FAQs

faqs

STIOLTO-SPIRIVA

Hospital to Home FAQs

FAQs

1. After I enroll my patient into the Hospital to Home program, what will they receive? 

Your patient will receive the following:

  • Free 30-day supply of prescribed COPD medication via a printable voucher. This voucher is not applicable for patients prescribed SPIRIVA HANDIHALER. If SPIRIVA HANDIHALER is prescribed at discharge, a separate process using a mail-order pharmacy is required. Please download and complete this form and fax to 877-816-5528.

  • Hospital to Home Welcome Kit with detailed educational information to help your patient understand COPD, including what to expect with their medication, and how to use the inhaler. These resources will be sent to your patient's shipping address.

2. When should I enroll my patient in the Hospital to Home program? 

It is recommended to enroll your patient early to ensure that their Hospital to Home Welcome Kit arrives when they return home. For admitted patients, enrollment should occur 2-3 days prior to discharge. If your patient is discharged on the same day as admission, enrollment should occur as soon as possible.

3. How many times is my patient eligible to participate in the Hospital to Home program? 

Patients are eligible to participate in the program once per lifetime per medication.

4. Does my patient need to be prescribed one of the program's COPD medications inpatient to be enrolled in the program at discharge? 

No. As long as your patient is prescribed one of the COPD program medications at discharge, they can be enrolled in Hospital to Home.

5. Can the 30-day free medication voucher be filled at my health system's outpatient pharmacy? 

Yes. You can also give the voucher to your patient to fill at their selected pharmacy. Please note: this voucher is not applicable for patients prescribed SPIRIVA HANDIHALER. Once prescribed SPIRIVA HANDIHALER and enrolled, your patient will receive a free 30-day supply of medication at the address provided at enrollment.

6. Can I enroll my discharged patients on SPIRIVA® HANDIHALER® (tiotropium bromide inhalation powder) in the Hospital to Home program? 

Yes, you may enroll your patients on SPIRIVA HANDIHALER here. After enrollment is completed, patients will receive their medication and educational materials in the mail.

7. Can I still enroll my discharged patients who are prescribed SPIRIVA® RESPIMAT® (tiotropium bromide) inhalation spray for asthma? 

No. At this time, the Hospital to Home program is only offered to COPD patients prescribed STIOLTO RESPIMAT, SPIRIVA RESPIMAT, or SPIRIVA HANDIHALER.

8. Can I photocopy or print multiple vouchers at once? 

No. Since each voucher comes with a unique code, only one can be used per patient. After you complete the enrollment process, please be sure to print the voucher provided for each patient.

ISI Accordian

ISI Mobile Tabs

INDICATION for STIOLTO RESPIMAT

STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray is a combination of tiotropium, an anticholinergic, and olodaterol, a long-acting beta2-adrenergic agonist (LABA), indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Important Limitations of Use

STIOLTO is NOT indicated to treat acute deterioration of COPD and is not indicated to treat asthma.

IMPORTANT SAFETY INFORMATION for STIOLTO RESPIMAT
CONTRAINDICATION

Use of a LABA, including STIOLTO RESPIMAT, without an inhaled corticosteroid (ICS) is contraindicated in patients with asthma.

STIOLTO is contraindicated in patients with hypersensitivity to tiotropium, ipratropium (atropine derivatives), olodaterol, or any component of this product.

In clinical trials and postmarketing experience with tiotropium, immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported. Hypersensitivity reactions were also reported in clinical trials with STIOLTO.

WARNINGS AND PRECAUTIONS

LABA as monotherapy (without an ICS), for asthma increases the risk of asthma-related death, and in pediatric and adolescent patients, increases the risk of asthma-related hospitalizations.

Do not initiate STIOLTO in patients with acutely deteriorating COPD, which may be a life-threatening condition, or used as rescue therapy for acute symptoms. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.

STIOLTO should not be used more often or at higher doses than recommended, or with other LABAs as an overdose may result.

If immediate hypersensitivity reactions occur, such as urticaria, angioedema, rash, bronchospasm, anaphylaxis, or itching, discontinue STIOLTO at once and consider alternative treatment. Patients with a history of hypersensitivity reactions to atropine or its derivatives should be closely monitored for similar hypersensitivity reactions to STIOLTO.

If paradoxical bronchospasm occurs, discontinue STIOLTO immediately and institute alternative therapy.

STIOLTO can produce a clinically significant cardiovascular effect in some patients, as measured by increases in pulse rate, systolic or diastolic blood pressure, and/or symptoms. If such effects occur, STIOLTO may need to be discontinued.

Use caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, in patients with known or suspected prolongation of the QT interval, and in patients who are unusually responsive to sympathomimetic amines.

Use with caution in patients with narrow-angle glaucoma. Instruct patients to contact a physician immediately if signs or symptoms of acute narrow-angle glaucoma develop.

Use with caution in patients with urinary retention 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 <60 mL/min) should be monitored closely for anticholinergic side effects.

Be alert to hypokalemia and hyperglycemia.

DRUG INTERACTIONS

The most common adverse reactions with STIOLTO (>3% incidence and higher than an active control) were: nasopharyngitis, 12.4% (11.7%/12.6%), cough, 3.9% (4.4%/3.0%), and back pain, 3.6% (1.8%/3.4%).

DRUG INTERACTIONS
  • Use caution if administering adrenergic drugs because sympathetic effects of olodaterol may be potentiated.
  • Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of olodaterol.
  • Use with caution in patients taking non–potassium-sparing diuretics, as the ECG changes and/or hypokalemia may worsen with concomitant beta-agonists.
  • The action of adrenergic agents on the cardiovascular system may be potentiated by monoamine oxidase inhibitors or tricyclic antidepressants or other drugs known to prolong the QTc interval. Therefore, STIOLTO should be used with extreme caution in patients being treated with these drugs. Use beta-blockers with caution as they not only block the therapeutic effects of beta-agonists, but may produce severe bronchospasm in patients with COPD.
  • Avoid co-administration of STIOLTO with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.

STIOLTO is for oral inhalation only.

The STIOLTO cartridge is only intended for use with the STIOLTO RESPIMAT inhaler.

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

CL-STO-100021 6.5.2019

INDICATIONS and IMPORTANT SAFETY INFORMATION for SPIRIVA RESPIMAT and SPIRIVA HANDIHALER (tiotropium bromide inhalation powder)
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 RESPIMAT, 1.25 mcg, is a bronchodilator indicated for the long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older.

SPIRIVA is not indicated for relief of acute bronchospasm.

IMPORTANT SAFETY INFORMATION

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 and should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. In the event of an attack, a rapid-acting beta2-agonist should be used.

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 <60 mL/min) and treated with SPIRIVA should be monitored closely for anticholinergic side effects.

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%).

The most common adverse reactions >2% incidence and higher than placebo with SPIRIVA RESPIMAT (placebo) in asthma trials in adults were pharyngitis 15.9% (12.4%), headache 3.8% (2.7%), bronchitis 3.3% (1.4%), and sinusitis 2.7% (1.4%). The adverse reaction profile for adolescent and pediatric patients was comparable to that observed in adult patients with asthma.

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%).

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. 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.

CL-SVR-0045 2.15.2017

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

 
INDICATION for STIOLTO RESPIMAT

STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray is a combination of tiotropium, an anticholinergic, and olodaterol, a long-acting beta2-adrenergic agonist (LABA), indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Important Limitations of Use

STIOLTO is NOT indicated to treat acute deterioration of COPD and is not indicated to treat asthma.

IMPORTANT SAFETY INFORMATION for STIOLTO RESPIMAT
CONTRAINDICATION

Use of a LABA, including STIOLTO RESPIMAT, without an inhaled corticosteroid (ICS) is contraindicated in patients with asthma.

STIOLTO is contraindicated in patients with hypersensitivity to tiotropium, ipratropium (atropine derivatives), olodaterol, or any component of this product.

In clinical trials and postmarketing experience with tiotropium, immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported. Hypersensitivity reactions were also reported in clinical trials with STIOLTO.

WARNINGS AND PRECAUTIONS

LABA as monotherapy (without an ICS), for asthma increases the risk of asthma-related death, and in pediatric and adolescent patients, increases the risk of asthma-related hospitalizations.

Do not initiate STIOLTO in patients with acutely deteriorating COPD, which may be a life-threatening condition, or used as rescue therapy for acute symptoms. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.

STIOLTO should not be used more often or at higher doses than recommended, or with other LABAs as an overdose may result.

If immediate hypersensitivity reactions occur, such as urticaria, angioedema, rash, bronchospasm, anaphylaxis, or itching, discontinue STIOLTO at once and consider alternative treatment. Patients with a history of hypersensitivity reactions to atropine or its derivatives should be closely monitored for similar hypersensitivity reactions to STIOLTO.

If paradoxical bronchospasm occurs, discontinue STIOLTO immediately and institute alternative therapy.

STIOLTO can produce a clinically significant cardiovascular effect in some patients, as measured by increases in pulse rate, systolic or diastolic blood pressure, and/or symptoms. If such effects occur, STIOLTO may need to be discontinued.

Use caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, in patients with known or suspected prolongation of the QT interval, and in patients who are unusually responsive to sympathomimetic amines.

Use with caution in patients with narrow-angle glaucoma. Instruct patients to contact a physician immediately if signs or symptoms of acute narrow-angle glaucoma develop.

Use with caution in patients with urinary retention 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 <60 mL/min) should be monitored closely for anticholinergic side effects.

Be alert to hypokalemia and hyperglycemia.

DRUG INTERACTIONS

The most common adverse reactions with STIOLTO (>3% incidence and higher than an active control) were: nasopharyngitis, 12.4% (11.7%/12.6%), cough, 3.9% (4.4%/3.0%), and back pain, 3.6% (1.8%/3.4%).

DRUG INTERACTIONS
  • Use caution if administering adrenergic drugs because sympathetic effects of olodaterol may be potentiated.
  • Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of olodaterol.
  • Use with caution in patients taking non–potassium-sparing diuretics, as the ECG changes and/or hypokalemia may worsen with concomitant beta-agonists.
  • The action of adrenergic agents on the cardiovascular system may be potentiated by monoamine oxidase inhibitors or tricyclic antidepressants or other drugs known to prolong the QTc interval. Therefore, STIOLTO should be used with extreme caution in patients being treated with these drugs. Use beta-blockers with caution as they not only block the therapeutic effects of beta-agonists, but may produce severe bronchospasm in patients with COPD.
  • Avoid co-administration of STIOLTO with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.

STIOLTO is for oral inhalation only.

The STIOLTO cartridge is only intended for use with the STIOLTO RESPIMAT inhaler.

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

CL-STO-100021 6.5.2019

INDICATIONS and IMPORTANT SAFETY INFORMATION for SPIRIVA RESPIMAT and SPIRIVA HANDIHALER (tiotropium bromide inhalation powder)
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 RESPIMAT, 1.25 mcg, is a bronchodilator indicated for the long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older.

SPIRIVA is not indicated for relief of acute bronchospasm.

IMPORTANT SAFETY INFORMATION

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 and should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. In the event of an attack, a rapid-acting beta2-agonist should be used.

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 <60 mL/min) and treated with SPIRIVA should be monitored closely for anticholinergic side effects.

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%).

The most common adverse reactions >2% incidence and higher than placebo with SPIRIVA RESPIMAT (placebo) in asthma trials in adults were pharyngitis 15.9% (12.4%), headache 3.8% (2.7%), bronchitis 3.3% (1.4%), and sinusitis 2.7% (1.4%). The adverse reaction profile for adolescent and pediatric patients was comparable to that observed in adult patients with asthma.

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%).

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. 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.

CL-SVR-0045 2.15.2017

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

indicationISI

INDICATION for STIOLTO RESPIMAT

STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray is a combination of tiotropium, an anticholinergic, and olodaterol, a long-acting beta2-adrenergic agonist (LABA), indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Important Limitations of Use

STIOLTO is NOT indicated to treat acute deterioration of COPD and is not indicated to treat asthma.

Important safety information for STIOLTO RESPIMAT

CONTRAINDICATION

Use of a LABA, including STIOLTO RESPIMAT, without an inhaled corticosteroid (ICS) is contraindicated in patients with asthma.

STIOLTO is contraindicated in patients with hypersensitivity to tiotropium, ipratropium (atropine derivatives), olodaterol, or any component of this product.

In clinical trials and postmarketing experience with tiotropium, immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported. Hypersensitivity reactions were also reported in clinical trials with STIOLTO.

WARNINGS AND PRECAUTIONS

LABA as monotherapy (without an ICS), for asthma increases the risk of asthma-related death, and in pediatric and adolescent patients, increases the risk of asthma-related hospitalizations.

Do not initiate STIOLTO in patients with acutely deteriorating COPD, which may be a life-threatening condition, or used as rescue therapy for acute symptoms. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.

STIOLTO should not be used more often or at higher doses than recommended, or with other LABAs as an overdose may result.

If immediate hypersensitivity reactions occur, such as urticaria, angioedema, rash, bronchospasm, anaphylaxis, or itching, discontinue STIOLTO at once and consider alternative treatment. Patients with a history of hypersensitivity reactions to atropine or its derivatives should be closely monitored for similar hypersensitivity reactions to STIOLTO.

If paradoxical bronchospasm occurs, discontinue STIOLTO immediately and institute alternative therapy.

STIOLTO can produce a clinically significant cardiovascular effect in some patients, as measured by increases in pulse rate, systolic or diastolic blood pressure, and/or symptoms. If such effects occur, STIOLTO may need to be discontinued.

Use caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, in patients with known or suspected prolongation of the QT interval, and in patients who are unusually responsive to sympathomimetic amines.

Use with caution in patients with narrow-angle glaucoma. Instruct patients to contact a physician immediately if signs or symptoms of acute narrow-angle glaucoma develop.

Use with caution in patients with urinary retention 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 <60 mL/min) should be monitored closely for anticholinergic side effects.

Be alert to hypokalemia and hyperglycemia.

ADVERSE REACTIONS

The most common adverse reactions with STIOLTO (>3% incidence and higher than an active control) were: nasopharyngitis, 12.4% (11.7%/12.6%), cough, 3.9% (4.4%/3.0%), and back pain, 3.6% (1.8%/3.4%).

DRUG INTERACTIONS

  • Use caution if administering adrenergic drugs because sympathetic effects of olodaterol may be potentiated.
  • Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of olodaterol.
  • Use with caution in patients taking non–potassium-sparing diuretics, as the ECG changes and/or hypokalemia may worsen with concomitant beta-agonists.
  • The action of adrenergic agents on the cardiovascular system may be potentiated by monoamine oxidase inhibitors or tricyclic antidepressants or other drugs known to prolong the QTc interval. Therefore, STIOLTO should be used with extreme caution in patients being treated with these drugs. Use beta-blockers with caution as they not only block the therapeutic effects of beta-agonists, but may produce severe bronchospasm in patients with COPD.
  • Avoid co-administration of STIOLTO with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.

STIOLTO is for oral inhalation only.

The STIOLTO cartridge is only intended for use with the STIOLTO RESPIMAT inhaler.

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

CL-STO-100021 6.5.2019

INDICATIONS and IMPORTANT SAFETY INFORMATION for SPIRIVA RESPIMAT and SPIRIVA HANDIHALER (tiotropium bromide inhalation powder)

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 RESPIMAT, 1.25 mcg, is a bronchodilator indicated for the long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older.

SPIRIVA is not indicated for relief of acute bronchospasm.

IMPORTANT SAFETY INFORMATION

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 and should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. In the event of an attack, a rapid-acting beta2-agonist should be used.

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 <60 mL/min) and treated with SPIRIVA should be monitored closely for anticholinergic side effects.

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%).

The most common adverse reactions >2% incidence and higher than placebo with SPIRIVA RESPIMAT (placebo) in asthma trials in adults were pharyngitis 15.9% (12.4%), headache 3.8% (2.7%), bronchitis 3.3% (1.4%), and sinusitis 2.7% (1.4%). The adverse reaction profile for adolescent and pediatric patients was comparable to that observed in adult patients with asthma.

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%).

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. 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.

CL-SVR-0045 2.15.2017