Considerations for prescribing Hysingla ER
Hysingla ER should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain
INDICATIONS AND USAGE
Hysingla® ER (hydrocodone bitartrate) is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use
- Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Hysingla ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
- Hysingla ER is not indicated as an as-needed (prn) analgesic.
Opioids should be prescribed only if expected benefits outweigh risks—and in combination with non-pharmacologic and non-opioid therapy, as appropriate1
When starting opioid therapy for chronic pain, consider an immediate-release (IR) opioid first before prescribing an extended-release (ER) opioid.
- Work with your patient to set realistic treatment goals, including a plan to discontinue opioid treatment if benefits do not outweigh risks
- Educate your patient about the realistic benefits and known risks of opioid therapy
- Discuss patient and clinician responsibilities for managing opioid treatment
- Evaluate risk factors for opioid-related harms—such as history of overdose, substance use disorder, high opioid dosages, or concurrent benzodiazepine use—and incorporate risk mitigation strategies
- Review state PDMP data to see if your patient is receiving opioid dosages or dangerous combinations that pose high risk for overdose
- Consider drug testing* to assess for prescribed opioid medications, other controlled prescription drugs, and illicit drugs
- Plan to evaluate benefits and harms with your patient within 1 to 4 weeks of starting therapy or dose escalation, and continually thereafter (every 3 months or more frequently)
- Avoid prescribing opioid pain medications and benzodiazepines concurrently whenever possible
During Hysingla ER therapy, use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals
*Not every urine drug test reliably detects synthetic or semisynthetic opioids, such as hydrocodone, especially those designed for in-office use, and many laboratories will report urine drug concentrations below a specified "cut-off" as "negative." Therefore, ensure that the assay's sensitivity and specificity are appropriate, and consider the urine drug test's limitations when interpreting results.2-4
PDMP = prescription drug monitoring program.
