Data from FDA - Curated by EPG Health - Last updated 09 February 2018

Indication(s)

1 INDICATIONS AND USAGE SEEBRI™ NEOHALER® 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. SEEBRI NEOHALER is an anticholinergic indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). (1)

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Advisory information

contraindications
4 CONTRAINDICATIONS SEEBRI NEOHALER is contraindicated in patients who have demonstrated hypersensitivity to glycopyrrolate or to any of the ingredients [see Warnings and Precautions (5.3)]. History of known hypersensitivity to glycopyrrolate or to any of the ingredients. (4, 5.3)
Adverse reactions
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)]. Most common adverse reactions (incidence greater than or equal to 2% and higher than placebo) are upper respiratory tract infection and nasopharyngitis. (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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice. The SEEBRI NEOHALER safety database included 3415 subjects with COPD in four 12-week lung function trials and one 52-week long-term safety study. A total of 1202 subjects received treatment with SEEBRI NEOHALER 15.6 mcg twice-daily (BID). The safety data described below are based on the four 12-week trials and the one 52-week trial. 12-Week Trials The incidence of adverse reactions associated with SEEBRI NEOHALER in Table 1 is based on four 12-week, placebo-controlled trials in 2908 subjects with COPD. In the total population, 61.2% of patients had moderate COPD and 37.8% had severe COPD. In these trials, 951 subjects received SEEBRI NEOHALER 15.6 mcg BID, 511 subjects received indacaterol 27.5 mcg BID, 508 subjects received a fixed-dose combination of indacaterol/glycopyrrolate 27.5 mcg/15.6 mcg BID, and 938 subjects received placebo. Overall, 62% were males, 90% were Caucasian, and the mean age was 63 years (ranging from 41 to 89 years). In this population, 53% were identified as current smokers with an average smoking history of 48 pack-years. The most common adverse reactions (incidence greater than or equal to 2% and higher than placebo) were upper respiratory tract infection and nasopharyngitis. The proportion of subjects who discontinued treatment due to adverse reactions was 2.4% for the SEEBRI NEOHALER-treated patients and 3.8% for placebo-treated patients. Table 1. Adverse reactions with SEEBRI NEOHALER (greater than or equal to 1% incidence and higher than placebo) in COPD patients Adverse Reaction SEEBRI NEOHALER 15.6 mcg BID (N=951) n (%) Placebo (N=938) n (%) Upper respiratory tract infection 32 (3.4) 22 (2.3) Nasopharyngitis 20 (2.1) 18 (1.9) Urinary tract infection 13 (1.4) 12 (1.3) Sinusitis 13 (1.4) 7 (0.7) Oropharyngeal pain 17 (1.8) 11 (1.2) Other adverse reactions occurring more frequently with SEEBRI NEOHALER than with placebo, but with an incidence of less than 1% include rash, pruritus, gastroenteritis, hypersensitivity, atrial fibrillation, insomnia, pain in extremity, dysuria, vomiting, productive cough, and diabetes mellitus/hyperglycemia. 52-Week Trial In a long-term safety trial, 507 subjects were treated for up to 52 weeks with glycopyrrolate 15.6 mcg twice-daily or indacaterol 75 mcg once-daily. The demographic and baseline characteristics of the long-term safety trial were similar to those of the placebo-controlled efficacy trials described above. The adverse reactions reported in the long-term safety trial were consistent with those observed in the placebo-controlled trials of 12 weeks. Additional adverse reactions that occurred with a frequency greater than or equal to 2% in the group receiving glycopyrrolate 15.6 mcg twice-daily that exceeded the frequency of indacaterol 75 mcg once-daily in this trial were: diarrhea, nausea, upper abdominal pain, fatigue, bronchitis, pneumonia, rhinitis, back pain, arthralgia, dyspnea, and wheezing. 6.2 Postmarketing Experience The following additional adverse reactions have been identified during worldwide post-approval use of glycopyrrolate, the active ingredient in SEEBRI NEOHALER, at higher than the recommended dose. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions are: angioedema, paradoxical bronchospasm and dysphonia.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION For oral inhalation only. Do not swallow SEEBRI capsules, as the intended effects on the lungs will not be obtained. SEEBRI capsules should only be used with the NEOHALER device [see Overdosage (10)]. The recommended dose of SEEBRI NEOHALER is the inhalation of the contents of one SEEBRI capsule twice-daily using the SEEBRI NEOHALER device. SEEBRI NEOHALER should be administered at the same time of the day, (1 capsule in the morning and 1 capsule in the evening), every day. More frequent administration or a greater number of inhalations (more than 1 capsule twice-daily) of SEEBRI NEOHALER is not recommended. Store SEEBRI capsules in the blister, and only remove IMMEDIATELY BEFORE USE with the NEOHALER device. No dosage adjustment is required for geriatric patients, patients with hepatic impairment, or patients with mild to moderate renal impairment. For oral inhalation only. Do not swallow SEEBRI capsules. Only use SEEBRI capsules with the NEOHALER device. (2) Maintenance treatment of COPD: The inhalation of the powder contents of one SEEBRI capsule (15.6 mcg) twice-daily (2)
Use in special populations
8 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) 8.1 Pregnancy Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies with SEEBRI NEOHALER in pregnant women. Because animal reproduction studies are not always predictive of human response, SEEBRI NEOHALER should only be used during pregnancy if the potential benefit to the patient justifies the potential risk to the fetus. Women should be advised to contact their physician if they become pregnant while taking SEEBRI NEOHALER. Glycopyrrolate was not teratogenic in Wistar rats and New Zealand White rabbits at approximately 1400 and 530 times, respectively, the MRHD in adults (on an AUC basis at maternal inhaled doses up to 3.83 mg/kg/day in rats and up to 4.4 mg/kg/day in rabbits). Non-teratogenic Effects: Glycopyrrolate had no effects on peri-natal and post-natal developments in rats at approximately 1100 times the MRHD in adults (on an AUC basis at maternal subcutaneous doses up to 1.88 mg/kg/day). 8.2 Labor and Delivery There are no adequate and well-controlled human trials that have investigated the effects of SEEBRI NEOHALER during labor and delivery. In human parturients undergoing Caesarean section, 86 minutes after a single intramuscular injection of 0.006 mg/kg glycopyrrolate, umbilical plasma concentrations were low. 8.3 Nursing Mothers It is not known whether SEEBRI NEOHALER is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when SEEBRI NEOHALER is administered to a nursing woman. Since there are no data from well-controlled human studies on the use of SEEBRI NEOHALER by nursing mothers, a decision should be made whether to discontinue nursing or to discontinue SEEBRI NEOHALER, taking into account the importance of SEEBRI NEOHALER to the mother. It is not known whether glycopyrrolate is excreted in human breast milk. Glycopyrrolate (including its metabolites) have been detected in the milk of lactating rats and reached up to 10-fold higher concentrations in the milk than in the blood of the dam. 8.4 Pediatric Use SEEBRI NEOHALER is not indicated for use in children. The safety and efficacy of SEEBRI NEOHALER in pediatric patients have not been established. 8.5 Geriatric Use Based on available data, no adjustment of the dosage of SEEBRI NEOHALER in geriatric patients is warranted. SEEBRI NEOHALER 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 SEEBRI NEOHALER, 45% were aged 65 and older, while 10% 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. 8.6 Renal Impairment No dose adjustment is required for patients with mild and moderate renal impairment. SEEBRI NEOHALER should be used in patients with severe renal impairment (estimated GFR less than 30 mL/min/1.73m2), including those with end-stage renal disease requiring dialysis, if the expected benefit outweighs the potential risk since the systemic exposure to glycopyrrolate may be increased in this population [see Clinical Pharmacology (12.3)]. 8.7 Hepatic Impairment No dose adjustment is required for patients with hepatic impairment. The effects of hepatic impairment on the pharmacokinetics of glycopyrrolate have not been studied [see Clinical Pharmacology (12.3)].
Pregnancy and lactation
8.3 Nursing Mothers It is not known whether SEEBRI NEOHALER is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when SEEBRI NEOHALER is administered to a nursing woman. Since there are no data from well-controlled human studies on the use of SEEBRI NEOHALER by nursing mothers, a decision should be made whether to discontinue nursing or to discontinue SEEBRI NEOHALER, taking into account the importance of SEEBRI NEOHALER to the mother. It is not known whether glycopyrrolate is excreted in human breast milk. Glycopyrrolate (including its metabolites) have been detected in the milk of lactating rats and reached up to 10-fold higher concentrations in the milk than in the blood of the dam.

Interactions

7 DRUG INTERACTIONS Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of SEEBRI NEOHALER with other anticholinergic-containing drugs. (7.2) 7.1 Sympathomimetics, Methylxanthines, Steroids In clinical studies, concurrent administration of short-acting and long-acting sympathomimetic (beta-agonists) bronchodilators (including indacaterol), methylxanthines, oral and inhaled steroids with SEEBRI NEOHALER showed no increases in adverse drug reactions. 7.2 Anticholinergics There is a potential for an additive interaction with concomitantly used anticholinergic medications. Therefore, avoid coadministration of SEEBRI NEOHALER with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic effects [see Warnings and Precautions (5.4, 5.5) and Adverse Reactions (6)].

More information

Category Value
Authorisation number NDA207923
Agency product number V92SO9WP2I
Orphan designation No
Product NDC 63402-815
Date Last Revised 30-01-2018
Type HUMAN PRESCRIPTION DRUG
Storage and handling Storage and Handling Store in a dry place at 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. SEEBRI capsules should be used with the NEOHALER device only. Do not use the NEOHALER device with any other capsules. Store SEEBRI capsules in the blister protected from moisture. Remove the SEEBRI capsules from the blister immediately before use. Always use the new NEOHALER inhaler provided with each new prescription. Keep out of the reach of children.
Marketing authorisation holder Sunovion Pharmacueticals Inc.