Addiction, abuse, misuse, and diversion

Hysingla ER can be abused and is subject to misuse, addiction, and criminal diversion

• Hysingla ER contains hydrocodone, a Schedule II controlled substance. As an opioid, Hysingla ER exposes users to the risks of addiction, abuse, and misuse. Because extended-release products such as Hysingla ER deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of hydrocodone present.
• Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Hysingla ER. Addiction can occur at recommended doses and if the drug is misused or abused.
• Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing Hysingla ER, and monitor all patients receiving Hysingla ER for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol addiction or abuse) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the prescribing of Hysingla ER for the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as Hysingla ER, but use in such patients necessitates intensive counseling about the risks and proper use of Hysingla ER along with intensive monitoring for signs of addiction, abuse, and misuse.
• Abuse or misuse of Hysingla ER by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of the hydrocodone and can result in overdose and death.
• Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing Hysingla ER. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug.
• Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

Risk Evaluation and Mitigation Strategy (REMS)

Hysingla ER is subject to the REMS for opioid analgesics

The goal of the REMS is to reduce serious adverse outcomes resulting from inappropriate prescribing, abuse, and misuse of opioid analgesics, while maintaining patient access to pain medications. Adverse outcomes of concern include addiction, unintentional overdose, and death.

• FDA has required a REMS for all opioid analgesics
• Purdue Pharma is a member of the REMS Program Companies

Hysingla ER should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

Documentation and maintenance of careful prescribing and treatment records are essential, and should include:

• Physician and patient agreement
• Proper assessment of the patient
• Proper prescribing practices
• Periodic reevaluation of therapy
• Proper dispensing and correct storage and handling
• Careful record keeping of prescribing information, including quantity, frequency, and renewal requests, is strongly advised
• Providing patient and/or caregiver with the Medication Guide
• Reviewing the Opioid REMS Patient Counseling Guide with the patient and/or caregiver at the time of prescribing

For more information, including REMS-compliant continuing medical education/continuing education (CME/CE) programs on safe prescribing of ER/LA opioid analgesics, visit opioidanalgesicrems.com.