Revefenacin nebulizer solution is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Revefenacin is a long-acting muscarinic antagonist (anticholinergic agent) with similar affinity for muscarinic receptor subtypes M1 to M5. In the airways, it produces its pharmacological effect mainly by blocking M3 receptors on airway smooth muscle, leading to bronchodilation. The antagonism is competitive and reversible, demonstrated in both human and animal receptor studies as well as isolated tissue preparations. In preclinical in vitro and in vivo models, revefenacin showed dose-dependent inhibition of methacholine- and acetylcholine-induced bronchoconstriction, with effects lasting more than 24 hours. The clinical relevance of these findings has not been fully established. Bronchodilation after inhalation is primarily a site-specific action within the lungs.

The recommended dosage is 175 mcg Revefenacin (one 175 mcg unit-dose vial) administered by oral inhalation once daily by nebulizer using a mouthpiece. Revefenacin should be administered by the orally inhaled route via a standard jet nebulizer connected to an air compressor. The safety and efficacy of Revefenacin delivered from non-compressor-based nebulizer systems have not been established. The Revefenacin unit-dose vial should only be removed from the foil pouch and opened immediately before use. The vial and any residual content should be discarded after use.

Use in Children and Adolescents: Efficacy and safety in children and adolescents under 18 years has not been established.

Geriatric Use: Based on available data, no adjustment of the dosage of Revefenacin in geriatric patients is necessary.

Renal impairment patient: No dosage adjustment is required for patients with renal impairment.

Additive effects may occur with other anticholinergic drugs. Avoid using Revefenacin nebulizer solution with other anticholinergic-containing medicines. Co-administration with OATP1B1 and OATP1B3 inhibitors (e.g., rifampicin, cyclosporine, etc.) may increase exposure of the active metabolite. Therefore, this combination is not recommended.

Revefenacin is contraindicated in patients with hypersensitivity to Revefenacin or any component of the product.

Common: Cough, runny nose, upper respiratory tract infection, headache.
Serious: Glaucoma, eye pain, blurred vision, painful urination, rash, swelling of face, mouth and tongue.

There are no adequate and well-controlled studies in pregnant women. Use only if clearly needed. Animal studies showed no fetal harm at high exposure levels.

It is unknown whether the drug is present in human milk, but it was detected in animal milk. Decision should balance benefits and risks of breastfeeding.

Deterioration of Disease and Acute Episodes: Revefenacin should not be started in patients during acutely worsening or life-threatening COPD episodes. It has not been studied in such acute conditions and is not appropriate for initiation in this setting.

Revefenacin is a once-daily maintenance treatment for COPD and should not be used for relief of acute symptoms or as rescue therapy for bronchospasm. Extra doses must not be used for this purpose. Acute symptoms should be treated with a short-acting inhaled beta2-agonist.

COPD may worsen suddenly or gradually over time. If symptoms of bronchoconstriction are not controlled, if short-acting bronchodilators become less effective, or if their use increases, this may indicate disease worsening. In such cases, patient re-evaluation and treatment adjustment are required immediately. Increasing the dose beyond the recommended level is not appropriate.

Paradoxical Bronchospasm: Like other inhaled medicines, Revefenacin may cause paradoxical bronchospasm, which can be life-threatening. If it occurs, treat immediately with a short-acting bronchodilator, discontinue Revefenacin, and switch to alternative therapy.

Worsening of Narrow-Angle Glaucoma: Use with caution in patients with narrow-angle glaucoma. Monitor for symptoms such as eye pain, blurred vision, halos, or red eyes with swelling. Patients should seek immediate medical attention if symptoms appear.

Worsening of Urinary Retention: Use with caution in patients with urinary retention, especially those with prostate enlargement or bladder-neck obstruction. Symptoms such as difficulty urinating or painful urination require immediate medical attention.

Immediate Hypersensitivity Reactions: Severe allergic reactions may occur. If hypersensitivity develops, discontinue Revefenacin immediately and consider alternative treatment.

May cause anticholinergic symptoms such as nausea, vomiting, dizziness, blurred vision, eye pain, fatigue, or urinary difficulty.

Anticholinergic bronchodilators

Store below 30°C in a dry place, away from light. Keep out of reach of children. Not for oral or injection use.