SINUVA is for adult patients (≥ 18 years of age) who have had previous ethmoid sinus surgery and continue to suffer from recurring sinus obstruction due to nasal polyps.1
SINUVA is for patients aged 18 and over who have had previous ethmoid sinus surgery and present with recurrent nasal polyps.1
PROPEL is for patients aged 18 and over following ethmoid sinus surgery to maintain patency, thereby reducing the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids.2
SINUVA contains 1350 mcg of mometasone furoate, the same corticosteroid as in the PROPEL family of products. Bilateral placement of SINUVA into the ethmoid sinuses was studied in our clinical studies for a total of 2700 mcg of mometasone furoate delivered locally in a patient’s ethmoid sinuses.1
SINUVA is implanted in your sinus cavity next to the nasal polyps to provide local delivery of a drug called mometasone furoate (a type of steroid). The Implant has been shown to be effective in reducing nasal obstructions / congestion and nasal polyps.1
The SINUVA Sinus Implant is to be used by physicians trained in otolaryngology.1
SINUVA is administered in the office for patients who have had previous ethmoid sinus surgery and suffer from nasal polyps.1 The Implant is designed to be administered under topical and/or local anesthetic in the physician’s office.3
The patient should be prepared following routine protocols for in-office sinonasal endoscopic procedures.1
In the clinical study, topical or local anesthetic—such as sprays, pledgets, and cottonoids—was recommended in accordance with protocols for in-office sinonasal endoscopic procedures.3
In the clinical study, anesthesia injections directly into the middle turbinate or surrounding tissue were used as necessary.4
Yes. SINUVA delivers mometasone furoate over the course of 90 days. Per the prescribing information, the implant may be removed at Day 90 or earlier at the physician’s discretion.
SINUVA is a bioabsorbable implant and is intended to soften over time. As the implant softens and polyps decrease, the implant may be expelled (in part or whole) out of the nose on its own or with actions such as sneezing or forceful nose blowing. Any remaining fragments should be removed by day 90 or earlier, at the physician’s discretion.1
No. Advise the patient that the Implant is bioabsorbable and intended to soften over time. As the Implant softens and polyps decrease, the Implant may be expelled out of the nose. If they experience excessing bleeding, pain, or a choking sensation in the throat, they should contact a physician immediately.1
Patients are encouraged to use both saline irrigation and nasal sprays as directed by their physician. The SINUVA prescribing information does not require concomitant use of intranasal corticosteroids but in the RESOLVE II pivotal study, all patients used mometasone furoate nasal spray (200 mcg) once daily.3
Repeat administration of SINUVA has not been studied. The SINUVA prescribing information does not specify how often SINUVA can be used.
Evaluation units of SINUVA are not available.
Providers should report HCPCS code J3490, unclassified drugs. Additionally, providers should include NDC number 10599-0003-01 on the claim form.
Providers should report the number of units rather than using the -50 modifier.
For further information, please contact Intersect ENT at 1-866-531-6004.
Reimbursement for SINUVA will vary by payor and may vary by plan type. It is advised to check with the payor for reimbursement based on the individual plan guidelines prior to use.
Whether SINUVA will be covered under the pharmacy benefit or medical benefit is at the discretion of each payor. Formulary inclusion may affect coverage of SINUVA. It is recommended to check with the payor for reimbursement based on the individual plan guidelines prior to use.
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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.
IMPORTANT SAFETY INFORMATION
Patients with a known hypersensitivity to the mometasone furoate drug or any of the ingredients in SINUVA, should not use SINUVA. Hypersensitivity reactions, including rash, pruritus, and angioedema have been reported with the use of corticosteroids. If corticosteroid effects such as hypercorticism and adrenal suppression appear in patients, consider sinus implant removal.
SINUVA is made from bioabsorbable polymers designed to soften over time. As the implant softens and 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. Repeat administration of SINUVA has not been studied.
As with other endoscopic sinus procedures, there are risks associated with the insertion or removal of SINUVA. SINUVA should be inserted by physicians trained in otolaryngology.
The nasal mucosa adjacent to the SINUVA Sinus Implant should be monitored for any signs of bleeding (epistaxis), irritation, infection, or perforation. Avoid the use of SINUVA in patients with nasal ulcers or trauma.
The most common adverse reactions observed in clinical studies were bronchitis, nasopharyngitis, otitis media, headache, presyncope, asthma, and epistaxis.
Patients experiencing 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, should immediately contact a healthcare professional.
Close monitoring is recommended if patients have a change of vision or a history of increased intraocular pressure, glaucoma and/or cataracts.
You may report side effects to your physician or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . You may also report side effects to Intersect ENT at 1-866-531-6004.
RX Only. For important risk and use information about SINUVA, please see Full Prescribing Information.
Reference: 1. SINUVA Prescribing Information, Intersect ENT. December 2017. 2. Han JK, Marple BF, Smith TL, et al. Int Forum Allergy Rhinol. 2012; 2:271-279. 3. RESOLVE II Protocol, P28017 Version: 2.0 October, 2014. 4. Data on file, Intersect ENT. RESOLVE II Rev. 3.0 CSR R 28017; February 2017.
IMPORTANT SAFETY INFORMATION
Patients with a known hypersensitivity to the mometasone furoate drug or any of the ingredients in SINUVA, should not use SINUVA. Hypersensitivity reactions, including rash, pruritus, and angioedema have been reported with the use of corticosteroids. If corticosteroid effects such as hypercorticism and adrenal suppression appear in patients, consider sinus implant removal. Continue Reading