VIATRIS PODMANAGER® Application Privacy Policy

Last Updated:  August 20, 2020

 

This Privacy Policy (the “Policy”) describes how, if you use the PODMANAGER software application (the “PODMANAGER app”) on your mobile device, information about you will be collected, used and shared by the PODMANAGER app and by its developer, Mylan Specialty L.P., a Viatris Company  (“Viatris” or “we” or “us”).   

To use the PODMANAGER app, you must agree to the app’s Terms of Service.

We may update this Policy at any time. Any changes to the Policy will become effective upon the date of our posting of the revised Policy on the PODMANAGER app. If you use the PODMANAGER app following the effective date of the revised Policy, you will be deemed to have accepted the Policy’s updated terms.

I.    What Types of Information Does the PODMANAGER App Collect From Users?

Almost all of the information collected about you by the PODMANAGER app (“Your Information”) is information that you, if you use the app, actively provide. In order to use the PODMANAGER app, you must provide your first and last name, email address and age, and you may also provide your gender and zip code. 

To use the PODMANAGER app to schedule and monitor your Medication, you will need to upload a dosing schedule to the app. Viatris does not collect this information; your adherence-related information remains in your device unless you choose to upload it to your iCloud or Google cloud. If you are a resident of California, please note that you must authorize Viatris to allow you to share that information with your iCloud of Google cloud as described below.

The PODMANAGER app also automatically collects some information from your device onto which you download the app, including the location of your device if you enable location-tracking by the app. You will need to enable location-tracking in order to obtain an air quality index (“AQI”) score for the location where you are when you use the app, as described further in Sections II and III below.  

II.    How Is Your Information Used?

There are different uses for the different types of information collected by the PODMANAGER app:

  • To Communicate AQI Scores to You. The PODMANAGER app provides a built-in AQI monitor that provides you with a range of AQI values for your location, and signals to you whether those values indicate a moderate health concern or very unhealthy air quality. The app uses the location of your device to send you this information (and this is the only use of your location information by the app or Viatris).
  • To Anticipate Your Needs. Viatris collects your and other PODMANAGER app users’ name, gender, zip code and age so that Viatris may understand the demographics of users of the PODMANAGER app and anticipate what information you and other app users might want to receive from us. 
  • To Communicate With You. Viatris may use your email address to send you notices or other information that we believe may be of interest to you, including information about our research, product development, product specifications, programs, or services of possible interest. You may opt out of receiving any of our commercial (promotional) communications, as described in those communications.
  • To Help You With Dosage Scheduling and Adherence. The PODMANAGER App allows you to upload your Medication dosing schedule and adherence experience so that you can be alerted to your planned dosage dates and review your actual adherence to your dosage schedule. Viatris does not access this information from the app.
  • To Enhance Our Operations. We may use Your Information for Viatris’ internal business purposes, such as to help us improve the PODMANAGER app, including by requesting feedback, and for related purposes such as data analysis, audits, and identifying usage trends.

III.    With Whom Is Your Information Shared?

Viatris shares Your Information on a very limited basis, as described below. We do not share Your Information with unaffiliated third parties for their own marketing purposes.

 

Air Quality Index Provider. To provide you with the AQI scores described above, the PODMANAGER app shares the location of your device with an application programming interface (“API”) maintained by ClimaCell, Inc., which automatically checks the air quality of that location and sends the location’s AQI score to your device. Viatris has bound ClimaCell not to use the location information of PODMANAGER app users for any purpose other than to transmit AQI scores to such users’ devices.

Other Service Providers. Viatris may in the future share Your Information with third parties who provide us with other services, such as technology assistance, data analysis, or similar services. 

Affiliates. We may share Your Information with our affiliates, on a need-to-know basis.

Acquirers or Assignees. In the event of a planned or completed  reorganization, merger, sale, joint venture, assignment, transfer or other disposition of all or any portion of Viatris or its assets, we may transfer any and all information that we collect from PODMANAGER app users to the acquiring party or assignee. We cannot guarantee that such acquiring party or assignee will handle Your Information under the same terms as those set forth in this Policy.

Entities Entitled Under Law. We may disclose Your Information as we believe appropriate in the following circumstances: (i) when required by applicable law, including laws outside your country of residence; (ii) to comply with legal process (iii) to respond to requests from public and government authorities; (iv) to enforce the terms and conditions for use of the PODMANAGER app, including this Policy; (v) to protect and defend our rights and property; (vi) to protect the interests of Viatris or others; and (vii) to permit us to pursue available remedies or limit the damages that we may sustain. We have no obligation to notify you of such disclosures except as required by applicable law.

As noted, as a user of the app, you have the option to upload (and thereby disclose) your adherence data to your iCloud or Google cloud, but Viatris does not access that data and therefore does not share it with others. You can choose to download that information and share it with others should You choose to do so. If you are a resident of California, please note that you must authorize Viatris to allow you to share that information with your iCloud of Google cloud as described below.

IV.    How Can You Manage Your Information That We Maintain?

To help keep Your Information accurate, current, and complete, please contact us as specified in Section VIII below. We will take reasonable steps to update or correct Your Information in our possession that you have submitted via the PODMANAGER app.

V.    How Does Viatris Protect Your Information?

We will take reasonable steps to protect the security of Your Information and to protect it from loss, misuse, and unauthorized access, disclosure, alteration, or destruction. You should be aware that no Internet transmission is ever fully secure or error-free. In particular, e-mail transmissions may not be secure, and you should therefore take special care in deciding what information you send to us via e-mail.

VI.    Use of the PODMANAGER App by Children. The PODMANAGER app is not directed to children under the age of thirteen (13), and we do not knowingly collect information from any children under age 13. If we discover that we have obtained personal information from a child under age 13, we will delete it. 

VII.    International Transfers of Information. By using the PODMANAGER app, you are deemed to understand and unambiguously consent to the collection and processing of Your Information in the United States, with the awareness that the laws of the United States may not provide as much protection for information as the laws of certain other countries or territories.

VIII.    Contacting Us. If you have any questions or concerns related to this Privacy Policy or the information practices of this PODMANAGER app, please contact us at:

Mylan Specialty L.P., a Viatris Company

Attn:  Head of Global Privacy

1000 Mylan Boulevard

Canonsburg, PA 15317

Phone:  1-724-514-1800

Email:  dataprivacy@viatris.com

FOR CALIFORNIA RESIDENTS:  ADDITIONAL AUTHORIZATION FOR USE AND DISCLOSURE OF PERSONAL HEALTH INFORMATION SHOULD YOU CHOOSE

 

As described above, you have the option to backup and store information you enter into the PODMANAGER app into your iCloud or Google Cloud. If you choose to do so, by clicking on the “Export” button on the “Export/Import Data” page, I authorize Viatris to use and disclose the information I provide through the PODMANAGER app to backup and export your data to your iCloud or Google Cloud. I understand this Authorization will remain in effect for thirty (30) years from the date I click on the “Export” button, unless I send a notice withdrawing my agreement before then to Mylan Specialty L.P., a Viatris Company, 1000 Mylan Boulevard, Canonsburg, PA 15317. I understand that I have the right to receive a copy of this Authorization. I understand that I cannot agree to this authorization on behalf of another person and that the PODMANAGER app is not intended for children under the age of 13.

 

 

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INDICATION

TOBI® PODHALER® (Tobramycin Inhalation Powder) 28 mg per capsule is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.

Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) <25% or >80% predicted, or patients colonized with Burkholderia cepacia.

IMPORTANT SAFETY INFORMATION

TOBI PODHALER is contraindicated in patients with known hypersensitivity to any aminoglycoside.

Bronchospasm can occur with inhalation of TOBI PODHALER. Bronchospasm should be treated as medically appropriate.

Caution should be exercised when prescribing TOBI PODHALER to patients with known or suspected auditory, vestibular, renal, or neuromuscular dysfunction.

Ototoxicity, as measured by complaints of hearing loss or tinnitus, was reported by patients in the TOBI PODHALER clinical studies. Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution. Ototoxicity, manifested as both auditory and vestibular toxicity, has been reported with parenteral aminoglycosides. Vestibular toxicity may be manifested by vertigo, ataxia, or dizziness.

Cases of ototoxicity with aminoglycosides have been observed in patients with certain variants in the mitochondrially encoded 12S rRNA gene (MT-RNR1), particularly the m.1555A>G variant. Ototoxicity occurred in some patients even when their aminoglycoside serum levels were within the recommended range. Mitochondrial DNA variants are present in less than 1% of the general US population, and the proportion of the variant carriers who may develop ototoxicity as well as the severity of ototoxicity is unknown. In case of known maternal history of ototoxicity due to aminoglycoside use or a known mitochondrial DNA variant in the patient, consider alternative treatments other than aminoglycosides unless the increased risk of permanent hearing loss is outweighed by the severity of infection and lack of safe and effective alternative therapies.

Caution should be exercised when prescribing TOBI PODHALER to patients with known or suspected renal dysfunction. Nephrotoxicity was not observed during TOBI PODHALER clinical studies but has been associated with aminoglycosides as a class.

TOBI PODHALER should be used cautiously in patients with neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease, since aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function.

Aminoglycosides can cause fetal harm when administered to a pregnant woman. Patients who use TOBI PODHALER during pregnancy, or who become pregnant while taking TOBI PODHALER, should be apprised of the potential hazard to the fetus. The amount of tobramycin excreted in human breast milk is unknown. However, systemic absorption of tobramycin following inhaled administration is expected to be minimal. A decision should be made whether to discontinue nursing or TOBI PODHALER. TOBI may cause intestinal flora alteration. Advise a woman to monitor the breastfed infant for loose or bloody stools and candidiasis.

Patients receiving concomitant TOBI and parenteral aminoglycoside therapy should be monitored as clinically appropriate for toxicities associated with aminoglycosides as a class. Serum tobramycin levels should be monitored.

Concurrent and/or sequential use of TOBI PODHALER with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided. Some diuretics can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. TOBI PODHALER should not be administered concomitantly with ethacrynic acid, furosemide, urea, or mannitol.

In a clinical trial, the most commonly observed adverse events with TOBI PODHALER occurring at a frequency of at least 10%, were cough, lung disorder, productive cough, dyspnea, pyrexia, oropharyngeal pain, dysphonia, hemoptysis, and headache.

Please see Full Prescribing Information

INDICATION

TOBI® PODHALER® (Tobramycin Inhalation Powder) 28 mg per capsule is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.

Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) <25% or >80% predicted, or patients colonized with Burkholderia cepacia.

IMPORTANT SAFETY INFORMATION

TOBI PODHALER is contraindicated in patients with known hypersensitivity to any aminoglycoside.

Bronchospasm can occur with inhalation of TOBI PODHALER. Bronchospasm should be treated as medically appropriate.

Caution should be exercised when prescribing TOBI PODHALER to patients with known or suspected auditory, vestibular, renal, or neuromuscular dysfunction.

Ototoxicity, as measured by complaints of hearing loss or tinnitus, was reported by patients in the TOBI PODHALER clinical studies. Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution. Ototoxicity, manifested as both auditory and vestibular toxicity, has been reported with parenteral aminoglycosides. Vestibular toxicity may be manifested by vertigo, ataxia, or dizziness.

Cases of ototoxicity with aminoglycosides have been observed in patients with certain variants in the mitochondrially encoded 12S rRNA gene (MT-RNR1), particularly the m.1555A>G variant. Ototoxicity occurred in some patients even when their aminoglycoside serum levels were within the recommended range. Mitochondrial DNA variants are present in less than 1% of the general US population, and the proportion of the variant carriers who may develop ototoxicity as well as the severity of ototoxicity is unknown. In case of known maternal history of ototoxicity due to aminoglycoside use or a known mitochondrial DNA variant in the patient, consider alternative treatments other than aminoglycosides unless the increased risk of permanent hearing loss is outweighed by the severity of infection and lack of safe and effective alternative therapies.

Caution should be exercised when prescribing TOBI PODHALER to patients with known or suspected renal dysfunction. Nephrotoxicity was not observed during TOBI PODHALER clinical studies but has been associated with aminoglycosides as a class.

TOBI PODHALER should be used cautiously in patients with neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease, since aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function.

Aminoglycosides can cause fetal harm when administered to a pregnant woman. Patients who use TOBI PODHALER during pregnancy, or who become pregnant while taking TOBI PODHALER, should be apprised of the potential hazard to the fetus. The amount of tobramycin excreted in human breast milk is unknown. However, systemic absorption of tobramycin following inhaled administration is expected to be minimal. A decision should be made whether to discontinue nursing or TOBI PODHALER. TOBI may cause intestinal flora alteration. Advise a woman to monitor the breastfed infant for loose or bloody stools and candidiasis.

Patients receiving concomitant TOBI and parenteral aminoglycoside therapy should be monitored as clinically appropriate for toxicities associated with aminoglycosides as a class. Serum tobramycin levels should be monitored.

Concurrent and/or sequential use of TOBI PODHALER with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided. Some diuretics can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. TOBI PODHALER should not be administered concomitantly with ethacrynic acid, furosemide, urea, or mannitol.

In a clinical trial, the most commonly observed adverse events with TOBI PODHALER occurring at a frequency of at least 10%, were cough, lung disorder, productive cough, dyspnea, pyrexia, oropharyngeal pain, dysphonia, hemoptysis, and headache.

Please see Full Prescribing Information