Rx Item-LONHALA MAGNAIR glycopyrrolate STARTER 25 MCG-ML VL 60 BY SUNOVION

For: Chronic Obstructive Pulmonary Disease

Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. LONHALA MAGNAIR is supplied as a 1 mL sterile, clear, colorless, aqueous solution in low-density polyethylene (LDPE) unit-dose vials overwrapped in foil. LONHALA MAGNAIR is available in a Starter Kit containing 60 unit-dose vials packaged with one MAGNAIR, and FDA approved patient labeling. LONHALA MAGNAIR is also supplied in a Refill Kit containing 60 unit-dose vials packaged with a MAGNAIR Replacement Handset and FDA approved patient labeling.
Package Configuration Dosage Strength NDC
Starter Kit with 30 day supply (30 foil pouches with 2 vials per pouch) and complete MAGNAIR Nebulizer System 25 mcg NDC: 63402-201-00
Refill Kit with 30 day supply (30 foil pouches with 2 vials per pouch) and MAGNAIR Replacement Handset 25 mcg NDC: 63402-301-01

16.2 Storage and Handling

Store LONHALA Inhalation Solution in the protective foil pouch at 20�-25�C (68�-77�F) [see USP Controlled Room Temperature].

LONHALA vials should be used with MAGNAIR only. Do not use MAGNAIR with any other vials.
Store LONHALA vials 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. Discard any unit-dose vial if the solution is not colorless.

Always use the MAGNAIR Replacement Handset parts that come with each LONHALA MAGNAIR refill prescription.

Keep out of the reach of children. These highlights do not include all the information needed to use LONHALA� MAGNAIR� safely and effectively. See full prescribing information for LONHALA MAGNAIR.
LONHALA MAGNAIR (glycopyrrolate) inhalation solution, for oral inhalation use
Initial U.S. Approval: 1961
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). (1)
DOSAGE AND ADMINISTRATION

For oral inhalation only. Do not swallow LONHALA solution. Only use LONHALA vials with MAGNAIR. (2)
Maintenance treatment of COPD: The contents of one LONHALA vial twice-daily. (2)

DOSAGE FORMS AND STRENGTHS

LONHALA Inhalation Solution is supplied as a sterile solution for inhalation in a unit-dose single-use low-density polyethylene (LDPE) vial. Each 1 mL vial contains 25 mcg of glycopyrrolate. (3)
CONTRAINDICATIONS

LONHALA MAGNAIR is contraindicated in patients with a hypersensitivity to glycopyrrolate or any of the ingredients. (4)
WARNINGS AND PRECAUTIONS

Do not initiate in acutely deteriorating COPD or to treat acute symptoms. (5.1)
If paradoxical bronchospasm occurs, discontinue LONHALA MAGNAIR immediately and institute alternative therapy. (5.2)
Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a physician immediately if symptoms occur. (5.4)
Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder neck obstruction and instruct patients to consult a physician immediately if symptoms occur. (5.5)

ADVERSE REACTIONS

Most common adverse reactions (incidence greater than or equal to 2.0% and higher than placebo) are dyspnea and urinary tract infection. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Sunovion Pharmaceuticals Inc. at 1-877-737-7226 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS

Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of LONHALA MAGNAIR with other anticholinergic-containing drugs. (7.2)
USE IN SPECIFIC POPULATIONS

Use in patients with severe renal impairment should be considered if the potential benefit of the treatment outweighs the risk. (8.6)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 6/2019

Rx Item-LONHALA MAGNAIR glycopyrrolate S
RX733790

Rx Item-LONHALA MAGNAIR glycopyrrolate S
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