Anoro Ellipta

FDA label

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Renal No adjustment needed

Hepatic Moderate (Child-Pugh 7–9): no adjustment. Severe: not studied.

Maximum 1 inhalation per 24 hours.

Instructions

• Oral inhalation only, at the same time every day
• Do not use more than 1 inhalation per 24 h; do not increase the daily dose
• Not for acute symptoms/rescue — prescribe and use an inhaled short-acting beta2-agonist for acute episodes
• Do not initiate during rapidly deteriorating COPD
• Do not use with any other LABA-containing therapy

Available strengths

• powder 0.0625/0.025 mg/inh

Contraindications

• Asthma — LABA without an inhaled corticosteroid is contraindicated; not indicated for asthma
• Severe hypersensitivity to milk proteins (lactose carrier)

Cautions

• LABA monotherapy in asthma increases asthma-related death (class effect; not for asthma)
• Do not combine with other LABAs — overdose/cardiovascular fatalities with excess sympathomimetics
• Caution with strong CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin, itraconazole…) — increased cardiovascular effects
• Paradoxical bronchospasm — discontinue immediately if it occurs
• Cardiovascular effects (pulse, BP, arrhythmias, QTc) — caution in coronary insufficiency, arrhythmias, hypertension
• Caution in convulsive disorders, thyrotoxicosis, diabetes/ketoacidosis
• Worsening narrow-angle glaucoma; worsening urinary retention (BPH/bladder-neck obstruction)
• Hypokalemia and hyperglycemia possible

Adverse reactions

• Pharyngitis
• Sinusitis
• Lower respiratory tract infection
• Constipation
• Diarrhea
• Pain in extremity
• Muscle spasms
• Neck pain
• Chest pain

Pregnancy Insufficient human data; use during late gestation/labor only if benefit justifies risk (beta-agonists may interfere with uterine contractility).

Lactation No human data; umeclidinium likely present in milk (rat data); weigh benefit vs need.