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, or any component of either product. Immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported.

SPIRIVA is intended as a once-daily maintenance treatment for COPD and should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm.

Immediate hypersensitivity reactions, including urticaria, angioedema (swelling of lips, tongue, or throat), rash, bronchospasm, anaphylaxis, or itching may occur after administration of SPIRIVA. If such a reaction occurs, discontinue SPIRIVA at once and consider alternative treatments. Given the similar structural formula of atropine to tiotropium, patients with a history of hypersensitivity reactions to atropine or its derivatives 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.

Inhaled medicines, including SPIRIVA, may cause paradoxical bronchospasm. If this occurs, it should be treated with an inhaled short-acting beta2-agonist such as albuterol. Treatment with SPIRIVA should be stopped and other treatments considered.

SPIRIVA 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.

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.

SPIRIVA 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.

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.

The most common adverse reactions >5% incidence and exceeded placebo by ≥1% with SPIRIVA HandiHaler (placebo) in COPD trials 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) in COPD trials were pharyngitis 11.5% (10.1%), cough 5.8% (5.5%), dry mouth 4.1% (1.6%), and sinusitis 3.1% (2.7%).

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

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.

INDICATIONS

SPIRIVA RESPIMAT, 2.5 mcg, and SPIRIVA HandiHaler 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.

SPIRIVA is not indicated for relief of acute bronchospasm.

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; 2015.
  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.
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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, or any component of either product. Immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported.

SPIRIVA is intended as a once-daily maintenance treatment for COPD and should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm.

Immediate hypersensitivity reactions, including urticaria, angioedema (swelling of lips, tongue, or throat), rash, bronchospasm, anaphylaxis, or itching may occur after administration of SPIRIVA. If such a reaction occurs, discontinue SPIRIVA at once and consider alternative treatments. Given the similar structural formula of atropine to tiotropium, patients with a history of hypersensitivity reactions to atropine or its derivatives 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.

Inhaled medicines, including SPIRIVA, may cause paradoxical bronchospasm. If this occurs, it should be treated with an inhaled short-acting beta2-agonist such as albuterol. Treatment with SPIRIVA should be stopped and other treatments considered.

SPIRIVA 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.

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.

SPIRIVA 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.

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.

The most common adverse reactions >5% incidence and exceeded placebo by ≥1% with SPIRIVA HandiHaler (placebo) in COPD trials 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) in COPD trials were pharyngitis 11.5% (10.1%), cough 5.8% (5.5%), dry mouth 4.1% (1.6%), and sinusitis 3.1% (2.7%).

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

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.

INDICATIONS

SPIRIVA RESPIMAT, 2.5 mcg, and SPIRIVA HandiHaler 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.

SPIRIVA is not indicated for relief of acute bronchospasm.

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