How LONHALA MAGNAIR Is Supplied

The Starter Kit contains everything patients need to get started with LONHALA MAGNAIR

LONHALA MAGNAIR is supplied as 1 mL of sterile solution in a unit-dose LONHALA® (glycopyrrolate) Inhalation Solution vial. The Starter Kit and Refill Kit should be written as 2 separate prescriptions at the first visit.1

PACKAGE CONFIGURATION1
NDC1

Starter Kit with complete MAGNAIR® Nebulizer System, 30-day supply (30 foil pouches with 2 vials per pouch), and FDA-approved patient labeling:

NDC: 63402-201-00

Dosage strength: 25 mcg

MAGNAIR Nebulizer System (assembly required)
30-day supply of LONHALA (60 vials)
Instructional video

Refill Kit with MAGNAIR Replacement Handset, 30-day supply (30 foil pouches with 2 vials per pouch), and FDA-approved patient labeling:

NDC: 63402-301-01

Dosage strength: 25 mcg

MAGNAIR Replacement Handset (assembly required)
30-day supply of LONHALA (60 vials)

 

Patients should discard the old handset parts and use all the replacement handset parts provided with the LONHALA refill kits.

 
 

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


Reference:
1. LONHALA MAGNAIR (glycopyrrolate) Inhalation Solution [prescribing information]. Marlborough, MA: 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.