Bevespi Aerosphere

Bevespi Aerosphere is a prescription medication used to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Bevespi Aerosphere is a single product containing 2 products: glycopyrrolate and formoterol fumarate.

Glycopyrrolate belongs to a group of drugs called anticholinergics. Formoterol fumarate belongs to a group of drugs called long-acting beta agonists (LABAs). Together these work to make it easier to breathe, because they help relax the muscles around the airways in your lungs. 

This medication is available as an inhalation and is typically used twice a day. 

Common side effects of Bevespi Aerosphere include urinary tract infection and cough.

Bevespi Aerosphere is a prescription medicine used to treat COPD. COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. 

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

• Astrazeneca

Serious side effects have been reported. See "Precautions".

Common side effects of Bevespi Aerosphere include: 

• urinary tract infection
• cough
• sore throat 
• arthralgia
• chest pain
• tooth abscess
• muscle spasms
• headache
• sore throat
• vomiting
• dizziness
• anxiety
• dry mouth
• fatigue
• contusion

Tell your healthcare provider about any side effect that bothers you or that does not go away. 

These are not all the side effects with Anoro Ellipta. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 

Bevespi Aerosphere and certain other medicines may interact with each other. This may cause serious side effects. Especially tell your healthcare provider if you take: 

• anticholinergics (including tiotropium, ipratropium, aclidinium, atropine)
• diuretics such as
  • acetazolamide (Diamox)
  • amiloride (Midamor)
  • bumetanide (Bumex)
  • chlorothiazide (Diuril)
  • chlorthalidone (Thalitone)
  • ethacrynic acid (Edecrin)
  • furosemide (Lasix)
  • hydrochlorothiazide (Microzide, HCTZ)
  • metolazone (Zaroxolyn)
  • torsemide (Demadex)
  • triamterene (Dyrenium, Dyazide, Maxzide)
• monoamine oxidase inhibitors such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)
• tricyclic antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)
• drugs that can cause an arrhythmia called Torsades des Point such as
  • certain anti-arrhythmia medications including
    • procainamide, sotalol (Betapace), quinidine (Nuedexta), dofetilide (Tikosyn), amiodarone (Nexterone, Pacerone, Cordarone), ibutilide (Corvert)
  • certain fluoroquinolone antibiotics including
    • levofloxacin (Levaquin), ciprofloxacin (Cipro), gatifloxacin (Zymar), moxifloxacin (Avelox)
  • certain macrolide antibiotics including
    • clarithromycin (Biaxin), erythromycin (EES, others)
  • certain azole antifungals including
    • ketoconazole (Nizoral), itraconazole (Sporanox, Onmel)
  • certain antidepressants including
    • amitriptyline, desipramine (Norpramin), imipramine (Tofranil, Surmontil), doxepin (Silenor), fluoxetine (Prozac, Sarafem), sertraline (Zoloft), venlafaxine (Effexor XR)
  • certain antipsychotics including
    • haloperidol (Haldol), droperidol (Inapsine), quetiapine (Seroquel XR), thioridazine, ziprasidone (Geodon)
  • and other medications including
    • cisapride, sumatriptan (Treximet, Imitrex, Alsuma, Zecuity), zolmitriptan (Zomig, arsenic (Trisenox), dolasetron (Anzemet), and methadone (Methadone, Dolophine)
  • beta blockers such as
    • metoprolol (Toprol XL, Lopressor)
    • carvedilol (Coreg)
    • bisoprolol (Zebeta)
    • betaxolol (Kerlone)
    • nebivolol (Bystolic)
    • propranolol (Inderal, Pronol)

Serious side effects have been reported with Bevespi Aerosphere including the following:

• sudden breathing problems immediately after inhaling your medicine
• 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
  • swelling of the face, mouth, and tongue
  • hives
  • breathing problems
• effects on your heart:
  • increase blood pressure
  • chest pain
  • a fast or irregular heartbeat
• effects on your nervous system:
  • tremor
  • nervousness
• new or worsened eye problems including acute narrow-angle glaucoma. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Tell your healthcare provider right away before taking another dose if you have some or all of the following symptoms of acute narrow-angle glaucoma:
  • eye pain or discomfort
  • seeing halos or bright colors around lights
  • nausea or vomiting
  • red eyes
  • blurred vision
• urinary retention. People who take Bevespi Aerosphere may develop new or worse urinary retention. Tell your healthcare provider right away before taking another dose if you have some or all of the following symptoms of urinary retention:
  • difficulty urinating
  • urinating frequently
  • painful urination
  • urination in a weak stream or drips
• changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia) which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm.

Do not take Bevespi Aerosphere if you

• are allergic to glycopyrrolate, formoterol fumarate, or to any component of this Bevespi Aerosphere.
• have asthma without use of a long-term asthma controller medication. Bevespi Aerosphere is not indicated for the treatment of asthma.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Anoro Ellipta, there are no specific foods that you must exclude from your diet when receiving this medication.

Before using Bevespi Aerosphere, 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 eye problems such as glaucoma. Bevespi Aerosphere may make your glaucoma worse.
• have prostate or bladder problems, or problems passing urine. Bevespi Aerosphere may make these problems worse.
• are allergic to any other medicines or food products
• have any other medical conditions
• are pregnant or planning to become pregnant. It is not known if Bevespi Aerosphere may harm your unborn baby
• are breastfeeding. It is not known if the medicines in Bevespi Aerosphere pass into your breast milk and if they can harm your baby

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal
supplements. Bevespi Aerosphere and certain other medicines may interact with each other. This may cause serious side effects.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no good studies that have been done in humans with Bevespi Aerosphere (glycopyrrolate and formoterol fumarate). In animal studies, pregnant animals were given formoterol fumurate and had some babies born with problems. Pregnant animals given glycopyrrolate, however, did not show any related medical issues with their babies. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Bevespi Aerosphere crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with the use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Bevespi Aerosphere.

• Use Bevespi Aerosphere exactly as prescribed.
• Do not use Bevespi Aerosphere unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly. 
• Use Bevespi Aerosphere exactly as your healthcare provider tells you to use it. Do not use Bevespi Aerosphere more often than prescribed. 
• Use 2 inhalations of Bevespi Aerosphere 2 times each day. Use Bevespi Aerosphere at the same times each day. 
• If you miss a dose of Bevespi Aerosphere, take your next dose at your usual time. 
• Do not take 2 doses (4 inhalations) at one time. 
• If you take too much Bevespi Aerosphere, 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 or an anticholinergic for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA or anticholinergic medicines. 
• Do not stop using Bevespi Aerosphere unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed. 
• Bevespi Aerosphere does not relieve sudden symptoms. 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. 

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

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Bevespi Aerosphere is 2 inhalations twice daily, inhaled by mouth.

If you take too much Bevespi Aerosphere call your healthcare provider or go to the nearest hospital emergency room right away, especially if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness. 

• Store Bevespi Aerosphere at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
• Do not put a hole in the Bevespi Aerosphere canister.
• Do not use or store Bevespi Aerosphere near heat or a flame.
• Temperatures above 120ºF (49ºC) may cause the canister to burst.
• Do not throw the Bevespi Aerosphere canister into a fire or an incinerator.
• Throw away Bevespi Aerosphere 3 months after you open the foil pouch or when the dose indicator reaches zero “0”, whichever comes first.
• Keep Bevespi Aerosphere and all medicines out of the reach of children.

WARNING: ASTHMA-RELATED DEATH

• Long-acting beta2-adrenergic agonists (LABAs), such as formoterol fumarate, one of the active ingredients in Bevespi Aerosphere, increase the risk of asthma-related death. A placebo-controlled trial with another LABA (salmeterol) showed an increase in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered a class effect of all LABAs, including formoterol fumarate.
• The safety and efficacy of Bevespi Aerosphere in patients with asthma have not been established. Bevespi Aerosphere is not indicated for the treatment of asthma.