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Prescribing Information: [ Ссылка ]

What is SINUVA®?

SINUVA Sinus Implant is a steroid-releasing (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

If you have a known hypersensitivity to the mometasone furoate drug or any of the ingredients in SINUVA, do not use SINUVA. Hypersensitivity reactions, including rash, itch, and swelling have been reported with use of steroids. If steroid effects such as Cushing Syndrome and adrenal suppression appear, consult your healthcare professional.

SINUVA is made from bioabsorbable polymers designed to soften over time. As the implant softens and polyps decrease, the implant may be expelled out of the nose on its own or with actions such as sneezing or forceful nose blowing. The implant can be removed 90 days after placement or earlier at the physician’s discretion. Repeat administration of SINUVA has not been studied.

As with other endoscopic sinus procedures, there are risks associated with the insertion or removal of SINUVA. SINUVA should be inserted by physicians trained in otolaryngology. Discuss risks related to insertion or removal of SINUVA with your healthcare professional.

Your healthcare professional will monitor the nasal tissue adjacent to the SINUVA Sinus Implant for any signs of bleeding, irritation, infection, or perforation. SINUVA should not be used in patients with nasal ulcers or trauma.

The most common adverse reactions observed (in more than 1% of subjects and that occurred more frequently in the treatment group compared to control) in clinical studies were bronchitis, upper respiratory or middle ear infection, headache, lightheadedness, asthma, and nose bleed.

If you experience excessive nasal bleeding, worsening symptoms of infections, viral eye infections, or symptoms suggesting that the implant has moved, such as irritation or a choking sensation in the back of the throat, immediately contact a healthcare professional.

Close monitoring is recommended if you have a change of vision or a history of increased intraocular pressure, glaucoma and/or cataracts.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit [ Ссылка ], or call 1-800-FDA-1088. You may also report side effects to Intersect ENT at 1-866-531-6004.

RX Only. For additional important risk and use information about SINUVA, please see Full Prescribing Information at www.SINUVA.com/PI

Find more information about SINUVA here: [ Ссылка ].

SINUVA is a registered trademark of Intersect ENT, Inc.
©2019 Intersect ENT, Inc. All rights reserved.

MPM-11338 Rev 1.0

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