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The goal of the Adasuve REMS is to mitigate the risk of negative outcomes (respiratory distress or respiratory arrest) associated
with Adasuve induced bronchospasm by:
Ensuring that Adasuve is dispensed only in certified healthcare settings that have:
immediate access on site to supplies and healthcare professionals competent
in the management of acute bronchospasm and access to emergency assistance for symptoms that require immediate attention. Healthcare settings must have a short-acting bronchodilator
(e.g. albuterol), for the immediate treatment of bronchospasm; this shortacting bronchodialter can be delivered by inhaler (with spacer) or nebulizer.
Processes and procedures to ensure that patients are screened for conditions for which
Adasuve is contraindicated and monitored for signs of bronchospasms.
What do participants need to know?
Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.
Have immediate access to supplies and personnel onsite competent in the management of acute bronchospasm including: a short-acting
bronchodilator (e.g., albuterol), delivered by inhaler (with spacer) or nebulizer, and access to emergency assistance for symptoms that
require immediate medical attention.
Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS
Program on behalf of the healthcare setting.
Have the authorized representative enroll in the REMS Program by completing the Healthcare Settings Enrollment Form and submitting it
to the REMS Program.
| Healthcare Setting Information and Enrollment Form |
Establish processes and procedures to verify (1) the patient is assessed for respiratory abnormalities before administration (by
medical history, medication history, and chest auscultation), (2) the patient is assessed for a minimum of 1 hour after administration for
bronchospasm, (3) no more than a single dose of ADASUVE is administered within a 24-hour period, (4) ADASUVE is not dispensed outside of the certified healthcare setting.
Before administering
Assess the patient’s health status for a current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD) or other lung
disease associated with bronchospasm, acute respiratory signs/symptoms (e.g. wheezing), and current use of medications to treat airway disease such as asthma or COPD.
Assess the patient’s health status for respiratory abnormalities by chest auscultation.
After administering, for a minimum of 1 hour
Assess the patient’s health status for signs and symptoms of bronchospasm.
During treatment, within a 24-hour period
Dispense no more than a single dose per patient.
To maintain certification to dispense
Have any new Authorized Representative enroll in the REMS Program by completing the Healthcare Setting Enrollment Form and
submitting to the REMS Program.
| Healthcare Setting Information and Enrollment Form |
At all times
Not dispense ADASUVE for use outside of the certified healthcare setting.
Report any adverse events of bronchospasm that occur following ADASUVE treatment to the REMS Program.
Not distribute, transfer, loan or sell ADASUVE.
Maintain appropriate documentation that all processes and procedures are being followed for the Adasuve REMS Program.
Comply with audits by Alexza Pharmaceuticals, Inc., or a third party acting on behalf of Alexza Pharmaceuticals, Inc. to ensure that all
processes and procedures are in place and are being followed.
Patients who are prescribed ADASUVE:
Before treatment initiation
Be monitored for signs and symptoms of breathing problems.
Complete a medical history and medication history with the prescriber.
During treatment; for at least 1 hour
Be monitored for signs and symptoms of bronchospasm.
Wholesalers-distributors that distribute ADASUVE must:
To be able to distribute
Establish processes and procedures to ensure that the drug is distributed only to certified healthcare settings.
Train all relevant staff involved in distributing ADASUVE.
At all times
Distribute only to certified healthcare settings.
Maintain records of distribution including all shipments of ADASUVE.
Comply with audits by Alexza Pharmaceuticals, Inc., or a third party acting on behalf of Alexza Pharmaceuticals, Inc. to ensure that all
processes and procedures are in place and being followed.
What materials are included in the REMS?
The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Adasuve REMS, see the DailyMed link(s).
REMS assessment plan unavailable for posting at this time.
What updates have been made to the REMS?
Date
Summary of change
01/27/2022
Modified to make the following changes:
adding that a short-acting bronchodilator (e.g., albuterol) by inhaler, with spacer,
is an acceptable option to treat bronchospasm caused by Adasuve
removal of the requirement to ensure all relevant staff are trained and replaced
with a requirement that the healthcare setting have processes and procedures to
ensure the safe use of Adasuve
removal of the every 15 minute monitoring requirement
removal of the need for post-dose chest auscultation
conversion of the REMS Document to the new standardized format
In addition, the REMS goal was modified to reflect the above changes.
10/10/2017
Revised to change the application holder's name or address.
10/19/2016
Revised to change the application holder’s name or address
09/28/2016
Modified to:
Change the goal of the Adasuve REMS.
Change the prescriber and healthcare setting attestations, and requirements for certified healthcare settings.
Update the REMS materials to reflect the supplies and personnel that a certified healthcare setting must now have available to manage acute bronchospasm.
Remove the communication plan as an element of the REMS.
update to reflect the change in ownership from Teva Pharmaceuticals to Alexza Pharmaceuticals, Inc.
clarify your (Alexza Pharmaceuticals, Inc.) responsibilities in the implementation system.
12/09/2013
Modified to document the change in ownership/address from Alexza Pharmaceuticals to Teva Pharmaceuticals.
12/21/2012
Approval of the REMS.
Disclaimer: This webpage provides general information about REMS programs
to various REMS participants (e.g., patients, pharmacies, and healthcare providers).
The summary information provided herein is not comprehensive and may not include
all of the information relevant to REMS participants. This webpage does not
constitute a replacement, modification, or revision of the approved REMS document,
including any appended REMS materials. Refer to the approved REMS document
for complete information on the REMS requirements for each approved application.
