What is SINUVA?

What is SINUVA?

SINUVA is an innovative technology that reduces polyps and nasal congestion and obstruction with a 2-in-1 approach1:

SINUVA is an innovative technology that reduces polyps and the sensation of nasal congestion and obstruction with a 2-in-1 approach1:

2-in-1

Designed to open in the
sinus cavity

Delivers anti-inflammatory medicine to treat nasal polyps

SINUVA is a nasal polyp treatment without surgery:

  • Delivered into the sinus cavity through the nasal opening during a routine office visit
  • Usually cannot be felt once it’s in place2
  • Removed at 90 days or earlier at your doctor’s discretion

How well does SINUVA work?

  • SINUVA may be an alternative to surgery and other treatment options for adults who have already had ethmoid sinus surgery
  • SINUVA is proven to shrink nasal polyps and reduce nasal obstruction and congestion
  • As it stays in the sinus and continues to release medicine, SINUVA offers sustained relief from nasal congestion/obstruction up to 90 days3
  • In addition, SINUVA has been shown to improve a patient’s impaired sense of smell3

How is SINUVA placed?

SINUVA is placed in your doctor’s office. After numbing your nose, your doctor will introduce the SINUVA implant into your nostril on the end of a delivery system, and place the implant within your sinus.

Is SINUVA safe?

The safety of SINUVA was established in 400 patients in 2 clinical trials

  • The most common adverse reactions observed in clinical studies were bronchitis, upper respiratory or middle ear infection, headache, lightheadedness, asthma, and nose bleed
  • The risks from SINUVA are similar to those associated with other endoscopic sinus procedures, such as nose bleed, injuries to blood vessels, and bacterial infection
  • SINUVA is not for people with hypersensitivity to corticosteroids or those with nasal ulcers or trauma

Contact a doctor immediately if you experience:

  • Excessive nasal bleeding or symptoms of infection, such as excessive pain or discomfort, persistent headache, or increased sinus discharge
  • Symptoms suggesting that the implant has moved, such as irritation or a choking sensation in the back of the throat
  • Hypersensitivity reactions, including rashes, itching, and hives

Close monitoring is recommended for patients with a change of vision or a history of increased intraocular pressure, glaucoma, and/or cataracts.

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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 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. 3. Data on File, Intersect ENT. RESOLVE II Rev 3.0 CSR R 28017; February 2017.

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

IMPORTANT SAFETY INFORMATION

Patients with a known hypersensitivity to the mometasone furoate drug or any of the ingredients in SINUVA, should not use SINUVA. Continue Reading

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