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(on package label)
1 mg/1 mL
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30 mg/30 mL
|Single-patient-use vial (PCA Only)||$110.00|
1 mg/1 mL
|Carton of 10 vials||$175.00|
2 mg/2 mL
|Carton of 10 vials||$257.50|
30 mg/30 mL
|Carton of 10 vials||$1,100.00|
Buy Oliceridine (Olynvik) Online. Adults with moderate to severe acute pain may benefit from the opioid drug oliceridine, also known by the brand name Olinvyk. It is administered intravenously (IV). The most frequent adverse reactions are low blood oxygen levels, nausea, vomiting, headaches, dizziness, and constipation.
What is oliceridine, or olinvyk?
For the treatment of people with acute pain that is severe enough to necessitate an intravenous (IV) opioid analgesic and for whom other therapies are ineffective, the U.S. Food and Drug Administration (fda.gov) has approved Olinvyk (oliceridine; Trevena). Full opioid agonist ocleridine has a high degree of mu-opioid receptor selectivity.
Adults who have acute pain that is severe enough to necessitate an IV opioid analgesic and for whom no other treatments are effective should take Olinvyk.
oliceridine, or olinvyk Use Restrictions
Reserve Olinvyk for use in individuals for whom alternative treatment choices [e.g., non-opioid analgesics or opioid combination products] are not appropriate due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses:
- have not received tolerance or are not anticipated to get tolerance
- Neither have delivered sufficient analgesia nor are they anticipated to do so.
In order to reduce the risk of QTc interval prolongation, the cumulative total daily dose should not be higher than 27 mg.
What adverse reactions can Olinvyk (oliceridine) cause?
Risks from concurrent use with benzodiazepines or other central nervous system (CNS) depressants include addiction, abuse, and misuse, life-threatening respiratory depression, neonatal opioid withdrawal syndrome, and addiction.
- 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
Inform patients about the possibility of severe constipation, along with how to manage it and when to seek medical help.
Are addiction and withdrawal symptoms caused by Olinvyk (oliceridine)?
As with other opioids like fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol, oliceridine, which is present in olinvyk, has a significant potential for misuse. Misuse, abuse, addiction, and criminal diversion are all possible with olinvyk.
At dosages of 1, 2, and 4 mg, the abuse potential of oliceridine was assessed in healthy, non-dependent, recreational opioid users. A positive control was used, consisting of 10 and 20 mg of intravenous morphine. On the majority of subjective effects (such as the Drug Liking VAS and pupillometry endpoints), statistically significant changes were seen between all doses of oliceridine and placebo (e.g., miosis). When compared to dose-matched doses of morphine delivered intravenously, intravenous oliceridine treatment showed equivalent subjective effects.
Since the use of opioid analgesic drugs carries the potential of addiction even when used appropriately medically, all patients receiving opioid treatment need to be carefully watched for signs of abuse and addiction.
The purposeful, non-therapeutic use of a medicine, even once, for its pleasurable psychological or physiological effects is known as prescription drug misuse.
Drug addiction is a collection of behavioural, cognitive, and physiological phenomena that can include a strong desire to use the drug, problems with self-control (e.g., continuing to use the drug despite negative consequences, prioritising drug use over other activities and responsibilities), and potential tolerance or physical dependence.
People with substance use disorders frequently engage in “drug seeking” behaviour. Drug-seeking strategies include making after-hours calls or visits, refusing to undergo necessary examinations, tests, or referrals, repeatedly misplacing prescriptions or tampering with them, and refusing to provide previous medical records or the names and contact information of other treating healthcare professionals (s). Drug abusers and those with untreated addiction are prone to “doctor shopping,” which involves going to several doctors or healthcare providers to get more prescriptions. In a patient with inadequate pain control, preoccupation with getting adequate pain relief may be appropriate behaviour.
Physical dependency and tolerance are different from abuse and addiction. Healthcare professionals should be aware that in some cases, tolerance and physical dependency signs may not coexist with addiction. Additionally, opioid abuse can happen even in the absence of actual addiction.
Like other opioids, olinvyk injection can be diverted for use outside of medicine and distributed through illegal means. It is strongly encouraged to keep meticulous records of prescription information, including quantity and frequency, and renewal requests, as required by law.
Suitable procedures that aid in limiting opioid drug addiction include appropriate patient assessment, appropriate prescribing practises, frequent reevaluation of therapy, and appropriate distribution and storage.
Throughout the clinical trial programme, there were no complaints of Olinvyk being diverted.
Risk Particular to Olinvyk Injection Abuse
Overdose and death are risks associated with Olinvyk injection abuse. Olinvyk use while also consuming alcohol and other drugs that affect the central nervous system increases the danger.
Abuse of parenteral drugs is frequently linked to the spread of infectious diseases including hepatitis and HIV.
People turn to want to Depend on Olinvyk
During long-term opioid medication, tolerance and physical dependency can both grow.
A physiological condition known as tolerance is defined by a diminished response to a medication following 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 dependency is a condition that arises through physiological adaptation in response to recurrent drug use and is characterised by withdrawal signs and symptoms following a sudden cessation of drug usage or a considerable dose reduction. In addition, the use of opioid antagonists like naloxone, mixed agonist/antagonist analgesics like pentazocine, butorphanol, or nalbuphine, or partial agonists might hasten withdrawal (e.g., buprenorphine). After several days to weeks of persistent opioid use, physical dependency may not start to develop to a clinically meaningful degree.
In a patient who is physically reliant, Olinvyk shouldn’t be abruptly stopped. A withdrawal syndrome could develop in a patient who is physically dependent if Olinvyk is abruptly stopped. This syndrome can be characterised by some or all of the following symptoms: agitation, lacrimation, rhinorrhea, yawning, sweat, chills, myalgia, and mydriasis. Along with this, other indications and symptoms, such as agitation, anxiety, backache, joint pain, weakness, cramping in the abdomen, insomnia, nausea, anorexia, vomiting, diarrhoea, or elevated blood pressure, respiration rate, or heart rate, may also appear.
Babies born to moms who are physically addicted to opioids will also be physically addicted and may show signs of withdrawal such as breathing problems. Buy Oliceridine (Olynvik) Online
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.|
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. Buy Oliceridine (Olynvik) Online
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. Buy Oliceridine (Olynvik) Online
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. Buy Oliceridine (Olynvik) Online
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. Buy Oliceridine (Olynvik) Online
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. Buy Oliceridine (Olynvik) Online
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