Oliceridine

Oliceridine (OLINVYK) is an opioid agonist.

What are the uses of this medicine?

• This medicine 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.

How does this medicine work?

• Oliceridine is a full opioid agonist and is relatively selective for the mu-opioid receptor.
• The principal therapeutic action of oliceridine is analgesia.
• The precise mechanism of the analgesic action is unknown.
• However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Significant respiratory depression
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Known or suspected gastrointestinal obstruction, including paralytic ileus
• Known hypersensitivity to oliceridine (e.g., anaphylaxis)

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

• Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse.
• Initiate treatment with a 1.5 mg dose.
• For patient controlled analgesia (PCA), recommended demand dose is 0.35 mg, with a 6-minute lock-out.
• A demand dose of 0.5 mg may be considered.
• Supplemental doses of 0.75 mg can be administered, beginning 1 hour after the initial dose, and hourly thereafter, as needed.
• Do not stop OLINVYK in a physically-dependent patient.
• Taper the dose gradually while monitoring carefully for signs and symptoms of withdrawal.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Injection:

• 1 mg/mL and 2 mg/2 ml (1 mg/mL) in single-dose vials
• 30 mg/30 mL (1 mg/mL) in single-patient-use vial, For PCA Use Only

This medicine is available in fallowing brand namesː

• OLINVYK

What side effects can this medication cause?

Common possible side effects of this medicine include:

• nausea
• vomiting
• dizziness
• headache
• constipation
• pruritus
• hypoxia

What special precautions should I follow?

• Do not exceed a cumulative daily dose of 27 mg, it may increase risk for QT interval prolongation.
• Monitor closely, life-threatening respiratory depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients particularly during initiation and titration.
• If adrenal Insufficiency is diagnosed, treat with physiologic replacement corticosteroids and wean the patient off the opioid.
• Avoid use of OLINVYK in patients with circulatory shock.
• Monitor for signs of sedation and respiratory depression.
• Avoid the use of OLINVYK in patients with impaired consciousness or coma.

What to do in case of emergency/overdose?

• 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.

Treatment for overdosage:

• 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.

Can this medicine be used in pregnancy?

• There are no available data on OLINVYK use in pregnant women to evaluate for a drug-associated risk of major birth defects and miscarriage.
• Prolonged use of opioid analgesics during pregnancy may result in neonatal opioid withdrawal syndrome.

Can this medicine be used in children?

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

What should I know about storage and disposal of this medication?

• Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F).
• Protect from freezing.
• Protect from light.

• Dailymed label info on Oliceridine
• FDA Oliceridine

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