SINUVA™ for Nasal Polyps

SINUVA™ for Nasal Polyps

Are you tired of beating yourself up over how to clear nasal congestion, obstruction, and loss of smell because of stubborn nasal polyps? The ENT specialists at Ascentist know that these cause seemingly endless nights of sleep loss that ultimately lead to hair loss, excessive weight loss, and other personal problems. You do not have to suffer anymore though. There is a treatment option designed to reduce nasal polyps called SINUVA™.

How are polyps normally treated?

As nasal polyps grow, they can block the nasal passages and cause major discomfort. Throughout the years, doctors have responded with saline rinses, steroid sprays, oral steroids, and/or biologics.

Despite these efforts, traditional treatments may not always provide sufficient and reliable relief. Accordingly, patients may be trapped going from one treatment to another trying to control their symptoms.

What can I expect with the SINUVA™ implant?

The device is placed into the nose via an endoscopic procedure. It delivers a corticosteroid directly into the sinuses where it will remain until it has been completely absorbed by the body. This treatment may last anywhere from 3 months to as long as 12 months depending on the patient's response. After removal, there should not be any noticeable scarring.

What Else Should I Know

If you have any other questions about the risks, benefits, and safety information regarding SINUVA™, please visit their parent site or schedule an appointment with an Ascentist ENT doctor.

What Patients are Saying

References

  1. SINUVA Prescribing Information, Intersect ENT. December 2017.
  2. Data on file, Intersect ENT. RESOLVE II Rev. 3.0 CSR R 28017; February 2017.

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.

SINUVA: a sinus implant treats nasal polyps without 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.

References

  1. SINUVA Prescribing Information, Intersect ENT. December 2017.
  2. Data on file, Intersect ENT. RESOLVE II Rev. 3.0 CSR R 28017; February 2017.

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.

SINUVA: a sinus implant treats nasal polyps without 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.