Management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.
Limitations of Use
Use only if alternative treatment options (eg, non-opioid analgesics or opioid combination products) have not been tolerated, are not expected to be tolerated, have not provided adequate analgesia, or are not expected to provide adequate analgesia.
OLINVYK DOSAGE AND ADMINISTRATION
Use lowest effective dose for shortest duration. Individualize. Onset of analgesia: 2–5mins after initial dose. Initially 1.5mg. For PCA: demand dose is 0.35mg, with a 6min lock-out; may consider 0.5mg if benefit outweighs the risks. Supplemental doses: 0.75mg may be given 1hr after the initial dose, then hourly thereafter as needed. Max single dose: 3mg. Max total daily dose: 27mg. Use alternative regimen if analgesia is still required after reaching a cumulative daily dose of 27mg. Safety of Olinvyk >48hrs has not been studied.
Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus.
OLINVYK BOXED WARNINGS
Addiction, abuse, and misuse. Life-threatening respiratory depression. Neonatal opioid withdrawal syndrome. Risks from concomitant use with benzodiazepines or other CNS depressants.
Abuse potential (monitor). Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. Potential for QT prolongation (with total daily doses exceeding 27mg). COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Monitor during PCA use. Drug abusers. Reevaluate periodically. Avoid abrupt cessation. Severe hepatic impairment: consider dose reduction. Poor CYP2D6 metabolizers: monitor. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery: not recommended. Nursing mothers: monitor infants.
Increased risk of hypotension, respiratory depression, sedation, coma, death with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor. May be potentiated by moderate to strong CYP3A4 inhibitors (eg, macrolides, azole antifungals, SSRIs, protease or NS3/4A inhibitors), moderate to strong CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine, bupropion); monitor. May be antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin); monitor. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3antagonists, mirtazapine, trazodone, tramadol, cyclobenzaprine, metaxalone, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and/or precipitate withdrawal symptoms. Potentiates muscle relaxants; monitor. May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics.
OLINVYK ADVERSE REACTIONS
Nausea, vomiting, dizziness, headache, constipation, pruritus, hypoxia; respiratory/CNS depression, severe hypotension, syncope.
OLINVYK CLINICAL TRIALS
OLINVYK PATIENT COUNSELING