Nasal Obstruction

NASAL POLYPS – WHAT ARE NASAL POLYPS?

Nasal polyps are small, noncancerous growths inside the nose that hang from the lining of the sinuses. They are pain-free and may not even cause problems if they’re small. However, if they become bigger, they may block the airway and seriously affect the quality of everyday life. Sufferers of nasal polyps complain of these symptoms:1

  • Nasal obstruction/congestion
  • Runny nose
  • Facial pain/pressure
  • Reduced sense of smell

TRADITIONAL NASAL POLYP TREATMENTS

For decades, the most traditional way to treat nasal polyps has been with medical management, which includes intranasal steroid sprays, nasal saline irrigation and oral steroids. But if medical management was not effective, sinus surgery was sometimes recommended to remove the polyps.


1Orlandi RR, Kingdom TT, Hwang PH, et al. International Consensus Statement on Allergy and Rhinology: Rhinosinusitis. Int Forum Allergy Rhinol. 2016, 6 Suppl 1:S22-S209.

INDICATION

SINUVA® Sinus Implant is a drug-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 clinical studies were bronchitis, upper respiratory or middle ear infection, headache, lightheadedness, asthma, and nose bleed. If you experience 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, 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 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 or visit www.SINUVA.com.

MPM-00763 Rev A


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