Braltus is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms in adults with COPD.
Each Braltus capsule contains 13 microgram tiotropium as powder for inhalation. Administered via the breath-actuated Zonda inhaler, Braltus provides the same 10 microgram delivered dose of tiotropium as the Spiriva HandiHaler.
The MHRA has received 2 Yellow Card reports of patients who have inhaled a Braltus capsule from the mouthpiece into the back of the throat as a result of incorrect use, causing a risk of aspiration or airway obstruction.
Healthcare professionals have also reported that some patients have placed the capsule into the mouthpiece when being trained to use the inhaler device.
Using the Zonda inhaler
To operate the Zonda inhaler patients must:
- Lift the mouthpiece and place the Braltus capsule in the capsule-shaped compartment in the base of the inhaler.
- Close the mouthpiece (confirmed with a ‘click’ sound).
- Press the piercing button to release the medication.
- Breathe out fully away from the mouthpiece.
- Place the mouthpiece between the teeth, forming a seal with their lips.
- Breathe in slowly and deeply - the capsule will vibrate to confirm the rate of inhalation is sufficient.
- Remove the inhaler, holding their breath for as long as they comfortably can, gently breathing out thereafter.
- Check the clear capsule for visual confirmation of dose delivery and discard it in the bin.
Healthcare professionals must advise patients never to place a capsule directly into the mouthpiece.
Placebo devices are available from Teva for training purposes and instructions are provided in the patient information leaflet and carton.