SINUVA FAQs

SINUVA is an alternative to surgery and other treatment options. For more information on how to treat nasal polyp symptoms, review the SINUVA FAQs below.

How is SINUVA implanted in my sinus cavity?

SINUVA is placed in your doctor’s office using local anesthesia. 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.

How long does the SINUVA procedure take?

In the SINUVA clinical studies, the typical procedure took 30-40 minutes. This includes 20-30 minutes to numb your nose and ~10 minutes to place the SINUVA Implants.

How big is SINUVA?

The approximate length of SINUVA is 20 mm. When prepared for the procedure, the Implant will be compressed to a size that is comparable to the head of a cotton swab.

Will placement of SINUVA hurt?

SINUVA is placed under local anesthesia in an ENT’s office. Your doctor will use topical and/or local anesthetic medication to numb your sinuses during placement.

Will I be able to feel SINUVA after it has been placed in my sinus?

Studies showed that following placement > 85% of clinical study patients felt only mild pain/pressure. However, if you experience irritation or a choking sensation in the back of the throat, please contact your healthcare professional, as the implant may have moved and should be evaluated.

Are there any placement-related complications?

Insertion of SINUVA is associated with risks similar to other endoscopic sinus procedures. It may also be associated with local adverse reactions such as nosebleed and injury to nerves or blood vessels in the nose/sinus.

Do I take other medications with SINUVA?

You should consult with your physician to determine the right therapy plan for you. In the SINUVA clinical studies, patients were advised to use nasal steroid sprays and sinus rinses for the duration of the study.

Should I continue to use saline irrigations or nasal sprays after the SINUVA procedure?

Yes, you are encouraged to use both saline irrigation and nasal sprays as directed by your physician. In the RESOLVE II study, all patients were required to use mometasone furoate nasal spray (eg, Nasonex) once daily through Day 90.

How long will SINUVA remain in my sinus?

SINUVA is designed to deliver drug over the course of 90 days and may be removed at that time or earlier at your physician’s discretion. As the implant softens and polyps decrease, the implant may be expelled earlier out of the nose on its own or with actions such as sneezing or forceful nose blowing.

Who should I contact if I still have questions?

Please speak with your physician regarding questions about SINUVA.

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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. RESOLVE II Protocol, P28017 Version: 2.0 October, 2014. 3. Data on file, Intersect ENT. RESOLVE II Rev. 3.0 CSR R 28017; February 2017. 4. Data on File, Intersect ENT. RESOLVE CSR R 28011. Version: 1.0, February 2016. Study did not meet its primary endpoint.

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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