Rebreath 175 mg/3 ml

INDICATIONS

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

PHARMACOLOGY

Revefenacin is a long-acting muscarinic antagonist, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation. The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations. In preclinical in vitro as well as in vivo models, prevention of methacholine- and acetylcholine-induced bronchoconstrictive effects was dose-dependent and lasted longer than 24 hours. The clinical relevance of these findings is unknown. The bronchodilation following inhalation of revefenacin is predominantly a site-specific effect.

DOSAGE & ADMINISTRATION

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.

INTERACTION

May interact additively with concomitantly used anticholinergic medications. Avoid administration of Rebreath nebulizer solution with other anticholinergiccontaining drugs. Coadministration of Rebreath nebulizer solution with OATP1B1 and OATP1B3 inhibitors (e.g. rifampicin, cyclosporine, etc.) may lead to an increase in exposure of the active metabolite. Therefore, coadministration with Rebreath is not recommended.

SIDE EFFECTS

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

PREGNANCY & LACTATION

There are no adequate and well-controlled studies with Revefenacin in pregnant women. Women should be advised to contact their physician if they become pregnant while taking Revefenacin. In animal reproduction studies, subcutaneous administration of revefenacin to pregnant rats and rabbits during the period of organogenesis produced no evidence of fetal harm at respective exposures approximately 209 times the exposure at the maximum recommended human dose (MRHD).There is no information regarding the presence of revefenacin in human milk, the effects on the breastfed infant, or the effects on milk production. However, revefenacin was present in the milk of lactating rats following dosing during pregnancy and lactation. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Revefenacin and any potential adverse effects on the breastfed infant from Revefenacin or from the underlying maternal condition.

PRECAUTIONS & WARNINGS

Deterioration of Disease and Acute Episodes: Revefenacin should not be initiated in patients during acutely deteriorating or potentially life-threatening episodes of COPD. Revefenacin has not been studied in subjects with acutely deteriorating COPD. The initiation of Revefenacin in this setting is not appropriate.Revefenacin is intended as a once-daily maintenance treatment for COPD and should not be used for relief of acute symptoms, i.e. as rescue therapy for the treatment of acute episodes of bronchospasm, and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.COPD may deteriorate acutely over a period of hours or chronically over several days or longer. If Revefenacin no longer controls symptoms of bronchoconstriction, the patient's inhaled, short-acting beta2-agonist becomes less effective, or the patient needs more inhalations of a short-acting beta2-agonist than usual, these may be markers of deterioration of disease. In this setting, a re-evaluation of the patient and the COPD treatment regimen should be undertaken at once. Increasing the daily dose of Revefenacin beyond the recommended dose is not appropriate in this situation. Paradoxical Bronchospasm: As with other inhaled medicines, Revefenacin can produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs following dosing with Revefenacin, it should be treated immediately with an inhaled, short-acting bronchodilator; Revefenacin should be discontinued immediately and alternative therapy should be instituted.Worsening of Narrow-Angle Glaucoma: Revefenacin should be used with caution in patients with narrow-angle glaucoma. Prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (e.g. eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a physician immediately if any of these signs or symptoms develops. Worsening of Urinary Retention: Revefenacin should be used with caution in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g. difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to consult a healthcare provider immediately if any of these signs or symptoms develops. Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions may occur after administration of Revefenacin. If such a reaction occurs, therapy with Revefenacin should be stopped at once and alternative treatments should be considered.

THERAPEUTIC CLASS

Anticholinergic bronchodilators

STORAGE CONDITIONS

Store below 30°C temperature & in dry place. Protect from direct sunlight and temperature. Keep all medicines out of reach of children. Discard ampoule and other part after use. Not for oral administration or injection.