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On March 26, Progressive Medical’s Friday Fast Facts alerted you to the release of Exalgo (extended-release hydromorphone HCl) for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.
Because Exalgo is an extended-release opioid product, the FDA has required the development of a Risk Evaluation and Mitigation Strategy (REMS) to ensure safe use of the product. Covidien, the manufacturer, has issued the finalized REMS, and the requirements for prescribing are:
1. Healthcare Professional (HCP) training on responsible Exalgo prescribing and use
2. Distribution of REMS educational materials to HCPs
3. Distribution of the Exalgo Medication Guide to patients and/or caregivers every time Exalgo is dispensed
Prior to prescribing this medication, physicians can review educational materials about the product that are available as part of the Exalgo REMS Healthcare Professional Education Program Kit. They then may submit an Essential Information Form, which is a brief quiz over the given material. After contacting the manufacturer to clarify, it should be noted that this process is recommended, but not required.
The following is a cost comparison of the different available strengths and the total approximated monthly cost, based on the recommended once-daily dosing schedule:
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Drug Name/Strength
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AWP per unit
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AWP per month (for #30)
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Exalgo 8 mg tablet
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$9.76 per tablet
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$292.80
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Exalgo 12 mg tablet
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$14.64 per tablet
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$439.20
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Exalgo 16 mg tablet
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$19.52 per tablet
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$585.60
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References:
Disclaimer: This content is intended for informational purposes only and is in no way intended to take the place of proper medical supervision and advice. If you have any questions or concerns about your client''s health, please contact a medical prescriber. The information contained herein is known to be correct at the time of posting; however, the content is not guaranteed due to the dynamic nature of healthcare.
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