of LABA monotherapy; when LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, and death) compared with ICS alone No study adequate to determine whether the rate of asthma-related death is increased in patients treated with inhalation solution has been conducted; clinical studies with racemic formoterol suggested a higher incidence of serious asthma exacerbations in patients who received racemic formoterol than in those who received placebo. The sizes of these studies were not adequate to precisely quantify the differences in serious asthma exacerbation rates between treatment groups. Available data do not suggest an increased risk of death with use of LABA in patients with COPD Deterioration of disease and acute episodes Inhalation solution should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition Use of inhalation solution in this setting is inappropriate; arformoterol inhalation solution is not indicated for treatment of acute episodes of bronchospasm, i.e, as rescue therapy and extra doses should not be used for that purpose Acute symptoms should be treated with an inhaled short-acting beta2-agonist; when beginning inhalation solution, patients who have been taking inhaled short-acting beta2-agonists on a regular basis (eg, four times a day) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms When prescribing inhalation solution, the healthcare provider should also prescribe an inhaled, short-acting beta2-agonist and instruct the patient how it should be used Increasing inhaled beta2-agonist use is a signal of deteriorating disease for which prompt medical attention is indicated; COPD may deteriorate acutely over a period of hours or chronically over several days or longer If inhalation solution no longer controls the symptoms of bronchoconstriction, or the patient’s inhaled, short-acting beta2-agonist becomes less effective or the patient needs more inhalation of short-acting beta2-agonist than usual, these may be markers of deterioration of disease In this setting, a reevaluation of the patient and the COPD treatment regimen should be undertaken at once; increasing the daily dosage of inhalation solution beyond recommended 15 mcg twice daily dose is not appropriate in this situation Cardiovascular effects Arformoterol inhalation solution, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic and/or diastolic blood pressure, and/or symptoms If such effects occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T-wave, prolongation of the QTc interval, and ST-segment depression; use with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension Arformoterol inhalation solution, like other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension Pregnancy There are no adequate and well-controlled studies in pregnant women; drug should only be used during pregnancy if expected benefit outweighs potential risk to fetus; women should be advised to contact their physician if they become pregnant while receiving therapy The potential effect of therapy on labor and delivery is unknown; because of potential for beta-agonists interference with uterine contractility, use of inhalation solution during labor should be restricted to whom benefits clearly outweigh risk Animal data In animal reproduction studies with rats and rabbits at exposures approximately 370 and 8,400 times adult exposure at maximum recommended human daily inhalation dose (MRHDID) of 15 mcg every 12 hours, respectively, there were findings of structural abnormalities, embryofetal and infant mortality, and alterations of growth Adverse effects generally occurred at large multiples of the MRHDID when drug was administered by oral route to achieve high systemic exposures; no evidence of fetal harm was observed in rabbits at an exposure approximately 4,900 times the MRHDID Lactation There are no data on presence of arformoterol or its metabolites in human milk, effects on breastfed infant, or on milk production; however, arformoterol was excreted in milk of lactating rats; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal conditionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Long-acting beta2-agonist, R,R-enantiomer of racemic formoterol; relaxes bronchial smooth muscle by acting selectively on beta2-receptors Pharmacokinetics Excretion: Urine (67%); feces (22%) Onset: 7-20 min Half-life: 26hr Peak plasma time: 0.5-3hr Peak Plasma: 4.3 pg/mL AUC: 34.5 pg.hr/mL Protein Bound: 52-65% Metabolism: uridine diphosphoglucuronosyltransferases (glucuronidation), CYP2D6, CYP2C19 (O-demethylation) Renal Clearance: 8.9 L/hr BRAND FORM. UNIT PRICE PILL IMAGE Brovana inhalation- 15 mcg/2 mL nebulizer solnBrovana inhalation- 15 mcg/2 mL nebulizer solnCopyright © 2010 First DataBank, Inc.Print Patient Educationarformoterol inhalation ARFORMOTEROL SOLUTION - INHALATION (AR-for-MOE-ter-ol) COMMON BRAND NAME(S): Brovana USES: Arformoterol is used as a long-term (maintenance) treatment to prevent and decrease wheezing and shortness of breath caused by breathing problems (such as chronic obstructive pulmonary disease, including chronic bronchitis and emphysema). Arformoterol belongs to the class of drugs known as long-acting beta agonists (LABAs). Arformoterol is also known as a bronchodilator. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Controlling symptoms of breathing problems can decrease time lost from work or school.This medication does not work right away and should not be used for sudden attacks of breathing trouble. Your doctor must prescribe a quick-relief medicine/inhaler (such as albuterol, also known as salbutamol) for sudden shortness of breath while you are using arformoterol. You should always have a quick-relief inhaler with you.Arformoterol is not approved to treat asthma. People with asthma using long-acting inhaled beta agonists (such as arformoterol) without also using an inhaled corticosteroid may have an increased risk of serious (sometimes fatal) breathing problems. HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. This medication is used with a special machine called a nebulizer that changes the solution to a fine mist that you inhale. Learn how to prepare the solution and use the nebulizer properly. If a child is using this medication, a parent or other responsible adult may need to help the child use the nebulizer properly. If you have any questions, ask your doctor, pharmacist, or respiratory therapist.This product should be clear and colorless. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.Using the nebulizer, inhale this medication into your lungs as directed by your doctor, usually 2 times a day (once in the morning and once in the evening). The 2 doses should be about 12 hours apart. Each treatment usually takes about 5 to 10 minutes. Use this medication only through a nebulizer. Do not swallow or inject the solution. Do not mix with other medicines in the nebulizer. To prevent infections, clean the nebulizer and mouthpiece/face mask according to the manufacturer's directions.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.The dosage is based on your medical condition, age, and response to treatment. Do not use more of this medication or use it more often than prescribed since this may cause serious side effects. Do not use more than 30 micrograms of arformoterol a day.If you have been using a quick-relief inhaler (albuterol, salbutamol) on a regular daily schedule (such as 4 times daily), your doctor will direct you to stop this schedule and only use the quick-relief inhaler as needed for sudden shortness of breath. Consult your doctor for details.Learn which of your inhalers/medications you should use every day and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler more often (more than 2 days a week), or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.Tell your doctor if your symptoms do not improve or if they worsen. SIDE EFFECTS: Nervousness, dizziness, shaking (tremor), headache, nausea, dry mouth, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.Tell your doctor right away if you have any serious side effects, including: muscle cramps/weakness, increased thirst/urination.Get medical help right away if you have any very serious side effects, including: chest pain, rapid breathing, confusion, fast/irregular heartbeat, severe dizziness, fainting.Rarely, this medication has caused severe (possibly fatal), sudden worsening of breathing problems (paradoxical bronchospasm). If you have trouble breathing or sudden wheezing, use your quick-relief inhaler and get medical help right away.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. PRECAUTIONS: Before using arformoterol, tell your doctor or pharmacist if you are allergic to it; or to formoterol; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart problems (such as irregular heartbeat, angina, previous heart attack), high blood pressure, liver problems, seizures, overactive thyroid (hyperthyroidism), swelling of an artery (aneurysm), a certain tumor of the adrenal gland (pheochromocytoma).Arformoterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using arformoterol, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using arformoterol safely.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about