Breo Ellipta 100-25mcg Oral Inh(30)

Breo Ellipta contains fluticasone furoate and vilanterol. Fluticasone furoate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It works by binding to glucocorticoid receptors, inhibiting inflammatory cells (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and the release of inflammatory mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines). This reduces airway hyperresponsiveness and inflammation. Vilanterol is a long-acting beta2-adrenergic agonist (LABA). It acts locally in the lungs as a bronchodilator by stimulating beta2-adrenergic receptors on airway smooth muscle, leading to relaxation of the smooth muscle and bronchodilation. The combination provides both anti-inflammatory and bronchodilator effects.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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 low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat
Signs of a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Chest pain or pressure, or a rapid heartbeat
Shakiness or tremors
Feeling nervous or excitable
Bone pain
Changes in vision, eye pain, or severe eye irritation
Mouth irritation or mouth sores
Redness or white patches in the mouth or throat
Feeling extremely tired or weak

Respiratory Emergency

This medication can cause severe breathing problems, which may be life-threatening. If you experience trouble breathing, worsening breathing, wheezing, or coughing after taking this medication, use a rescue inhaler and seek medical help immediately.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor:

Headache
Runny nose
Nose or throat irritation
Common cold symptoms
Flu-like symptoms
Changes in voice
Back pain
Joint pain

This is not an exhaustive list of possible side effects. If you have questions or concerns, contact 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:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have a milk allergy.
* If you are currently taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor.

Important Warnings and Cautions for Patients Taking This Medication

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

Blood Sugar Control
If you have diabetes (high blood sugar), this medication may cause your blood sugar levels to rise. Discuss with your doctor how to maintain control over your blood sugar levels.

Respiratory Problems
If your breathing problems worsen, your rescue inhaler is less effective, or you need to use it more frequently, contact your doctor immediately.

Dosage and Administration
Do not exceed the prescribed dose or use this medication more often than directed. Overdose can be fatal. Consult your doctor if you have any concerns.

Transitioning from Oral Steroids
When switching from an oral steroid to another form of steroid, you may be at risk for severe and potentially life-threatening side effects. Monitor for symptoms such as weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar, and contact your doctor immediately if you experience any of these signs.

Stressful Situations
In cases of severe injury, surgery, or infection, you may require additional doses of oral steroids to help your body cope with stress. Carry a warning card indicating that you may need extra steroids in such situations.

Long-term Use and Eye Health
Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this with your doctor and follow their recommendations for regular eye exams.

Bone Health
Long-term use of this medication may also lead to weak bones (osteoporosis). Consult your doctor to assess your risk and discuss any concerns. Have a bone density test as advised by your doctor.

Infection Risk
You may be more susceptible to infections while taking this medication. Practice good hygiene by washing your hands frequently, and avoid close contact with people who have infections, colds, or flu.

Viral Infections
Chickenpox and measles can be severe or even fatal in individuals taking steroid medications like this one. Avoid exposure to anyone with these conditions if you have not had them before. If you have been exposed, contact your doctor.

Growth and Development in Children and Teens
This medication may affect growth in some cases. 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, consult your doctor to weigh the benefits and risks to you and your baby.

COPD Patients
If you have Chronic Obstructive Pulmonary Disease (COPD), you are at a higher risk of developing pneumonia, which can be severe or even fatal. This medication may also increase the likelihood of hospitalization due to pneumonia. Discuss this with your doctor.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin, itraconazole, cobicistat-containing products): May significantly increase systemic exposure to fluticasone furoate and vilanterol, leading to increased risk of cardiovascular and systemic corticosteroid adverse effects.
• Beta-blockers (non-cardioselective): May block the bronchodilatory effect of vilanterol and produce severe bronchospasm in patients with COPD or asthma. Cardioselective beta-blockers should be used with caution.

• Diuretics (non-potassium-sparing): ECG changes and/or hypokalemia resulting from non-potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially at higher doses. Use with caution.
• Tricyclic antidepressants (TCAs) and Monoamine Oxidase Inhibitors (MAOIs): May potentiate the effect of vilanterol on the cardiovascular system. Administer with extreme caution to patients being treated with MAOIs or TCAs, or within 2 weeks of discontinuation of such agents.

• Other sympathomimetics: Concomitant administration may potentiate adverse cardiovascular effects. Use with caution.

• Worsening shortness of breath
• Increased wheezing
• Increased cough
• Increased need for rescue inhaler
• Chest pain or palpitations
• Tremor
• Nervousness
• Muscle cramps
• Vision changes
• Oral thrush (white patches in mouth/throat)
• Hoarseness
• Signs of infection (fever, chills, increased sputum)

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Poorly controlled asthma in pregnancy is associated with risks to both mother and fetus. There are no adequate and well-controlled studies of Breo Ellipta in pregnant women. Animal studies have shown reproductive toxicity with both fluticasone furoate and vilanterol.

It is unknown if fluticasone furoate or vilanterol are excreted in human milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Breo Ellipta and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition. Fluticasone furoate and vilanterol are detected in the milk of lactating rats.

Breo Ellipta is approved for asthma in patients 12 years and older. Safety and effectiveness in children younger than 12 years of age have not been established. Inhaled corticosteroids can cause a reduction in growth velocity in pediatric patients. Monitor growth in pediatric patients receiving Breo Ellipta.

No overall differences in safety or effectiveness were observed between elderly patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dosage adjustment based on age alone is not necessary.

• Breo Ellipta is a once-daily maintenance treatment for asthma and COPD, not for acute bronchospasm.
• Patients should be instructed to rinse their mouth with water and spit after each dose to reduce the risk of oral candidiasis (thrush).
• Emphasize the importance of consistent daily use, even when symptoms are well-controlled.
• Warn patients about the black box warning regarding the increased risk of asthma-related death with LABA monotherapy, and clarify that Breo Ellipta is a combination product and should not be used with other LABA-containing products.
• Monitor for signs of systemic corticosteroid effects, especially with long-term use or higher doses, including adrenal suppression, bone mineral density changes, and ocular effects (glaucoma, cataracts).
• Caution should be exercised when co-administering with strong CYP3A4 inhibitors due to increased systemic exposure of both components.
• Patients should carry a rescue inhaler for acute symptoms and understand that Breo Ellipta is not a rescue medication.

• Inhaled Corticosteroids (ICS) monotherapy (e.g., fluticasone propionate, budesonide, mometasone)
• Long-acting Beta2-Adrenergic Agonists (LABA) monotherapy (e.g., salmeterol, formoterol, indacaterol, olodaterol) - *Note: LABA monotherapy is generally not recommended for asthma due to black box warning, but may be used for COPD.*
• Long-acting Muscarinic Antagonists (LAMA) monotherapy (e.g., tiotropium, umeclidinium, glycopyrronium)
• Oral corticosteroids (for severe exacerbations or refractory cases)
• Leukotriene receptor antagonists (e.g., montelukast)
• Phosphodiesterase-4 inhibitors (e.g., roflumilast - for severe COPD)
• Biologics (e.g., omalizumab, mepolizumab, benralizumab, dupilumab - for severe asthma)

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, including the amount taken and the time it happened, to ensure you receive the best possible care.