Generic Name and Formulations:
Mometasone furoate 1350mcg; per sinus implant.
Intersect ENT, Inc.
Indications for SINUVA:
Nasal polyps in patients ≥18yrs who have had ethmoid sinus surgery.
To be used by physicians trained in otolaryngology for placement in ethmoid sinus under endoscopic visualization. Insert 1 implant for 90 days. Implant can be removed at Day 90 or earlier based on physician's discretion. Do not reprocess or reuse.
<18yrs: not established.
Respiratory tract tuberculosis. Systemic infections. Ocular herpes simplex. Immunosuppression. If exposed to measles or chickenpox, consider anti-infective prophylactic therapy. Nasal ulcers or trauma: avoid. Monitor nasal mucosa for epistaxis, irritation, infection, perforation. Change in vision, history of increased intraocular pressure, glaucoma, and/or cataracts: monitor closely. Monitor post-operatively and during periods of stress for adrenal response. Consider implant removal if hypercorticism and adrenal suppression occurs. Hepatic impairment. Pregnancy. Nursing mothers.
May be potentiated by strong CYP3A4 inhibitors (eg, ketoconazole).
Bronchitis, nasopharyngitis, otitis media, headache, presyncope, asthma, epistaxis; hypersensitivity reactions, immunosuppression, HPA axis effects.
Kit—1 (implant + delivery system)
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