OLINVYK Dosage & Rx Info | Uses, Side Effects

Olinvyk Generic Name & Formulations

Legal Class

CII

General Description

Oliceridine 1mg/mL; soln for IV infusion; preservative-free; contains mannitol.

Pharmacological Class

Opioid agonist.

How Supplied

Single-dose vials (1mL, 2mL)—10; Single-patient-use vials (30mL)—10 (for PCA use only)

Manufacturer

Trevena, Inc

Generic Availability

Mechanism of Action

Oliceridine is a full opioid agonist and is relatively selective for the mu-opioid receptor. The precise mechanism of oliceridine for analgesia is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

Olinvyk Indications

Indications

Management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.

Limitations of Use

Due to risks of addiction, abuse, and misuse with opioids (can occur at any dosage or duration), reserve for use in patients for whom alternative treatment options (eg, non-opioid analgesics, opioid combination products) are not tolerated or inadequate to provide analgesia.

Olinvyk Dosage and Administration

Adult

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.

Children

Not established.

Olinvyk Contraindications

Contraindications

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

Boxed Warning

Serious and life-threatening risks from use of Olinvyk: Addiction, abuse, and misuse; Life-threatening respiratory depression; Risks from concomitant use with benzodiazepines or other CNS depressants; Neonatal opioid withdrawal syndrome.

Olinvyk Warnings/Precautions

Warnings/Precautions

Abuse potential (monitor). Life-threatening respiratory depression; monitor during initiation or following a dose increase. 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). Opioid-induced hyperalgesia (OIH) and allodynia; consider decreasing dose of current opioid or opioid rotation if OIH is suspected. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Adrenal insufficiency. Monitor for signs of hypotension when initiating or titrating dose. 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.

Olinvyk Pharmacokinetics

Distribution

Volume of distribution: 90–120 L. Plasma protein bound: 77%.

Metabolism

Hepatic (CYP3A4, CYP2D6).

Elimination

Renal (70%), fecal. Half-life: 2.1 hours.

Olinvyk Interactions

Interactions

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

Adverse Reactions

Nausea, vomiting, dizziness, headache, constipation, pruritus, hypoxia; respiratory/CNS depression, orthostatic hypotension, syncope, OIH and allodynia.

Olinvyk Clinical Trials

See Literature

Olinvyk Note

Not Applicable

Olinvyk Patient Counseling