SINUVA

One pharmacokinetics study was conducted with the SINUVA Sinus Implant. The remaining information is from other products containing mometasone furoate. Absorption A pharmacokinetics study was conducted to evaluate the potential for systemic exposure to mometasone furoate from the sinonasal route of administration following bilateral placement of the SINUVA Sinus Implant. Baseline blood samples were taken before the procedure, and on Days 3, 7, 14, 21 and 30 to assess systemic concentrations of m...

The SINUVA Sinus Implant was evaluated in 450 patients, 18 years of age and older, with chronic rhinosinusitis with nasal polyps and a history of ethmoid sinus surgery. The development program included a trial of 6 months duration (

Study 1NCT01732536), another trial of 90 days duration (

Study 2NCT02291549), and a repeat placement study of 1-year duration (

Study 3NCT03358329) [see Adverse Reactions (6.1) ] . The efficacy of SINUVA Sinus Implant is based primarily on Study 2 as described below. Study 2 was a randomized, controlled, single-blind, multicenter (all sites were in the US) study...

The following clinically significant adverse reactions are described elsewhere in the labeling: Local Nasal Adverse Reactions [see Warnings and Precautions (5.1) ] Glaucoma and Cataracts [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Immunosuppression and Risk of Infections [see Warnings and Precautions (5.4) ] Hypercorticism and Adrenal Suppression [see Warnings and Precautions (5.5) ] The most common adverse reactions (in more than 1% of ...

Patients with known hypersensitivity to mometasone furoate, or to any of the copolymers of the SINUVA Sinus Implant [see Description (11) ] . Patients with known hypersensitivity to mometasone furoate and any of the ingredients of the SINUVA Sinus Implant . ( 4 )

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 tuberculo...

7 DRUG INTERACTIONS Formal drug-drug interaction studies have not been conducted with the SINUVA Sinus Implant. An evaluation of the concurrent administration of the SINUVA Sinus Implant and other commonly used nasal drugs was not associated with any unusual adverse reactions. 7.1 Inhibitors of Cytochrome P450 3A4 Co-administration with ketoconazole, a potent CYP 3A4 inhibitor, may increase the pl...