BRIEF SUMMARY OF FULL PRESCRIBING INFORMA TION
Please see package insert for full Prescribing Information,
including Patient Information.
INDICATIONS AND USAGE
LONHALA™ MAGNAIR™ 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.
LONHALA MAGNAIR is contraindicated in patients with a
hypersensitivity to glycopyrrolate or any of the ingredients.
WARNINGS AND PRECAUTIONS
Deterioration of Disease and Acute Episodes
LONHALA MAGNAIR should not be initiated in patients during
acutely deteriorating or potentially life-threatening episodes of
COPD. LONHALA MAGNAIR has not been studied in subjects with
acutely deteriorating COPD. The initiation of LONHALA MAGNAIR
in this setting is not appropriate.
LONHALA MAGNAIR should not be used as rescue therapy for
the treatment of acute episodes of bronchospasm. LONHALA
MAGNAIR has not been studied in the relief of acute symptoms and
extra doses should not be used for that purpose. Acute symptoms
should be treated with an inhaled, short-acting beta2-agonist.
COPD may deteriorate acutely over a period of hours or
chronically over several days or longer. If LONHALA MAGNAIR no
longer controls symptoms of bronchoconstriction the patient’s
inhaled, short-acting beta2-agonist becomes less effective; or the
patient needs more inhalations of a short-acting beta2-agonist
than usual, these may be markers of deterioration of disease.
In this setting, a re-evaluation of the patient and the COPD
treatment regimen should be undertaken at once. Increasing
the daily dose of LONHALA MAGNAIR beyond the recommended
dose is not appropriate in this situation.
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
Immediate hypersensitivity reactions may occur after
administration of LONHALA MAGNAIR. If signs suggesting allergic
reactions occur, in particular, angioedema (including difficulties
in breathing or swallowing, swelling of the tongue, lips, and
face), urticaria, or skin rash, LONHALA MAGNAIR should be
discontinued immediately and alternative therapy instituted.
Worsening of Narrow-Angle Glaucoma
LONHALA MAGNAIR should be used with caution in patients
with narrow-angle glaucoma. 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). Instruct patients to consult a physician
immediately should any of these signs or symptoms develop.
Worsening of Urinary Retention
LONHALA MAGNAIR should be used with caution in patients with
urinary retention. Prescribers and patients should be alert for
signs and symptoms of urinary retention (e.g., difficulty passing
urine, painful urination), especially in patients with prostatic
hyperplasia or bladder-neck obstruction. Instruct patients to
consult a physician immediately should any of these signs or
Clinical Trials Experience
Because clinical trials are conducted under widely varying
conditions, adverse reaction rates observed in the clinical trials of
a drug cannot be directly compared to rates in the clinical trials of
another drug and may not reflect the rates observed in practice.
The LONHALA MAGNAIR safety database included 2379 subjects
with COPD in two 12-week efficacy studies and one 48-week
long-term safety study. A total of 431 subjects received
treatment with LONHALA MAGNAIR 25 mcg twice-daily (BID).
The safety data described below are based on the two 12-week
trials and the one 48-week trial.
LONHALA MAGNAIR was studied in two 12-week placebo-controlled trials in 431 subjects with COPD, treated with
LONHALA MAGNAIR at the recommended dose of 25 mcg, twice
daily. The population had a mean age of 63 years (ranging from
40 to 87 years), with 56% males, 90% Caucasian, and a mean
post-bronchodilator forced expiratory volume in one second
(FEV1) percent predicted of 52% of predicted normal value (20%-
80%) at study entry. The study population also included subjects
with pre-existing cardiovascular disease as well as subjects with
continued use of stable long-acting bronchodilator (LABA) +/-
inhaled corticosteroid (ICS) and ipratropium bromide background
therapy. Subjects with unstable cardiac disease, narrow-angle
glaucoma, or symptomatic prostatic hypertrophy or bladder outlet
obstruction were excluded from these studies.
The proportion of subjects who discontinued treatment due to
adverse reactions was 5% for the LONHALA MAGNAIR-treated
subjects and 9% for placebo-treated subjects.
Table 1: Adverse Reactions with LONHALA MAGNAIR
≥ 2.0% Incidence and Higher than Placebo
(N=430) N (%)
25 mcg BID
(N=431) N (%)
Dyspnea 13 ( 3.0) 21 ( 4. 9)
Urinary Tract Infection 6 (1.4) 9 ( 2.1)
Other adverse reactions defined as events with an incidence of
≥ 1.0% but less than 2.0% with LONHALA MAGNAIR but more
common than with placebo included the following: wheezing,
upper respiratory tract infection, nasopharyngitis, oedema
peripheral, and fatigue.
In a long-term open-label safety trial, 1086 subjects were treated
for up to 48 weeks with LONHALA MAGNAIR 50 mcg twice-daily
(N=620) or tiotropium (N=466). The demographic and baseline
characteristics of the long-term safety trial were similar to those
of the placebo-controlled efficacy studies described above.
The adverse reactions reported in the long-term safety trial
were consistent with those observed in the placebo-controlled
studies of 12 weeks. Adverse reactions that occurred at a
frequency greater than that seen in either active treatment dose
in the pooled 12-week placebo controlled studies and ≥ 2.0%
were: diarrhea, edema peripheral, bronchitis, nasopharyngitis,
pneumonia, sinusitis, upper respiratory tract infection, urinary
tract infection, back pain, headache, Chronic Obstructive
Pulmonary Disease, cough, dyspnea, oropharyngeal pain,
DRUG INTERAC TIONS
There is a potential for an additive interaction with concomitantly
used anticholinergic medications. Therefore, avoid unnecessary
co-administration of LONHALA MAGNAIR with other
anticholinergic-containing drugs as this may lead to an increase
in anticholinergic effects.
USE IN SPECIFIC POPULA TIONS
There are no adequate and well-controlled studies in pregnant
women. LONHALA MAGNAIR should only be used during
pregnancy if the expected benefit to the patient outweighs
the potential risk to the fetus. Women should be advised to
contact their physician if they become pregnant while taking
LONHALA MAGNAIR. In animal reproduction studies, there were
no teratogenic effects in Wistar rats and New Zealand White
rabbits at inhaled doses approximating 1521 and 580 times,
respectively, the maximum recommended human daily inhalation
dose (MRHDID) based on an AUC comparison.
The estimated background risk of major birth defects and
miscarriage for the indicated population is unknown. In the U.S.
general population, the estimated background risk of major birth
defects and miscarriage in clinically recognized pregnancies is
2-4% and 15-20%, respectively.
Labor or Delivery
The potential effect of LONHALA MAGNAIR on labor and delivery
is unknown. LONHALA MAGNAIR should be used during labor
and delivery only if the potential benefit to the patient justifies the
potential risk to the fetus.
Developmental studies in Wistar rats and New Zealand White
rabbits in which glycopyrrolate was administered by inhalation
during the period of organogenesis did not result in evidence of
teratogenicity at exposures approximately 1521 and 580 times,
respectively, the MRHDID of LONHALA MAGNAIR based on a
comparison of plasma AUC levels (maternal doses up to
3. 8 mg/kg/day in rats and 4. 4 mg/kg/day in rabbits).
Glycopyrrolate had no effects on peri-natal and post-natal
development in rats following subcutaneous exposure of
approximately 1137 times the MRHDID of LONHALA MAGNAIR
based on an AUC comparison (at a maternal dose of up to
There are no data on the presence of glycopyrrolate or its
metabolites in human milk, the effects on the breastfed infant, or
the effects on milk production. However, in a study of lactating
rats, glycopyrrolate was present in the milk. The developmental
and health benefits of breastfeeding should be considered along
with the mother’s clinical need for LONHALA MAGNAIR and any
potential adverse effects on the breastfed infant from LONHALA
MAGNAIR or from the underlying maternal condition.
Glycopyrrolate (and its metabolites) was detected in the milk of
lactating rats following a single intravenous injection of 4 mg/kg
of radiolabeled glycopyrrolate.
LONHALA MAGNAIR is not indicated for use in children. The
safety and efficacy of LONHALA MAGNAIR in pediatric patients
have not been established.
Based on available data, no adjustment of the dosage of
LONHALA MAGNAIR in geriatric patients is warranted. LONHALA
MAGNAIR can be used at the recommended dose in elderly
patients 75 years of age and older.
Of the total number of subjects in clinical studies of LONHALA
MAGNAIR, 41% were aged 65 and older, while 8% were aged
75 and older. No overall differences in safety or effectiveness
were observed between these subjects and younger subjects,
and other reported clinical experience has not identified
differences in responses between the elderly and younger
patients, but greater sensitivity of some older individuals cannot
be ruled out.
No dose adjustment is required for patients with mild and
moderate renal impairment. The effects of renal impairment on
the pharmacokinetics of glycopyrrolate have not been studied.
No dose adjustment is required for patients with hepatic
impairment. The effects of hepatic impairment on the
pharmacokinetics of glycopyrrolate have not been studied.
An overdose of glycopyrrolate may lead to anticholinergic
signs and symptoms such as nausea, vomiting, dizziness,
lightheadedness, blurred vision, increased intraocular pressure
(causing pain, vision disturbances, or reddening of the eye),
obstipation or difficulties in voiding.
In COPD patients, orally inhaled administration of LONHALA
MAGNAIR at a total daily dose of 200 mcg for 28 consecutive
days (maximum of 1 mg) was well tolerated.
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling
(Patient Information and Instructions for Use).
LONHALA and are trademarks of Sunovion
Pharmaceuticals Inc. MAGNAIR is a trademark of
PARI Pharma GmbH, used under license.
SUNOVION and are registered trademarks of Sumitomo
Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Inc. is a
U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd.
PARI and are registered trademarks of PARI GmbH.
eFlow is a registered trademark of PARI Pharma GmbH.
Made under license of The Technology Partnership plc.
Sunovion Respiratory Development Inc.,
a wholly-owned subsidiary of Sunovion Pharmaceuticals Inc.,
Marlborough, MA 01752 USA
To report suspected adverse reactions, call 1-877-737-7226.
For customer service, call 1-888-394-7377.
©2017 Sunovion Pharmaceuticals Inc.
All rights reserved. 12/17 LON048-17
For oral inhalation use