulation of anti-inflammatory proteins. In Duchenne Muscular Dystrophy, its exact mechanism of action is not fully understood but is thought to involve reducing inflammation and stabilizing muscle cell 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 or seek medical attention immediately:

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, trouble 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 changed sputum production, 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 weakness: 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 medical help immediately 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 may not experience any side effects or only mild ones. However, if you notice any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor or seek medical attention:

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 about side effects, 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. Be sure to describe the allergic reaction and its symptoms.
The presence of any infection, such as bacterial, viral, or fungal infections, including:
+ Amoeba infection (e.g., traveler's diarrhea)
+ Herpes infection of the eye
+ Malaria infection in the brain
+ Threadworm infestation
+ Other types of infections
Certain health problems, 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 problems with your doctor and pharmacist. 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.

Monitoring and Tests

Your doctor will need to monitor your blood work regularly. Additionally, if you take this medication for an extended period, you may require regular checks for eye pressure and bone density.

Potential Risks and Side Effects

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

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

You may need to reduce your salt intake and take extra potassium supplements. Consult with your doctor to determine the best course of action.

Dietary Restrictions and Interactions

Avoid consuming grapefruit and grapefruit juice while taking this medication.

Vaccinations and Infections

If you are not up to date with all your vaccinations, discuss this with your doctor. You may need to receive certain vaccinations 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 with your doctor before receiving any vaccinations.

Infection Risks

Steroid medications like this one can increase the risk of infection. They can also worsen existing infections and make it more challenging to detect signs of infection. Infections can range from mild to severe and potentially life-threatening. The risk of infection is typically higher with higher doses of steroids.

To minimize the risk of infection, wash your hands frequently, avoid close contact with people who have infections, colds, or flu, and inform your doctor if you experience any signs of infection.

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 decrease the natural production of steroids in your body. If you experience a fever, infection, surgery, or injury, consult with 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 potentially life-threatening conditions, 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

This medication may increase the risk of blood clots. 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. Discuss this risk with your doctor.

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 guide you on how to gradually taper off the dose. If you miss 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 Considerations

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

Pregnancy and Breastfeeding

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.

• Live or live attenuated vaccines (increased risk of infection)
• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) - may significantly increase deflazacort exposure and adverse effects.
• Strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital) - may significantly decrease deflazacort exposure and efficacy.

• Moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, verapamil)
• Moderate CYP3A4 inducers (e.g., efavirenz, etravirine)
• Antidiabetic agents (may require increased dose of antidiabetic agent due to deflazacort-induced hyperglycemia)
• NSAIDs (increased risk of gastrointestinal ulceration and bleeding)
• Diuretics (thiazide and loop diuretics - increased risk of hypokalemia)
• Anticoagulants (warfarin - may alter anticoagulant effect, monitor INR)
• Cardiac glycosides (e.g., digoxin - increased risk of toxicity with hypokalemia)
• Immunosuppressants (e.g., cyclosporine - increased risk of adverse effects of both drugs)

• Oral contraceptives (may increase deflazacort exposure)
• Antacids (may decrease deflazacort absorption, separate administration)

• Signs of infection (fever, chills, sore throat, unusual fatigue)
• Changes in mood or behavior (irritability, anxiety, depression, insomnia)
• Gastrointestinal symptoms (abdominal pain, black/tarry stools)
• Muscle weakness or pain (beyond baseline DMD symptoms)
• Swelling (edema), weight gain
• Vision changes
• Increased thirst or urination (signs of hyperglycemia)
• Easy bruising or skin thinning
• Signs of adrenal insufficiency upon withdrawal (fatigue, weakness, nausea, vomiting, hypotension)

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects. Corticosteroids can cross the placenta.

Deflazacort and its active metabolite are excreted into human milk. Due to the potential for serious adverse reactions in the breastfed infant (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.

Deflazacort is indicated for Duchenne Muscular Dystrophy in patients 5 years of age and older. Long-term corticosteroid use in children can lead to growth suppression, delayed puberty, and bone density issues. Close monitoring of growth, bone health, and development is essential.

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 more susceptible to the adverse effects of corticosteroids, such as osteoporosis and fluid retention.

• Deflazacort is a prodrug that is rapidly converted to its active metabolite, 21-desacetyl deflazacort.
• It is a corticosteroid with anti-inflammatory and immunosuppressive properties, specifically approved for Duchenne Muscular Dystrophy.
• Patients should be educated on the importance of not abruptly discontinuing the medication due to the risk of adrenal insufficiency.
• Due to its immunosuppressive effects, patients are at increased risk of infection, and live vaccines are generally contraindicated.
• Long-term use requires careful monitoring for common corticosteroid side effects including hyperglycemia, hypertension, osteoporosis, cataracts, and growth suppression in children.
• Dosing is weight-based for DMD, and careful calculation is necessary.

• Prednisone (another corticosteroid used in 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, not FDA approved in US)
• Gene therapies (e.g., Elevidys - for DMD with specific mutations)

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.