Olinvyk
Joey Sweeney, PharmD, BCPS
FDA approved the first new I.V. opioid in decades. The drug, oliceridine (Olinvyk—Trevena), is a µ-receptor agonist that has been shown to be slightly less effective than morphine at reducing pain experienced in hospital settings (primarily postoperative settings), according to the APOLLO-1 and APOLLO-2 trials. Oliceridine is limited to hospital settings (not approved for outpatient use) and will be available as early as fourth quarter 2020. DEA has not yet scheduled the drug at the time this article was written.
Important limitations
Oliceridine is a new drug to use for postoperative pain in the hospital setting. This new opioid, while addictive, is unlikely to get into the hands of the general population and reach those individuals with an opioid use disorder. It must be given either by a clinician or via patient-controlled analgesic (PCA). Patients will not be able to have the prescription filled at a community pharmacy.
Takeaways for pharmacists
Oliceridine has a dosing advantage over many other opioids in that renal impairment does not affect clearance of this drug. However, it does have a daily maximum dose and there is little data on reversal in case of overdose.
Oliceridine has several benefits. Pharmacists and other health care providers do not need to dose adjust the drug based on renal function and its rapid onset of action (less than 5 minutes). Adverse drug events are similar to other opioids, and can include nausea, vomiting, constipation, dizziness, and headache. The drug carries the same risk of respiratory depression as other opioids as well.
Interestingly, this new I.V. opioid has a maximum daily dose of 27 mg, whereas other I.V. opioids do not have a maximum daily dose. According to the Athena trial, a Phase III, open-label study of the safety and effectiveness of oliceridine, about 3% of patients experienced electrolyte abnormalities such as hypokalemia, calcemia, and phostotemia.
Animal trials have shown some efficacy of reversal of oliceridine overdose with naloxone, although human data are not available. Despite this dearth of data, the manufacturers of oliceridine advise the use of naloxone in addition to other supportive measures in the case of overdose.
Direct efficacy and adverse drug event comparisons to other opioids are not available at this time and should be a focus of future research to more fully elucidate oliceridine’s place in hospital setting–based pain treatment algorithms.
Dosing for oliceridine via bolus/I.V. push is 1.5 mg I.V. push for initial dose, followed by 0.75 mg every hour thereafter as needed. Dosing for oliceridine via PCA is an initial bolus of 1.5 mg followed by a demand dose of 0.35 mg to 0.5 mg with a 6-minute lockout.
Oliceridine will be available as a 1 mg/mL vial in both 1 mL and 2 mL sizes (vials will have different colored caps), and a 30 mL 1 mg/mL PCA vial (also a different colored cap). It is required to be stored at room temperature and protected from light.