Oliceridine

OLINVYK

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Oliceridine ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Oliceridine ballicule

What it isMu-opioid agonist with G-protein-biased signaling; IV treatment of acute severe pain.

Why this oneIt was designed to separate analgesia from respiratory depression, but its clinical advantage over conventional mu agonists is modest.

What limits it⚑ It retains boxed warnings for respiratory depression, misuse, and benzodiazepines; QT prolongation limits cumulative exposure.

Oliceridine molecular structure (skeletal formula) — Molecular structure: Oliceridine

FDA-approved for

acute pain (IV) (2020)

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Opioid addiction, abuse, and misuse; life-threatening respiratory depression; risks from concomitant benzodiazepines/CNS depressants; neonatal opioid withdrawal syndrome

FDA dosing	Population	Start	Target	Max
Acute pain severe enough to require an IV opioid	Adults	1.5 mg IV	Demand 0.35 mg (6-min lockout) or supplemental 0.75 mg	27 mg/day cumulative

Renal No adjustment needed

Hepatic Mild-moderate: no initial-dose change but may need less frequent dosing; severe: reduce initial dose and space subsequent doses

PCA demand dose 0.35 mg with 6-min lockout (may consider 0.5 mg); supplemental 0.75 mg beginning 1 h after initial dose, then hourly PRN

Instructions

For IV administration only
Use lowest effective dose for shortest duration
Do not exceed a cumulative 27 mg/day (QT prolongation risk)
CYP2D6 poor metabolizers may require less frequent dosing

Available strengths

inj 1 mg/mL

Contraindications

Significant respiratory depression
Acute or severe bronchial asthma in an unmonitored setting or without resuscitative equipment
Known or suspected GI obstruction, including paralytic ileus

Cautions

Opioid-induced hyperalgesia/allodynia
QT prolongation at daily doses >27 mg
Life-threatening respiratory depression in chronic pulmonary disease or elderly/cachectic/debilitated
Adrenal insufficiency
Severe hypotension; avoid in circulatory shock
Risk with increased ICP/head injury/impaired consciousness

Adverse reactions

Nausea
Vomiting
Dizziness
Headache
Constipation
Pruritus
Hypoxia

Pregnancy No human data; prolonged use in pregnancy can cause neonatal opioid withdrawal syndrome

Lactation Presence in human milk unknown; monitor breastfed infant for excess sedation and respiratory depression

Cost

Oliceridine (OLINVYK)

Strength		#/mo	generic $/unit	CostPlus
1 mg/mL	inj	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Oliceridine is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

⚠ BOXED WARNINGS

Addiction, abuse and misuse
Life-threatening respiratory depression
Risk from concomitant use with benzodiazepines

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Overdose danger4 / 4

Weight-gain liability0 / 4

Sedation liability2 / 4

QT / Torsades2 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryN/A (post-2015 labeling)

Defining liabilityRespiratory depression and dose-limited QT prolongation

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