10599-003-01

Indications, Safety, and WarningsIndicationsSINUVA™ sinus implant is a corticosteroid-eluting implant indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult patients equal to or greater than 18 years of age who have had ethmoid sinus surgery.ContraindicationsPatients with known hypersensitivity to mometasone furoate and any of the ingredients of the SINUVA™ sinus implant.Warnings and precautionsLocal nasal adverse reactions: Monitor nasal mucosa adjacent to the SINUVA™ sinus implant for any signs of bleeding (epistaxis), irritation, infection, or perforation. Avoid use in patients with nasal ulcers or trauma.Glaucoma and cataracts: Nasal steroids may result in development of glaucoma and/or cataracts. Glaucoma, cataracts, and clinically significant elevation of intraocular pressure were not observed in patients from the treatment group of one randomized controlled clinical study (N = 53) who underwent bilateral placement of SINUVA™ sinus implants. Close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.Hypersensitivity reactions: Hypersensitivity reactions, including rash, pruritus, angioedema have been reported with the use of corticosteroids.Immunosuppression and risk of infections: Persons who are using drugs that suppress the immune system, such as corticosteroids, including SINUVA™ sinus implant are more susceptible to infections than healthy individuals. The safety and effectiveness of the SINUVA™ sinus implant have not been established in pediatric patients less than 18 years of age and SINUVA™ is not indicated for use in this population. Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.Hypercorticism and adrenal suppression: If corticosteroid effects such as hypercorticism and adrenal suppression appear in patients, consider sinus implant removal.Adverse reactionsThe most common adverse reactions observed (greater than 1% of subjects) in clinical studies were asthma, headache, epistaxis, presyncope, bronchitis, otitis media, and nasopharyngitis.Postmarketing experienceThe following adverse reactions have been identified during post-approval use of the SINUVA™ sinus implant. These events include implant migration, lack of efficacy, nasal pain, headache, epistaxis.Rx only. Please see full prescribing information for SINUVA™.

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