Addiction, Abuse, and Misuse; Life-Threatening Respiratory Depression; Neonatal Opioid Withdrawal Syndrome; and Risks from Concomitant Use With Benzodiazepines or Other CNS Depressants; Risk Evaluation and Mitigation Strategy (REMS)

Risk of Medication Errors

• DILAUDID-HP INJECTION is a more concentrated solution of hydromorphone than DILAUDID INJECTION, and is for use in opioid-tolerant patients only. Do not confuse DILAUDID-HP INJECTION with standard parenteral formulations of DILAUDID INJECTION or other opioids, as overdose and death could result

Addiction, Abuse, and Misuse 

• DILAUDID INJECTION and DILAUDID-HP INJECTION exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing DILAUDID INJECTION and DILAUDID-HP INJECTION and monitor all patients regularly for the development of these behaviors and conditions
• Patients at increased risk may be prescribed opioids, but use in such patients necessitates intensive counseling about the risks and proper use along with intensive monitoring for signs of addiction, abuse, and misuse. Consider prescribing naloxone for the emergency treatment of opioid overdose.  

Life-Threatening Respiratory Depression 

• Serious, life-threatening, or fatal respiratory depression may occur with use of DILAUDID INJECTION or DILAUDID-HP INJECTION. Monitor for respiratory depression, especially during initiation of DILAUDID INJECTION or DILAUDID-HP INJECTION or following a dose increase
• Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper.

Neonatal Opioid Withdrawal Syndrome 

• Prolonged use of DILAUDID INJECTION or DILAUDID-HP INJECTION during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants 
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death 

• Reserve concomitant prescribing of DILAUDID or DILAUDID-HP Injection and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
• Limit dosages and durations to the minimum required.
• Follow patients for signs and symptoms of respiratory depression and sedation.

Opiod Analgesic Risk Evaluation and Mitigation Strategy (REMS)

To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to:

• complete a REMS-compliant education program,
• counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,
• emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and
• consider other tools to improve patient, household, and community safety.