LONHALA MAGNAIR

LONHALA MAGNAIR- glycopyrrolate solution
Sunovion Pharmaceuticals Inc.

1. INDICATIONS AND USAGE

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

2. DOSAGE AND ADMINISTRATION

For oral inhalation only. Do not swallow LONHALA solution. LONHALA vials should only be used with MAGNAIR [see Overdosage (10)].

The recommended dose of LONHALA is the inhalation of the contents of one LONHALA vial twice-daily using MAGNAIR. LONHALA vials should only be administered with MAGNAIR. Patients should be instructed on the correct use of this drug product and device.

LONHALA MAGNAIR should be administered at the same time of the day, (1 vial in the morning and 1 vial in the evening), every day. More frequent administration or a greater number of inhalations (more than 1 vial twice daily) of LONHALA MAGNAIR is not recommended.

Store LONHALA vials in the foil pouch, and only remove IMMEDIATELY BEFORE USE with MAGNAIR.

No dosage adjustment is required for geriatric patients, patients with hepatic impairment, or patients with mild to moderate renal impairment.

3. DOSAGE FORMS AND STRENGTHS

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

4. CONTRAINDICATIONS

LONHALA MAGNAIR is contraindicated in patients with a hypersensitivity to glycopyrrolate or any of the ingredients [see Warnings and Precautions (5.3) ].

5. WARNINGS AND PRECAUTIONS

5.1. 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.

5.2. Paradoxical Bronchospasm

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.

5.3. 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.

5.4. 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.

5.5. 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 symptoms develop.

6. ADVERSE REACTIONS

The following adverse reactions are described in greater detail in other sections:

  • Paradoxical bronchospasm [see Warnings and Precautions (5.2) ]
  • Immediate hypersensitivity reactions [see Warnings and Precautions (5.3) ]
  • Worsening of narrow-angle glaucoma [see Warnings and Precautions (5.4) ]
  • Worsening of urinary retention [see Warnings and Precautions (5.5) ]

6.1. 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.

12-Week Trials

LONHALA MAGNAIR was studied in two 12-week placebo-controlled trials in subjects with COPD. In these trials, 431 subjects were 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.

Table 1 shows the most common adverse reactions incidence greater than or equal to 2.0% in the LONHALA MAGNAIR group and higher than placebo in the two 12-week placebo-controlled trials.

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
Placebo (N=430) N (%) LONHALA MAGNAIR 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.

48-Week Trial

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, and hypertension.

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