- Side Effects
- Pregnancy Safety
What is Olinvyk (oliceridine)?
Olinvyk is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.
Limitations Of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Olinvyk for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
- Have not been tolerated, or are not expected to be tolerated
- Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
The cumulative total daily dose should not exceed 27 mg, as total daily doses greater than 27 mg may increase the risk for QTc interval prolongation.
What are the side effects of Olinvyk (oliceridine)?
ADDICTION, ABUSE, AND MISUSE; LIFETHREATENING RESPIRATORY DEPRESSION NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS
- Addiction, Abuse, and Misuse
- Life-threatening Respiratory Depression
- Neonatal Opioid Withdrawal Syndrome
- Interactions with Benzodiazepines or Other CNS Depressants
- Adrenal Insufficiency
- Severe Hypotension
- Gastrointestinal Adverse Reactions
Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention.
Does Olinvyk (oliceridine) cause addiction and withdrawal?
Olinvyk contains oliceridine, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. Olinvyk can be abused and is subject to misuse, abuse, addiction, and criminal diversion .
The abuse potential of oliceridine was evaluated in healthy, nondependent, recreational opioid users at doses of 1, 2, and 4 mg. Intravenous morphine was used as a positive control at doses of 10 and 20 mg. Statistically significant differences were observed between all doses of oliceridine and placebo on most subjective effects (e.g., Drug Liking VAS) and pupillometry endpoints (e.g., miosis). Intravenous administration of oliceridine demonstrated comparable subjective effects when compared to dose-matched levels of intravenously administered morphine.
All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use.
Prescription abuse is the intentional, non-therapeutic use of a drug, even once, for its rewarding psychological or physiological effects.
Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence.
“Drug seeking” behavior is very common in persons with substance use disorders. Drug seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering of prescriptions, and reluctance to provide prior medical records or contact information for other treating health care provider(s). “Doctor shopping” (visiting multiple prescribers or healthcare prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control.
Abuse and addiction are separate and distinct from physical dependence and tolerance. Healthcare providers should be aware that addiction in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. In addition, abuse of opioids can occur in the absence of true addiction.
Olinvyk injection, like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity and frequency, and renewal requests, as required by law, is strongly advised.
Proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
There were no reports of diversion of Olinvyk during the clinical development program.
Risk Specific To Abuse Of Olinvyk Injection
Abuse of Olinvyk injection poses a risk of overdose and death. The risk is increased with concurrent use of Olinvyk with alcohol and other central nervous system depressants.
Both tolerance and physical dependence can develop during chronic opioid therapy.
Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).
Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage.
Olinvyk should not be abruptly discontinued in a physically-dependent patient. If Olinvyk is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur. Some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.
Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs.
What is the dosage for Olinvyk (oliceridine)?
Important Dosage And Administration Instructions
For intravenous administration only.
Individual single doses greater than 3 mg have not been evaluated.
The cumulative daily dose should not exceed 27 mg.
Olinvyk 30 mg/30 mL (1mg/mL) vial is intended for patient-controlled analgesia (PCA) use only. Draw Olinvyk directly from the vial into the PCA syringe or IV bag without diluting.
Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Use of Olinvyk beyond 48 hours has not been studied in controlled clinical trials.
Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse.
Monitor patients closely for respiratory depression, especially within the first 24 to 48 hours of initiating therapy and following dosage increases with Olinvyk, and adjust the dosage accordingly.
Visually inspect parenteral drug products for particulate matter and discoloration prior to administration. The solution is a clear, colorless, preservative free solution for intravenous use. If visibly opaque particles, discoloration, or other foreign particles are observed, do not use.
Olinvyk can be administered by a healthcare provider with an initial dose of 1.5 mg. For PCA, the initial dose can be followed by access to patient demand doses with a 6-minute lockout. The recommended demand dose is 0.35 mg. A demand dose of 0.5 mg may be considered for some patients if the potential benefit outweighs the risks. Supplemental doses of 0.75 mg Olinvyk can be administered by healthcare providers, beginning 1 hour after the initial dose, and hourly thereafter as needed.
Onset of analgesic effect is expected within 2 to 5 minutes after the initial dose.
Do not administer single doses greater than 3 mg.
The cumulative total daily dose should not exceed 27 mg. If patients reach a 27 mg cumulative daily dose and analgesia is still required, an alternative analgesic regimen should be administered until Olinvyk can be resumed the next day. Alternative analgesia may include multi-modal therapies. The safety of Olinvyk beyond 48 hours of use was not evaluated in controlled clinical trials.
Conversion Between Morphine Intravenous Injection And Olinvyk Intravenous Injection
Based on data collected in clinical studies, an initial 1 mg dose of Olinvyk is approximately equipotent to morphine 5 mg. As individual patients differ in their response to opioid drugs, this comparison should be used only as a guide.
Titration And Maintenance Of Therapy
Individually titrate Olinvyk to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving Olinvyk to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as to monitor for the development of addiction, abuse, or misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.
If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the Olinvyk dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
Safe Reduction Or Discontinuation Of Olinvyk
When a patient who has been taking opioids regularly and may be physically dependent no longer requires therapy with Olinvyk, taper the dose gradually while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue Olinvyk in a physically-dependent patient.
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What drugs interact with Olinvyk (oliceridine)?
Clinically Significant Drug Interactions with Olinvyk
|Moderate to Strong Inhibitors of CYP2D6|
|Clinical Impact:||Concomitant administration of a moderate to strong CYP2D6 inhibitor can increase the plasma concentration of oliceridine, resulting in increased or prolonged opioid effects.|
|Intervention:||If concomitant use is necessary, patients taking a moderate to strong CYP2D6 inhibitor may require less frequent dosing of Olinvyk. Monitor closely for respiratory depression and sedation at frequent intervals and base subsequent doses on the patient’s severity of pain and response to treatment. If a CYP2D6 inhibitor is discontinued, increase of the Olinvyk dosage may be considered until stable drug effects are achieved. Monitor for signs of opioid withdrawal.|
|Examples:||Paroxetine, fluoxetine, quinidine, bupropion|
|Moderate to Strong Inhibitors of CYP3A4|
|Clinical Impact:||The concomitant administration of moderate to strong CYP3A4 inhibitors can increase the plasma concentration of oliceridine, resulting in increased or prolonged opioid adverse reactions. After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oliceridine concentration may decrease, resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to oliceridine.|
|Intervention:||Caution should be used when administering Olinvyk to patients taking inhibitors of the CYP3A4 enzyme. If concomitant use is necessary, patients taking a CYP3A4 inhibitor may require less frequent dosing. Monitor patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, increase of the Olinvyk dosage may be considered until stable drug effects are achieved. Monitor for signs of opioid withdrawal.|
|Examples:||Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), protease inhibitors (e.g., ritonavir).|
|Strong and Moderate CYP3A4 Inhibitors and CYP2D6 Inhibitors|
|Clinical Impact:||Olinvyk is primarily metabolized by both CYP3A4 and CYP2D6. Compared to inhibition of either metabolic pathway, inhibition of both pathways can result in a greater increase of the plasma concentrations of oliceridine and prolong opioid adverse reactions .|
|Intervention:||Patients who are CYP2D6 normal metabolizers taking a CYP2D6 inhibitor, and a strong CYP3A4 inhibitor (or discontinuation of CYP3A4 inducers) may require less frequent dosing. Patients who are known CYP2D6 poor metabolizers and taking a CYP3A4 inhibitor (or discontinuation of CYP3A4 inducers) may require less frequent dosing. These patients should be closely monitored for respiratory depression and sedation at frequent intervals, and subsequent doses should be based on the patient’s severity of pain and response to treatment.|
|Examples:||Inhibitors of CYP3A4: Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole, itraconazole), anti-retroviral agents, selective serotonin re-uptake inhibitors (SSRIs), protease inhibitors (e.g., ritonavir), NS3/4A inhibitors Inhibitors of CYP2D6: Paroxetine, fluoxetine, quinidine, bupropion|
|Inducers of CYP3A4|
|Clinical Impact:||The concomitant use of Olinvyk and CYP3A4 inducers can decrease the plasma concentration of oliceridine, resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to oliceridine. After stopping a CYP3A4 inducer, as the effects of the inducer decline, the oliceridine plasma concentration may increase, which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.|
|Intervention:||If concomitant use with CYP3A4 inducer is necessary, increase of the Olinvyk dosage may be considered until stable drug effects are achieved. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider Olinvyk dosage reduction and monitor for signs of respiratory depression.|
|Examples:||Rifampin, carbamazepine, phenytoin.|
|Benzodiazepines and Other Central Nervous System (CNS) Depressants|
|Clinical Impact:||Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, increases the risk of hypotension, respiratory depression, profound sedation, coma, and death .|
|Intervention:||Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation .|
|Examples:||Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol|
|Clinical Impact:||The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome.|
|Intervention:||If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Olinvyk if serotonin syndrome is suspected.|
|Examples:||Selective serotonin reuptake 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 (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).|
|Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics|
|Clinical Impact:||May reduce the analgesic effect of Olinvyk and/or precipitate withdrawal symptoms.|
|Intervention:||Avoid concomitant use.|
|Examples:||butorphanol, nalbuphine, pentazocine, buprenorphine,|
|Clinical Impact:||Olinvyk may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.|
|Intervention:||Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of Olinvyk and/or the muscle relaxant as necessary.|
|Clinical Impact:||Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.|
|Intervention:||Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.|
|Clinical Impact:||The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.|
|Intervention:||Monitor patients for signs of urinary retention or reduced gastric motility when Olinvyk is used concomitantly with anticholinergic drugs.|
Is Olinvyk (oliceridine) safe to use while pregnant or breast feeding?
Labor Or Delivery
Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, should be available for reversal of opioid induced respiratory depression in the neonate. Olinvyk is not recommended for use in pregnant women during and immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics can prolong labor through actions that temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor. Monitor neonates exposed to Olinvyk during labor for signs of excess sedation and respiratory depression.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of opioids during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
The developmental and health benefits of breastfeeding should be considered along with the motherâ€™s clinical need for Olinvyk and any potential adverse effects on the breastfed infant from Olinvyk or from the underlying maternal condition. Monitor infants exposed to Olinvyk through breast milk for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped or when breastfeeding is stopped.
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