Glycopyrronium bromide (Seebri) for chronic obstructive pulmonary disease

Published in Medicine Update

Date published: About this date

Health and medicines information in this article may have changed since the date published. This information does not replace advice from a health professional.

This Medicine Update is for people with chronic obstructive pulmonary disease (COPD) who are taking, or thinking about taking, glycopyrronium bromide.

Summary

  • Glycopyrronium bromide (brand name Seebri Breezhaler) is an inhaled treatment for people with stable chronic obstructive pulmonary disease (COPD).
  • Glycopyrronium is a long-acting bronchodilator. It works by relaxing the airways in the lungs over about 24 hours, to make breathing easier.
  • Glycopyrronium is not a reliever medicine. You should still carry a reliever medicine with you for sudden breathlessness.
  • Glycopyrronium appears to be as effective as tiotropium (Spiriva), another maintenance inhaler (often referred to as a symptom controller) that works in a similar way. However, glycopyrronium is a newer medicine for COPD, and information about its effectiveness and side effects is limited.
  • Glycopyrronium can help to control the symptoms of COPD such as shortness of breath, and reduce the number of flare-ups or exacerbations you experience. The amount of benefit you get from glycopyrronium can depend on your lung function and overall health.
  • Glycopyrronium is for inhalation only and must be used with the Breezhaler device. Do not swallow the capsules.
  • Do not take glycopyrronium if you are also taking tiotropium or ipratropium as part of your current COPD management plan.
  • Common side effects of glycopyrronium include dry mouth, insomnia (difficulty sleeping), stomach cramps, diarrhoea, vomiting, nose and throat irritation, and muscle, bone or joint pain. For more information, see What are the side effects of glycopyrronium?

Contents


What is glycopyrronium bromide (Seebri Breezhaler)?

Glycopyrronium bromide (brand name Seebri Breezhaler) is an inhaled medicine for chronic obstructive pulmonary disease (COPD). It belongs to a group of medicines called anticholinergics.

The active ingredient is glycopyrronium bromide (pronounced GLY-co-pi-RO-ni-um BRO-mide). The medicine is also known by the brand name Seebri Breezhaler. The Breezhaler is the device you use to take the medicine.

In this Medicine Update, glycopyrronium bromide will be referred to as glycopyrronium.

The active ingredient is the chemical in the medicine that makes the medicine work. The brand name (the name the medicine is sold under) is given to the medicine by the manufacturer.

Some medicines are available under several different brand names. Look up the active ingredient or brand name of your medicines using the NPS MedicineWise medicine search.

Back to Contents


What is glycopyrronium for?

Glycopyrronium is a maintenance treatment (also known as a symptom controller) for people with controlled COPD (mild, moderate or severe). It is a type of medicine known as a long-acting bronchodilator. The effects from one inhaled dose of glycopyrronium (one 50 microgram capsule) should last for 24 hours.

Glycopyrronium may reduce symptoms of COPD such as shortness of breath. It may also reduce the likelihood of flare-ups and prevent further deterioration of your condition. It should be taken regularly to keep your symptoms under control.

Glycopyrronium is not a reliever medicine — you should still carry a reliever medicine with you for when you feel sudden breathlessness.

Back to Contents


How does glycopyrronium work?

Glycopyrronium is a long-acting bronchodilator and belongs to the same group of medicines as tiotropium (Spiriva) and ipratropium (e.g. Atrovent, Ipravent). These medicines are called anticholinergics. Their action is to relax the muscles in your airways (bronchi) and help them to open (dilate) as much as possible, making it easier for you to breathe. The effect on your airways can last for up to six hours for ipratropium and up to 24 hours for glycopyrronium and tiotropium.

You should only have one anticholinergic medicine in your COPD treatment plan. If you are prescribed glycopyrronium, your health professional may need to change the other inhaler medicines you are using. Follow their instructions carefully.

Long-acting bronchodilators are maintenance inhalers (symptom controllers) and are an ongoing treatment for COPD. They need to be taken at the same time every day.

Long-acting bronchodilators are different to short-acting bronchodilators (also known as reliever inhalers or rescue medicines). If you feel suddenly breathless, use your reliever inhaler as instructed by your health professional.

Do not use glycopyrronium as a reliever medicine.

Glycopyronium can be used alone or in combination

Depending on your condition, glycopyrronium may be the only maintenance inhaler you need, or your health professional may also prescribe glycopyrronium in addition to another maintenance inhaler.

You should never take glycopyrronium if you are also using tiotropium (a symptom controller) or ipratropium (a reliever inhaler) as part of your COPD management.

For more information on the different types of medicines used to treat COPD, see What other COPD medicines are there?Back to Contents


How effective is glycopyrronium?

For people with COPD, glycopyrronium appears to be as effective in controlling symptoms as tiotropium (Spiriva) — another medicine that works in a similar way.

In clinical trials where glycopyrronium was given as a symptom controller to people with moderate or severe COPD, they had:

  • improved lung function — which means the lungs were able to inhale, hold and exhale more air than before  treatment with glycopyrronium
  • increased control of COPD symptoms — which means people had less breathlessness and less difficulty breathing during the time they were being treated with glycopyrronium
  • reduced need for reliever inhalers (rescue medicines).

Improvement in quality of life was also reported. Quality of life is an important part of COPD management. It describes how a particular disease is impacting the life of a person, and can help them and their health professionals decide which treatments provide the greatest benefits for their circumstances.

For example, in some people with COPD a medicine may improve lung function, as measured by spirometry tests, but this improvement may not have any real impact on the types or amount of activity they are doing. So their quality of life might not be greatly changed by that medicine. However, for someone else, even a small increase in lung function might allow them to move around more, or need less of another medicine, and for these people this could be a substantial improvement in their quality of life.

A clinical trial is a research study conducted with patients. It compares one treatment with one or more other treatments, to assess its effectiveness and safety.Back to Contents


What are the side effects of glycopyrronium?

Glycopyrronium, like all medicines, has possible side effects, although not everybody will experience them. Knowing what the possible side effects are and how often they occur in people taking the same medicine is important when you are trying to decide whether a medicine is right for you.

Some of the side effects that may occur with glycopyrronium, such as dry mouth, are typical side effects seen with all anticholinergic medicines. Other side effects can occur because glycopyrromium is inhaled and can irritate the airway passages.

As well as possible risks, medicines also have benefits. When you are recommended a medicine, it’s good to ask your health professional questions that can help you weigh up the positive and negative effects of a medicine.

If you notice any of the side effects listed below and feel worried about them or other signs or symptoms, let your health professional know.

The terms 'common', 'uncommon' and 'rare' have a very specific meaning when used to describe side effects for medicines. Common side effects for glycopyrronium affect between 1 and 10 in every 100 people who take the medicine, and include:

  • dry mouth
  • symptoms of gastroenteritis (such as stomach cramps, diarrhoea and vomiting)
  • insomnia
  • urinary tract infection (in people over 75 years)
  • headache (in people over 75 years).

Consumer medicine information (CMI) is another source of information about side effects for prescription (and some non-prescription) medicines. The CMI for Seebri Breezhaler contains a complete list of side effects, many that have only been reported in very low numbers.

You can download the CMI for your medicine, or ask your health professional for it.

If you take glycopyrronium and have any of the following side effects, immediately have someone call 000 for an ambulance or go to the Emergency Department at your nearest hospital:

  • one or more symptoms or signs of severe allergy such as swelling of the face, mouth, tongue or throat, sudden onset of breathing difficulty, wheezing or feeling faint, itchiness or skin rash
  • find passing urine painful or difficult
  • have severe eye pain, eye redness, blurred vision, or start seeing halos or rainbow colours around objects
  • irregular heart beat
  • high blood sugar (this is called hyperglycaemia and typical symptoms are excessive thirst or hunger, and frequent urination).

People with questions about their medicines or seeking general information about side effects can call NPS Medicines Line on 1300 633 424 (1300 MEDICINE).

To report possible side effects, call the Adverse Medicine Events (AME) Line on 1300 134 237.

Both these services are available Monday to Friday, 9am to 5pm AEST  .

Back to Contents


Can glycopyrronium interact with other medicines?

Sometimes a medicine can mix badly with another medicine in your body, and this can change how strongly the medicine works or change its side effects. This is called an interaction, and it can also happen when medicines mix with certain foods or drink (including alcohol).

Always talk to your health professional before you start a medicine, as some medicines can interact with glycopyrronium.

Tell your health professional if you are taking another inhaled anticholinergic medicine, such as tiotropium (Spiriva) or ipratropium (e.g. Atrovent, Ipravent).

A medicines list is a useful way of keeping track of all your prescription, non-prescription and complementary medicines. If you don’t have a medicine list you can:

  • download and print Medicines List that you and your health professional can fill out
  • create and edit a personal Medicines eList using your computer's internet browser
  • download our free MedicineList+ smartphone app (iPhone and Android).

Show your medicines list to your health professionals and ask them about which medicines you should keep taking and which ones you should stop.

Return any unused medicines to a pharmacy for safe disposal to avoid confusion.Back to Contents


Who shouldn’t take glycopyrronium?

Glycopyrronium may not be a suitable medicine if you:

  • are allergic to the active ingredient glycopyrronium bromide or to any of the inactive ingredients used to make this medicine
  • are using another anticholinergic medicine; for example, a reliever such as ipratropium (e.g. Atrovent, Ipravent), or a symptom controller such as tiotropium (Spiriva)
  • have a prostate or kidney problem
  • have difficulty passing urine
  • have glaucoma (an eye condition)
  • are pregnant or breastfeeding.

It is important that all your health professionals know your full medical history and are aware of all the medicines you take — including those you buy without a prescription at a pharmacy or supermarket, and any complementary medicines (including natural or herbal medicines, vitamins and minerals).

As well as the active ingredient(s), medicines contain other ingredients known as excipients or inactive ingredients. Excipients are ingredients such as fillers, binders or coatings. For most people, inactive ingredients won’t matter. However, if you have particular allergies or intolerances, or avoid certain substances for cultural or medical reasons you may need to know what excipients are in your medicine.

You can find a list of excipients under ‘inactive ingredients’ in the consumer medicine information (CMI) for your medicine.Back to Contents


What other COPD medicines are there?

Most medicines for COPD are inhaled, so they go directly to the airways in the lungs where they are needed.

If you use other inhalers, make sure you know what they are for and when you need to use them. Talk to your health professional if you are not sure.

To help you remember when and how much of each medicine you need to take, you and your health professional should prepare a written COPD Action Plan that you can refer to.

Glycopyrronium is a symptom controller (maintenance inhaler). It needs to be taken at the same time every day to control symptoms and help prevent flare-ups (exacerbations).

Examples of other symptom controller medicines include:

  • tiotropium (Spiriva) — a type of long-acting anticholinergic
  • indacaterol (Onbrez) — a type of long-acting beta2 agonist (also known as a LABA)
  • eformoterol (Foradile, Oxis) — a type of long-acting beta2 agonist
  • salmeterol (Serevent) — a type of long-acting beta2 agonist.

Other types of medicines that are used to treat COPD are:

  • Reliever inhalers — used to provide quick relief from a sudden attack of breathlessness. These are short-acting bronchodilators, sometimes called rescue medicines.
  • Preventer inhalers — prescribed for long-term regular use in people with more severe COPD who have frequent flare-ups. They contain steroids to reduce inflammation.
  • Flare-up medicines — prescribed when your symptoms get worse quite quickly over a few days. These medicines include steroid tablets (prednisolone) and antibiotics. Sometimes a mucolytic is also recommended, to help break down the stickiness of phlegm.

You may need to go to hospital for treatment if you have a flare-up.Back to Contents


How to decide between glycopyrronium and other medicines for COPD

At times there will be a clear need for you to take a particular medicine, and the benefits for your health condition will likely outweigh the risk of side effects or other medicine problems.

But often the decision is not so clear cut, and the balance of benefits and risks will depend on what is most important to you — including what you want to achieve with your health and wellbeing.

It's important to ask questions and discuss your needs and concerns about medicines with a health professional, and to take an active role in your health care. Knowing the questions to ask your health professional is an important step in helping you to do this.

Benefits

Glycopyrronium appears to be as effective at controlling symptoms of COPD as tiotropium — another long-acting anticholinergic maintenance inhaler.

Glycopyrronium only needs to be taken once daily. Some of the other maintenance inhalers need to be taken twice a day. This may be a consideration for you if you find it more convenient to take a once-daily dose.

Side effects

Many side effects experienced with glycopyrronium are similar to tiotropium (e.g. dry mouth, insomnia, stomach cramps, diarrhoea) — as they are both anticholinergics. Other side effects may be similar to those of other long-acting bronchodilators (e.g. nose and throat irritation).Back to contents


How to take glycopyrronium

Each Seebri Breezhaler box includes 30 Seebri capsules (clear, orange coloured with black writing) in a peel-off foil pack, a white plastic Breezhaler inhalation device and a leaflet with detailed instructions and diagrams explaining how to use the inhaler. Carefully read the instructions, and follow the advice of your health professional.

Each dose of glycopyrronium comes as a dry powder contained inside a Seebri capsule. The powder from the capsule is inhaled using the Breezhaler device that comes with the medicine.

Glycopyrronium must be taken using the Breezhaler device:

  • do not use any other inhaler device with this medicine
  • do not swallow the capsules
  • do not use the same inhaler device for longer than 30 days.

Make sure your inhaler technique is correct

You will need to load a Seebri capsule into the Breezhaler device every time you use it. Make sure you know how to do this correctly. Ask your health professional to show you if you’re not sure. Your technique should be checked regularly during follow-up visits. This helps to ensure that the right amount of medicine is delivered to your lungs and helps to prevent side effects.

Dose

Inhale the contents of one (50 microgram) capsule — using the Breezhaler device — at the same time each day to get the best effect. Only take one dose of glycopyrronium each day.

Do not inhale more than the prescribed amount of glycopyrronium even if you feel that your normal dose is not working as well as usual. Taking an extra dose will not provide any extra benefit and will put you at risk of side effects. If you feel that your medicine is not working as well as it should, ask your health professional to review your COPD treatment plan.

Do not stop taking your medicine

Even if you are feeling better, do not stop taking any of your medicines without first discussing it with your health professional.

What to do if you forget a dose

If you miss a dose, take it as soon as you remember and then go back to taking the next dose as you would normally. However, if you remember when it’s almost time for your next dose, just take the next dose when you’re meant to. Do not take a double dose to make up for the one that you missed.

If you take too much

If you think you may have taken an overdose of glycopyrronium, or any other medicine, contact a health professional or call the Poisons Information Centre (13 11 26) for advice. You can also go the nearest hospital Emergency Department. Do not wait for signs of a problem, get help immediately.Back to Contents


What else you should know about glycopyrronium

Make sure you have a COPD Action Plan

It is important that you understand which medicines you should be taking and when. Your health professional can help you prepare a COPD Action Plan that sets out when to take your regular medicines, how to recognise changes in your symptoms that indicate a flare-up and what to do if you have a flare-up.

COPD is a progressive condition that may get worse over time. Your health professional will need to regularly review how well you are going and may revise the medicines you are taking.

Clinical trial information is ongoing

Glycopyrronium has not been studied in people with COPD who also have or have had cardiovascular conditions like congestive heart failure or heart attack. If you are prescribed glycopyrronium and have had either of these conditions, or any other heart-related problem, make sure your health professional knows.

It is important to understand that information about a medicine’s benefits and side effects grows with time. This means side effects that are rare, that happen after long-term use or that only occur in certain types of people may not yet have come to light. The longest clinical trial involving glycopyrronium is 16 months.

Keep medicines out of reach and sight of children

Children are curious and love to copy adults. Make sure you keep all your medicines, including Seebri Breezhaler, safely out of reach and out of sight of children. Store medicines at least 1.5 metres (five feet) above floor level, preferably in a cupboard secured with a child-proof latch.

If you keep medicines in a prominent place as a reminder of when to take them, try using a note instead, or setting an alarm using the free NPS MedicineList+ smartphone app.
Back to Contents


Other ways to help manage COPD

There are many steps you can take to help slow the progression of COPD and keep you active for as long as possible.

Quit smoking

Smoking is the major cause of COPD. Stopping smoking is the single most important thing you can do to improve your lung health, help slow down the progression of your COPD and help you live longer. The sooner you quit smoking the better. If you continue smoking, your lungs are likely to get worse far more quickly than if you quit.

Your health professional or Quitline (call 137 848) can help you increase your chance of success.

It’s also important for you to avoid places where other people are smoking to prevent breathing air that contains cigarette smoke.

Vaccinations

If you have COPD, it is currently recommended that you receive an influenza (flu) vaccination every year (ideally before the flu season begins) and are up to date with the pneumococcal vaccine.

Exercise regularly

People with COPD who exercise regularly often breathe more easily, have fewer COPD symptoms and maintain a better quality of life compared with those who do not exercise.

Ideally, the activity you do should make you a little out of breath. Don’t avoid exercise because it makes you feel a bit puffed.

Aim for at least 30 minutes a day, five times a week. You do not have to do all 30 minutes at once. Check with your health professional whether this amount of activity is recommended for you.

Pulmonary rehabilitation

Some people will benefit from a program of education and exercise classes designed specifically for people with COPD. Speak to your health professional to find out if a pulmonary rehabilitation program is available that is suitable for you.

Eat healthily

Maintaining a healthy weight — not overweight but not underweight either — is good for your overall health. Eating a healthy diet will help you to stay strong and have more energy. Many people with COPD can find it hard to eat properly and may lose weight. If this is a problem, a dietitian can provide advice on how to adapt your diet.

Read more about healthy lifestyle choices.
Back to Contents


Can you get glycopyrronium through the PBS?

Glycopyrronium bromide (brand name Seebri Breezhaler) is listed on the Pharmaceutical Benefits Scheme (PBS) for use as maintenance therapy in people with COPD. It can be prescribed by a doctor or nurse practitioner.

In Australia, many of the medicines prescribed by a doctor or nurse practitioner are covered on the PBS. This means the amount a person pays at the pharmacy may be less than the full price, because the medicine has been subsidised by the Australian Government for use in that particular condition. The amount you pay is known as the co-payment.

Glycopyrronium bromide (Seebri Breezhaler) is listed on the PBS for treatment of COPD, but not for any other condition.

If you do not meet the criteria to get glycopyrronium bromide (Seebri Breezhaler) on the PBS, you will need to pay the full price for a prescription. The cost may vary between pharmacies.

Read more about the PBS and how to keep your medicines costs down.

Cost to the individual

If you are eligible to receive glycopyrronium bromide (Seebri Breezhaler) through the PBS (i.e. you have COPD), then the maximum amount you would need to pay (i.e. co-payment) is:

  • $36.90 for people without a concession card
  • $6.00 for concession card holders.

Cost to the Government

The full cost of glycopyrronium bromide (Seebri Breezhaler) to the Australian Government is:

  • $73.65 for a pack of 30 capsules (50µg) with inhaler device.

Each prescription is for a 30-day supply.Back to Contents


Where to find more information about glycopyrronium

Read the Seebri Breezhaler Consumer Medicine Information to find out more about:

  • who should not use it
  • how to take it
  • most of the possible side effects
  • the ingredients.

You can get the CMI leaflet from:

Information over the phone

To get information about glycopyrronium bromide (brand name Seebri Breezhaler), or any other medicine, call the NPS Medicines Line on 1300 633 424 (1300 MEDICINE) from anywhere in Australia. The service is available Monday–Friday, 9am–5pm AEST (except NSW public holidays).

To report a side effect with glycopyrronium

The AME Line lets you report and discuss side effects that might be related to your medicine. Medicine-related side effects are then reported to the Therapeutic Goods Administration (TGA) for assessment and contribute to national medicine safety efforts. Your personal information will remain confidential and your privacy maintained.

Call the Adverse Medicine Events (AME) Line on 1300 134 237 from anywhere in Australia. The service is available Monday–Friday, 9am–5pm AEST (except NSW public holidays).

More about COPD

Lung Foundation Australia provides support and education for people living with lung conditions including COPD. Call 1800 654 301 for more information about COPD and COPD medicines.

More about using medicines wisely

Back to Contents

References

  • Novartis Pharmaceuticals Australia Pty Limited. Seebri Breezhaler Product Information. 2012. http://www.tga.gov.au/pdf/auspar/auspar-glycopyrronium-130710-pi.pdf (accessed 31 January 2014)
  • Therapeutic Guidelines. Respiratory. Chronic Obstructive Pulmonary Disease. 2013. http://etg.hcn.com.au
  • NPS Radar. Glycopyrronium bromide (Seebri) for chronic obstructive pulmonary disease http://www.nps.org.au/publications/health-professional/nps-radar/2014/april-2014. 1 April 2014.
  • Kerwin E, Hebert J, Gallagher N, et al. Efficacy and safety of NVA237 versus placebo and tiotropium in patients with COPD: the GLOW2 study. Eur Respir J 2012;40:1106-14. [PubMed]
  • Chapman KR, Beeh KM, Beier J, et al. A blinded evaluation of the efficacy and safety of glycopyrronium, a once-daily long-acting muscarinic antagonist, versus tiotropium, in patients with COPD: the GLOW5 study.BMC Pulm Med. 2014 Jan 17;14(1):4. [PubMed]
  • Wedzicha JA, Decramer M, Ficker JH, et al. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study Lancet Respir Med 2013; 1: 199–209 [PubMed]
  • Queensland Health Statewide Respiratory Clinical Network and The Australian Lung Foundation, COPD National Program – Better Living with Chronic Obstructive Pulmonary Disease. A Patient Guide 2012. http://lungfoundation.com.au/patient-area/resources/better-living-with-lung-cancer-a-patient-guide/
  • Bateman ED, Ferguson GT, Barnes N, et al. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. Eur Respir J 2013;42:1484-94. [PubMed]
  • Cope S, Donohue JF, Jansen JP, et al. Comparative efficacy of long-acting bronchodilators for COPD - a network meta-analysis. Respir Res 2013;14:100. [PubMed]
  • Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. 2013. http://www.goldcopd.org/uploads/users/files/GOLD_Report_2013_Feb20.pdf
  • Australian Government. Department of Health. Pharmaceutical Benefits Scheme. http://www.pbs.gov.au/info/about-the-pbs#What_you_pay_for_PBS_medicines (accessed 3 February 2014)