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#TRELOGY ICS LABA LAMA TRIAL#

BREZTRI should be administered with caution to patients being treated with:.

BREZTRI should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors and tricyclic antidepressants, as these may potentiate the effect of formoterol fumarate on the cardiovascular system.

In a 24-week trial, adverse reactions (incidence ≥ 2%) were dysphonia (3.3%) and muscle spasms (3.3%)

#TRELOGY ICS LABA LAMA TRIAL#

Most common adverse reactions in a 52-week trial (incidence ≥ 2%) were upper respiratory tract infection (5.7%), pneumonia (4.6%), back pain (3.1%), oral candidiasis (3.0%), influenza (2.9%), muscle spasms (2.8%), urinary tract infection (2.7%), cough (2.7%), sinusitis (2.6%), and diarrhea (2.1%).Be alert to hypokalemia or hyperglycemia.Use caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis or unusually responsive to sympathomimetic amines.Instruct patients to contact a healthcare provider immediately if symptoms occur Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction. Worsening of urinary retention may occur.Consider referral to an ophthalmologist in patients who develop ocular symptoms or use BREZTRI long term. Worsening of narrow-angle glaucoma may occur, so use with caution. Glaucoma and cataracts may occur with long-term use of ICS.Assess initially and periodically thereafter in patients at high risk for decreased bone mineral content Decreases in bone mineral density have been observed with long-term administration of ICS.Use caution in patients with cardiovascular disorders, especially coronary insufficiency, as formoterol fumarate can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias, such as supraventricular tachycardia and extrasystoles.Discontinue and consider alternative therapy Anaphylaxis and other hypersensitivity reactions (eg, angioedema, urticaria or rash) have been reported.If paradoxical bronchospasm occurs, discontinue BREZTRI immediately and institute alternative therapy.Adverse effects related to increased systemic exposure to budesonide may occur

Caution should be exercised when considering the coadministration of BREZTRI with long-term ketoconazole and other known strong CYP3A4 Inhibitors.If such changes occur, consider appropriate therapy Hypercorticism and adrenal suppression may occur with regular or very high dosage in susceptible individuals.Taper patients slowly from systemic corticosteroids if transferring to BREZTRI Particular care is needed for patients transferred from systemic corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients during and after transfer.A more serious or fatal course of chickenpox or measles can occur in susceptible patients Due to possible immunosuppression, potential worsening of infections could occur.Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap Lower respiratory tract infections, including pneumonia, have been reported following ICS.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 budesonide.Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs BREZTRI should not be used more often than recommended at higher doses than recommended or in combination with LABA-containing medicines, due to risk of overdose.Do NOT use to relieve acute symptoms treat with an inhaled short-acting beta 2-agonist BREZTRI should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition.Available data do not suggest an increased risk of death with use of LABA in patients with COPD When a LABA is 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, 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 is associated with an increased risk of asthma-related death. BREZTRI is not indicated for treatment of asthma.BREZTRI is contraindicated in patients who have a hypersensitivity to budesonide, glycopyrrolate, formoterol fumarate, or product excipients.