A Non-Surgical Treatment for Nasal Polyps

SINUVA® (mometasone furoate) Sinus Implant

SINUVA is a non-surgical treatment that shrinks nasal polyps and may be an alternative to surgery. SINUVA is for adults 18 years of age or older with nasal polyps who have had ethmoid sinus surgery.

Choosing SINUVA Sinus Implants

SINUVA may be appealing to nasal polyp sufferers who would prefer an in-office treatment instead of sinus surgery in an operating room. SINUVA is placed during an office visit and patients are usually able to resume normal activities with little to no recovery days needed.

SINUVA was clinically proven to1,2

·       Shrink nasal polyps at 90 days

·       Reduce symptoms of nasal obstruction and congestion

·       Improve patients altered sense of smell

The most common adverse reactions observed in clinical trials were bronchitis, upper respiratory or middle ear infection, headache, light-headedness, asthma and nose bleed.

SINUVA is not for people with hypersensitivity to corticosteroids or those with nasal ulcers or trauma. See more Important Safety Information below.

What to Expect with SINUVA Sinus Implants2

 

Actual SINUVA Patient Experience

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 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.

INDICATION

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.

RX Only.  For additional important risk and use information about SINUVA, please see Full Prescribing Information.

REFERENCES

1 SINUVA Prescribing Information, Intersect ENT. December 2017

2 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;8:471–81.

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