Wixela Inhub

Wixela Inhub is a prescription medication used to treat asthma and chronic obstructive pulmonary disease (COPD) in patients over 4 years. Wixela Inhub has both a corticosteroid and long-acting beta agonist. It works by opening the airways and preventing inflammation of the lungs.

This medication comes as a dry powder inhaler for oral inhalation. Wixela Inhub is taken as 1 inhalation 2 times each day.

Common side effects of Wixela Inhub include upper respiratory tract infection, throat irritation, pharyngitis, loss of voice, oral thrush, cough, headaches, nausea, and vomiting.

Wixela Inhub is a prescription medication used to control symptoms of asthma and to prevent symptoms such as wheezing in patients 4 years and older. It can also be used to treat chronic obstructive pulmonary disease (COPD) in patients over 4 years. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Wixhela Inhub. See the “Wixhela Inhub Precautions” section.

Common side effects of Wixhela Inhub nclude the following:

• upper respiratory tract infection or inflammation
• pharyngitis
• headache
• nausea
• vomiting
• oral thrush
• throat irritation
• loss of voice
• muskuloskeletal pain

This is not a complete list of Wixela Inhub side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone.

• Monoamine oxidase inhibitors such as:

  • isocarboxazid (Marplan)
  • phenelzine (Nardil)
  • tranylcypromine (Parnate)
  • selegiline (Emsam, Eldepryl, Zelapar)
  • rasagiline (Azilect)

• Tricyclic antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil).

• Beta blockers such as:

  • metoprolol (Toprol XL, Lopressor)
  • carvedilol (Coreg)
  • bisoprolol (Zebeta)
  • betaxolol (Kerlone)
  • nebivolol (Bystolic)
  • propranolol (Inderal)

• Diuretics such as:

  • acetazolamide (Diamox)
  • amiloride (Midamor)
  • bumetanide (Bumex)
  • chlorothiazide (Diuril)
  • chlorthalidone (Thalitone)
  • ethacrynic acid (Edecrin)
  • furosemide (Lasix)
  • hydrochlorothiazide (Microzide, HCTZ)
  • metolazone (Zaroxolyn)
  • torsemide (Demadex)
  • triamterene (Dyrenium, Dyazide, Maxzide)

This is not a complete list of Wixela Inhub drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Wixela Inhub including the following:

• serious asthma-related events - hospitalizations, intubations, death. Using a long-acting beta agonist without an inhaled corticosteroid is linked to an increased-risk of asthma-related death. However, this medication has both a long-acting beta agonist with an inhaled corticosteroid. 
• deterioration of disease and acute episodes. This medication should not be started for patients who have rapidly deterioriating or life-threatening asthma or COPD. This has not been studied for patients who have completely uncontrolled asthma or COPD. Serious respiratory events that can be fatal. Patients that increase their use of a rescue inhaler (like albuterol or levalbuterol) may need to be re-evaluated and put on a higher strengh of Wixela Inhub. Wixela Inhub should only be used twice a day. Wixela Inhub also shoud not be used for acute symptom management or rescue therapy for acute episodes of shortness of breath or wheezing. 
• excessive use of Wixela Inhub and use with other long-acting beta2-agonists. Wixela Inhub should not be used more than recommended or with other medications containing a long -acting beta agonist (salmeterol, formoterol, arformoterol, indacaterol). This can cause an overdose, which can result in problems with the heart or death.
• local effects of inhaled corticosteroids. Wixela Inhub has been found to cause infections of the mouth and throat. These infections should be treated with antifungal therapy if they occur. Wixhela Inhub may have to be interrupted during this treatment period. Patients should be told to rinse their mouth out after using Wixhela Inhub to reduce the potential for infections.
• pneumonia. Physicians should carefully watch patients on this medication to look for signs of pneumonia. Lower respiratory tract infections like pneumonia have been seen in patients taking this medication. 
• immunosuppression. Patients who take medications that suppress the immune system (like corticosteroids) are more prone to infections. Wixhela Inhub should be used with caution for patients with active infections.
• transferring patients from systemic corticosteroid therapy. Patients who are on active corticosteroids must be carefully transitioned to inhaled corticosteroids. Adrenal insufficiency can cause death in patients who are poorly managed during the change. Patients on 20 mg or more of prednisone are most at risk. Patients with oral steroids should be weaned slowly after changing to Wixela Inhub. A healthcare provider can help provide the dosing for this transition. 
• hypercorticism and adrenal suppression. Wixela Inhub contains an inhaled corticosteroid. There can be the potential for systemic corticosteroid effects, which can cause adrenal suppression. Patients should watch for signs of adrenal crisis like dehydration or fatigue.
• drug interactions with strong cytochrome P450 3A4 inhibitors. Increased risk of heart problems or increased steroid concentration can occur with this medication when used with strong P450 3A4 inhibitors. Wixela Inhub should not be used with medications such as ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, or telithromycin.
• paradoxical bronchospasm and upper airway symptoms. Wixela Inhub can cause paradoxical bronchospasm (wheezing, harder work of breathing), which can be life-threatening. A bronchodilator like albuterol should be used immediately if this occurs. If this occurs, Wixela Inhub should be stopped and changed to another medication.
• immediate hypersensitivity reactions. Itching, swelling, or rash can occur with Wixela Inhub. Patients with severe milk protein allergies are most at risk. These patients should not use Wixela Inhub.
• cardiovascular and central nervous system effects. Wixela Inhub should be used in caution with patients with heart disorders such as high blood pressure or abnormal heart rhythm. Seizures, angina, blood pressure changes, or faster rate rates can occur. Excessive use of this medication can be fatal. 
• reductions in bone mineral density. Decreases in bone mineral density have been seen with long-term use of products with an inhaled corticosteroid. Patients with risk factors for lower bone mineral content such as prolonged immobilization, family history of osteoporosis, tobacco use, advanced age, or poor nutrition should be monitored. 
• effect on growth. Inhaled corticoteroids may reduce the rate of growth for younger patients. Pediatric patients receiving Wixela Inhub should be monitored routinely and use the lowest possible dose.
• glaucoma and cataracts. Long-term use of inhaled corticosteroids can increase pressure in the eye and cause cataracts. Wixela Inhub should be used in the lowest possible dose to minimize this risk.
• eosinophilic conditions and Churg-Strauss Syndrome. In rare cases, patients on inhaled corticosteroids can see white blood cell complications. Eosinophilic conditions like a rash, worsening lung symptoms, heart issues, or nerve pain should be monitored. 
• coexisting conditions. Wixela Inhub should be used cautiously in patients with convulsive disorders. Medications like Wixela Inhub have been found to exacerbate diabetes and ketoacidosis when injected.
• hypokalemia and hyperglycemia. Beta agonists can cause a significant decrease in potassium in some patients. Lowered blood glucose can also be observed in patients using this medication.

Do not take Wixela Inhub if you:

• to relieve sudden breathing problems. 
• as a rescue inhaler. 
• if you have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure. 
• if you are allergic to fluticasone propionate, salmeterol, or any of the ingredients in Wixela Inhub.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Wixela Inhub, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Wixela Inhub, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Wixela Inhub or to any of its ingredients
• have high blood pressure
• have heart pboelms
• have seizures
• have thyroid problems
• have diabetes
• have liver problems
• have weak bones
• have an immune system problem
• have or have had eye problems like glaucoma, increased pressure in the eye, cataracts, or changes in vision
• are allergic to milk proteins
• have any type of viral, bacterial, or fungal infection
• are exposed to chickenpox or measles
• are pregnant or plan to become pregnant
• are breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. This medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control of asthma. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

Wixela Inhub has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Wixela Inhub, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take Wixela Inhub exactly as prescribed.

Wixela Inhub comes in an inhaled powder form and is taken one inhalation twice a day. Do not take more than two doses a day.

Do not shake this medication. After using this medication, rinse your mouth out with water. Swish and spit it out, do not swallow any water.

To get the most of this medication, follow these instructions. Ask your pharmacist or doctor if you have any concerns with using this medication:

1. Hold the inhaler and lower the mouth piece cover from top to bottom.
2. Push the yellow level down to the end. You should hear a click. Do not do this step until you are ready to take the medication. The dose will be wasted if you lower the lever and do not use the inhaler.
3. Inhale your medicine.
   1. Breathe out as long as you can, holding the inhaler away from your mouth.
   2. Put the mouthpiece to your lips. Breathe in deeply through your mouth.
   3. Hold your breath for about 10 seconds or as long as you comfortably can.
   4. Breathe out slowly for as long as you can.
4. Push the mouth piece cover and close the inhaler. The number on the inhaler will go down by one. 
5. Rinse your mouth out with water. Spit out the water and do not swallow it.

The number on the inhaler shows how many doses of medicine are left. The medication is a fine powder that you may or may not taste. Do not take an extra dose if you do not feel or taste the medication.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Wixela Inhub at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Asthma

For adults and patients aged 12 years and older, the recommended dose of Wixela Inhub is based on the patients’ disease severity, based on their previous asthma therapy, including the ICS dosage, as well as the patients’ current control of asthma symptoms and risk of future exacerbation.

Wixela Inhub is available in 3 strengths: 100/50, 250/50, and 500/50 mcg. The dosage is 1 inhalation twice daily. The maximum recommended dosage is Wixela Inhub 500/50 twice daily.

For patients with asthma aged 4 to 11 years who are not controlled on an ICS, the dosage is 1 inhalation of Wixela Inhub 100/50 twice daily, approximately 12 hours apart.

Chronic Obstructive Pulmonary Disease (COPD)

The recommended dosage for patients with COPD is 1 inhalation of Wixela Inhub 250/50 twice daily, approximately 12 hours apart. 

If shortness of breath occurs in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.

If you take too much Wixela Inhub, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Wixela Inhub at room temperature between 20° to 25°C (68° to 77°F).
• Keep in a dry place away from direct heat and sunlight. Store Wixela Inhub in the unopened foil pouch and only open when ready for use. 
• Safely throw away Wixela Inhub in the trash 1 month after you open the foil pouch or when the counter reads 0, whichever comes first. 
• Keep Wixela Inhub and all medicines out of the reach of children.