SINUVA is an FDA-approved stent for the treatment of nasal polyps that can be placed in office. SINUVA has a 2-in-1 design that expands in the sinus and delivers
No. SINUVA is not a surgery. Your doctor will place SINUVA during an in-office visit, using local anesthesia.
SINUVA is slightly larger than the head of a cotton swab
SINUVA is used in adult patients with nasal polyps who have had ethmoid sinus surgery.
In a clinical trial, SINUVA was proven to shrink nasal polyps and reduce symptoms of nasal obstruction and congestion for up to 90 days. Patients treated with SINUVA had reduced sinus obstruction and reported an improved impaired sense of smell compared to patients treated with daily steroid nasal spray.
SINUVA is placed in your ethmoid sinus cavity next to the nasal polyps, delivering a steroid directly where it is needed. This enables effective anti-inflammatory action and low distribution throughout the body. SINUVA has been shown to be effective in reducing nasal obstruction and congestion and shrinking polyps.
SINUVA is designed to release medicine over the course of 90 days. It will gradually soften over time while it's in your sinus.
You don’t need to do anything to prepare for SINUVA placement, but your doctor may provide you with specific instructions prior to the procedure. Talk to your doctor if you have questions.
The whole procedure typically takes less than an hour, usually 30 to 40 minutes. This includes 10 to 30 minutes to numb the nose and about 5 to 10 minutes to place SINUVA.
Your doctor will use topical and/or local anesthetic medication to numb your sinuses during placement of SINUVA. Following placement, most patients (over 85%) felt no pain to mild pain/pressure in clinical trials.
In clinical trials, most patients (over 85%) felt no pain to mild pain/pressure following placement.
Insertion of SINUVA has risks similar to other endoscopic sinus procedures. It may also cause local side effects such as nosebleed and injury to nerves or blood vessels in the nose/sinus, serious allergic reactions, weakened immune system, and adrenal insufficiency. The most common side effects of SINUVA in clinical studies were bronchitis, cold symptoms, middle ear infections, headache, lightheadedness or dizziness, asthma, and nosebleeds. During post-approval use of SINUVA, implant migration, lack of efficacy, nasal pain, headache, and nosebleeds, were also identified as side effects.
One of the benefits of treatment with SINUVA is that SINUVA may shrink your nasal polyps. As your polyps decrease in size, SINUVA may be ejected out of your nose on its own or when you sneeze or blow your nose.
Yes. SINUVA is designed to deliver the drug over the course of 90 days. It will be removed at that time unless your doctor decides to remove it earlier.
SINUVA is designed to deliver anti-inflammatory medicine over the course of 90 days. Based on preclinical animal studies, about 80% of the anti-inflammatory medicine will be supplied in the first 60 days after placement.
No. SINUVA will be placed in your ethmoid sinus and does not have to be administered routinely. After placement of SINUVA, your doctor will let you know how often he/she will check your progress. Your doctor will remove SINUVA 90 days after placement or sooner.
SINUVA is designed to deliver medicine over the course of 90 days. At that time, your doctor will remove it unless he or she has decided to remove it earlier. As the stent softens and nasal polyps decrease, it may be ejected from the nose on its own or when you sneeze or blow your nose.
You should talk with your doctor to determine what treatments you may need following the SINUVA procedure.
Depending upon your insurance, you may get SINUVA either from a specialty pharmacy or from your doctor. In either case, SINUVA will be delivered directly to your doctor.
If you get SINUVA from a specialty pharmacy, you will receive phone calls from either Gentry Health Services, AllianceRx Walgreens Prime, or Orsini Specialty Pharmacy to collect your co-pay directly. It’s very important that you answer all calls or messages from a specialty pharmacy or your doctor can’t proceed.
If you get SINUVA from your doctor, your doctor will collect your payment at the time of the procedure.
Many insurance policies cover SINUVA, including certain types of Medicare. Be sure to check with your insurance provider to ensure that your treatment plan is covered under their policy.
Please speak with your doctor regarding questions about SINUVA.
SINUVA Sinus Implant is a prescription steroid-releasing (mometasone furoate) implant indicated for the treatment of nasal polyps in patients 18 years or older who have had ethmoid sinus surgery.
Do not use SINUVA if you are allergic to mometasone furoate or any ingredients of the implant.
Before you receive SINUVA, tell your doctor about all medical conditions you have including nasal/sinus problems (such as nasal ulcers or trauma), eye problems (such as glaucoma or cataracts), or any untreated fungal, bacterial, or viral infections.
Local reactions including nosebleed and injury to nerves or blood vessels in the nose/sinus.
Serious allergic reactions have happened in patients using mometasone furoate including rash, itching or swelling of the lips, face, tongue, and throat, and breathing problems. Call your doctor right away if you have any of these reactions.
Weakened immune system that may increase your risk of infections. Avoid contact with people who have contagious diseases such as chickenpox or measles. Call your doctor right away if you have been near someone with chickenpox or measles.
is a condition in which the adrenal glands do not make enough steroid hormones and can cause tiredness, weakness, nausea and vomiting and low blood pressure. Talk to your doctor if steroid effects such as Cushing Syndrome and adrenal suppression appear.
The most common side effects of SINUVA in clinical studies were bronchitis, cold symptoms, middle ear infections, headache, lightheadedness or dizziness, asthma, and nosebleeds. The following side effects have been identified during post-approval use of the SINUVA sinus implant. These events include implant migration, lack of efficacy, nasal pain, headache, and nosebleeds.
Tell your doctor if you have any side effects that bother you or don’t go away.
Risks related with the insertion and removal of SINUVA are similar to other endoscopic sinus procedures.
SINUVA is made from materials designed to soften over time and may fall out of the nose on its
own as polyps decrease or if you sneeze or blow your nose forcefully. The implant will be removed 90 days after placement or earlier at your doctor’s discretion.
Contact your doctor immediately if you have any changes in vision, 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.
For important risk and use information, please see Full Prescribing Information for SINUVA.
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MPM-11923. Rev. 1.0 12/20