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Olinvyk

Last reviewed on RxList: 8/13/2020
Olinvyk Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Olinvyk?

Olinvyk (oliceridine) is an opioid agonist used in adults to manage acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.

What Are Side Effects of Olinvyk?

Side effects of Olinvyk include:

  • nausea,
  • vomiting,
  • dizziness,
  • headache,
  • constipation,
  • itching, and
  • low blood oxygen (hypoxia)

As an opioid, Olinvyk exposes users to the risks of addiction, abuse, and misuse. Rapid tapering of Olinvyk in a patient physically dependent on opioids may lead to a withdrawal syndrome and return of pain.

Dosage for Olinvyk

The dose of Olinvyk is individualized based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. Initiate treatment with Olinvyk with a 1.5 mg dose. For patient-controlled analgesia (PCA), the recommended demand dose of Olinvyk is 0.35mg, with a 6-minute lock-out. A demand dose of 0.5 mg may be considered.

Olinvyk In Children

The safety and effectiveness of Olinvyk in pediatric patients has not been established.

What Drugs, Substances, or Supplements Interact with Olinvyk?

Olinvyk may interact with other medicines such as:

  • paroxetine,
  • fluoxetine,
  • quinidine,
  • bupropion,
  • macrolide antibiotics,
  • azole-antifungal agents,
  • protease inhibitors,
  • anti-retroviral agents,
  • NS3/4A inhibitors,
  • rifampin,
  • carbamazepine,
  • phenytoin,
  • benzodiazepines,
  • sedatives/hypnotics,
  • anxiolytics,
  • tranquilizers,
  • muscle relaxants,
  • general anesthetics,
  • antipsychotics,
  • other opioids,
  • alcohol,
  • selective serotonin re-uptake inhibitors (SSRIs),
  • serotonin and norepinephrine reuptake inhibitors (SNRIs),
  • tricyclic antidepressants (TCAs),
  • triptans, 5-HT3 receptor antagonists,
  • drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol),
  • certain muscle relaxants,
  • monoamine oxidase inhibitors (MAOIs),
  • butorphanol,
  • nalbuphine,
  • pentazocine,
  • buprenorphine,
  • diuretics, and
  • anticholinergics

Tell your doctor all medications and supplements you use.

Olinvyk During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Olinvyk; it may harm a fetus. Prolonged use of opioid analgesics during pregnancy may result in neonatal opioid withdrawal syndrome. It is unknown if passes into breast milk. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped or when breastfeeding is stopped. Consult your doctor before breastfeeding.

Additional Information

Our Olinvyk (oliceridine) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Medically speaking, the term "myalgia" refers to what type of pain? See Answer
Olinvyk Professional Information

SIDE EFFECTS

The following adverse reactions are described, or described in greater detail, in other sections:

  • Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
  • Life-threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
  • Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
  • Interactions with Benzodiazepines or Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
  • Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
  • Severe Hypotension [see WARNINGS AND PRECAUTIONS]
  • Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Seizures [see WARNINGS AND PRECAUTIONS]
  • Withdrawal [see WARNINGS AND PRECAUTIONS]

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

A total of 1535 patients were treated with OLINVYK in controlled and open-label trials in patients with moderate to severe acute pain. Of these, 1181 patients received a total daily dose ≤27 mg and 354 patients received a total daily dose >27 mg during the first 24-hour treatment period. Among patients who received a daily dose of >27 mg, 198 patients received a daily dose between 27 mg and 40 mg, and 142 patients received a daily dose >40 mg.

The most common adverse drug reactions (≥10%) in controlled efficacy trials (Study 1 and Study 2) were nausea, vomiting, dizziness, headache, constipation, pruritus and hypoxia. Adverse reactions leading to discontinuation of OLINVYK were hypotension, hypoxia, nausea, hypoventilation, oxygen saturation decreased, alanine aminotransferase increased, aspartate aminotransferase increased, electrocardiogram QT prolongation, and urticaria. In two randomized, double-blind, placebo- and morphine-controlled studies, when stratified by 27 mg daily dosing limit, discontinuation of OLINVYK due to adverse reactions occurred in 4% of patients who received a daily dose ≤ 27 mg, and less than 1% of patients who received a daily dose >27 mg. In these same studies, discontinuation due to adverse reactions occurred in 5% of morphine-treated patients, and no placebo-treated patients. In an open-label safety study, discontinuation of OLINVYK due to adverse drug reactions occurred in 3% of patients who received a daily dose ≤ 27 mg, and 1% of patients who received a daily dose >27 mg.

In two randomized, double-blind, placebo- and morphine-controlled studies in patients with moderate to severe acute pain following either orthopedic surgery-bunionectomy (Study 1), or plastic surgery-abdominoplasty (Study 2), patients received one of three OLINVYK dosing regimens, a morphine- control regimen, or a volume-matched placebo-control regimen. All dosing regimens were administered via patient-controlled analgesia (PCA), allowing patients to individually titrate the dose available to an acceptable level of analgesia. Patients were treated for up to 48 hours in the bunionectomy study (Study 1), and for up to 24 hours in the abdominoplasty study (Study 2) [see Clinical Studies]. The loading dose for all OLINVYK treatment regimens was 1.5 mg; demand doses were 0.1, 0.35, or 0.5 mg, according to assigned treatment group; supplemental doses of 0.75 mg were permitted, beginning 1 hour after the loading dose, and hourly thereafter, as needed. The loading dose for the morphine treatment regimen was 4 mg; the demand dose was 1 mg; and supplemental doses of 2 mg were permitted, beginning 1 hour after the loading dose, and hourly thereafter, as needed. A lockout interval of 6 minutes was used for all PCA regimens.

In Study 1, a total of 136 patients received OLINVYK ≤27 mg/day, and 98 patients received OLINVYK >27 mg/day during the first 24 hours. In Study 2, a total of 180 patients received OLINVYK ≤27 mg/day, and 56 patients received OLINVYK >27 mg/day during the first 24 hours.

Table 1 and Table 2 list adverse drug reactions that were reported in ≥5% of OLINVYK-treated patients in each study, and that occurred at a frequency greater than placebo in at least one of the studies.

Table 3 lists adverse drug reactions that were reported in ≥5% of OLINVYK-treated patients for pooled Studies 1 and 2 stratified by total daily dose (≤27 mg/day or >27 mg/day).

These data are not an adequate basis for comparison of rates between the OLINVYK treatment group and the morphine treatment group. The OLINVYK and morphine dosing regimens studied are not considered equipotent.

Table 1: Adverse Drug Reactions Reported in ≥5% of OLINVYK-Treated Patients Following Orthopedic Surgery-Bunionectomy (Study 1)

Adverse Drug ReactionPlacebo
(N = 79)
OLINVYK 0.35 mga
(N = 79)
OLINVYK 0.5 mga
(N = 79)
Morphineb
(N = 76)
Patients with any TEAEc (%)68869196
Nausea24566365
Vomiting6394150
Dizziness10323534
Somnolence6191313
Constipation11111417
Pruritus815420
Hypoxia0599
Sedation1543
Oxygen saturation decreased0459
a Each OLINVYK regimen included a loading dose of 1.5 mg, followed by access to demand doses of 0.35 or 0.5 mg, with a 6-minute lockout period between doses, and 0.75-mg supplemental doses, beginning 1 hour after the initial dose, and hourly thereafter, as needed.
b The morphine regimen included a loading dose of 4 mg, followed by access to a demand dose of 1 mg, with a 6- minute lockout period between doses, and 2-mg supplemental doses, beginning 1 hour after the initial dose, and hourly thereafter, as needed.
c Treatment Emergent Adverse Event

Table 2: Adverse Drug Reactions Reported in ≥5% of OLINVYK-Treated Patients Following Plastic Surgery-Abdominoplasty (Study 2)

Adverse Drug ReactionPlacebo
(N = 79)
OLINVYK 0.35 mga
(N = 79)
OLINVYK 0.5 mga
(N = 79)
Morphineb
(N = 76)
Patients with any TEAEc (%)78949598
Nausea46627574
Vomiting13224354
Hypoxia5201823
Constipation7171111
Pruritus5171118
Dizziness119916
Sedation814923
Back pain613119
Somnolence1057
a Each OLINVYK regimen included a loading dose of 1.5 mg, followed by access to demand doses of 0.35 or 0.5 mg with a 6-minute lockout period between doses, and 0.75-mg supplemental doses beginning 1 hour after the initial dose and hourly thereafter as needed.
b The morphine regimen included a loading dose of 4 mg, followed by access to a demand dose of 1 mg with a 6- minute lockout period between doses, and 2-mg supplemental doses beginning 1 hour after the initial dose, and hourly thereafter, as needed.
c Treatment Emergent Adverse Event

Table 3: Adverse Drug Reactions Reported in ≥5% of OLINVYK-Treated Patients Stratified by Daily Dose (Study 1 and 2 Pooled)

Adverse Drug ReactionPlacebo
(N = 162)
OLINVYK ≤ 27 mg
(N = 316)
OLINVYK > 27 mg
(N= 154)
Morphine
(N =158)
Patients with any TEAEa (%)73869296
Nausea35526670
Vomiting10264252
Headache30262630
Dizziness11182725
Constipation9141214
Hypoxia312617
Pruritus691419
Sedation57713
Somnolence461010
Back pain4646
Hot flush4478
Pruritus generalized12510
a Treatment Emergent Adverse Event

In an open-label safety study of patients with moderate to severe acute pain following a surgical procedure or due to a medical condition (Study 3), a total of 768 patients received at least one dose of OLINVYK. OLINVYK was administered via clinician-administered bolus dosing, PCA, or a combination of the two. Bolus dosing was initiated at 1 to 2 mg, with supplemental doses of 1 to 3 mg every 1 to 3 hours, as needed, based on individual patient need and previous response to OLINVYK. If OLINVYK was administered via PCA, the loading dose was 1.5 mg, the demand dose was 0.5 mg, and the lockout interval was 6 minutes. Supplemental doses of 1 mg were given as needed, taking into account the patient's utilization of PCA demand doses, individual patient need, and previous response to OLINVYK.

In Study 3, for the patients within the highest cumulative dose group (exposure >36 mg), the mean cumulative exposure was 67 mg (range: 37 mg to 224 mg) and the mean cumulative duration of exposure was 54 hours (range: 6 hours to 143 hours). The mean cumulative dose of OLINVYK administered to patients in the Study 3 was 30 mg over a mean cumulative duration of 29 hours. The most frequent condition treated in Study 3 was post-surgical acute pain, and included (in order of decreasing frequency): orthopedic, gynecologic, colorectal, general, plastic, urologic, neurologic (including spinal), bariatric, and cardiothoracic surgical procedures.

In Study 3, of the 768 patients treated with OLINVYK, 32% were age 65 years or older and 78% had a Body Mass Index ≥25 kg/m². OLINVYK was administered as needed; 55% of patients received OLINVYK via clinician bolus administration only, and 45% of patients received OLINVYK via PCA self-administration or a combination of clinician bolus- and PCA self-administration.

In Study 3 (open-label), a total of 592 patients received OLINVYK ≤27 mg/day and 176 received OLINVYK >27 mg during the first 24 hours. Adverse drug reactions reported in ≥5% of patients receiving OLINVYK in Study 3, stratified by total daily dose (≤27 mg/day or >27 mg/day), are presented in Table 4.

Table 4: Adverse Drug Reactions Reported in ≥5% OLINVYK-Treated Patients in Study 3 (Open-Label)

Adverse Drug ReactionOLINVYK ≤ 27mg
N = 592
OLINVYK > 27mg
N = 176
Patients with any TEAEa (%)6269
Nausea2938
Constipation1013
Vomiting915
Headache45
Hypokalaemia47
Pruritus48
Pyrexia35
a Treatment Emergent Adverse Event

Adverse Drug Reactions Reported in >1% to <5% of Patients in the controlled and open-label studies (Study 1, Study 2, and Study 3) are listed in descending order of frequency within System Organ Class in Table 5.

Table 5: Adverse Drug Reactions Reported in >1% to <5% of Patients in Studies 1-3

System Organ ClassAdverse Drug Reaction Preferred Term
Blood and lymphatic disordersAnemia
Cardiac disordersTachycardia
Gastrointestinal disordersFlatulence, Dry mouth, Dyspepsia, Diarrhea
General disorders and administration site conditionsPyrexia, Infusion site extravasation
Injury, poisoning and procedural complicationsProcedural nausea
InvestigationsOxygen saturation decreased, Alanine aminotransferase increased, Blood pressure increased
Metabolism and nutritional disordersHypokalaemia, Hypocalcaemia, Hypophosphataemia, Hypomagnesaemia
Musculoskeletal and connective tissue disordersMuscle spasms
Nervous system disordersHeadache
Psychiatric disordersAnxiety, Insomnia, Restlessness
Respiratory, thoracic and mediastinal disordersCough, Dyspnea
Skin and subcutaneous tissue disordersHyperhidrosis, Rash, Pruritus generalised
Vascular disordersHypotension, Hot flush, Flushing

Read the entire FDA prescribing information for Olinvyk (Oliceridine Injection)

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© Olinvyk Patient Information is supplied by Cerner Multum, Inc. and Olinvyk Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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