Bevespi Aerosphere

(Glycopyrrolate/Formeterol Fumarate)

The active ingredients in Bevespi Aerosphere are glycopyrrolate and formoterol fumarate. Glycopyrrolate (or glycopyrronium) is a long-acting muscarinic antagonist (LAMA) that acts on receptors in your lungs to help you breathe easier. Formoterol fumarate is a long-acting beta-2 agonist (LABA) that works by relaxing the smooth muscle in your lungs to open them up and ease symptoms of COPD.

Though it may reduce the need for a rescue inhaler, Bevespi Aerosphere is not intended to replace your short-acting inhaler in the case of severe breathlessness.

Though it may reduce the need for a rescue inhaler, Bevespi Aerosphere is not intended to replace your short-acting inhaler in the case of severe breathlessness.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Bevespi Aerosphere. However, the following is a synopsis of the general guidelines for the use of Bevespi Aerosphere:

1. Before using this inhaler for the first time, take it out of the foil pouch and remove the cap from the mouthpiece.

2. Hold the inhaler upright, and point the mouthpiece away from your face. Shake well.

3. Press down on the top of the canister to prime the inhaler. Repeat 3 more times, shaking between each puff.

4. The top of the inhaler has a dose indicator, which should now read “120”.

5. To use the inhaler, remove the cap and shake well.

6. Breathe out fully, away from the device.

7. Place the mouthpiece between your lips and tilt your head back.

8. Breathe in slowly and deeply while pressing down on the actuator (top of canister).

9. Remove the mouthpiece from your mouth, and hold your breath for up to 10 seconds. Breathe out away from the device.

10. Repeat steps 5-9 to take another puff. Then replace the cap.

11. Once per week, clean the inhaler as follows. Remove the canister from the actuator (plastic holder). Do not clean the canister or allow it to get wet. Remove the cap, then hold the actuator under the faucet and run warm water through it for 30 seconds. Flip it upside down and repeat.

12. Shake off excess water, and let air-dry overnight. Once dry, replace the canister by pressing it in gently (do not press down too hard).

13. Make sure to re-prime the inhaler two times (two puffs) after each cleaning, or if it has not been used for 7 days or more.

14. Watch the dose indicator on the top of the canister, which will turn red when 20 doses remain.

The most common side effects of Bevespi Aerosphere seen in clinical trials as compared to placebo include:

• Urinary tract infection.
• Cough.
• Chest pain.
• Headache.
• Dizziness.
• Dry mouth.
• Muscle spasms.

Some individuals may experience serious side effects while using Bevespi Aerosphere. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Heart problems, including irregular heartbeat (arrhythmia), and increased blood pressure.
• Serious life-threatening allergic reactions, which may present as skin rash, hives, swelling of the face, mouth, or tongue, and/ or trouble breathing.
• Eye problems, including signs of acute narrow-angle glaucoma (eye pain, blurred vision, visual halos) and worsening of existing narrow-angle glaucoma.
• Urinary retention may present as difficulty passing urine or painful urination.
• Change in blood potassium levels (hypokalemia).

This medication also has the potential to cause paradoxical bronchospasm, an initial worsening of your COPD symptoms. This may lead you to use it more often, experience nighttime awakenings due to your symptoms, or have acute asthma attacks (severe exacerbation). Contact your physician if this occurs at any time.

These are not all of the possible side effects of Bevespi Aerosphere. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Bevespi Aerosphere, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Heart problems, including coronary insufficiency, cardiac arrhythmias, and hypertension.
• Urinary retention, benign prostatic hypertrophy, or bladder-neck obstruction.
• Narrow-angle glaucoma.
• Convulsive disorders.
• Thyroid problems, such as thyrotoxicosis.
• Diabetes.
• Ketoacidosis.
• Liver impairment.

Treatment of asthma or sudden breathing problems.

Known or suspected hypersensitivity reactions to glycopyrrolate or formoterol fumarate.

Formoterol acts quickly, within 5 minutes, to open up your airways and help you breathe easier. The full action of this medication may take several days to be seen.

When Bevespi Aerosphere is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Other adrenergic agonists, in any route, may increase the effects of formoterol fumarate when used together.
• Xanthine derivatives, steroids, and diuretics may increase the risk of hypokalemia (low potassium) when used with formoterol fumarate.
• Monoamine oxidase inhibitors and tricyclic antidepressants may increase the risk of arrhythmias when used with formoterol fumarate.
• Beta-blockers may reduce the efficacy of formoterol fumarate.
• Other anticholinergic medications, including antihistamines, certain antidepressants, bladder control medications, and antipsychotics, may increase the side effects of glycopyrrolate when used together.

Bevespi Aerosphere metered-dose inhalers contain 9 mcg of glycopyrrolate and 4.8 mcg of formoterol fumarate per actuation.

It should be kept at room temperature, out of reach of children and pets.

It is manufactured by AstraZeneca.

No, there is no generic version available, but other LAMA/ LABA combination inhalers such as umeclidinium/ vilanterol (Anoro Ellipta) or tiotropium/ olodaterol (Stiolto Respimat) are on the market.

Barring serious side effects as listed above or under direct advice of a physician, you should not discontinue this medication abruptly.

While there are concerns of interference with uterine contractility during labour with formoterol fumarate, it is considered safe for use during pregnancy. Glycopyrrolate is also considered safe during pregnancy.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is not known whether formoterol fumarate is found in breast milk, though it is considered probably acceptable for use while breastfeeding. Not much is known about the exposure to glycopyrrolate in a growing infant, and therefore, careful risk vs benefit decisions should be made when considering Bevespi Aerosphere during breastfeeding.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.