Sinuva - (Mometasone Furoate) Sinus Implant

INDICATION

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.

IMPORTANT SAFETY INFORMATION

Who should not use SINUVA?

Do not use SINUVA if you are allergic to mometasone furoate or any ingredients of the implant.

What should I tell my doctor before receiving SINUVA?

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.

What are the possible side effects of SINUVA?

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 adverse reactions 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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For important risk and use information, please see Full Prescribing Information for SINUVA at www.SINUVA.com/PI

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