Xhance

Xhance is a prescription medication used to treat nasal polyps which are soft, painless, non-cancerous growths that line the nasal passage.

Xhance belongs to a group of drugs called corticosteroids. These work by decreasing inflammation; however, it is not known how Xhance works on nasal polyps.

This medication comes in a nasal spray and is used up to two times daily.

Common side effects of Xhance include nose bleeds and nasal congestion.

Xhance is a prescription medication used to treat nasal polyps which are soft, painless, non-cancerous growths that line the nasal passage.

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

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

Common side effects of Xhance include the following:

• nose bleeds
• nasal congestion
• headache
• pain or swelling of the nose or throat
• crusting in the nose
• sores (ulcers) in the nose
• redness in your nose
• sinus infection

This is not a complete list of Xhance 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.

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

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone

This is not a complete list of Xhance drug interactions. Ask your doctor or pharmacist for more information.

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

• Nose problems. Nose problems include nose bleeds, sores (ulcers) in your nose, a certain fungal infection in your nose, mouth, and/or throat (thrush), and a hole in the cartilage of your nose (nasal septal perforation). Symptoms of nasal septal perforation include crusting in the nose, nosebleeds, runny nose, or whistling sound when you breathe.
• Decrease in activity of your immune system. This will make you more likely to get an infection. Symptoms of infection may including fever, pain, aches, chills, feeling tired, nausea and vomiting. Tell your doctor about any signs of infection while you use Xhance. Also, tell your doctor if you are exposed to chickenpox or measles.
• Eye problems including glaucoma and cataracts. Tell your doctor about any vision changes while using Xhance. Be sure to have regular eye exams while you are taking this medication.
• Allergic reaction (anaphylaxis). Call your doctor and stop Xhance right away if you have any of the following symptoms of an allergic reaction such as swelling of the face or throat, hives, rash, or difficulty breathing or swallowing.
• Reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing a corticosteroid (such as Xhance). When your body is under stress from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include feeling tired (fatigue), lack of energy, weakness, nausea and vomiting, and low blood pressure.
• Bone thinning or weakness (osteoporosis).
• Slow growth in children. A child using Xhance should have his/her growth checked regularly.

To avoid withdrawal side effects, do not stop using Xhance at once. Discuss with your doctor about slowly decreasing the dose before stopping the use of this medication altogether.

When using this product, do not share this bottle with anyone else as this may spread germs.

Do not use Xhance if you are allergic to Xhance or 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 Xhance, there are no specific foods that you must exclude from your diet when receiving this medication.

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

• are allergic to Xhance or to any of its ingredients
• have or have had any nasal problems such as sores, surgery, or injury
• have eye problems such as glaucoma or cataracts
• have any immune system problems
• have an infection
• are or have been exposed to chickenpox or measles
• have weak bones (osteoporosis)
• have liver 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 Xhance 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 Xhance.

Use Xhance exactly as your healthcare provider tells you. Do not use Xhance more often than prescribed. Xhance comes in the form of a nasal spray and is usually sprayed once a day. Xhance is for use in your nose only. Do not spray it in your eyes or mouth.

You will get the best results if you keep using Xhance regularly each day without missing a dose. After you begin to feel better, your healthcare provider may decrease your dose. Do not stop using Xhance unless your healthcare provider tells you to do so.

Xhance is not approved for use in person less than 18 years of age.

Do not share Xhance with other people.

If you miss a dose by several hours, skip the missed dose and take your next dose at the regular time. Do not take two doses of Xhance at the same time.

Priming and Using Your Xhance Nasal Spray

Your Xhance must be primed before you use it for the first time and when you have not used it for a week or more.

How to prime your Xhance Nasal Spray:

• Shake the bottle gently and then remove the cap
• Hold the bottle with the nasal applicator (tapered tip) pointing away from you.
• Press down on the bottle and release 7 times or until a fine spray appears. The pump is now ready for use.

If you have not you have used Xhance for a week or more, Xhance only has to be sprayed 2 times.

Using your Xhance Nasal Spray:

Step 1. Blow your nose to clear your nostrils.

Remove cap and shake Xhance.

Step 2. Hold Xhance between index and middle finger where thumb can be placed on the bottle at the bottom.

Step 3. Insert nosepiece into one nostril as far back as comfortable

Step 4. Insert flexible mouthpiece into the mouth

Step 5. Aim Xhance upward to allow medicine to go deep into the nostril

Step 6. Blow hard into the mouthpiece like you are blowing up a balloon. While blowing, do not breath in through your nose or sniff. Do not block your other nostril.

Step 7. While blowing into the mouthpiece, use your thumb to press on the bottle to deliver Xhance into your nose.

Step 8. Repeat steps 1-7 in the other nostril.

Do not use this bottle for more than 120 sprays even though the bottle is not completely empty. Before you throw the bottle away, you should talk to your healthcare provider to see if a refill is needed. Do not take extra doses or stop taking Xhance without talking to your healthcare provider.

You do not have to clean Xhance. Xhance may be cleaned with a dry lint-free cloth.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Xhance for the treatment of nasal polyps is 1 spray in each nostril twice daily. This can be increased to a max dose of Xhance of 2 sprays in each nostril twice daily.

If you take too much Xhance, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Xhance at room temperature between 59°F and 77°F (15°C and 25°C).
• Do not use your Xhance after the date shown as “EXP” on the label or box.
• Throw away XHANCE after using 120 sprays after initial priming. Even though the bottle may not be completely empty, you may not get the correct dose of medicine if you continue to use it.
• Keep this and all medicines out of the reach of children.