Patient Medication Information: uses, side effects, how to take - Breztri Aerosphere

What is BREZTRI AEROSPHERE used for?

BREZTRI AEROSPHERE is used in adults for the long-term treatment of a lung disease called chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
BREZTRI AEROSPHERE is used to make breathing easier and help prevent worsening of COPD symptoms (“flare ups”). You may experience “flare-ups” during which your symptoms become worse. If you have a history of experiencing “flare-ups” BREZTRI AEROSPHERE can help prevent them from developing in the first place.

How does BREZTRI AEROSPHERE work?

BREZTRI AEROSPHERE contains 3 medicinal ingredients:

budesonide is an inhaled corticosteroid (ICS).
glycopyrronium is a long-acting muscarinic antagonist (LAMA).
formoterol fumarate dihydrate is a long-acting beta2 agonist (LABA).

Budesonide belongs to a group of medicines called corticosteroids. It reduces inflammation in the airways of your lungs, which can ease breathing problems, and help prevent “flare-ups” of your COPD. Glycopyrronium and formoterol fumarate dihydrate belong to a group of medicines called bronchodilators. These two medicines work together to help open and relax the muscles of the airways. This allows more air to get in and out of the lungs. This makes it easier for people with COPD to breathe and helps prevent shortness of breath and wheezing. BREZTRI AEROSPHERE is not a cure for COPD, but it can help to control it. Therefore, it is important to continue to take it regularly, even if you feel fine.

What are the ingredients in BREZTRI AEROSPHERE?

Medicinal ingredients: budesonide, glycopyrronium (as bromide), and formoterol fumarate dihydrate

Non-medicinal ingredients: hydrofluoroalkane (HFA-134a), porous particles (comprised of: 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) and calcium chloride).

BREZTRI AEROSPHERE comes in the following dosage forms:

Pressurized inhalation suspension in a metered dose inhaler (for oral inhalation) that delivers 160 mcg budesonide / 7.2 mcg glycopyrronium (as bromide) / 5 mcg formoterol fumarate dihydrate per actuation.

Do not use BREZTRI AEROSPHERE:

if you are allergic to budesonide, glycopyrronium, formoterol fumarate dihydrate or any of the other ingredients of BREZTRI AEROSPHERE;
to treat sudden severe symptoms of COPD, such as shortness of breath or wheezing. Always have a rescue inhaler with you to treat sudden symptoms (“flare ups”). If you do not have a rescue inhaler, ask your healthcare professional to prescribe one for you;
to treat asthma.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take BREZTRI AEROSPHERE. Talk about any health conditions or problems you may have, including if you:

are a smoker. It is important to quit smoking if you use BREZTRI AEROSPHERE, this will help decrease the symptoms of COPD and may increase your lifespan;
are using a rescue inhaler on a regular basis;
have heart problems, such as:
- heart disease
- rapid or irregular heart beat or any problems with how your heart beats
- a condition called “QT prolongation”
have high blood pressure;
have eye problems such as increased pressure in the eye, glaucoma, cataracts, blurry vision or other changes in vision;
have prostate or bladder problems, or any problems passing urine;
used to take 20 mg or more of prednisone per day;
have or are at risk for decreased bone mineral content;
have ever had seizures;
have problems with your thyroid gland;
have diabetes;
have ever had to stop taking another medication for your breathing problems because you were allergic to it or it caused problems;
have been taking other corticosteroids by mouth or by inhalation;
have any allergies to food or drugs;
have or have a history of lung infections such as pneumonia;
have low levels of potassium in your blood;
have kidney or liver problems;
have or have ever had tuberculosis;
have chronic or untreated infections:
- bacterial infection
- viral infection
- fungal infection (yeast infection or thrush)
- parasitic infection
- herpes simplex infection of the eye
are pregnant or trying to become pregnant. Your healthcare professional will consider the benefit to you and the risk to your unborn baby;
are breastfeeding or planning to breastfeed.

Other warnings you should know about:

Do not stop taking BREZTRI AEROSPHERE without talking to your doctor first. If you stop treatment on your own, your symptoms may worsen. Talk to your doctor right away if:

there is a change in your symptoms such as more coughing, wheezing, chest tightness or breathlessness;
you find that you need to use your rescue inhaler more often than usual.

These could be warning signs that your condition may be getting worse.

Paradoxical bronchospasm: if you feel tightness of the chest, coughing, wheezing or breathlessness right after using BREZTRI AEROSPHERE, you may have a serious condition called “paradoxical bronchospasm” (an unexpected closing of your airways). Stop using BREZTRI AEROSPHERE and seek medical help right away.

Monitoring: During treatment with BREZTRI AEROSPHERE, your doctor may monitor:

your bones and eyes;
the effects of corticosteroid therapy on your body;
your blood sugar levels, especially if you have diabetes;
your blood potassium levels, especially if you already have low levels of potassium.

Eye problems: BREZTRI AEROSPEHRE can cause eye disorders such as:

cataracts: clouding of the lens in the eye, blurry vision, eye pain;
glaucoma: an increased pressure in your eyes, eye pain, halos around lights or coloured images, red eyes. Untreated, it may lead to permanent vision loss.

If you have any changes in your vision, tell your healthcare professional right away. You may need regular eye exams.

Chicken pox and measles: You should avoid exposure to chicken pox and measles, and tell your doctor if you are exposed. This is important if you are taking any cortisone-type medicine and your immune system is not working well (if you have difficulty in fighting an infection).

Eosinophilic granulomatosis with polyangiitis (EGPA): Some people experience a flu-like illness called EGPA when taking an inhaled corticosteroid. Tell your healthcare professional if you have:

a rash,
pins and needles or numbness of your arms or legs,
a severe sinus infection and
worsening lung or breathing problems.

Driving and using machines: BREZTRI AEROSPHERE can cause headaches, or nausea which may affect your ability to drive and use machines. Use caution when driving and using machines until you know how BREZTRI AEROSPHERE affects you.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with BREZTRI AEROSPHERE:

medicines called beta-blockers (such as atenolol or propranolol), to treat high blood pressure or other heart problems, or to treat glaucoma (such as timolol);
ketoconazole or itraconazole, to treat fungal infections;
ritonavir, nelfinavir or cobicistat, to treat HIV infection;
oral corticosteroids such as prednisone;
medicines that lower the amount of potassium in your blood, such as some diuretics (“water pills”);
other long-acting medicines similar to this medicine that are used to treat breathing problems, such as medicines containing tiotropium, ipratropium, aclidinium, umeclidinium
medicines which are used to treat heart rhythm problems, such as amiodarone;
medicines used in the treatment of depression (antidepressants or monoamine oxidase inhibitors);
medicines called “anticholinergics”.

Ask your healthcare professional if you are not sure. The use of BREZTRI AEROSPHERE with these medicines is not recommended.

How to take BREZTRI AEROSPHERE:

Read the Instructions for Use for instructions on how to use BREZTRI AEROSPHERE. If you have any questions, talk to your healthcare professional.
This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
Take BREZTRI AEROSPHERE exactly as your healthcare professional tells you to.
Take every day as prescribed, even if you have no symptoms of COPD.
After you take your dose, always rinse your mouth with water and spit it out, do not swallow.

Usual dose:

The recommended dose is 2 oral inhalations (puffs) taken twice daily in the morning and evening.

Overdose:

Signs of an overdosage may include:

blurred vision;
dry mouth;
nausea;
muscle spasm;
tremor;
headache;
increased heart rate; and
increased blood pressure.

If you think you, or a person you are caring for, have taken too much BREZTRI AEROSPHERE, contact a healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

Do not take a double dose to make up for a forgotten dose. If you miss a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take more than 2 puffs twice a day.

What are possible side effects from using BREZTRI AEROSPHERE?

These are not all the possible side effects you may have when taking BREZTRI AEROSPHERE. If you experience any side effects not listed here, tell your healthcare professional.

feeling anxious;
trouble sleeping;
headache;
feeling sick (nausea);
cough and/or a hoarse voice;
muscle spasms;
shaking/tremors;
dry mouth;
mild irritation in the throat;
bruising of the skin;
feeling restless, nervous or agitated;
feeling dizzy;
changes in behaviour.

Serious side effects and what to do about them

Symptom / effect	Talk to your healthcare professional	Stop taking drug and get immediate medical help
Only if severe	In all cases
COMMON
Hyperglycemia (high blood sugar): increased thirst, frequent urination, headache, blurred vision and fatigue		✓
Palpitation (fast-beating, fluttering or pounding heart): skipping beats, beating too fast, pounding, fluttering rapidly		✓
Pneumonia (infection in the lungs): chest pain when you breathe or cough, confusion, cough which may produce phlegm, fatigue, fever, sweating and shaking, chills, shortness of breath		✓
Thrush (yeast infection of the mouth or throat): thick white patches in the mouth, tongue or on the throat, sore throat		✓
Urinary tract infection (infection in urinary system including kidneys, ureters, bladder and urethra): pain or burning sensation while urinating, frequent urination, blood in urine, pain in the pelvis, strong smelling urine, cloudy urine		✓
UNCOMMON
Allergic Reaction: difficulty swallowing or breathing, wheezing, feeling weak or light			✓

Serious side effects and what to do about them

Symptom / effect	Talk to your healthcare professional	Stop taking drug and get immediate medical help
Only if severe	In all cases
headed, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat
Angina (not enough oxygen to the heart muscle): discomfort in the shoulder, arm, back, throat, jaw or teeth; pain or pressure in the chest		✓
Arrhythmia (abnormal heart rhythms): rapid, slow or irregular heartbeat		✓
Bronchospasm (when there is a sudden narrowing of the airway): difficulty breathing with wheezing or coughing			✓
Depression (sad mood that won’t go away): difficulty sleeping or sleeping too much, changes in appetite or weight, feelings of worthlessness, guilt, regret, helplessness or hopelessness, withdrawal from social situations, family, gatherings and activities with friends, reduced sex drive and thoughts of death or suicide. If you have a history of depression, your depression may become worse		✓
Tachycardia (abnormally fast heartbeat): dizziness, light headedness, shortness of breath, racing heart		✓
Urinary retention (inability to pass urine or to empty the bladder): painful urination, pain or swelling in the lower abdomen		✓
VERY RARE
Decreased Adrenal Function: tiredness, weakness, nausea and vomiting, low blood pressure	✓
UNKNOWN
Cataracts: clouding of the lens		✓

Serious side effects and what to do about them

Symptom / effect	Talk to your healthcare professional	Stop taking drug and get immediate medical help
Symptom / effect	Only if severe	In all cases
in the eye, blurry vision, dim vision and/or eye pain
Glaucoma: increased pressure in your eyes, eye and head pain, swelling or redness in or around the eye, changes in vision, hazy or blurred vision, sudden sight loss
	✓

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store between 15 to 30°C. Store in a dry place.

Warning: The canister should not be broken, punctured or burnt, even when it seems empty. Do not use or store near heat or open flames. Do not expose to temperatures higher than 50°C and protect from freezing temperatures. If exposed to freezing temperatures, the inhaler should be equilibrated for 1 hour at room temperature prior to taking a dose.

Use by date: Do not use BREZTRI AEROSPHERE after the expiry date on the label/carton. The expiry date refers to the last day of the month.

After opening the pouch, the inhaler must be used within:

6 weeks for an inhaler that contains 56 actuations;
3 months for an inhaler than contains 120 actuations.

Dispose of your inhaler after the last dose, following local guidelines. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

Keep out of reach and sight of children.

If you want more information about BREZTRI AEROSPHERE:

Talk to your healthcare professional.
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.astrazeneca.ca, or by calling 1-800-668-6000.
This Patient Medication Information is current at the time of printing. The most up-to-date version can be found at www.astrazeneca.ca.

BREZTRI™ is a trademark of, and AEROSPHERE^®and the AstraZeneca logo are registered trademarks of AstraZeneca AB, all used under license by AstraZeneca Canada Inc.

Last Revised: APR 14, 2023

Read prior to using inhaler

INSTRUCTIONS FOR USE