Hysingla Er

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYSINGLA ER

• HYSINGLA ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing, and reassess regularly for these behaviors and conditions.
• Serious, life-threatening, or fatal respiratory depression may occur, especially upon initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of HYSINGLA ER are essential. Instruct patients to swallow HYSINGLA ER whole to avoid exposure to a potentially fatal dose of hydrocodone.
• Accidental ingestion of HYSINGLA ER, especially by children, can result in fatal overdose of hydrocodone.
• 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 for use in patients for whom alternative treatment options are inadequate.
• If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery
• Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription.
• Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of hydrocodone.

• HYSINGLA ER should be prescribed only by healthcare professionals who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks.
• Daily doses of HYSINGLA ER greater than or equal to 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established.
• Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.
• Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals . Reserve titration to higher doses of HYSINGLA ER for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using higher dose opioid clearly outweigh the substantial risks.
• Initiate the dosing regimen for each patient individually, taking into account the patient's underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse.
• Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with HYSINGLA ER. Consider this risk when selecting an initial dose and when making dose adjustments.
• Discuss availability of naloxone with the patient and caregiver and assess each patient's need for access to naloxone, both when initiating and renewing treatment with HYSINGLA ER. Consider prescribing naloxone based on the patient's risk factors for overdose
• Instruct patients to swallow HYSINGLA ER intact, and not to crush, chew, or dissolve the tablets (risk of potentially fatal overdose).
• Instruct patients to take tablets one at a time, with enough water to ensure complete swallowing immediately after placing in the mouth
• For opioid-naïve patients, initiate with 20 mg tablets orally every 24 hours.
• To convert to HYSINGLA ER from another opioid, follow the conversion instructions to obtain an estimated dose.
• Dose titration of HYSINGLA ER may occur every 3 to 5 days
• Patients with Severe Hepatic Impairment
  : Initiate dosing with one half of the recommended starting dosage and titrate carefully. Regularly evaluate for respiratory depression, sedation, and hypotension.
• Patients with Moderate to Severe Renal Impairment and End-Stage Renal Disease
  : Initiate dosing at one half the recommended starting dosage and titrate carefully. Regularly evaluate for signs of respiratory depression, sedation, and hypotension.
• Do not abruptly discontinue HYSINGLA ER in a physically dependent patient because rapid discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide.

• 20 mg film-coated extended-release tablets (round, green-colored, bi-convex tablets printed with "HYD 20")
• 30 mg film-coated extended-release tablets (round, yellow-colored, bi-convex tablets printed with "HYD 30")
• 40 mg film-coated extended-release tablets (round, grey-colored, bi-convex tablets printed with "HYD 40")
• 60 mg film-coated extended-release tablets (round, beige-colored, bi-convex tablets printed with "HYD 60")
• 80 mg film-coated extended-release tablets (round, pink-colored, bi-convex tablets printed with "HYD 80")
• 100 mg film-coated extended-release tablets (round, blue-colored, bi-convex tablets printed with "HYD 100")
• 120 mg film-coated extended-release tablets (round, white-colored, bi-convex tablets printed with "HYD 120")

• Pregnancy
  : May cause fetal harm.
• Lactation
  : Not recommended.