IMPORTANT SAFETY INFORMATION for SPIRIVA RESPIMAT and Spiriva® HandiHaler® (tiotropium bromide inhalation powder)

SPIRIVA is contraindicated in patients with a history of hypersensitivity to tiotropium, ipratropium (atropine derivatives), or any component of either product.

SPIRIVA 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.

SPIRIVA HandiHaler should be used with caution in patients with severe hypersensitivity to milk proteins.

SPIRIVA 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, prostatic hyperplasia or bladder-neck obstruction occur.

Since dizziness and blurred vision may occur with the use of SPIRIVA, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery.

Patients with moderate to severe renal impairment (creatinine clearance of ≤50 mL/min for SPIRIVA HandiHaler and creatinine clearance of <60 mL/min for SPIRIVA RESPIMAT) and treated with SPIRIVA should be monitored closely for anticholinergic side effects.

SPIRIVA may interact additively with concomitantly used anticholinergic medications. Avoid coadministration with other anticholinergic-containing drugs.

The most common adverse reactions >5% incidence and exceeded placebo by ≥1% with SPIRIVA HandiHaler (placebo) were upper respiratory tract infection 41% (37%), dry mouth 16% (3%), sinusitis 11% (9%), pharyngitis 9% (7%), non-specific chest pain 7% (5%), urinary tract infection 7% (5%), dyspepsia 6% (5%), and rhinitis 6% (5%). In addition, the most common reported adverse reaction ≥3% incidence and higher than placebo from the 4-year trial with SPIRIVA HandiHaler (placebo) not included above were headache 5.7% (4.5%), depression 4.4% (3.3%), insomnia 4.4% (3.0%), and arthralgia 4.2% (3.1%).

The most common adverse reactions >3% incidence and higher than placebo with SPIRIVA RESPIMAT (placebo) were pharyngitis 11.5% (10.1%), cough 5.8% (5.5%), dry mouth 4.1% (1.6%), and sinusitis 3.1% (2.7%).

SPIRIVA capsules should not be swallowed and should only be inhaled through the mouth (oral inhalation) using the HandiHaler device and the HandiHaler device should not be used for administering other medications.

Inform patients not to spray SPIRIVA RESPIMAT into the eyes as this may cause blurring of vision and pupil dilation.

INDICATION

SPIRIVA HandiHaler and SPIRIVA RESPIMAT are 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.

Please see full Prescribing Information for SPIRIVA RESPIMAT and SPIRIVA HandiHaler, including Instructions for Use.

REFERENCES

  1. SPIRIVA RESPIMAT [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2014.
  2. SPIRIVA HandiHaler [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2014.
  3. Bateman ED, Tashkin D, Siafakas N, et al. A one-year trial of tiotropium Respimat® plus usual therapy in COPD patients. Respir Med. 2010;104(10):1460-1472.
  4. Data on file. Boehringer Ingelheim Pharmaceuticals, Inc.
Hold your phone upright to continue browsing spiriva.com
SEE MORE

IMPORTANT SAFETY INFORMATION for SPIRIVA RESPIMAT and Spiriva® HandiHaler® (tiotropium bromide inhalation powder)

SPIRIVA is contraindicated in patients with a history of hypersensitivity to tiotropium, ipratropium (atropine derivatives), or any component of either product.

SPIRIVA 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.

SPIRIVA HandiHaler should be used with caution in patients with severe hypersensitivity to milk proteins.

SPIRIVA 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, prostatic hyperplasia or bladder-neck obstruction occur.

Since dizziness and blurred vision may occur with the use of SPIRIVA, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery.

Patients with moderate to severe renal impairment (creatinine clearance of ≤50 mL/min for SPIRIVA HandiHaler and creatinine clearance of <60 mL/min for SPIRIVA RESPIMAT) and treated with SPIRIVA should be monitored closely for anticholinergic side effects.

SPIRIVA may interact additively with concomitantly used anticholinergic medications. Avoid coadministration with other anticholinergic-containing drugs.

The most common adverse reactions >5% incidence and exceeded placebo by ≥1% with SPIRIVA HandiHaler (placebo) were upper respiratory tract infection 41% (37%), dry mouth 16% (3%), sinusitis 11% (9%), pharyngitis 9% (7%), non-specific chest pain 7% (5%), urinary tract infection 7% (5%), dyspepsia 6% (5%), and rhinitis 6% (5%). In addition, the most common reported adverse reaction ≥3% incidence and higher than placebo from the 4-year trial with SPIRIVA HandiHaler (placebo) not included above were headache 5.7% (4.5%), depression 4.4% (3.3%), insomnia 4.4% (3.0%), and arthralgia 4.2% (3.1%).

The most common adverse reactions >3% incidence and higher than placebo with SPIRIVA RESPIMAT (placebo) were pharyngitis 11.5% (10.1%), cough 5.8% (5.5%), dry mouth 4.1% (1.6%), and sinusitis 3.1% (2.7%).

SPIRIVA capsules should not be swallowed and should only be inhaled through the mouth (oral inhalation) using the HandiHaler device and the HandiHaler device should not be used for administering other medications.

Inform patients not to spray SPIRIVA RESPIMAT into the eyes as this may cause blurring of vision and pupil dilation.

INDICATION

SPIRIVA HandiHaler and SPIRIVA RESPIMAT are 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.

Please see full Prescribing Information for SPIRIVA RESPIMAT and SPIRIVA HandiHaler, including Instructions for Use.