Sinuva

Sinuva is a prescription medication used to treat adults with nasal polyps, which are soft, non-cancerous growths in the nose. Sinuva is used in patients who have had ethmoid sinus surgery.

Sinuva belongs to a group of drugs called corticosteroids, more commonly known as steroids. These work by affecting the immune system to decrease inflammation of the nasal passages.

Sinuva comes as an implant device that is placed in the sinuses by a healthcare professional. 

Common side effects of Sinuva include a cold, and an ear infection.

Sinuva is a prescription medication used to treat adults with nasal polyps, which are soft, non-cancerous growths in the nose. Sinuva is approved for use in patients who have had ethmoid sinus surgery.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Sinuva. See the “Sinuva Precautions” section.

Common side effects of Sinuva include the following:

• bronchitis which is inflammation of the bronchial tubes which is part of the lungs
• nasopharyngitis or cold
• ear infection
• headache
• fainting
• asthma
• nose bleeding

This is not a complete list of Sinuva side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Sinuva including the following:

• nasal bleeding, irritation, infection, or holes. Your healthcare provider will monitor the area around the implant for this. Tell your doctor if you are having nosebleeds or any signs of infections like fever, chills, sore throat, ongoing cough, ongoing congestion, or other signs of infection.
• eye problems such as glaucoma, cataracts, or increased eye pressure. Tell your healthcare provider if you have any changes in vision or a history of eye issues.
• hypersensitivity (severe allergic reaction). Tell your healthcare provider about any signs or symptoms of hypersensitivity, including chest pain, rash, difficulty breathing or swallowing, or swelling of the face, eyes, lips, tongue, arms, or legs
• higher risk of infections. Tell your healthcare provider if you experience any of the following symptoms, call your doctor immediately: fever, chills, sore throat, ongoing cough, ongoing congestion, or other signs of infection. Tell your healthcare provider immediately if you around anyone with the measles or chickenpox.
• adrenal suppression. Tell your healthcare provider if you have tiredness, weight loss, and decreased appetite.

Do not take Sinuva if you are allergic to Sinuva or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Sinuva, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Sinuva, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Sinuva or to any of its ingredients
• have or have had recent nasal sores, nasal surgery, or nasal injury
• have tuberculosis or any untreated fungal, bacterial, viral infections, or eye infections caused by herpes.
• have been near someone who has chickenpox or measles.
• have eye or vision problems such as glaucoma, cataracts, or increased eye pressure
• have immune system problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Sinuva crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Sinuva.

Sinuva comes as an implant device that is placed in the sinuses by a healthcare professional. 

Sinuva releases medicine over 90 days and can be removed at 90 days or earlier.

Sinuva has not been studied to be placed more than once.

Use saline irrigations or nasal spray regularly with Sinuva.

• One Sinuva implant contains 1350 mcg of medication that is gradually released over a 90 day period.
• 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 your physician's discretion using standard surgical instruments. 

It is unlikely that Sinuva overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Sinuva softens over time. As Sinuva softens and polyps decrease, there is a chance that the Sinuva implant may come out of the nose on its own with sneezing or forceful nose blowing.