The only long-acting anticholinergic indicated to reduce exacerbations1
SPIRIVA achieved a significant delay in time to first exacerbation by 33% (or 4.2 months) longer in a 4-year study vs control1,3
— Exacerbations were evaluated as a secondary endpoint in the UPLIFT study1,3
In the 6-month Veterans Affairs (VA) trial, the proportion of patients who experienced COPD exacerbations was 27.9% in the SPIRIVA group vs 32.3% in the control group (p=0.037), and the proportion of patients hospitalized due to COPD exacerbations was 7.0% in the SPIRIVA group vs 9.5% in the control group (p=0.056)1
SPIRIVA sustained improvement in lung function vs control throughout a 4-year trial3
— SPIRIVA did not slow the yearly rate of decline in pre- and post-bronchodilator FEV1 vs control, which were the co-primary endpoints of the study (p=NS)3
Important Safety Information
Spiriva® HandiHaler® (tiotropium bromide inhalation powder) is contraindicated in patients with a history of hypersensitivity to tiotropium, ipratropium (atropine derivatives), or any components of SPIRIVA capsules.
SPIRIVA HandiHaler is not indicated for the initial treatment of acute episodes of bronchospasm, i.e., rescue therapy.
Immediate hypersensitivity reactions, including urticaria, angioedema (swelling of lips, tongue or throat), rash, bronchospasm, anaphylaxis, or itching may occur after administration of SPIRIVA. Additionally, inhaled medicines, including SPIRIVA, may cause paradoxical bronchospasm. If any of these occurs, treatment with SPIRIVA should be stopped and other treatments considered.
Patients with a history of hypersensitivity reactions to atropine should be closely monitored for similar hypersensitivity reactions to SPIRIVA.
Use with caution in patients with severe hypersensitivity to milk proteins.
SPIRIVA HandiHaler should be used with caution in patients with narrow-angle glaucoma or urinary retention. Prescribers should instruct patients to consult a physician immediately should any signs or symptoms of narrow-angle glaucoma, or prostatic hyperplasia or bladder-neck obstruction occur.
Since dizziness and blurred vision may occur with the use of SPIRIVA HandiHaler, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery.
As SPIRIVA is a predominantly renally excreted drug, SPIRIVA use should be monitored closely in patients with moderate to severe renal impairment (creatinine clearance of ≤ 50 mL/min).
SPIRIVA HandiHaler has been used concomitantly with short-acting and long-acting sympathomimetic (beta-agonists) bronchodilators, methylxanthines, and oral and inhaled steroids without increases in adverse drug reactions.
SPIRIVA may interact additively with concomitantly used anticholinergic medications. Avoid coadministration with other anticholinergic-containing drugs.
The most common adverse reactions in the 1-year placebo-controlled trials were dry mouth, upper respiratory tract infection, sinusitis, pharyngitis, non-specific chest pain, and urinary tract infection. In addition, the most commonly reported adverse reactions from the 4-year trial not included above were headache, constipation, depression, insomnia, and arthralgia.
SPIRIVA capsules should not be swallowed and should only be inhaled through the mouth (oral inhalation) using the HandiHaler device. The HandiHaler device should not be used for administering other medications.
SPIRIVA capsules should always be stored in the sealed blisters, and only removed immediately before use, or else its effectiveness may be reduced.
Please refer to the Instructions for Use for additional information on the use of SPIRIVA HandiHaler.
Spiriva® HandiHaler® is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and for reducing COPD exacerbations.
- SPIRIVA Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2012.
- Data on file. Boehringer Ingelheim Pharmaceuticals, Inc.
- Tashkin DP, Celli B, Senn S, et al; for the UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med. 2008;359(15):1543-1554.
Spiriva® and HandiHaler® are registered trademarks and are used under license from Boehringer Ingelheim International GmbH.
SPIRIVA was developed by Boehringer Ingelheim and is being co-promoted by Boehringer Ingelheim and Pfizer.
Copyright ©2013 Boehringer Ingelheim Pharmaceuticals, Inc. All rights reserved.