The SINUVA Sinus Implant delivers a sustained release of steroids directly to nasal polyps1
- an outpatient nasal polyp treatment, placed in-office, that delivers a steroid over the course of 90 days and can be removed at 90 days or earlier at the physician’s discretion
- an alternative to current treatment options for appropriate adult patients with nasal polyps who already had ethmoid sinus surgery
- clinically proven to reduce nasal obstruction/congestion and polyp burden
Who is SINUVA appropriate for?1
Seeking an alternative to
current treatment options
SINUVA opens upon placement in the ethmoid sinus1 In a clinical study, over 85% of patients reported via survey that they either did not feel or felt only mild facial pain or pressure.2
Who is SINUVA not right for?1
SINUVA is not for people with hypersensitivity to mometasone furoate and other ingredients in SINUVA
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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
Patients with a known hypersensitivity to the mometasone furoate drug or any of the ingredients in SINUVA, should not use SINUVA. Hypersensitivity reactions, including rash, pruritus, and angioedema have been reported with the use of corticosteroids. If corticosteroid effects such as hypercorticism and adrenal suppression appear in patients, consider sinus implant removal.
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.
The nasal mucosa adjacent to the SINUVA Sinus Implant should be monitored for any signs of bleeding (epistaxis), irritation, infection, or perforation. Avoid the use of SINUVA in patients with nasal ulcers or trauma.
The most common adverse reactions observed in clinical studies were bronchitis, nasopharyngitis, otitis media, headache, presyncope, asthma, and epistaxis.
Patients experiencing excessive nasal bleeding, symptoms of infection or symptoms suggesting that the implant has moved, such as irritation or a choking sensation in the back of the throat, should immediately contact a healthcare professional.
Close monitoring is recommended if patients have a change of vision or a history of increased intraocular pressure, glaucoma and/or cataracts.
You may report side effects to your physician or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . You may also report side effects to Intersect ENT at 1-866-531-6004.
RX Only. For important risk and use information about SINUVA, please see Full Prescribing Information.
References: 1. SINUVA Prescribing Information, Intersect ENT. December 2017. 2. Data on File, Intersect ENT. RESOLVE CSR R 28011. Version: 1.0, February 2016. Study did not meet its primary endpoint.
IMPORTANT SAFETY INFORMATION
Patients with a known hypersensitivity to the mometasone furoate drug or any of the ingredients in SINUVA, should not use SINUVA. Hypersensitivity reactions, including rash, pruritus, and angioedema have been reported with the use of corticosteroids. If corticosteroid effects such as hypercorticism and adrenal suppression appear in patients, consider sinus implant removal. Continue Reading