Advair HFA (fluticasone-salmeterol)

Fluticasone-salmeterol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required.

Fluticasone-salmeterol is contraindicated in patients with severe milk protein allergy.

Long-acting beta 2 adrenergic agonists, such as salmeterol may increase the risk of asthma-related death. Therefore, when treating patients with asthma, fluticasone-salmeterol should only be prescribed for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies. Data from a large placebo-controlled US study that compared the safety of salmeterol or placebo added to usual therapy showed an increase in asthma related deaths in patients received salmeterol (13 deaths out of 13,176 patients treated for 28 weeks) versus placebo (3 of 13, 179). Subgroup analysis suggests the risk may be greater in African-American patients compared to Caucasians.

Fluticasone-salmeterol should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma or COPD. Serious acute respiratory events, including fatalities, have been reported when salmeterol has been initiated in this situation.

An inhaled, short acting beta 2 agonist should be used to relieve acute symptoms of shortness of breath.

Patients who are receiving fluticasone-salmeterol twice daily should not use additional salmeterol or other inhaled, long-acting beta 2 agonists for prevention of exercise-induced bronchospasm for the maintenance treatment of asthma or the maintenance treatment of bronchospasm associated with COPD.

Fluticasone-salmeterol should not be used for transferring patients from systemic corticosteroid therapy. Fluticasone does not provide a patient with the systemic steroids necessary for periods of stress, severe asthma attacks, or other emergencies. Patients who have been previously maintained on 20 mg or more per day of prednisone may be most susceptible, particularly when their systemic steroids have been almost completely withdrawn. Patients should be tapered from systemic corticosteroids and monitored for signs and symptoms of adrenal insufficiency. Higher doses of salmeterol should be used with caution in patients with cardiac disease, arrhythmias, or hypertension. Inhaled bronchodilators may cause paroxysmal bronchoconstriction by an unknown mechanism. If an appropriate therapeutic response to salmeterol is not seen, alternative therapy should be sought.

Patients should be instructed to avoid exposure to chickenpox or measles and, if they are exposed, to consult their physicians without delay.

Patients should receive thorough instructions concerning the proper use of a fluticasone-salmeterol inhaler. Most patients are able to taste or feel a dry powder dose. However, whether or not patients are able to sense delivery of a dose, they should be instructed not to exceed the prescribed dose.

Cardiovascular and central nervous system effects seen with all sympathomimetic drugs (e.g., increased blood pressure, heart rate, excitement) can occur after use of salmeterol. Like all medications containing sympathomimetic amines, fluticasone-salmeterol should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders or thyrotoxicosis; and in patients who are unusually responsive to sympathomimetic amines.

Long-term use of orally inhaled corticosteroids may affect normal bone metabolism, resulting in a loss of bone mineral density.

Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with asthma and COPD following the long-term administration of inhaled corticosteroids, including fluticasone, therefore, regular eye examinations should be considered.

Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids. There was a higher incidence of pneumonia among COPD patients receiving fluticasone-salmeterol (7%) than among those receiving salmeterol (4%) in a clinical study. In a 3-year study of 6,184 patients with COPD, there was a higher incidence of pneumonia reported in patients receiving fluticasone-salmeterol 500/50 compared with placebo (16% on fluticasone-salmeterol 500/50, 14% on fluticasone propionate 500 mcg, 11% on salmeterol 50 mcg, and 9% on placebo). Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap.

Due to safety concerns, FDA is requiring a risk management strategy (REMS) and class-labeling changes for all long-acting beta-agonists (LABAs). Healthcare professionals are reminded that to ensure the safe use of these products: single-ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone; LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications; LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved; and, pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure compliance with both medications.