Lower respiratory tract infections, including pneumonia, have been reported following use of ICS, like fluticasone furoate.Advise patients to rinse their mouths with water without swallowing after inhalation. Oropharyngeal candidiasis has occurred in patients treated with orally inhaled drug products containing fluticasone furoate.Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs, like LABA.
TRELEGY should not be used more often or at higher doses than recommended or with another LABA for any reason, as an overdose may result.Acute symptoms should be treated with an inhaled, short-acting beta 2-agonist. TRELEGY is NOT a rescue medication and should NOT be used for the relief of acute bronchospasm or symptoms.TRELEGY should NOT be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD or asthma.TRELEGY is not indicated for use in pediatric patients aged 17 years and younger. When LABA are used in fixed-dose combination with inhaled corticosteroids (ICS), data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone.
These findings are considered a class effect of LABA monotherapy. Long-acting beta 2-adrenergic agonist (LABA) monotherapy for asthma increases the risk of asthma-related death, and in pediatric and adolescent patients, available data also suggest an increased risk of asthma-related hospitalization.Patients with severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate (FF), umeclidinium (UMEC), vilanterol (VI), or any of the excipients.Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required.TRELEGY is contraindicated in the following: "Easy to use” was defined as a rating of very easy or easy on a 4-point scale (very easy, easy, difficult, very difficult). In the ASTHMA study, 98% of patients demonstrated correct use. In the COPD study, 97% of patients demonstrated correct use. On Day 28, patients were evaluated for correct use in a single attempt without additional instruction. At enrollment, patients were allowed up to 3 attempts to demonstrate correct use (with training between attempts 1 and 2, and 2 and 3, if necessary), and all patients were able to demonstrate correct use. Correct use was evaluated using instructions derived from the prescribing information for products delivered in the ELLIPTA inhaler. Inhalers did not contain active treatment.īoth studies were 28-day, open-label, placebo studies designed to assess ease of use of the ELLIPTA inhaler among adult patients who used the inhaler correctly on Day 28. One study was conducted in patients with COPD (N=266), and one study was conducted in patients with ASTHMA (N=250).
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See Dosage and Administration in the full Prescribing Information. For patients who do not respond adequately to TRELEGY 200 once daily, re-evaluate and consider other therapeutic regimens and additional therapeutic options. Maximum recommended dosage is 1 inhalation of TRELEGY 200 once daily.
TRELEGY 100/62.5/25 mcg is the only strength indicated for treatment of COPD.Įither strength-100/62.5/25 mcg or 200/62.5/25 mcg-can be the starting dose. No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with moderate hepatic impairment.
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