Sinuva

Sinuva is an FDA-registered drug product whose active ingredient is MOMETASONE FUROATE. It is labelled by Intersect ENT, Inc. taken by intrasinal and marketed as a human prescription drug product. Identifiers on file: NDC 10599-003, application NDA209310, label effective 20230126. It is one of 22 FDA drug label records sharing the active ingredient MOMETASONE FUROATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing MOMETASONE FUROATE are most often described in connection with: sinuva sinus, implant indicated, treatment chronic, nasal polyps, adult patients, years age. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE SINUVA Sinus Implant is indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult patients ≥18 years of age who have had ethmoid sinus surgery. SINUVA Sinus Implant is a corticosteroid-eluting implant indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult patients ≥ 18years of age who have had ethmoid sinus surgery. ( 1 )

2 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. Remove the implant by 90 days or earlier at the physician's discretion using standard surgical instruments. ( 2.2 ) To be inserted by physicians trained in otolaryngology. ( 2.3 ) 2.1 Recommended Dosage The recommended dosage is one SINUVA Sinus Implant (1350 mcg of mometasone furoate) placed in an ethmoid sinus [see Dosage and Administration (2.3) ] . The SINUVA Sinus Implant may be left in the sinus to gradually release the corticosteroid over 90 days. Remove the SINUVA Sinus Implant by 90 days or earlier at the physician's discretion [see Dosage and Administration (2.4) ] . 2.2 Health Care Provider Training The SINUVA Sinus Implant is to be used by physicians trained in otolaryngology. Specialized training is not required for these physicians . 2.3 Placement of SINUVA Sinus Implant The SINUVA Sinus Implant is designed for single patient use only. Do not reprocess or reuse. Do not use if the package is open, the package or product is damaged, or has evidence of gross contamination. Special care should be taken to avoid bending, twisting, or damaging the implant. The implant is not designed to be modified by the physician. The implant is not intended to be compressed and loaded into the Delivery System more than two times. The implant must be placed under endoscopic visualization. Patient Preparation The patient should be prepared following routine protocols for in-office sinonasal endoscopic procedures. Implant Preparation The SINUVA Sinus Implant (Figure 1) is loaded into a Delivery System and placed in the ethmoid sinus. Remove the Crimper (Figure 2) and the Delivery System (Figure 3) from their protective packaging using sterile technique. Inspect the SINUVA Sinus Implant located inside of the Crimper (Figure 2). Do not remove the Implant from the Crimper. Prior to use, the SINUVA Sinus Implant must be crimped and loaded into the Delivery System. If the SINUVA Sinus Implant is not fully seated inside of the Crimper, secure the SINUVA Sinus Implant before proceeding. See instructions to secure the SINUVA Sinus Implant (Figure 12–15). IMPLANT Length (nominal): 20 mm Expanded Diameter (nominal): 34 mm DELIVERY SYSTEM Shaft Length 117 mm Figure 1: Implant Figure 2: Crimper with Implant Figure 3: Delivery System Place the Crimper on a flat surface and hold to prevent any potential slipping of the Crimper during loading of the SINUVA Sinus Implant into the Delivery System. Orient the Crimper such that the short ends of the Implant are in the 12 o'clock and 6 o'clock position (Figure 4). Figure 4 Grasp the Delivery System with the index and middle fingers on the left or right hand using the Finger Rests and the thumb in the Thumb Rest (Figure 5). Figure 5 Pull back on the Finger Rests while pressing down on the Thumb Rest to retract the Cup and expose the Seeker (Figure 6). Figure 6 Position the tip of the Seeker with its 10° angled tip downwards toward the user in the depression in the center of the SINUVA Sinus Implant (Figure 7). The distal end of the angled shaft must be in a vertical position, perpendicular to the Crimper, during positioning. Ensure the plane of the angled tip is in the same plane as the short ends of the Implant that were oriented in the 12 o'clock / 6 o'clock position in step 1. Figure 7 With the Thumb Rest depressed, gradually apply perpendicular downward force to the SINUVA Sinus Implant until the ends of the Implant collapse around the Seeker of Delivery System (Figure 8). Make sure that the Finger Rests are not released while pushing downwards. Figure 8 The SINUVA Sinus Implant should crimp in a radial fashion onto the Seeker. Implant ends should not cross over or past each other when being crimped onto the Seeker by the Crimper. While maintaining steady downward pressure on the Thumb Rest, slowly release the Finger Rests with the index and middle fingers until the Cup lowers and captures all ends of the SINUVA Sinus Implant (Figure 9). If necessary, adjust the position of the Delivery System with slight circular movements, slightly lifting and then lowering the Cup into position to ensure that all eight ends of the SINUVA Sinus Implant are secured within the Cup. Figure 9 Apply a downward push on the Delivery System to ensure that the SINUVA Sinus Implant is secured in the Cup (Figure 10). This will also ensure the Implant is compressed to its smallest profile for insertion. Figure 10 Retract the Delivery System from the Crimper. The SINUVA Sinus Implant should remain symmetrically loaded in the Cup of the Delivery System (Figure 11). Figure 11 CAUTION: Do not leave the SINUVA Sinus Implant in the crimped state for more than 5 minutes prior to placement. Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10 Figure 11 Instructions to Secure the SINUVA Sinus Implant in the Crimper If necessary, the Implant may be reloaded into the Crimper for a second time. CAUTION: The SINUVA Sinus Implant should not be used if the second attempt to crimp is unsuccessful. Hold the SINUVA Sinus Implant by one end as shown in Figure 12. Figure 12 Holding the SINUVA Sinus Implant with the dome-shaped Cap positioned downward (Figure 13), place the Implant back into the Crimper. Figure 13 Ensure that each Implant is secured in the Crimper by pressing down on the center of the Implant until all ends of the Implant are below the rim of the Crimper (Figure 14). Figure 14 Inspect the Implant and the Crimper to ensure that all the Implant ends are secured below the rim of the Crimper (Figure 15). Return to Implant Preparation Step 1 for instructions on how to load the re-secured implant into the delivery system. Figure 15 Figure 12 Figure 13 Figure 14 Figure 15 Instructions for the SINUVA Sinus Implant Placement Advance the Delivery System under endoscopic visualization into the ethmoid sinus cavity. Ensure that the Delivery System is oriented such that the 10° curvature of the distal tip is curved superiorly. Insert the Delivery System such that the Shaft is parallel to roof of ethmoid sinus. If the SINUVA Sinus Implant becomes dislodged from the Delivery System prior to placement into the ethmoid sinus, remove the Implant and inspect for damage, re-load the undamaged Implant in the Crimper, and re-crimp the Implant into the Delivery System. Note that the SINUVA Sinus Implant should not be loaded into the Delivery System more than twice. Release the SINUVA Sinus Implant by pressing down on the Thumb Rest while pulling back on the Finger Rests in a controlled manner. Place the SINUVA Sinus Implant amongst the sinus polyps with the cap oriented toward the posterior ethmoid sinus, and with the Implant positioned as superiorly as possible in the sinus. The long ends of the Implant should be in approximately the 2 o'clock, 4 o'clock, 8 o'clock and 10 o'clock positions, respectively. Confirm final placement of the SINUVA Sinus Implant by endoscopic visualization. To adjust the position of the SINUVA Sinus Implant, use the Seeker on the Delivery System or standard endoscopic surgical instruments. Post Placement Instructions Reposition the Implant if its ends are perpendicular to and in contact with the nasal septum. Avoid excessive manipulation of the Implant during follow-up, as this can cause dislodgement. 2.4 Removal Instructions The SINUVA Sinus Implant is made from bioabsorbable polymers designed to gradually soften over time. Remove the SINUVA Sinus Implant by day 90 or earlier at the physician's discretion using standard endoscopic instruments.

4 CONTRAINDICATIONS 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 )

6 ADVERSE REACTIONS 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 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 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of the SINUVA Sinus Implant was evaluated and demonstrated in 400 patients in 2 controlled, randomized, parallel group, single-blind studies. In Study 1, one-hundred (100) subjects were followed for 6 months. In Study 2, three-hundred (300) subjects were followed for 90 days. Of the 400 patients, 254 were assigned to the treatment group and underwent bilateral placement of SINUVA Sinus Implants in the ethmoid sinuses, totaling 2700 mcg of mometasone furoate, and 146 patients were assigned to the control group and underwent a sham procedure consisting of advancement of the Delivery System with the SINUVA Sinus Implant followed by removal without deployment. The Implants were removed by Day 60. All patients were required to use mometasone furoate nasal spray once daily (200 mcg of mometasone furoate) through Day 90. Table 1 shows the common adverse reactions (in greater than 1% of subjects) that occurred more frequently in patients treated with SINUVA Sinus Implant compared to the control group. Table 1: Adverse Reactions with > 1% Incidence and More Common than Control in 90-Day Controlled Clinical Trials with SINUVA Sinus Implant Study 1 & Study 2 Combined Data Adverse Reaction Treatment Patients in the treatment group received SINUVA Sinus Implants placed bilaterally in the ethmoid sinuses and used mometasone furoate nasal spray once daily (200 mcg mometasone furoate) through Day 90. (N = 254) n (%) Control Patients in the control group underwent a sham procedure and used mometasone furoate nasal spray once daily (200 mcg mometasone furoate) through Day 90. (N = 146) n (%) Values represent patient counts and percentages. A patient reporting more than one adverse event for a particular MedDRA preferred term is counted only once. Asthma 12 (4.7) 6 (4.1) Headache 9 (3.5) 5 (3.4) Epistaxis 6 (2.4) 2 (1.4) Presyncope 6 (2.4) 3 (2.1) Bronchitis 5 (2.0) 2 (1.4) Otitis media 5 (2.0) 2 (1.4) Nasopharyngitis 3 (1.2) 1 (0.7) Study 1 monitored patients from Day 90 through 6 months. Hypersensitivity (4% (n=2) vs. 0), chronic rhinosinusitis (11% (n=6) vs. 9% (n=4)), and upper respiratory tract infections (8% (n=4) vs. 2% (n=1)) were reported in more than 2 subjects in the treatment group, and more commonly than the control group during this time period. The safety of repeat administration of the SINUVA Sinus Implant was evaluated in Study 3 that was an open-label, single-arm, multicenter study in 50 patients. All patients underwent an in- office bilateral placement of the SINUVA Sinus Implant in each ethmoid sinus (totaling 2 implants) and were followed for 365 days. Patients were required to use mometasone furoate nasal spray once daily (200 mcg of mometasone furoate) through 365 days. At 90 days, the remaining implants were removed. To maximize the size of the safety population, patients with ethmoid sinus polyps grade ≥ 1 on any side were considered for repeat implant placement. Repeat placement was not performed if polyp grade was < 1, or if the patient declined it. Of the 50 patients, 41 received repeat implant placement (33 bilaterally and 8 unilaterally). Acute sinusitis (29%, n=12), upper respiratory infection (17%, n=7) epistaxis (12%, n=5), nasal discomfort or rhinalgia (12%, n=5), headache (7%, n=3), were the common adverse reactions that occurred in at least 3 subjects who underwent repeat placement during the study period. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of the SINUVA sinus implant. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to SINUVA, or a combination of these factors, include: implant migration, lack of efficacy, nasal pain, headache, epistaxis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug experience.

FDA lists 22 drug label records with MOMETASONE FUROATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Sinuva used for?
1 INDICATIONS AND USAGE SINUVA Sinus Implant is indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult patients ≥18 years of age who have had ethmoid sinus surgery. SINUVA Sinus Implant is a corticosteroid-eluting implant indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult patients ≥ 18years of age who have had ethmoid sinus surgery. ( 1 )

Who makes Sinuva?
Intersect ENT, Inc. is the labeler of record for Sinuva. 22 FDA label records share the active ingredient MOMETASONE FUROATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Sinuva come in?
administered by intrasinal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Sinuva prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing MOMETASONE FUROATE?
Yes. 22 FDA drug label records list MOMETASONE FUROATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Sinuva been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.