Sinuva Approval History
Reviewed on Dec 10, 2017 by J.Stewart B.Pharm.
- FDA approved: Yes (First approved December 8th, 2017)
- Brand name: Sinuva
- Generic name: mometasone furoate
- Dosage form: Sinus Implant
- Company: Intersect ENT, Inc.
- Treatment for: Nasal Polyps
Sinuva (mometasone furoate) is a corticosteroid-eluting sinus implant indicated for the treatment of recurrent nasal polyp disease.
Important Safety Information
- Sinuva should not be used by patients with a known hypersensitivity to mometasone furoate or any of the other ingredients contained in the implant.
- Corticosteroids (including Sinuva) may cause hypersensitivity reactions that include rash, pruritus, and angioedema. If corticosteroid effects such as hypercorticism and adrenal suppression appear in patients, the sinus implant should removed.
- The Sinuva implant is made from bioabsorbable polymers designed to soften over time. As the implant softens and the nasal 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.
- Sinuva should only be inserted and removed by physicians trained in otolaryngology.
- Patients should be monitored for any signs of bleeding (epistaxis), irritation, infection, or perforation of the nasal mucosa. Patients with with nasal ulcers or trauma should not use Sinuva.
- Common side effects observed in clinical studies were bronchitis, nasopharyngitis, otitis media, headache, presyncope, asthma, and epistaxis.
- Patients should contact their healthcare professional immediately if they 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.
- Patients should be monitored closely if they have a change of vision or a history of increased intraocular pressure, glaucoma and/or cataracts.
Development History and FDA Approval Process for Sinuva
|Dec 11, 2017||Intersect ENT Announces FDA Approval of Sinuva (mometasone furoate) Sinus Implant, a New In-Office Treatment Option for Recurrent Nasal Polyps|
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