Breo Ellipta (Vilanterol Trifenatate / Fluticasone Furoate)
Relvar Ellipta (℞)
(℞) Prescription required. Product of UK/EU. Shipped from United Kingdom. Breo Ellipta is also marketed internationally under the name Relvar Ellipta.
Breo Ellipta (℞)
(℞) Prescription required. Product of New Zealand. Shipped from New Zealand.
To comply with Canadian International Pharmacy Association regulations you are permitted to order a 3-month supply or the closest package size available based on your personal prescription. read more
Vilanterol Trifenatate / Fluticasone Furoate Information
(floo tik' a sone) (vye lan' ter ol)[Posted 12/20/2017] AUDIENCE: Pharmacy, Pulmonology, Internal Medicine, Family Practice ISSUE: FDA's most prominent warning, the Boxed Warning, about asthma-related death has been removed from the drug labels of medicines that contain both an ICS and LABA. A FDA review of four large clinical safety trials shows that treating asthma with long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) does not result in significantly more serious asthma-related side effects than treatment with ICS alone. A description of the four trials is now also included in the Warnings and Precautions section of the drug labels. These trials showed that LABAs, when used with ICS, did not significantly increase the risk of asthma-related hospitalizations, the need to insert a breathing tube known as intubation, or asthma-related deaths, compared to ICS alone. BACKGROUND: In 2011, FDA required the drug companies manufacturing fixed-dose combination drugs containing an ICS and LABA (GlaxoSmithKline, Merck, Astra Zeneca) to conduct several large, 26-week, randomized, double-blind, active-controlled clinical safety trials to evaluate the risk of serious asthma-related events when long-acting beta agonists (LABAs) were used in fixed-dose combination with an inhaled corticosteroid (ICS) compared to ICS alone in patients with asthma. FDA reviewed the results of four trials involving 41,297 patients. The results demonstrate that the use of ICS/LABA in fixed-dose combination does not result in a significant increase in the risk of serious asthma-related events compared to ICS alone. The results of subgroup analyses for gender, adolescents 12-18 years, and African Americans are consistent with the primary endpoint results. The four trials also assessed efficacy of the ICS/LABA products. The primary efficacy endpoint was asthma exacerbation, defined as a deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days, or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. The results showed that the ICS/LABA combination reduced asthma exacerbations compared to ICS alone, noting that the majority of these exacerbations were those that required at least 3 days of systemic corticosteroids. This efficacy information has been added to the Clinical Studies section of the ICS/LABA drug labels. RECOMMENDATION: Health care professionals should refer to the most recently approved drug labels for recommendations on using ICS/LABA medicines (see links in Table 1 of the Drug Safety Communication, available at: http://bit.ly/2kC3Kc4,). Patients and parents/caregivers should talk to your health care professional if you have any questions or concerns. Do not stop taking your asthma medicines without first talking to your health care professional. Also read the patient information leaflet that comes with every prescription. In a large clinical study, more people who used an asthma medication similar to vilanterol experienced severe episodes of asthma that had to be treated in a hospital or caused death than patients who did not use the medication. Use of vilanterol inhalation may increase the risk of serious asthma problems or death in people who have asthma. Fluticasone and vilanterol inhalation has not been approved by the Food and Drug Administration (FDA) for the treatment of asthma. There is not enough information to tell whether inhaling fluticasone and vilanterol increases the risk of death in people who have chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways, which includes chronic bronchitis and emphysema). Talk to your doctor about the risks of using this medication.
- If you will be using a new inhaler for the first time, remove it from the box and the foil wrapper. Fill in the "Tray opened" and "Discard" blanks on the inhaler label with the date that you opened the pouch and the date 6 weeks later when you must replace the inhaler.
- When you are ready to inhale your dose, slide the cover down to expose the mouthpiece until it clicks. If you open and close the inhaler without using your dose, you will waste the medication.
- The counter will count down by 1 each time you open the cover. If the counter does not count down, your inhaler will not provide the medicine. If your inhaler does not count down, call your pharmacist or doctor.
- Hold the inhaler away from your mouth and breathe out as far as you comfortably can. Do not breathe out into the mouthpiece.
- Put the mouthpiece between your lips, and close your lips firmly around it. Take a long, steady, deep breath in through your mouth. Do not breathe in through your nose. Be careful not block the air vent with your fingers.
- Remove the inhaler from your mouth, and hold your breath for about 3 to 4 seconds or as long as you comfortably can. Breathe out slowly.
- You may or may not taste or feel the medicine released by the inhaler. Even if you do not, do not inhale another dose. If you are not sure you are getting your dose of fluticasone and vilanterol, call your doctor or pharmacist.
- You may clean the mouthpiece with a dry tissue, if needed. Slide the cover up over the mouthpiece as far as it will go to close the inhaler.
- Rinse your mouth with water, but do not swallow.
Before using fluticasone and vilanterol,
- tell your doctor and pharmacist if you are allergic to fluticasone (Flonase, Flovent), vilanterol, any other medications, milk protein, or any of the ingredients in fluticasone and vilanterol inhalation. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor if you use another LABA such as formoterol (Foradil, in Symbicort) or salmeterol (in Advair, Serevent). These medications should not be used with fluticasone and vilanterol inhalation. Your doctor will tell you which medication you should use and which medication you should stop using.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: antifungals such as itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); beta-blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); clarithromycin (Biaxin); conivaptan (Vaprisol); diuretics ('water pills'); HIV protease inhibitors such as indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase); other medications for COPD; metronidazole (Flagyl); nefazodone (Serzone); telithromycin (Ketek); and troleandomycin (TAO) Also tell your doctor and pharmacist if you are taking the following medications or have stopped taking them during the past 2 weeks: antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); and monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate). Many other medications may also interact with fluticasone and vilanterol, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you or anyone in your family has or has ever had osteoporosis (a condition in which the bones become weak and fragile), and if you have or have ever had high blood pressure, irregular heartbeat, seizures, hyperthyroidism (condition in which there is too much thyroid hormone in the body), diabetes, tuberculosis (TB), glaucoma (an eye disease), cataracts (clouding of the lens of the eyes), any condition that affects your immune system, or heart or liver disease. Also tell your doctor if you have a herpes eye infection, pneumonia, or any other type of infection.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using fluticasone and vilanterol, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using fluticasone and vilanterol.
- tell your doctor if you have never had chickenpox or measles and have not been vaccinated against these infections. Stay away from people who are sick, especially people who have chickenpox or measles. If you are exposed to these infections or if you develop symptoms of these infections, call your doctor immediately. You may need to get a vaccine (shot) to protect you from these infections.
- shaking of a part of your body that you cannot control
- joint pain
- runny nose, sore throat
- swelling of the face, throat, tongue
- pounding fast, or irregular heartbeat
- chest pain
- coughing, wheezing, or chest tightness that begins after you inhale fluticasone and vilanterol.
- blurred vision
- white patches in the mouth or throat
- fever, chills, or other signs of infection
- cough, difficulty breathing, or change in the color of sputum (the mucus you may cough up)