For: Nasal Polyps
Sinuva (mometasone furoate) is a corticosteroid-eluting sinus implant indicated for the treatment of recurrent nasal polyp disease. One SINUVA Sinus Implant kit consists of an individual Implant inside of a Crimper and one disposable Delivery System packaged in a foil pouch. The SINUVA Sinus Implant is 20 mm in length and 34 mm in expanded diameter (Figure 1) and contains 1350 mcg of mometasone furoate.
Store the SINUVA Sinus Implant at 20–25°C (68–77°F); excursions permitted at 15–30°C (59–86°F) [see USP Controlled Room Temperature].
The NDC code for the SINUVA Sinus Implant is 10599-003-01. These highlights do not include all the information needed to use SINUVA™ safely and effectively. See full prescribing information for SINUVA.
SINUVA (mometasone furoate) sinus implant
Initial U.S. Approval: 1987
INDICATIONS AND USAGE
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. (1)
DOSAGE AND ADMINISTRATION
The SINUVA Sinus Implant is loaded into a Delivery System and placed in the ethmoid sinus under endoscopic visualization. The Implant may be left in the sinus to gradually release the corticosteroid over 90 days. The Implant can be removed at Day 90 or earlier at the physician's discretion using standard surgical instruments. (2.2)
To be inserted by physicians trained in otolaryngology. (2.3)
Repeat administration has not been studied. (2.4)
DOSAGE FORMS AND STRENGTHS
One SINUVA Sinus Implant system contains 1350 mcg of mometasone furoate and a sterile Delivery System. (3)
Patients with known hypersensitivity to mometasone furoate and any of the ingredients of the SINUVA Sinus Implant. (4)
WARNINGS AND PRECAUTIONS
Monitor nasal mucosa adjacent to the SINUVA Sinus Implant for any signs of bleeding (epistaxis), irritation, infection, or perforation. Avoid use in patients with nasal ulcers or trauma. (5.1)
Monitor patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts closely. (5.2)
Hypersensitivity reactions, including rash, pruritus, and angioedema, have been reported with use of corticosteroids. (5.3)
Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with the above because of the potential for worsening of these infections. (5.4)
If corticosteroid effects such as hypercorticism and adrenal suppression appear in patients, consider sinus implant removal. (5.5)
The most common adverse reactions (in more than 1% of subjects) were bronchitis, nasopharyngitis, otitis media, headache, presyncope, asthma, and epistaxis. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Intersect ENT at 1-866 531-6004 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
See 17 for PATIENT COUNSELING INFORMATION.