LONHALA® MAGNAIR® (glycopyrrolate) Safety Results

LONHALA MAGNAIR Clinical Trial Safety Results

LONHALA MAGNAIR Safety Profile

63 years was the mean age, with all patients aged ≥40 years

53% were current smokers (average smoking history of 52 pack-years)

~30% had background LABA use

19% had an exacerbation in the past 12 months

64% had high CV risk. More information on safety and efficacy for background CV risk

*Both studies were conducted with LONHALA MAGNAIR 25 mcg, 50 mcg, or placebo twice daily. Information for the LONHALA MAGNAIR 25 mcg arm is displayed here (the 50 mcg dosage strength did not provide significant additional benefit and is not presented or approved for use). Baseline patient characteristics were similar across all arms of the studies.

Any subject with a preexisting diagnosis of ischemic heart disease, cerebrovascular disease, peripheral arterial disease, hypertension, clinically significant arrhythmia, or heart failure.

CV=cardiovascular; LABA=long-acting beta2-agonist.

Pooled analysis of two 12-week trials

  • The safety of LONHALA MAGNAIR was evaluated in two 12-week, randomized, double-blind, placebo-controlled, parallel group, confirmatory studies, and a 48-week,  long-term, open-label safety clinical trial

Adverse reactions with ≥2% incidence and higher than placebo1

LONHALA® MAGNAIR® adverse reactions greater than or equal to 2% and higher than placebo in two 12-week trials

LONHALA® MAGNAIR® adverse reactions greater than or equal to 2% and higher than placebo in two 12-week trials

  • The incidence of discontinuation due to adverse reactions was greater for placebo (9.3%) than for LONHALA MAGNAIR (5.1%)2

48-week, long-term, open-label safety clinical trial1

  • Adverse reactions reported in a randomized, open-label, active-controlled, parallel-group, 48-week, long-term safety trial (N=620) were consistent with those observed in the 12-week studies (Study 1 and Study 2)
    • Additional adverse reactions with LONHALA MAGNAIR (50 mcg BID) that occurred at a frequency greater than those seen in either active treatment dose in the pooled 12-week studies and ≥2% were diarrhea, edema peripheral, bronchitis, nasopharyngitis, pneumonia, sinusitis, upper respiratory tract infection, urinary tract infection, back pain, headache, COPD, cough, dyspnea, oropharyngeal pain, and hypertension

BID=twice daily; COPD=chronic obstructive pulmonary disease.


Efficacy and safety were assessed in two 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter trials in subjects with moderate to very severe COPD. Subjects were randomized using a 1:1:1 ratio to 1 of 3 treatments: placebo BID, LONHALA MAGNAIR 25 mcg BID, and glycopyrrolate 50 mcg BID. Safety end points included the number and percentage of subjects with treatment-emergent adverse events (TEAEs) and serious AEs, and the number and percentage of subjects who discountinued treatment due to TEAEs.2,3


References:
1. LONHALA MAGNAIR (glycopyrrolate) Inhalation Solution [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals Inc. 
2. Data on file. Integrated Summary of Safety. 156. Sunovion Pharmaceuticals Inc.
3. Kerwin E, Donohue JF, Goodin T, et al. Efficacy and safety of glycopyrrolate/eFlow® CS (nebulized glycopyrrolate) in moderate-to-severe COPD: results from the glycopyrrolate for obstructive lung disease via electronic nebulizer (GOLDEN) 3 and 4 randomized controlled trials. Respir Med. 2017;132:238–250.
4. Data on file. Glycopyrrolate Inhalation Solution Protocol SUN101-303 Clinical Study Report. NCT identifier: 0227622. Sunovion Pharmaceuticals Inc.
5. Data on file. Summary of Clinical Safety. Sunovion Pharmaceuticals Inc.

Important Safety Information & Indication

Important Safety Information
 

LONHALA MAGNAIR is contraindicated in patients with a hypersensitivity to glycopyrrolate or to any of the ingredients.

LONHALA MAGNAIR should not be initiated in patients with acutely deteriorating or potentially life-threatening episodes of COPD or used as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.

As with other inhaled medicines, LONHALA MAGNAIR can produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs following dosing with LONHALA MAGNAIR, it should be treated immediately with an inhaled, short-acting bronchodilator; LONHALA MAGNAIR should be discontinued immediately and alternative therapy instituted.

Immediate hypersensitivity reactions have been reported with LONHALA MAGNAIR. If signs occur, discontinue LONHALA MAGNAIR immediately and institute alternative therapy.

LONHALA MAGNAIR should be used with caution in patients with narrow-angle glaucoma and in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema) and of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Patients should be instructed to consult a physician immediately should any of these signs or symptoms develop.

The most common adverse events reported in ≥2% of patients taking LONHALA MAGNAIR, and occurring more frequently than in patients taking placebo, were dyspnea (4.9% vs 3.0%) and urinary tract infection (2.1% vs 1.4%).

LONHALA solution is for oral inhalation only and should not be injected or swallowed. LONHALA vials should only be administered with MAGNAIR.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional information, please see full Prescribing Information and Patient Information for LONHALA MAGNAIR at www.sunovionprofile.com/lonhala-magnair.

Indication
 

LONHALA® MAGNAIR® (glycopyrrolate) is an anticholinergic indicated for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.