Patient information: uses, side effects, how to take - Wixela Inhub

What is Wixela Inhub^®?

Wixela Inhub^®combines the inhaled corticosteroid (ICS) medicine fluticasone propionate and the long-acting beta₂-adrenergic agonist (LABA) medicine salmeterol.
ICS medicines such as fluticasone propionate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.
LABA medicines such as salmeterol help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe.
Wixela Inhub^®is not used to relieve sudden breathing problems and will not replace a rescue inhaler.
It is not known if Wixela Inhub^®is safe and effective in children younger than 4 years.
Wixela Inhub^®is used for asthma and COPD as follows:
Asthma:
- Wixela Inhub^®is a prescription medicine used to control symptoms of asthma and to prevent symptoms such as wheezing in adults and children aged 4 years and older.
- Wixela Inhub^®contains salmeterol, the same medicine found in SEREVENT^®DISKUS^®(salmeterol xinafoate inhalation powder). LABA medicines such as salmeterol when used alone increase the risk of hospitalizations and death from asthma problems. Wixela Inhub^®contains an ICS and a LABA. When an ICS and LABA are used together there is not a significant increased risk in hospitalizations and death from asthma problems.
- Wixela Inhub^®is not for adults and children with asthma who are well controlled with an asthma control medicine, such as a low to medium dose of an ICS medicine. Wixela Inhub^®is for adults and children with asthma who need both an ICS and LABA medicine.
COPD:
Wixela Inhub^®250/50 is a prescription medicine used to treat COPD. COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. Wixela Inhub^®250/50 is used long term as 1 inhalation 2 times each day to improve symptoms of COPD for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms for several days).

Do not use Wixela Inhub^®:

to relieve sudden breathing problems.
as a rescue inhaler.
if you have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
if you are allergic to fluticasone propionate, salmeterol, or any of the ingredients in Wixela Inhub^®. See the end of this Patient Information for a complete list of ingredients in Wixela Inhub^®.

Before using Wixela Inhub^®, tell your healthcare provider about all of your medical conditions, including if you:

have heart problems.
have high blood pressure.
have seizures.
have thyroid problems.
have diabetes.
have liver problems.
have weak bones (osteoporosis).
have an immune system problem.
have or have had eye problems such as glaucoma, increased pressure in your eye, cataracts, or other changes in vision.
are allergic to milk proteins.
have any type of viral, bacterial, or fungal infection.
are exposed to chickenpox or measles.
are pregnant or plan to become pregnant. It is not known if Wixela Inhub^®may harm your unborn baby.
are breastfeeding. It is not known if the medicines in Wixela Inhub^®pass into your milk and if they can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Wixela Inhub^®and certain other medicines may interact with each other. This may cause serious side effects. Especially tell your healthcare provider if you take antifungal or anti-HIV medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use Wixela Inhub^®?

Read the step-by-step instructions for using Wixela Inhub^®at the end of this Patient Information.

Do not use Wixela Inhub^®unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
Children should use Wixela Inhub^®with an adult’s help, as instructed by the child’s healthcare provider.
Wixela Inhub^®comes in 3 different strengths. Your healthcare provider prescribed the strength that is best for you.
Use Wixela Inhub^®exactly as your healthcare provider tells you to use it. Do not use Wixela Inhub^®more often than prescribed.
Use 1 inhalation of Wixela Inhub^®2 times each day. Use Wixela Inhub^®at the same time each day, about 12 hours apart.
If you miss a dose of Wixela Inhub^®, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at 1 time.
If you take too much Wixela Inhub^®, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.
Do not use other medicines that contain a LABA for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.
Do not stop using Wixela Inhub^®, even if you are feeling better, unless your healthcare provider tells you to.
Wixela Inhub^®does not relieve sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
Rinse your mouth with water without swallowing after each dose of Wixela Inhub^®. This will help lessen the chance of getting a yeast infection (thrush) in your mouth and throat.
Call your healthcare provider or get medical care right away if:
- your breathing problems get worse.
- you need to use your rescue inhaler more often than usual.
- your rescue inhaler does not work as well to relieve your symptoms.
- you need to use 4 or more inhalations of your rescue inhaler in 24 hours for 2 or more days in a row.
- you use 1 whole canister of your rescue inhaler in 8 weeks.
- your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
- you have asthma and your symptoms do not improve after using Wixela Inhub^®regularly for 1 week.

What are the possible side effects of Wixela Inhub^®?

Wixela Inhub^®can cause serious side effects, including:

fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using Wixela Inhub^®to help reduce your chance of getting thrush.
pneumonia. People with COPD have a higher chance of getting pneumonia. Wixela Inhub^®may increase the chance of you getting pneumonia. Call your healthcare provider right away if you have any of the following symptoms:

increase in mucus (sputum) production
change in mucus color
fever

chills
increased cough
increased breathing problems

weakened immune system and increased chance of getting infections (immunosuppression)
reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where 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 an inhaled steroid (such as Wixela Inhub^®). During this transition period when your body is under stress such as from fever, trauma (such as a car accident), infection, surgery, or worse COPD symptoms, adrenal insufficiency can get worse and may cause death.
Symptoms of adrenal insufficiency include:

feeling tired
lack of energy
weakness

nausea and vomiting
low blood pressure (hypotension)

sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine stop using Wixela Inhub^®and call your healthcare provider right away.
serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:

rash
hives

swelling of your face, mouth, and tongue
breathing problems

effects on heart

increased blood pressure
a fast or irregular heartbeat

chest pain

effects on nervous system

tremor

nervousness

bone thinning or weakness (osteoporosis)
slowed growth in children. Your child’s growth should be checked regularly by the healthcare provider while using Wixela Inhub^®.
eye problems including glaucoma, increased pressure in your eye, cataracts, or other changes in vision. You should have regular eye exams while using Wixela Inhub^®.
changes in laboratory blood levels (sugar, potassium, certain types of white blood cells).

Common side effects of Wixela Inhub^®include:

Asthma:

upper respiratory tract infection
throat irritation
hoarseness and voice changes
thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this

bronchitis
cough
headache
nausea and vomiting

In children with asthma, infections in the ear, nose, and throat are common.

COPD:

thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this
throat irritation
hoarseness and voice changes

viral respiratory infections
headache
muscle and bone pain

These are not all the possible side effects of Wixela Inhub^®.

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

How should I store Wixela Inhub^®?

Store Wixela Inhub^®at room temperature between 20° to 25°C (68° to 77°F). Keep in a dry place away from direct heat and sunlight.
Store Wixela Inhub^®in the unopened foil pouch and only open when ready for use.
Safely throw away Wixela Inhub^®in the trash 1 month after you open the foil pouch or when the counter reads 0, whichever comes first.
Keep Wixela Inhub^®and all medicines out of the reach of children.

General information about the safe and effective use of Wixela Inhub^®.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Wixela Inhub^®for a condition for which it was not prescribed. Do not give your Wixela Inhub^®to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your healthcare provider or pharmacist for information about Wixela Inhub^®that was written for health professionals.

What are the ingredients in Wixela Inhub^®?

Active ingredients: fluticasone propionate, salmeterol xinafoate

Inactive ingredients: lactose monohydrate (which contains milk proteins)

For more information about Wixela Inhub^®, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

The brands listed are trademarks of their respective owners.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Instructions for Use

WIXELA INHUB^®(wicks-EL-uh IN-hub)

(fluticasone propionate and salmeterol inhalation powder, USP)

for oral inhalation use

Read this Instructions for Use before you start using WIXELA INHUB and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Your WIXELA INHUB inhaler

Closed Position

Open Position

Figure A

Figure B

Important information about your WIXELA INHUB inhaler:

WIXELA INHUB is for oral inhalation use only.
Take WIXELA INHUB out of the foil pouch just before you use it for the first time. Safely throw away the pouch. The INHUB will be in the closed position. See Figure A.
Write the date you opened the foil pouch in the first blank line on the label. See Figure B.
Write the “use by” date in the second blank line on the label. See Figure B. That date is 1 month after the date you wrote in the first line.
The counter should read 60. See Figure A.

How to use your WIXELA INHUB inhaler

Follow these steps every time you use WIXELA INHUB.

Step 1. Open your WIXELA INHUB.

Hold the INHUB in one hand and with your other hand on the grip lower the mouthpiece cover from top to bottom. See Figure C.

Step 2. Push down the lever.

Hold the INHUB in the vertical position. Push the yellow lever down to the end of the purple arrows (you may hear a click). See Figure D.
The INHUB is now ready to use.
Follow the instructions below so you will not accidentally waste a dose:
Do not close the INHUB.
Do not move the lever on the INHUB once pushed down.

Step 3. Inhale your medicine.

Before you breathe in your dose from the INHUB, breathe out (exhale) as long as you can while you hold the INHUB away from your mouth. See Figure E. Do not breathe into the mouthpiece.
Put the mouthpiece to your lips. See Figure F. Breathe in quickly and deeply through the INHUB. Do not breathe in through your nose.
Remove the INHUB from your mouth and hold your breath for about 10 seconds, or for as long as is comfortable for you.
Breathe out slowly for as long as you can. See Figure E.
The INHUB delivers your dose of medicine as a very fine powder that you may or may not taste or feel. Do not take an extra dose from the INHUB even if you do not taste or feel the medicine.

Step 4. Close the INHUB.

Push the mouthpiece cover up to the closed position, this will automatically return the yellow lever to the start position. See Figure G. Make sure the INHUB is shut and you cannot see the mouthpiece.
The dose counter will count down 1 dose as you close the mouthpiece cover. This will now tell you how many doses are left.
The INHUB is now ready for you to take your next scheduled dose in about 12 hours. When you are ready to take your next dose, repeat Steps 1 through 4.

Step 5. Rinse your mouth.

Rinse your mouth with water after breathing in the medicine. Spit out the water. Do not swallow it. See Figure H.

When should you get a refill?

The dose counter on the INHUB shows you how many doses are left.

Your dose counter will be

set at 60 when you first receive your INHUB.

After you have taken 51 doses, a

red indicator will be present. This indicator warns you there are 9 or fewer doses left and is a reminder to get a refill.

The dose counter will read 0 and the lever will not reach the end of the purple arrows when there are no doses remaining.

For correct use of the INHUB, remember:

Hold your breath for about 10 seconds after inhaling. Then breathe out fully.
After each dose, rinse your mouth with water and spit it out. Do not swallow the water.
Do not take an extra dose, even if you did not taste or feel the powder.
Do not take the INHUB apart.
Do not wash the INHUB.
Always keep the INHUB in a dry place.
Do not use the INHUB with a spacer device.

For more information about WIXELA INHUB or how to use your inhaler, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

The brands listed are trademarks of their respective owners.

Wixela Inhub^®is a registered trademark of Mylan Pharmaceuticals Inc., a Viatris Company.

The Inhub^®device is patent protected. U.S. Pat. Nos. 7,401,713, 7,987,985, 8,181,645, 8,256,416, 8,528,549, 8,851,070, 9,056,175, 9,314,578, 9,399,103, 10,124,130, D569,967, D560,793.

Pfizer Limited, Sandwich, Kent, CT13 9NJ, England, exclusively licensed to Mylan Pharmaceuticals Inc., a Viatris Company.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured for:

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A.

Manufactured by:

McDermott Laboratories Ltd.

t/a Mylan Dublin Respiratory

Unit 25 Baldoyle Industrial Estate, Grange Road, Baldoyle, Dublin 13, Ireland

Revised: 8/2022

MDR:FPSX:R11/MDR:PI:FPSX:R6/MDR:IFU:FPSX:R7

Wixela Inhub: Uses, Side Effects and Dosage