Bevespi contains the active ingredients glycopyrrolate, an anticholinergic, and formoterol fumarate, a long-acting beta-adrenergic agonist, formulated as an inhalation aerosol. It is available as a pressurized metered-dose inhaler, administering glycopyrrolate and formoterol fumarate via oral inhalation. Key inactive ingredients include 1,2-Distearoyl-snglycero-3-phosphocholine (DSPC) and calcium chloride, which help form porous particles that are cosuspended with the drug crystals. Bevespi is intended to be used as an inhaler for managing respiratory conditions.

How should I use this medication?

This medication is inhaled through the mouth. Take it as directed on the prescription label at the same time every day. Do not use it more often than directed. Keep taking it unless your care team tells you to stop.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. It is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep inhaler away from extreme heat, cold or humidity. Get rid of it 3 months after removing it from the foil pouch, when the dose counter reads "0" or after the expiration date, whichever is first.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Increase in blood pressure
• Muscle pain or cramps
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Trouble passing urine
• Wheezing or trouble breathing that is worse after use

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Constipation
• Cough
• Dry mouth
• Headache
• Sore throat
• Tremors or shaking
• Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetes
• Glaucoma
• Heart disease
• High blood pressure
• Irregular heartbeat or rhythm
• Kidney disease
• Liver disease
• Prostate disease
• Seizures
• Thyroid disease
• An unusual or allergic reaction to glycopyrrolate, formoterol, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dofetilide
• Dronedarone
• Other medications that contain long-acting beta-2 agonists (LABAs) like formoterol, indacaterol, olodaterol, salmeterol, vilanterol
• Pimozide
• Thioridazine
• Ziprasidone

This medication may also interact with the following:

• Antihistamines for allergy, cough, and cold
• Certain medications for bladder problems like oxybutynin and tolterodine
• Certain medications for blood pressure, heart disease, irregular heart beat
• Certain medications for depression, anxiety, or psychotic disturbances
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Other medications that contain an anticholinergic like aclidinium, ipratropium, glycopyrrolate, tiotropium, umeclidinium
• Other medications that prolong the QT interval (cause an abnormal heart rhythm)
• Steroid medications like prednisone or cortisone
• Stimulant medications for attention disorders, weight loss, or to stay awake
• Theophylline

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

NEVER use this medication for an acute asthma attack. You should use your short-acting rescue inhaler for an acute attack. If your symptoms get worse or if you need your short-acting inhalers more often, call your care team right away.

This medication can worsen breathing or cause wheezing right after you use it. Be sure you have a short-acting inhaler for acute attacks (wheezing) nearby. If this happens, stop using this medication right away and call your care team.

This medication may increase the risk of serious asthma-related problems. Talk to your care team if you have questions.

Do not treat yourself for coughs, colds or allergies without asking your care team for advice. Some nonprescription medications can affect this one.