Data from FDA - Curated by EPG Health - Last updated 09 February 2018

Indication(s)

1 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. 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.

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Advisory information

contraindications
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)
Adverse reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Local effects including epistaxis, irritation, infection, or perforation [see Warnings and Precautions (5.1) ] Cataracts and glaucoma [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Immunosuppression [see Warnings and Precautions (5.4) ] Hypothalamic-pituitary-adrenal (HPA) axis effects [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 sinusitis (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. 6.2 Post-Marketing Experience No post-marketing data exist at this time for the SINUVA Sinus Implant.

Usage information

Dosing and administration
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. 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) 2.1 Dosing One SINUVA Sinus Implant containing 1350 mcg of mometasone furoate. 2.2 General Instructions The SINUVA Sinus Implant (Figure 1) is loaded into a Delivery System and placed in the ethmoid sinus under endoscopic visualization. The SINUVA Sinus Implant is made from bioabsorbable polymers designed to gradually soften over time. The SINUVA Sinus Implant may be left in the sinus to gradually release the corticosteroid over 90 days. The SINUVA Sinus Implant can be removed at day 90 or earlier at the physician's discretion using standard surgical instruments. 2.3 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. 2.4 Repeat Administration There are no studies evaluating repeat implantation of the SINUVA Sinus Implant. 2.5 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 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. 2.6 Removal Instructions The SINUVA Sinus Implant is made from bioabsorbable polymers designed to gradually soften over time. The Implant may be left in the sinus to gradually release the corticosteroid over 90 days. The SINUVA Sinus Implant can be removed at any time at the physician's discretion using standard endoscopic instruments.
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no randomized clinical studies of SINUVA Sinus Implant or mometasone furoate in pregnant women. The active pharmaceutical ingredient, mometasone furoate is systemically available when administered topically or when inhaled. In animal reproduction studies, subcutaneous administration of mometasone furoate to pregnant mice, rats, or rabbits caused increased fetal malformations and decreased fetal survival and growth following administration of doses that produced exposures approximately 1/3 to 8 times the maximum recommended human dose (MRHD) on a mcg/m2 or AUC basis [see Data ]. However, experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroid exposure than humans. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In an embryofetal development study with pregnant mice dosed throughout the period of organogenesis, mometasone furoate produced cleft palate at an exposure approximately one-third of the MRHD (on a mcg/m2 basis with maternal subcutaneous doses of 60 mcg/kg and above) and decreased fetal survival at an exposure approximately equivalent to the MRHD (on a mcg/m2 basis with a maternal subcutaneous dose of 180 mcg/kg). No toxicity was observed with a dose that produced an exposure approximately one-tenth of the MRHD (on a mcg/m2 basis with maternal topical dermal doses of 20 mcg/kg and above). In an embryofetal development study with pregnant rats dosed throughout the period of organogenesis, mometasone furoate produced fetal umbilical hernia at exposures approximately 6 times the MRHD (on a mcg/m2 basis with maternal topical dermal doses of 600 mcg/kg and above) and delays in fetal ossification at exposures approximately 3 times the MRHD (on a mcg/m2 basis with maternal topical dermal doses of 300 mcg/kg and above). In another reproductive toxicity study, pregnant rats were dosed with mometasone furoate throughout pregnancy or late in gestation. Treated animals had prolonged and difficult labor, fewer live births, lower birth weight, and reduced early pup survival at an exposure that was approximately 8 times the MRHD (on an area under the curve (AUC) basis with a maternal subcutaneous dose of 15 mcg/kg). There were no findings with an exposure approximately 4 times the MRHD (on an AUC basis with a maternal subcutaneous dose of 7.5 mcg/kg). Embryofetal development studies were conducted with pregnant rabbits dosed with mometasone furoate by either the topical dermal route or oral route throughout the period of organogenesis. In the study using the topical dermal route, mometasone furoate caused multiple malformations in fetuses (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at an exposure approximately 3 times the MRHD (on a mcg/m2 basis with maternal topical dermal doses of 150 mcg/kg and above). In the study using the oral route, mometasone furoate caused increased fetal resorptions and cleft palate and/or head malformations (hydrocephaly and domed head) at an exposure approximately 1/2 of the MRHD (on AUC basis with a maternal oral dose of 700 mcg/kg). At an exposure approximately 2 times the MRHD (on an AUC basis with a maternal oral dose of 2800 mcg/kg), most litters were aborted or resorbed. No effects were observed at an exposure approximately 1/10 of the MRHD (on an AUC basis with a maternal oral dose of 140 mcg/kg). 8.2 Lactation Risk Summary There are no available data on the presence of SINUVA Sinus Implant in human milk, the effects on the breastfed child or the effects on milk production. Systemic absorption of a single inhaled 400 mcg mometasone dose was less than 1%. It is not known if mometasone furoate is excreted in human milk. Other inhaled corticosteroids, similar to mometasone furoate, are present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for the SINUVA Sinus Implant and any potential adverse effects on the breastfed infant from the SINUVA Sinus Implant. 8.4 Pediatric Use The safety and effectiveness of the SINUVA Sinus Implant have not been established in children or adolescents less than 18 years of age. 8.5 Geriatric Use A total of 33 patients 65 years of age or older received the SINUVA Sinus Implant in 2 controlled randomized clinical trials. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 8.6 Hepatic Impairment Concentrations of mometasone furoate appear to increase with severity of hepatic impairment [see Clinical Pharmacology (12.3) ].

Interactions

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 plasma concentrations of mometasone furoate [see Clinical Pharmacology (12.3) ].

More information

Category Value
Authorisation number NDA209310
Agency product number 04201GDN4R
Orphan designation No
Product NDC 10599-003
Date Last Revised 22-12-2017
Type HUMAN PRESCRIPTION DRUG
Storage and handling 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.
Marketing authorisation holder Intersect ENT, Inc.