| The SINUVA Sinus Implant delivers sustained symptom relief for your patients with nasal polyps—without surgery or oral corticosteroids |
|
 |
|
| What is SINUVA? |
|
| • |
SINUVA is an outpatient nasal polyp treatment that delivers a steroid (mometasone furoate) over the course of 90 days and can be removed at 90 days or earlier at your discretion |
|
|
| • |
SINUVA is placed during a routine office visit using local or topical anesthetic, with the entire procedure typically lasting 30 to 40 minutes |
|
|
 |
|
|
|
| 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.
Please see additional Important Safety Information below |
|
|
|
SINUVA was clinically proven to reduce the symptoms
of nasal obstruction/congestion and polyp burden |
|
| SINUVA was studied in 300 patients in RESOLVE II trial—click here to learn more about the clinical study and its design. |
|
 |
|
Patients with SINUVA experienced a 74% relative improvement in bilateral polyp grade compared to control at Day 90*
Mean change for SINUVA -0.56 vs -0.15 with control (p=0.0073) |
|
|
 |
|
Patients with SINUVA experienced a 30% relative improvement in nasal obstruction/congestion score at Day 30†
Mean change for SINUVA -0.80 vs -0.56 with control (p=0.0074) |
|
|
 |
|
SINUVA reduced the proportion of patients still indicated for sinus surgery (61% vs 37%; p=0.0004) |
|
|
| The most common adverse reactions observed in clinical studies were bronchitis, nasopharyngitis, otitis media, headache, presyncope, asthma, and epistaxis. |
|
*Change from baseline to Day 90 in bilateral polyp grade, as determined by an independent panel graded on an 8-point scale, that represented a sum of 0 (no polyp) to 4 (obstructing passage) on each side.
†Change from baseline to Day 30 in nasal obstruction/congestion score, as determined by patients, on a scale of 0 to 3. |
|
|
|
| Effect of SINUVA in the ethmoid sinus cavity |
|
| |
 |
|
 |
|
|
|
|
|
|
| |
| |
Baseline |
| |
72-year-old male |
| |
| • |
Polyp grade: 3.5 |
| • |
ESO: 100% |
|
|
|
| |
Day 90 |
| |
| • |
Polyp grade: 1.5 |
| • |
ESO: 25% |
|
| |
|
|
|
|
|
| Example taken from the RESOLVE II Study. The mean reduction in nasal obstruction/congestion score from baseline to Day 30 was -0.80 (scale 0 to 3) and the mean reduction in bilateral polyp grade was -0.56 (scale 0 to 8) for the treatment arm of the RESOLVE II study. |
|
| 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 |
|
| 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 more than 1% of subjects) in clinical studies were bronchitis, nasopharyngitis, otitis media, headache, presyncope, asthma, and epistaxis. |
|
| 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. |
|
| Close monitoring is recommended if patients 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 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. |
|
| RX Only. For additional important risk and use information about SINUVA, please see Full Prescribing Information. |
|
SINUVA is a trademark of Intersect ENT.
1555 Adams Drive, Menlo Park, CA 94025
©2018 Intersect ENT. All rights reserved. |
