| The SINUVA Sinus Implant is an alternative to current treatment options for recurring nasal polyps—including surgery and systemic corticosteroids |
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| What is SINUVA? |
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SINUVA is an outpatient nasal polyp implant, 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. |
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| Who is SINUVA for? |
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| SINUVA is appropriate for adult patients with nasal polyps who have had ethmoid sinus surgery |
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| Patients in the clinical trials for SINUVA had moderate-to-severe polyposis1 |
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To be included in the trials, patients were required to have bilateral sinus obstruction due to nasal polyps (grade ≥2 on a scale from 0 to 4) and were excluded if they had grade 4 nasal polyps on at least 1 side |
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| SINUVA is not for people with hypersensitivity to mometasone furoate and other ingredients in SINUVA |
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| Why choose SINUVA? |
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| There may be disadvantages to using current treatment options for nasal polyps |
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70% of patients who have revision surgery have recurring nasal polyps2 |
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Only 34% of patients use intranasal corticosteroids as directed3 |
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Polyps may block access to the sinus, preventing nasal sprays/rinses from reaching the intended target site1 |
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Some possible side effects of oral corticosteroid use include hyperglycemia, bone loss, adrenal suppression, and psychiatric symptoms4 |
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| Learn about the efficacy of SINUVA and how it may help your patients. |
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| The most common adverse reactions observed (in more than 1% of subjects) in clinical studies were bronchitis, nasopharyngitis, otitis media, headache, presyncope, asthma, and epistaxis. |
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| INDICATION |
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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. |
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| IMPORTANT SAFETY INFORMATION |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| The most common adverse reactions observed (in more than 1% of subjects) in clinical studies were bronchitis, nasopharyngitis, otitis media, headache, presyncope, asthma, and epistaxis. |
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| Patients experiencing excessive nasal bleeding, worsening of existing tuberculosis, fungal, bacterial, viral or parasitic infection, ocular herpes, 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. |
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| Close monitoring is recommended if patients have a change of vision or a history of increased intraocular pressure, glaucoma and/or cataracts. |
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| You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch (www.fda.gov/medwatch) or call 1-800-FDA-1088. You may also report side effects to Intersect ENT at 1-866-531-6004. |
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| RX Only. For additional important risk and use information about SINUVA, please see Full Prescribing Information. |
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| References |
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| 1. Kern RC, Stolovitzky JP, Silvers SL, et al. A phase 3 trial of mometasone furoate sinus implants for chronic sinusitis with recurrent nasal polyps. Int Forum Allergy Rhinol. 2018;8(4):471-481. 2. Data on file, Intersect ENT. 2016 ENT Market Research. Q2 2016. 3. Bender BG. Motivating patient adherence to allergic rhinitis treatments. Curr Allergy Asthma Rep. 2015;15(10):1-7. 4. Poetker DM. Oral corticosteroids in the management of chronic rhinosinusitis with and without nasal polyps: risks and benefits. Am J Rhinol Allergy. 2015;29(5):339-342. |
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SINUVA is a trademark of Intersect ENT. 1555 Adams Drive, Menlo Park, CA 94025 ©2018 Intersect ENT. All rights reserved. |