The FDA approved this nebulized long-acting muscarinic antagonist in December 2017, and it is expected to be launched this spring.
Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease, affecting more than 30 million Americans.1 It is the third-leading cause of death in the United States and presents a significant burden for the health care system through direct medical costs and reduced productivity.
In December 2017, the FDA approved Sunovion’s Lonhala Magnair (glycopyrrolate), a nebulized long-acting muscarinic antagonist (LAMA) indicated for the long-term maintenance treatment of airflow obstruction in patients COPD, including chronic bronchitis and/or emphysema. With its approval, Lonhala Magnair became the first nebulized LAMA for the treatment of COPD. It also is the first medication that uses the Magnair eFlow technology system. It is expected to be available in the spring.
Here are key therapeutic areas with Lonhala Magnair that every pharmacist should know.
Lonhala Magnair is an anticholinergic indicated for the long-term, maintenance treatment of airflow obstruction in patients with COPD.
Limitation of Use2
Lonhala Magnair is not indicated as rescue therapy for the treatment of acute bronchospasm or for asthma. Additionally, the medication is not indicated for use in children, as the efficacy and safety in this population have not been established.
Additionally, it should not be initiated in patients during acutely deteriorating or potentially life-threatening episodes of COPD, as it has not been studied in subjects with acutely deteriorating COPD.
Mechanism of Action2
Glycopyrrolate is a long-acting muscarinic antagonist that exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation. Notably, the bronchodilation following inhalation of glycopyrrolate is thought to be predominantly a site-specific effect.
Formulation and Storage2
Lonhala Magnair is supplied as a 1 mL clear, colorless, and sterile solution in unit-dos vials wrapped in foil. It is available in 2 package configurations: a starter kit containing 60 unit-dose vials packaged with one Magnair and a refill kit containing 60 unit-dose vials packaged with a Magnair handset refill. Each package contains 30 foil pouches with 2 vials per pouch. The dosage for each individual vial is 25 mcg of glycopyrrolate.
Lonhala Magnair vials should be stored at room temperature in the protective foil pouch. After opening the foil pouch, unused unit-dose vials should be returned to and stored in the foil pouch. Once a foil pouch is opened, discard the vials if not used within 7 days. An opened unit-dose vial should be used right away.
The recommended dose is inhalation of 1 vial twice daily, using the Magnair device. Each treatment should take about 2 to 3 minutes.
Lonhala Magnair should be administered at the same time of the day (1 vial in the morning and 1 vial in the evening). Remove the vials from the foil pouch only immediately before use.
No dosage adjustment is required for geriatric patients, individuals with hepatic impairment, or those with mild to moderate renal impairment.
The efficacy of Lonhala Magnair to treat COPD was established in 2 placebo-controlled confirmatory studies. Both trials were randomized, double-blind, placebo-controlled 12-week studies to evaluate the efficacy of Longhala Magnair 25 and 50 mcg twice daily on lung function. The studies treated 1293 subjects who had a clinical diagnosis of COPD, were 40 or older, had a history of smoking greater than or equal to 10 pack-years, a post-bronchodilator FEV1 less than or equal to 80% of predicted. The primary endpoint was the change from baseline in trough FEV1 at day 84 compared with the placebo.
Study results showed statistically significant increases in the primary endpoint with Lonhala Magnair compared with the placebo. Compared with the 25 mcg twice daily, 50 mcg twice daily did not provide a sufficient additional benefit on a variety of clinical endpoints.
The most common adverse reactions of Lonhala Magnair reported in clinical trials include dyspnea and urinary tract infection.
Lonhala Magnair should be used in caution in patients with bladder neck obstruction, narrow-angle glaucoma, or prostatic hyperplasia.
Lonhala Magnair (glycopyrrolate)
Seebri Neohaler (glycopyrrolate)
Spiriva HandiHaler (tiotropium)
Spiriva Respimat (tiotropium)
Tudorza Pressair (aclidinium)
Patients should be instructed to store the medication vials in the sealed foil pouch and only open the pouch immediately before use. Unopened vials should be returned to the opened foil pouch for use at their next treatment and discarded if not used within 7 days or it may not be as effective. Discard any vials if the solution is not colorless.
If a patient misses a dose of medication, they should use their next vial at the usual time. Patients should be instructed to not use 2 vials at one time and to not use more than 2 vials in a day.
Patients should be informed that Lonhala Magnair is not meant to relieve acute symptoms of COPD, and extra doses should not be used for that purpose.
The old handset parts should be thrown away after using 60 vials of the medication, and the replacement handset parts should be used with the next 60 vials.
Steps for Use2
Assembling the Magnair device (refer to the package insert for instructions with pictures):
Using Magnair Lonhala:
1. COPD Foundation. COPD statistics across America. copdfoundation.org/What-is-COPD/COPD-Facts/Statistics.aspx. Accessed February 17, 2018.
2. Lonhala Magnair [prescribing Information]. Marlborough, MA: Sunovion Pharmaceuticals, Inc; 2017. accessdata.fda.gov/drugsatfda_docs/label/2017/208437lbl.pdf. Accessed February 23, 2018.
3. Lexicomp Online, Lexi-Drugs, Hudson, Ohio: Lexi-Comp, Inc; February 17, 2018.