Breztri Aerosphere

FDA label

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Renal No formal PK studies in renal impairment; in severe renal impairment (CrCl <=30 mL/min/1.73 m2) or end-stage renal disease requiring dialysis, use only if the expected benefit outweighs the potential risk

Hepatic No formal PK studies in hepatic impairment; budesonide and formoterol are predominantly cleared by hepatic metabolism and may accumulate in plasma - closely monitor patients with severe hepatic disease

Not for acute bronchospasm; max 2 inhalations BID

Instructions

• Oral inhalation only; rinse mouth with water without swallowing after each dose (reduces candidiasis risk)
• Prime before first use: 4 sprays into air, shaking before each; re-prime with 2 sprays if unused >7 days, dropped, or after weekly rinsing
• Discard when dose indicator pointer reaches zero (red zone)
• Taper slowly from systemic corticosteroids when transferring to BREZTRI
• Do not use with any additional LABA-containing medicine; use SABA for acute symptoms

Available strengths

• inhaler 160/9/4.8, 160/18/4.8 mcg/inh

Contraindications

• Primary treatment of status asthmaticus or other acute episodes of COPD or asthma requiring intensive measures

Cautions

• LABA monotherapy (without ICS) increases serious asthma-related events — combo mitigates; never add another LABA
• Do not initiate in acutely deteriorating COPD/asthma; not for acute symptom relief
• Oropharyngeal candidiasis — rinse mouth after use; monitor
• Increased pneumonia risk in COPD — monitor
• Immunosuppression: worsening TB, fungal/bacterial/viral/parasitic infections, ocular herpes; severe chickenpox/measles in susceptible patients
• Adrenal suppression / hypercorticism; taper systemic corticosteroids slowly on transfer
• Paradoxical bronchospasm — discontinue if it occurs
• Caution in cardiovascular disorders (beta-adrenergic stimulation)
• Bone mineral density decrease — assess initially and periodically
• Glaucoma and cataracts with long-term ICS; worsening narrow-angle glaucoma
• Worsening urinary retention (prostatic hyperplasia, bladder-neck obstruction)
• Caution in convulsive disorders, thyrotoxicosis, diabetes, ketoacidosis; watch hypokalemia and hyperglycemia

Adverse reactions

• COPD (>=2%): upper respiratory tract infection, pneumonia, back pain, oral candidiasis, influenza, muscle spasm, UTI, cough, sinusitis, diarrhea
• Asthma (>=2%): nasopharyngitis, pneumonia, headache

Pregnancy No adequate combo data; human data with inhaled budesonide show no increased abnormality risk; restrict use during labor (beta-agonist uterine effects) to clear benefit

Lactation Budesonide present in human milk (~0.3-1% of maternal inhaled dose); no data for glycopyrrolate/formoterol; weigh breastfeeding benefit vs risk