5.1 Addiction,
Abuse, and Misuse
Additions and/or
revisions underlined:
OLINVYK
contains oliceridine, a Schedule II controlled substance. As an opioid, OLINVYK
exposes users to the risks of addiction, abuse, and misuse
[see Drug Abuse and Dependence (9)].
Although
the risk of addiction in any individual is unknown, it can occur in patients
appropriately prescribed OLINVYK.
Addiction can occur at recommended dosages and if the
drug is misused or abused [see Drug Abuse
and Dependence (9)]. The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists
over the course of therapy. In
postmarketing studies, addiction, abuse, misuse, and fatal and non-fatal opioid
overdose were observed in patients with long-term opioid use [see Adverse Reactions (6.2)].
…
5.2
Life-Threatening Respiratory Depression
Additions and/or
revisions underlined:
Serious,
life-threatening respiratory depression has been reported with the use of
opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead
to respiratory arrest and death. Management
of respiratory depression may include close observation, supportive measures,
and use of opioid overdose reversal agents (e.g., naloxone, nalmefene),
depending on the patient’s clinical status [see
Overdosage (10.2)].
Carbon dioxide (CO2) retention
from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.
…
5.3 Risks from Concomitant
Use with Benzodiazepines or Other CNS Depressants
Additions and/or
revisions underlined:
Profound sedation, respiratory depression, coma,
and death may result from the concomitant use of OLINVYK with benzodiazepines and/or other CNS depressants, including alcohol (e.g., non-benzodiazepine sedatives/hypnotics,
anxiolytics, tranquilizers, muscle relaxants, general anesthetics,
antipsychotics, gabapentinoids [gabapentin or pregabalin], and other
opioids, or alcohol). Because of these risks, reserve concomitant prescribing
of these drugs for use in patients for whom alternative treatment options are
inadequate.
…
5.12 Risks of
Gastrointestinal Complications
Subsection
title revised
Additions and/or
revisions underlined:
OLINVYK is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus.
The oliceridine in OLINVYK may cause spasm of the sphincter of Oddi. Opioids
may cause increases in serum
amylase. Monitor patients with biliary tract disease, including acute pancreatitis,
for worsening symptoms.
Cases of opioid-induced esophageal dysfunction (OIED) have been reported
in patients taking opioids. The risk of OIED may increase as the dose and/or duration of
opioids increases.
Regularly evaluate patients for signs and symptoms of OIED (e.g.,
dysphagia, regurgitation, non-cardiac chest pain) and, if
necessary, adjust opioid therapy as clinically appropriate [see Clinical Pharmacology (12.2)].
5.14 Withdrawal
Additions and/or
revisions underlined:
Do
not rapidly reduce or abruptly discontinue OLINVYK in a patient
physically dependent on opioids. When
discontinuing OLINVYK in a physically-dependent patient, gradually taper the
dosage. Rapid tapering of oliceridine in a patient
physically dependent on opioids may lead to a
withdrawal syndrome and return of pain [see Dosage
and Administration (2.4),
Drug Abuse and Dependence (9.3), Nonclinical
Toxicology (13.2)].
Additionally, avoid the use of
mixed agonist/antagonist (e.g, pentazocine, nalbuphine, and butorphanol) or
partial agonist (e.g., buprenorphine) analgesics in patients who are receiving
a full opioid agonist analgesic, including OLINVYK. In these patients, mixed
agonist/antagonist and partial agonist analgesics may reduce the
analgesic effect and/or precipitate withdrawal symptoms [see Drug Interactions (7)].
6.2 Postmarketing
Experience
Additions and/or
revisions underlined:
…
Opioid-induced esophageal
dysfunction (OIED): Cases of OIED have been reported in patients taking opioids and may occur more frequently in patients taking
higher doses of opioids, and/or in patients taking opioids longer
term [see Warnings and Precautions
(5.12)].
Adverse Reactions from Observational Studies
A prospective, observational cohort
study estimated the risks of addiction, abuse, and misuse in patients initiating long-term use of Schedule II opioid analgesics between 2017 and 2021. Study participants include in one or more
analyses had been enrolled in selected insurance plans or health systems for at
least one year, were free of at least one outcome at baseline, completed a minimum number of follow-up assessments, and either: 1) filled multiple extended-release/long-acting opioid
analgesic prescriptions during
a 90-day period
(n=978); or 2) filled any Schedule II opioid analgesic prescriptions
covering at least 70 of 90 days (n=1,244). Those
included also had no dispensing of the qualifying opioids in the previous 6
months.
Over 12 months:
approximately 1% to 6% of participants across the two cohorts newly
met criteria for addiction, as assessed with two
validated interview-based measures of moderate-to-severe opioid use disorder
based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
(DSM-5) criteria, and
approximately 9% and 22% of participants across the two cohorts newly
met criteria for prescription opioid abuse and misuse [defined in Drug Abuse and Dependence (9.2)],
respectively, as measured with a validated self-reported instrument.
A retrospective, observational
cohort study estimated the risk of opioid-involved overdose or opioid
overdose-related death in patients with new long-term use of Schedule II opioid analgesics from 2006 through 2016
(n=220,249). Included patients had
been enrolled in either one of two commercial insurance programs, one managed
care program, or one Medicaid program for at least 9 months. New
long-term use was defined as having Schedule II opioid analgesic
prescriptions covering at least 70 days’ supply over the 3 months prior to
study entry and none during the preceding 6 months. Patients were excluded if they had an opioid-involved overdose in the 9 months prior to study
entry. Overdose was measured using
a validated medical code-based algorithm with linkage to the National Death Index database. The 5-year cumulative incidence estimates for opioid-involved
overdose or opioid overdose-related death ranged from approximately 1.5% to 4%
across study sites, counting only the first event during follow-up.
Approximately 17% of first opioid overdoses observed over the entire study
period (5-11 years, depending on the study stite)
were fatal. Higher
baseline opioid dose was the strongest and most
consistent predictor of opioid-involved overdose or opioid overdose-related
death. Study exclusion criteria may
have selected patients at lower risk of overdose, and substantial loss to
follow-up (approximately 80%) also may have biased estimates.
The risk estimates from the studies
described above may not be generalizable to all patients receiving opioid
analgesics, such as those with exposures shorter
or longer than the duration evaluated in the studies.
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