OLINVYK Solution for injection Ref.[10350] Active ingredients:

2.1 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 [see Warnings and Precautions (5)].

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 [see Warnings and Precautions (5.1)].

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 [see Warnings and Precautions (5.2)].

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.

2.2 Dosing Information

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 lock-out. 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 [see Clinical Pharmacology (12.2)].

Do not administer single doses greater than 3 mg [see Adverse Reactions (6.1)].

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 [see Warnings and Precautions (5.5)].

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 [see Clinical Pharmacology (12.2)]. As individual patients differ in their response to opioid drugs, this comparison should be used only as a guide.

2.3 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 [see Warnings and Precautions (5.1)]. 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.

2.4 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 [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.3), and Nonclinical Toxicology (13.2)].

10.1 Clinical Presentation

Acute overdose with OLINVYK can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen due to severe hypoxia in overdose situations [see Clinical Pharmacology (12.2)].

10.2 Treatment of Overdose

In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques.

The opioid antagonist, naloxone, is a specific antidote for respiratory depression resulting from opioid overdose. While naloxone reversal of OLINVYK’s effects has not been established in humans, some pharmacological effects (analgesia) of oliceridine have been shown to be reversed by naloxone in animals [see Clinical Pharmacology (12.2)]. For clinically significant respiratory or circulatory depression secondary to oliceridine overdose, administer an opioid antagonist.

Because the duration of opioid reversal is expected to be less than the duration of oliceridine in OLINVYK injection, carefully monitor the patient until spontaneous respiration is reliably reestablished. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information.

In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.

Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from freezing. Protect from light.