Revefenacin Oral Inhalation

WHY is this medicine prescribed?

Revefenacin oral inhalation is used to control wheezing, shortness of breath, coughing, and chest tightness in patients with chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways, that includes chronic bronchitis and emphysema). Revefenacin is in a class of medications called anticholinergics. It works by relaxing the muscles around the airways in your lungs which makes it easier to breathe.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Revefenacin comes as a solution (liquid) to inhale by mouth using a nebulizer (machine that turns medication into a mist that can be inhaled). It is usually inhaled once a day. Inhale revefenacin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use revefenacin exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Always look at revefenacin nebulizer solution before you inhale it. It should be clear and colorless. Do not use the solution if it is colored, cloudy, or contains solid particles, or if the expiration date on the vial has passed.

Do not use revefenacin during a sudden COPD attack. Your doctor will prescribe a short-acting (rescue) inhaler to use during COPD attacks.

Call your doctor or get emergency medical help if your breathing problems worsen, if you have to use your short-acting inhaler to treat attacks of COPD more often, or if your short-acting inhaler does not relieve your symptoms.

Revefenacin controls COPD but does not cure it. Continue to use revefenacin even if you feel well. Do not stop using revefenacin without talking to your doctor. If you stop using revefenacin, your symptoms may get worse.

Before you use revefenacin for the first time, read the written instructions that come with it. Ask your doctor, pharmacist, or respiratory therapist to show you how to use the nebulizer and compressor. Practice using the nebulizer and compressor while he or she watches.

Revefenacin oral inhalation should be used only in a standard jet nebulizer with a mouthpiece connected to an air compressor. Do not swallow or inject revefenacin nebulizer solution. Do not mix the solution with anything else.

To inhale the solution using a nebulizer, follow these steps;

• Twist off the top of one vial of revefenacin solution and squeeze all of the liquid into the nebulizer reservoir.
• Connect the mouthpiece to the nebulizer reservoir. Connect the nebulizer to the compressor.
• Sit in an upright, comfortable position. Place the mouthpiece in your mouth or put on the face mask.
• Turn on the compressor.
• Breathe in calmly, deeply, and evenly for about 8 minutes until mist stops forming in the nebulizer chamber.
• Dispose of the vial of revefenacin and any remaining medication after use.

Clean your nebulizer regularly. Follow the manufacturer's directions carefully and ask your doctor or pharmacist if you have any questions about cleaning your nebulizer.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using revefenacin,

• tell your doctor and pharmacist if you are allergic to revefenacin, any other medications, or any of the ingredients in the revefenacin nebulizer solution. Ask your pharmacist or check the Patient Information for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antihistamines; atropine (in Lomotil, Motofen); other medications for COPD including aclidinium (Tudorza Pressair), glycopyrrolate (Cuvposa, Lonhala Magnair, Seebri, in Bevespi, Utibron), ipratropium (Atrovent HFA, in Combivent Respimat), tiotropium (Spiriva, in Stioloto Respimat), and umeclidinium (Incruse Ellipta, in Anoro Ellipta, Trelegy Ellipta); cyclosporine (Gengraf, Neoral, Sandimmune); medications for irritable bowel disease, motion sickness, Parkinson's disease, ulcers, or urinary problems; and rifampin (Rifadin, Rimactane, in Rifamate, Rifater). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with revefenacin, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have or have ever had glaucoma (increased pressure in the eye that may cause vision loss), urinary retention (inability to empty your bladder completely or at all), prostate or bladder problems, or liver or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using revefenacin, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Inhale the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use more than one dose in a day and do not inhale a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Revefenacin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• runny or stuffed nose
• sore throat
• cough
• headache
• back pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• sudden shortness of breath immediately after inhaling the medication
• rash; hives; swelling of the face, throat, tongue, lips, and eyes; difficulty swallowing or breathing
• eye pain, red eyes, nausea, vomiting. blurred vision, seeing bright circles around lights or other colored images
• difficult, frequent, painful, or weak urination

Revefenacin may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the foil pouch it comes in, sealed, and out of reach of children. Do not open the foil pouch until you are ready to use the medication. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• nausea
• vomiting
• feeling lightheaded
• blurred vision, or changes in vision
• eye pain or redness
• severe constipation
• difficulty urination

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.