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Olinvyk Prescribing Information
Addiction, Abuse, and Misuse
Because the use of OLINVYK exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions
[see Warnings and
Precautions (
5.1
)]
.Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of OLINVYK, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of OLINVYK are essential
[see Warnings and Precautions ].
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of OLINVYK and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate
[see Warnings and Precautions , Drug Interactions ].
Neonatal Opioid Withdrawal Syndrome
If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery
[see Warnings and Precautions ].
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, which can occur at any dosage or duration
[see Warnings and Precautions ]
, 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
[see Warnings and Precautions ( 5.5]
.Injection: clear, colorless, sterile, preservative-free solution for intravenous use supplied as follows:
- 1 mg/mL, equivalent to 1.3 mg/mL oliceridine fumarate salt, in single-dose, 2 mL, clear glass vials with gray plastic flip-off caps
- 2 mg/2 mL (1 mg/mL), equivalent to 2.6 mg/2 mL (1.3 mg/mL) oliceridine fumarate salt, in single-dose, 2 mL, clear glass vials with orange plastic flip-off caps
- 30 mg/30 mL (1 mg/mL), equivalent to 39 mg/30 mL (1.3 mg/mL) oliceridine fumarate salt, in single-patient-use, 30 mL, clear glass vials with purple plastic flip-off caps. For PCA Use Only.
OLINVYK is contraindicated in patients with:
- Significant respiratory depression [see Warnings and Precautions (5.2)]
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.8)]
- Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.12)]
- Known hypersensitivity to oliceridine (e.g., anaphylaxis)
The following adverse reactions are described, or described in greater detail, in other sections:
- Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)]
- Life-threatening Respiratory Depression [see Warnings and Precautions ]
- Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions ]
- Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions ]
- Opioid-Induced Hyperalgesia and Allodynia[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 ]
Table 6 includes 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 [see Clinical Pharmacology ] , 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 [see Warnings and Precautions ] . |
| 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 [See Clinical Pharmacology ]. |
| 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 [see Clinical Pharmacology ] , resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to oliceridine. [see Warnings and Precautions ] .After stopping a CYP3A4 inducer, as the effects of the inducer decline, the oliceridine plasma concentration may increase [see Clinical Pharmacology ] , 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 [see Warnings and Precautions ]. |
| 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. Monitor closely for signs of respiratory depression and sedation [see Warnings and Precautions ]. |
| Examples: | Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol |
Serotonergic Drugs | |
| 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 |
Muscle Relaxants | |
| 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. |
Diuretics | |
| 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. |
Anticholinergic Drugs | |
| 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. |
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