批准日期：2019年1月30日

公司：Mylan N.V.

治疗：哮喘，慢性阻塞性肺病

wixela inhub（丙酸氟替卡松和沙美特罗）是一种皮质类固醇和长效β2肾上腺素能激动剂（laba）联合治疗哮喘和慢性阻塞性肺疾病（copd）。

wixela inhub是第一个批准的advair diskus通用版本。

Wixela Inhub (fluticasone propionate and salmeterol) Inhalation Powder

Date of Approval: January 30, 2019
Company: Mylan N.V.
Treatment for: Asthma, Chronic Obstructive Pulmonary Disease

Wixela Inhub (fluticasone propionate and salmeterol) is a corticosteroid and long-acting beta2-adrenergic agonist (LABA) combination indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD).

Wixela Inhub is the first approved generic version of Advair Diskus.

Uses of Wixela Inhub:

· It is used to treat asthma.

· Some brands are used to treat COPD (chronic obstructive pulmonary disease).

· It may be given to you for other reasons. Talk with the doctor.

· This medicine is not to be used to treat intense flare-ups of shortness of breath. Use a rescue inhaler. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Wixela Inhub?

· If you have an allergy to fluticasone, salmeterol, or any other part of Wixela Inhub (fluticasone and salmeterol inhalation powder).

· If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

· If you are using another drug like this one. If you are not sure, ask your doctor or pharmacist.

· If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with Wixela Inhub (fluticasone and salmeterol inhalation powder), like certain drugs that are used for HIV, infections, or depression. There are many drugs that must not be taken with Wixela Inhub (fluticasone and salmeterol inhalation powder). Your doctor or pharmacist can tell you if you are taking a drug that must not be taken with Wixela Inhub (fluticasone and salmeterol inhalation powder).

· If you have a milk allergy.

This is not a list of all drugs or health problems that interact with Wixela Inhub (fluticasone and salmeterol inhalation powder).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Wixela Inhub (fluticasone and salmeterol inhalation powder) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Wixela Inhub?

For all uses of Wixela Inhub (fluticasone and salmeterol inhalation powder):

· Tell all of your health care providers that you take Wixela Inhub (fluticasone and salmeterol inhalation powder). This includes your doctors, nurses, pharmacists, and dentists.

· It may take 1 week to see the full effect.

· If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.

· Call your doctor right away if your breathing problems get worse, if your rescue inhaler does not work as well, or if you need to use your rescue inhaler more often.

· Do not take more of Wixela Inhub (fluticasone and salmeterol inhalation powder) or use it more often than you have been told. Deaths have happened when too much of this type of drug has been taken. Talk with your doctor.

· When changing from an oral steroid to another form of a steroid, there may be very bad and sometimes deadly side effects. Signs like weakness, feeling tired, dizziness, upset stomach, throwing up, not thinking clearly, or low blood sugar may happen. Call your doctor right away if you have any of these signs. If you have a bad injury, have surgery, or any type of infection, you may need extra doses of oral steroids. These extra steroids will help your body deal with these stresses. Carry a warning card saying that there may be times when you may need extra steroids.

· Long-term use may raise the chance of cataracts or glaucoma. Talk with the doctor.

· Have an eye exam as you have been told by your doctor.

· This medicine may cause weak bones (osteoporosis) with long-term use. Talk with your doctor to see if you have a higher chance of weak bones or if you have any questions.

· Have a bone density test as you have been told by your doctor. Talk with your doctor.

· You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.

· Chickenpox and measles can be very bad or even deadly in some people taking steroid drugs like Wixela Inhub (fluticasone and salmeterol inhalation powder). Avoid being near anyone with chickenpox or measles if you have not had these health problems before. If you have been exposed to chickenpox or measles, talk with your doctor.

· If you are 65 or older, use Wixela Inhub (fluticasone and salmeterol inhalation powder) with care. You could have more side effects.

· Use with care in children. Talk with the doctor.

· This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.

· Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

COPD:

· The chance of getting pneumonia is higher in people with COPD. This medicine may raise the chance of getting pneumonia. Talk with the doctor.

How is this medicine (Wixela Inhub) best taken?

Use Wixela Inhub (fluticasone and salmeterol inhalation powder) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

· For breathing in only.

· Keep using Wixela Inhub (fluticasone and salmeterol inhalation powder) as you have been told by your doctor or other health care provider, even if you feel well.

· Use Wixela Inhub (fluticasone and salmeterol inhalation powder) at the same time of day.

· Rinse out mouth after each use. Do not swallow the rinse water. Spit it out.

· If you are using more than 1 inhaled drug, ask the doctor which drug to use first.

· Do not prepare a dose until you need to take it. If you prepare a dose and close the inhaler without taking a dose, it will waste the drug and may damage the inhaler.

· Do not breathe out into the inhaler. Close the inhaler after you use your dose.

· Do not take the device apart or wash it. Do not use it with a spacer. Do not breathe out into the device.

· Clean mouthpiece by wiping with a dry tissue or cloth. Do not wash or put in water.

· This inhaler has a dose counter to keep track of how many doses are left. Throw away the inhaler when the dose counter has a 0 in it, 1 month after opening the foil pouch, or after the expiration date, whichever comes first.

What do I do if I miss a dose?

· Skip the missed dose and go back to your normal time.

· Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

· Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

· Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.

· Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.

· Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.

· Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.

· Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.

· Chest pain or pressure.

· Fast or abnormal heartbeat.

· Shakiness.

· Feeling nervous and excitable.

· Change in how you act.

· Change in eyesight, eye pain, or very bad eye irritation.

· A burning, numbness, or tingling feeling that is not normal.

· Choking.

· Change in voice.

· Seizures.

· Bone pain.

· Trouble sleeping.

· Feeling very tired or weak.

· Vaginal itching or discharge.

· Weight gain.

· Mouth irritation or mouth sores.

· Redness or white patches in mouth or throat.

· This medicine can cause very bad breathing problems right after you take a dose. Sometimes, this may be life-threatening. If you have trouble breathing, breathing that is worse, wheezing, or coughing after using Wixela Inhub (fluticasone and salmeterol inhalation powder), use a rescue inhaler and get medical help right away.

What are some other side effects of Wixela Inhub?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

· Headache.

· Upset stomach or throwing up.

· Throat irritation.

· Signs of a common cold.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

See also:

Wixela Inhub side effects (in more detail)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Wixela Inhub?

· Store at room temperature.

· Store in foil pouch until ready for use.

· Protect from heat, cold, and light.

· Store in a dry place. Do not store in a bathroom.

· Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.

· Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use

· If your symptoms or health problems do not get better or if they become worse, call your doctor.

· Do not share your drugs with others and do not take anyone else's drugs.

· Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.

· Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.

· This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Wixela Inhub (fluticasone and salmeterol inhalation powder) is refilled. If you have any questions about Wixela Inhub (fluticasone and salmeterol inhalation powder), please talk with the doctor, pharmacist, or other health care provider.

· If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.