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FILED: SUFFOLK COUNTY CLERK 01/23/2017 10:17 PM NYSE DOC. NO. 69INDEX NO. 613760/2016 RECEIVED NYSE: 01/23/2017 EXHIBIT Initial REMS approval: 12/2011 Most recent modification: 12/2014TRANSMUCOSAL
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How to fill out tirf rems
01
To fill out TIRF REMS, follow the steps below:
02
Obtain the patient's prescription for a TIRF medication.
03
Verify that the patient meets the FDA-approved indication and meets the criteria for TIRF REMS.
04
Access the TIRF REMS Access program website.
05
Enroll in the TIRF REMS Access program, if not already enrolled.
06
Complete the necessary training and education modules provided by the program.
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Provide the requested patient and prescriber information, including demographics, medical history, and current medications.
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Upload supporting documentation, if required.
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Review and submit the completed TIRF REMS form.
10
Await approval from the program.
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If approved, follow the instructions provided by the program for dispensing and monitoring the TIRF medication for the patient.
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Ensure ongoing compliance with the TIRF REMS program requirements.
Who needs tirf rems?
01
TIRF REMS is required for patients who are prescribed Transmucosal Immediate-Release Fentanyl (TIRF) medications.
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These medications are indicated for the management of breakthrough pain in adults with cancer who are already receiving and are tolerant to opioid therapy.
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Therefore, individuals with cancer who experience breakthrough pain and have already been prescribed and are tolerant to opioids may need TIRF REMS.
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