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The information on this site is intended for health care professionals in the United States, its territories, and Puerto Rico, and is not intended for the general public.

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sinuva

INDICATION

SINUVA Sinus Implant is a corticosteroid-eluting (mometasone furoate) implant indicated for the treatment of nasal polyps, in patients ≥ 18 years of age who have had ethmoid sinus surgery.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Patients with a known hypersensitivity to mometasone furoate or any of the ingredients in SINUVA should not use SINUVA.

WARNINGS AND PRECAUTIONS

Local Effects: 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.

Ocular Effects: Monitor patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts closely.

Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, and angioedema have been reported with the use of corticosteroids.

Immunosuppression: Patients taking corticosteroids are more susceptible to a more serious or even fatal course of chickenpox or measles than healthy individuals. 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.

There are no studies evaluating repeat implantation of the SINUVA Sinus Implant.

ADVERSE REACTIONS

The most common adverse reactions observed (> 1% of subjects and that occurred more frequently in the treatment group compared to control) in clinical studies were asthma, headache, epistaxis, presyncope, bronchitis, otitis media, and nasopharyngitis.

Rx only. Please see Full Prescribing Information. for SINUVA.

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