OLINVYK

2 DOSAGE AND ADMINISTRATION For intravenous administration only. OLINVYK should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. ( 2.1 ) Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. Reserve titration to higher doses of OLINVYK for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. ( 2.1 , 5 ) 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. ( 2.1 , 5.1 ) Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with OLINVYK. Consider this risk when selecting an initial dose and when making dose adjustments. ( 2.1 , 5.2 ) Initiate treatment with a 1.5 mg dose. ( 2.2 ) For patient controlled analgesia (PCA), recommended demand dose is 0.35 mg, with a 6-minute lock-out. A demand dose of 0.5 mg may be considered. ( 2.2 ) Supplemental doses of 0.75 mg can be administered, beginning 1 hour after the initial dose, and hourly thereafter, as needed. ( 2.2 ) Periodically reassess patients receiving OLINVYK to evaluate the continued need for opioid analgesics to maintain pain control, for the signs or symptoms of adverse reactions, and for the development of addiction, abuse, or misuse. ( 2.3 ) Do not rapidly reduce or abruptly discontinue OLINVYK in a physically-dependent patient. ( 2.4 , 5.14 ) 2.1 Important Dosage and Administration Instructions For intravenous administration only. OLINVYK should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. Individual single doses greater than 3 mg have not been evaluated. The cumulative daily dose should not exceed 27 mg. OLINVYK 30 mg/30 mL (1mg/mL) vial is intended for patient-controlled analgesia (PCA) use only. Draw OLINVYK directly from the vial into the PCA syringe or IV bag without diluting. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions ( 5 )] . Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of OLINVYK for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. Use of OLINVYK beyond 48 hours has not been studied in controlled clinical trials. There is variability in opioid analgesic dose and duration needed to adequately manage pain due both to the cause of pain and to individual patient factors. 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 ( 5.1 )] . Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with OLINVYK. Consider this risk when selecting an initial dose and when making dose adjustments [see Warnings and Precautions ( 5 ) ] . Inspect OLINVYK for particulate matter and discoloration prior to administration. The solution is a clear, colorless, preservative free solution for intravenous use. If visibly opaque particles, discoloration, or other foreign particles are observed, do not use. 2.2 Initial Dosage OLINVYK can be administered by a healthcare provider with an initial dose of 1.5 mg. For PCA, the initial dose can be followed by access to patient demand doses with a 6-minute lock-out. The recommended demand dose is 0.35 mg. A demand dose of 0.5 mg may be considered for some patients if the potential benefit outweighs the risks. Supplemental doses of 0.75 mg OLINVYK can be administered by healthcare providers, beginning 1 hour after the initial dose, and hourly thereafter as needed. Onset of analgesic effect is expected within 2 to 5 minutes after the initial dose [see Clinical Pharmacology ( 12.2 )] . Do not administer single doses greater than 3 mg [see Adverse Reactions ( 6.1 )] . The cumulative total daily dose should not exceed 27 mg. If patients reach a 27 mg cumulative daily dose and analgesia is still required, an alternative analgesic regimen should be administered until OLINVYK can be resumed the next day. Alternative analgesia may include multi-modal therapies. The safety of OLINVYK beyond 48 hours of use was not evaluated in controlled clinical trials [see Warnings and Precautions ( 5.5 )] . Conversion Between Morphine Intravenous Injection and OLINVYK Intravenous Injection Based on data collected in clinical studies, an initial 1 mg dose of OLINVYK is approximately equipotent to morphine 5 mg [see Clinical Pharmacology ( 12.2 )]. As individual patients differ in their response to opioid drugs, this comparison should be used only as a guide. 2.3 Titration and Maintenance of Therapy Titrate the dose based upon the individual patient’s response to their initial dose of OLINVYK. Individually titrate OLINVYK to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving OLINVYK to assess the maintenance of pain control, signs and symptoms of opioid withdrawal, and other adverse reactions, as well as to reassess for the development of addiction, abuse, or misuse [see Warnings and Precautions ( 5.1 , 5.14 )] . Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the OLINVYK dosage. If after increasing the dosage, unacceptable opioid-related adverse reactions are observed (including an increase in pain after a dosage increase), consider reducing the dosage [see Warnings and Precautions ( 5 )] . Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions. 2.4 Safe Reduction or Discontinuation of OLINVYK When a patient who has been taking opioids regularly and may be physically dependent no longer requires therapy with OLINVYK, taper the dose gradually while regularly evaluating for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not rapidly reduce or abruptly discontinue OLINVYK in patients who may be physically dependent on opioids [see Warnings and Precautions ( 5.1 , 5.14 ), Drug Abuse and Dependence ( 9.3 ); Nonclinical Toxicology ( 13.2 )] .

See official label

1 INDICATIONS AND USAGE OLINVYK is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.