SPIRIVA RESPIMAT 1.25 mcg/puff—for uncontrolled asthma in patients ages 6 and older! OPEN

An expanded indication adds new expectations for SPIRIVA RESPIMAT—now for the treatment of asthma in patients ages 6 and older!

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Respimat Delivers

RESPIMAT® Is Designed for Improved Drug Delivery1–5

  • Lung deposition: The mist is comprised of highly respirable, small particle-sized droplets4,5
  • Inhalation effort: Unlike dry powder inhalers, RESPIMAT operates independent of inspiratory effort to help get medication deep into patients’ lungs1,3
  • Coordination: RESPIMAT may help facilitate actuation and inhalation4,5

As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. The duration of inspiration should be at least as long as the spray duration (1.5 seconds).6

View lung deposition data for RESPIMAT for Asthma
SPIRIVA RESPIMAT Inhaler Device for Asthma and COPD Maintenance Treatment
SPIRIVA RESPIMAT Inhaler Device Video

See the RESPIMAT Inhaler in action

You and your patients can watch this video to learn more about the RESPIMAT mist.

Watch video

RESPIMAT delivers medication efficiently and effectively to the lungs and helps reduce oropharyngeal deposition1–5

Asthma: Dose deposition patient profile2*
SPIRIVA RESPIMAT Inhaler Dose Deposition Efficacy, Asthma and COPD

There is no correlation between deposition data and clinical efficacy. Active ingredients used in the studies are not commercially available in RESPIMAT. The specific physical–chemical characteristics of the drug may affect lung deposition.

*Data were collected from asthma patients. The images above are typical scintographic pictures, taken from a study patient, comparing drug deposition profiles. The percentage of dose deposition is the mean of 14 asthma study patients. Analysis of deposition in central, intermediate, and peripheral lung regions showed that deposition occurred in all 3 regions but was concentrated in the central lung region for Turbuhaler® to a greater extent than for RESPIMAT and Becloforte® (pressurized metered-dose inhaler [pMDI]). This was reflected in significantly (p<0.01) higher mean peripheral zone/central zone deposition ratios for RESPIMAT (1.34) and Becloforte (1.27) than for Turbuhaler with fast flow (0.95) or Turbuhaler with slow flow (0.82). The publisher for the copyrighted material is Mary Ann Liebert, Inc. publishers.2

All trademarks are the property of their respective owners.

How to use

Helping Your Patients Use SPIRIVA RESPIMAT

Preparing the Inhaler
for First-Time Use
  1. Remove clear base
    • Keep the cap closed.
    • Press the safety catch while firmly pulling off the clear base with your other hand. Be careful not to touch the piercing element.
    • Write the discard by date on the label (3 months from the date the cartridge is inserted).
  2. Insert cartridge
    • Insert the narrow end of the cartridge into the inhaler.
    • Place the inhaler on a firm surface and push down firmly until it clicks into place.
  3. Replace clear base
    • Put the clear base back into place until it clicks.
    • Do not remove the clear base or the cartridge after it has been put together.
  4. Turn
    • Keep the cap closed.
    • Turn the clear base in the direction of the arrows on the label until it clicks (half a turn).
  5. Open
    • Open the cap until it snaps fully open.
  6. Press
    • Point the inhaler toward the ground.
    • Press the dose-release button.
    • Close the cap.
    • If you do not see a mist, repeat steps 4 to 6 until a mist is seen.
    • After a mist is seen, repeat steps 4–6 three more times.
    • After complete preparation of your inhaler, it will be ready to deliver the number of puffs on the label.

3 steps for daily use

After preparing the device, patients can remember the steps for daily use with T.O.P.6 These steps must be repeated 2 times, once‑daily, to receive the full dose of medication.

SPIRIVA RESPIMAT Inhaler Dosing Instructions, Turn

Turn

  • Keep the cap closed
  • Turn the clear base in the direction of the arrows on the label until it clicks (half a turn)
SPIRIVA RESPIMAT Inhaler Dosing Instructions, Open

Open

  • Open the cap until it snaps fully open
SPIRIVA RESPIMAT Inhaler Dosing Instructions, Press

Press

  • Breathe out slowly and fully
  • Close your lips around the mouthpiece without covering the air vents
  • Point the inhaler to the back of your throat
  • While taking a slow, deep breath through your mouth, Press the dose-release button and continue to breathe in
  • Hold your breath for 10 seconds or for as long as comfortable
  • Repeat Turn, Open, Press (TOP) for a total of 2 puffs
  • Close the cap until you use your inhaler again
Watch our video for a demonstration

With SPIRIVA RESPIMAT,
remember to tell your patients

1 DOSE = 2 PUFFS ONCE DAILY6

SPIRIVA RESPIMAT Asthma-Specific Dosing

In the treatment of asthma, the maximum benefits in lung function may take up to 4 to 8 weeks of dosing.

Children should use SPIRIVA RESPIMAT with the help of an adult, as instructed by their physician.

For detailed instructions, patients should refer to the Instructions for Use enclosed with their prescription.

Note: SPIRIVA RESPIMAT should not be sprayed in the eyes as this may cause blurred vision and pupil dilation.

SPIRIVA RESPIMAT Inhaler, Dose Indicator

Dose Indicator

This dose indicator shows approximately how much medicine is left. When the dose indicator enters the red area of the scale, a refill is required; there is enough medicine for 7 days left (if your patient has a sample, there is enough medicine for 3 days left).6

Solutions Plus Patient Support Program, Asthma

Do Your Patients Need More Help Using SPIRIVA RESPIMAT?

For live support, patients can call Solutions Plus at 1-888-784-5415 Monday-Friday 8AM-8PM ET

Give your asthma patients the support they need

IMPORTANT SAFETY INFORMATION for SPIRIVA HANDIHALER and SPIRIVA RESPIMAT

SEE MORE

INDICATIONS

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 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.

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.

More Important Safety Information

Important Safety Information (continued)

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.

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

INDICATIONS

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 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.

IMPORTANT SAFETY INFORMATION for SPIRIVA HANDIHALER and SPIRIVA RESPIMAT

SEE MORE

INDICATIONS

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 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.

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.

More Important Safety Information

Important Safety Information (continued)

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.

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

INDICATIONS

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 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. Newman SP, Brown J, Steed KP, Reader SJ, Kladders H. Lung deposition of fenoterol and flunisolide delivered using a novel device for inhaled medicines: comparison of RESPIMAT with conventional metered-dose inhalers with and without spacer devices. Chest. 1998;113(4):957-963.
  2. Pitcairn G, Reader S, Pavia D, Newman S. Deposition of corticosteroid aerosol in the human lung by Respimat® Soft Mist™ Inhaler compared to deposition by metered dose inhaler or by Turbuhaler® Dry Powder Inhaler. J Aerosol Med. 2005;18(3):264-272.
  3. Brand P, Hederer B, Austen G, Dewberry H, Meyer T. Higher lung deposition with Respimat® Soft Mist™ Inhaler than HFA-MDI in COPD patients with poor technique. Int J COPD. 2008;3(4):763-770.
  4. Hochrainer D, Hölz H, Kreher C, Scaffildi L, Spallek M, Wachtel H. Comparison of the aerosol velocity and spray duration of Respimat® Soft Mist™ Inhaler and pressurized metered dose inhalers. J Aerosol Med. 2005;18(3):273-282.
  5. Dalby RN, Eicher J, Zierenberg B. Development of Respimat® Soft Mist™ Inhaler and its clinical utility in respiratory disorders. Med Devices (Auckl). 2011;4:145-155. doi:10.2147/MDER.S7409.
  6. SPIRIVA RESPIMAT [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2017.