Enurev Breezhaler (Glycopyrronium Bromide)

What Is Enurev Breezhaler and What Is It Used For?

Enurev Breezhaler is a prescription inhaled medicine containing glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA) used as once-daily maintenance bronchodilator treatment to relieve symptoms of chronic obstructive pulmonary disease (COPD) in adults.

Enurev Breezhaler belongs to a class of medicines known as long-acting muscarinic antagonists, or LAMAs. These medicines work by blocking the action of a chemical messenger called acetylcholine at muscarinic receptors in the airway smooth muscle. When acetylcholine is blocked, the muscles around the airways relax, allowing the airways to open wider and making it easier to breathe. This bronchodilatory effect lasts for approximately 24 hours after a single inhalation, which is why Enurev Breezhaler only needs to be taken once daily.

COPD is a progressive lung disease characterized by persistent airflow limitation that is usually associated with chronic inflammatory responses in the airways and lungs. The disease encompasses conditions previously known as chronic bronchitis and emphysema. According to the World Health Organization (WHO), COPD is the third leading cause of death worldwide, responsible for approximately 3.23 million deaths annually. The disease significantly impairs quality of life by causing breathlessness, chronic cough, and frequent chest infections.

Glycopyrronium bromide, the active substance in Enurev Breezhaler, was developed specifically for inhaled delivery to the lungs. After inhalation, peak plasma concentrations are reached within approximately 5 minutes, providing rapid onset of bronchodilation. The drug has a terminal elimination half-life of 33 to 57 hours, supporting its once-daily dosing regimen. Approximately 90% of the systemic exposure following inhalation comes from the drug deposited in the lungs rather than from the gastrointestinal tract, making it a highly targeted respiratory therapy.

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 guidelines recommend long-acting bronchodilators such as LAMAs as a cornerstone of COPD maintenance therapy. In clinical trials, glycopyrronium bromide demonstrated statistically significant and clinically meaningful improvements in lung function as measured by trough FEV1 (forced expiratory volume in one second) compared to placebo, with improvements evident from the first day of treatment and sustained throughout the treatment period.

What Should You Know Before Taking Enurev Breezhaler?

Before using Enurev Breezhaler, your doctor needs to know about any allergies, eye conditions such as narrow-angle glaucoma, prostate or bladder problems, kidney disease, and all other medicines you are currently taking, particularly other anticholinergic drugs.

Contraindications

Enurev Breezhaler must not be used if you are allergic (hypersensitive) to glycopyrronium bromide or to any of the other ingredients in the medicine, including lactose monohydrate. An allergic reaction may include rash, hives, swelling of the face, lips, tongue or throat, or difficulty breathing. If you experience any of these symptoms, stop using the medicine immediately and seek emergency medical attention.

This medicine is not approved for the treatment of asthma. Using Enurev Breezhaler for asthma could lead to inadequate disease control and potentially dangerous outcomes, as it does not address the underlying airway inflammation that characterizes asthma. If you have been diagnosed with asthma rather than COPD, your doctor will prescribe appropriate asthma treatments such as inhaled corticosteroids.

Warnings and Precautions

Tell your doctor or pharmacist before using Enurev Breezhaler if any of the following conditions apply to you:

• Narrow-angle glaucoma: Glycopyrronium bromide may increase intraocular pressure and worsen this condition. If you develop eye pain, blurred vision, visual halos, or colored images in association with red eyes, stop using the medicine and contact your doctor immediately
• Urinary retention or prostatic hyperplasia: As an anticholinergic agent, glycopyrronium may worsen urinary retention. Patients with pre-existing bladder outflow obstruction or prostatic hyperplasia should be monitored carefully
• Severe kidney disease: Glycopyrronium is partly eliminated through the kidneys. Patients with severe renal impairment (estimated glomerular filtration rate below 30 mL/min/1.73m²) should use this medicine with caution and under close medical supervision. No dose adjustment is needed for mild to moderate kidney disease
• Heart conditions: Although cardiovascular effects are uncommon with inhaled glycopyrronium at recommended doses, patients with clinically significant cardiovascular disease should be monitored. The drug should be used with caution in patients with unstable ischaemic heart disease, heart failure, cardiac arrhythmias, or prolonged QTc interval
• Paradoxical bronchospasm: As with other inhaled medicines, Enurev Breezhaler may in rare cases cause paradoxical bronchospasm (sudden tightening of the airways). If this occurs, discontinue the medicine immediately and use a fast-acting rescue bronchodilator

Pregnancy and Breastfeeding

There is limited data on the use of glycopyrronium bromide in pregnant women. Animal studies do not indicate direct harmful effects on fertility, pregnancy, embryonal/fetal development, birth, or postnatal development at clinically relevant doses. However, as a precautionary measure, Enurev Breezhaler should preferably be avoided during pregnancy unless the expected benefit to the mother outweighs any potential risk to the unborn child.

It is not known whether glycopyrronium bromide is excreted in human breast milk. A decision must be made whether to discontinue breastfeeding or to discontinue therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother. Discuss your options with your doctor before using this medicine if you are pregnant, planning to become pregnant, or breastfeeding.

How Does Enurev Breezhaler Interact with Other Drugs?

Enurev Breezhaler may interact with other anticholinergic medicines, potentially increasing the risk of side effects such as dry mouth, constipation, and urinary retention. No clinically significant pharmacokinetic interactions have been observed with commonly co-administered COPD medications.

Drug interactions with inhaled glycopyrronium bromide are generally limited because of its low systemic bioavailability when administered by inhalation. However, certain combinations require caution or monitoring. The most important consideration is the concurrent use of other anticholinergic (antimuscarinic) medicines, as additive effects may increase the risk of anticholinergic side effects.

Clinical interaction studies have shown that co-administration of glycopyrronium bromide with other commonly used COPD medicines, including inhaled corticosteroids, long-acting beta2-agonists (LABAs), and short-acting bronchodilators, does not result in clinically significant pharmacokinetic or pharmacodynamic interactions. The drug can therefore be safely used alongside these treatments as part of a comprehensive COPD management plan.

Major Interactions

Minor Interactions

Always inform your doctor or pharmacist about all medicines you are taking, including prescription medicines, over-the-counter drugs, herbal products, and dietary supplements. This helps prevent unexpected interactions and ensures the safe and effective use of Enurev Breezhaler as part of your COPD treatment plan.

What Is the Correct Dosage of Enurev Breezhaler?

The recommended dose of Enurev Breezhaler is one 44 microgram capsule inhaled once daily using the Breezhaler device. The capsule should be inhaled at approximately the same time each day. Do not swallow the capsules.

Adults

The Enurev Breezhaler capsules are for inhalation use only and must be administered using the Breezhaler inhaler device supplied in the pack. The capsules must not be swallowed. Each new prescription comes with a new Breezhaler device. If your inhaler device appears damaged or the mouthpiece becomes detached, do not use it – use the new device provided with your next prescription.

To ensure optimal drug delivery, patients should be instructed on the correct inhalation technique. After piercing the capsule and inhaling, it is important to check that the capsule is empty. If powder remains in the capsule, close the inhaler and inhale again. Most capsules are emptied in one or two inhalations. The characteristic whirring sound confirms that the capsule is spinning and the powder is being released.

Children and Adolescents

Elderly Patients

Missed Dose

If you forget to inhale your dose at the usual time, take it as soon as you remember on that day. However, do not take two doses on the same day. If it is almost time for your next dose, skip the missed dose entirely and take your next dose at the regular time the following day. Do not double the dose to make up for a forgotten one.

Overdose

If you accidentally inhale more Enurev Breezhaler than prescribed, you may experience an increase in anticholinergic side effects such as a dry mouth, faster heartbeat (tachycardia), tremor, or difficulty urinating. In clinical trials, glycopyrronium bromide was administered at doses up to eight times the recommended therapeutic dose (a single inhaled dose of 352 micrograms) and was generally well tolerated. The main effects observed at supratherapeutic doses included dry mouth and an increase in heart rate.

In the event of a suspected overdose, symptomatic and supportive treatment should be given as necessary. Contact your doctor or local poison control centre for advice. There is no specific antidote for glycopyrronium overdose.

What Are the Side Effects of Enurev Breezhaler?

Like all medicines, Enurev Breezhaler can cause side effects, although not everybody gets them. The most frequently reported side effects are dry mouth, nasopharyngitis (common cold symptoms), and insomnia. Most side effects are mild to moderate in severity.

The side effects listed below are based on data from clinical trials and post-marketing surveillance. They are classified by frequency according to the standard medical convention. The frequency categories are: very common (affects more than 1 in 10 people), common (affects 1 in 10 to 1 in 100 people), uncommon (affects 1 in 100 to 1 in 1,000 people), and rare (affects fewer than 1 in 1,000 people).

It is important to understand that most patients tolerate Enurev Breezhaler well. In the pivotal clinical trials (GLOW1, GLOW2, and GLOW3), the overall incidence of adverse events was similar between the glycopyrronium group and the placebo group, indicating a favourable safety profile. The majority of side effects are mild and transient, and they do not usually require discontinuation of treatment.

If any of the side effects become troublesome or if you notice any effects not listed in this guide, consult your doctor or pharmacist. Reporting suspected side effects helps regulatory authorities continue to monitor the benefit-risk balance of the medicine.

How Should You Store Enurev Breezhaler?

Store Enurev Breezhaler capsules in the original blister packaging to protect them from moisture. Do not store above 25°C. Keep out of the reach and sight of children.

Proper storage of Enurev Breezhaler is important to ensure that the medicine remains effective throughout its shelf life. The glycopyrronium bromide inhalation powder is sensitive to moisture, which is why the capsules are supplied in individually sealed blister packs. Each capsule should only be removed from its blister immediately before use.

The following storage instructions should be observed to maintain the quality and efficacy of the medicine:

• Temperature: Store below 25°C (77°F). Do not freeze the capsules
• Moisture protection: Keep capsules in the sealed blister pack until ready to use. Do not transfer capsules to other containers
• Light exposure: Keep the blister cards in the outer carton to protect from light
• Shelf life: Do not use after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month
• Breezhaler device: Each inhaler device should be used for one pack of capsules (30 capsules/30 days) and then disposed of with each new prescription
• Children: Keep all medicines out of the reach and sight of children

If you notice that a capsule is broken, cracked, or appears damp or damaged in any way, do not use it. Dispose of it safely and use a new capsule instead. Do not dispose of medicines via household waste or wastewater. Ask your pharmacist about proper disposal of medicines you no longer use – these measures help to protect the environment.

What Does Enurev Breezhaler Contain?

Each Enurev Breezhaler capsule contains 63 micrograms of glycopyrronium bromide, equivalent to 50 micrograms of glycopyrronium, delivering 44 micrograms of glycopyrronium bromide (equivalent to 55 micrograms glycopyrronium) from the mouthpiece of the inhaler.

Understanding the composition of your medicine is important, particularly if you have known allergies or intolerances to certain substances. Enurev Breezhaler capsules contain the following ingredients:

Active Ingredient

• Glycopyrronium bromide – 63 micrograms per capsule (equivalent to 50 micrograms glycopyrronium). The delivered dose from the mouthpiece is 44 micrograms glycopyrronium bromide (equivalent to 55 micrograms glycopyrronium)

Inactive Ingredients (Excipients)

• Lactose monohydrate – used as a carrier to aid the delivery of the fine drug particles to the lungs. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine
• Magnesium stearate – used as a lubricant in the capsule formulation

Capsule Shell

The capsule shell is composed of gelatin and a colour mixture containing titanium dioxide (E171), yellow iron oxide (E172), and indigotine (E132). The transparent hard capsule is designed to be pierced by the Breezhaler device to release the powder for inhalation. The capsule itself should never be swallowed.

Frequently Asked Questions About Enurev Breezhaler