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Olinvyk (Intravenous)

Generic Name: oliceridine (Intravenous route)

Intravenous route(Solution)

Warning: Addiction, abuse, and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome; and risks from concomitant use with benzodiazepines or other CNS depressantsOliceridine 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 before prescribing, and monitor all patients regularly for the development of behaviors or conditions.Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation or following a dose increase.Prolonged use of oliceridine during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Concomitant use of oliceridine with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation .

Commonly used brand name(s)

In the U.S.

  • Olinvyk

Uses for Olinvyk

Oliceridine injection is used to relieve acute pain severe enough to require a narcotic pain medicine and in patients who have been previously treated with other medicines that did not work well.

Oliceridine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

When oliceridine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is to be given only by or under the direct supervision of your doctor.

Before using Olinvyk

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of oliceridine injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oliceridine injection in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults, and are more likely to have age-related kidney, liver, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol or drug abuse or addiction, history of or
  • Brain problems (eg, increased pressure, tumors) or
  • Head injury or
  • Hypovolemia (low blood volume) or
  • Lung or breathing problems (eg, COPD, cor pulmonale, hypercapnia, hypoxia, sleep apnea) or
  • Mental illness (eg, depression), history of—Use with caution. May increase risk for more serious side effects.
  • Asthma, unmonitored or
  • Coma (loss of consciousness) or
  • Lung or breathing problems, severe (eg, respiratory depression) or
  • Shock or
  • Stomach or bowel blockage (eg, paralytic ileus)—Should not be used in patients with these conditions.
  • Gallbladder problems or
  • Pancreatitis (inflammation of the pancreas), acute or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Liver disease or
  • Poor metabolizers of certain enzymes (eg, CYP2D6)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper use of Olinvyk

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins.

Your doctor may also let you decide when you will get a dose of the pain medicine by pressing a button on a computerized machine pump (patient-controlled analgesia).

Precautions while using Olinvyk

It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Symptoms of an overdose include: extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, or cold, clammy skin. Tell your doctor right away if you notice these symptoms.

This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while receiving this medicine.

Receiving this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the other medicines listed above while you are receiving this medicine.

This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, nausea, depression, skin rash, unusual tiredness or weakness, or vomiting.

Severe dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may make you dizzy or less alert than you are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

If you have been receiving this medicine regularly for several days, do not suddenly stop receiving it without first checking with your doctor. You or your child may be directed to slowly reduce the amount you are using before stopping treatment completely to lessen the chance of withdrawal side effects (eg, stomach cramps, fever, runny nose, anxiety, or restlessness).

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you or your child to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Receiving too much of this medicine may cause infertility (unable to have children). Talk with your doctor before receiving this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Olinvyk side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

  • Confusion
  • decreased urine
  • dizziness
  • dry mouth
  • fast or irregular heartbeat
  • increased thirst
  • loss of appetite
  • mood changes
  • muscle pain or cramps
  • nausea
  • numbness or tingling in the hands, feet, or lips
  • seizures
  • unusual tiredness or weakness
  • vomiting

Less common

  • Blurred vision
  • bone pain
  • chest tightness
  • difficult or labored breathing
  • dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • extremely shallow or slow breathing
  • fainting
  • fever
  • muscle spasms (tetany) or twitching seizures
  • numbness and tingling around the mouth, fingertips, or feet
  • pale skin
  • stomach cramps
  • sweating
  • trembling
  • tremor
  • unusual bleeding or bruising

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  • Bigger, dilated, or enlarged pupils (black part of the eye)
  • chest pain or discomfort
  • cold and clammy skin
  • confusion
  • constricted pupils
  • coughing that sometimes produces a pink frothy sputum
  • increased sensitivity of the eyes to light
  • irregular, fast or slow, or shallow breathing
  • loss of consciousness
  • no muscle tone or movement
  • pale or blue lips, fingernails, or skin
  • slow heartbeat
  • swelling in the legs and ankles

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Back pain
  • constipation
  • feeling of warmth
  • headache
  • itching, skin rash
  • redness of the face, neck, arms, and occasionally, upper chest

Less common

  • Anxiety
  • belching
  • diarrhea
  • heartburn
  • indigestion
  • muscle spasm
  • pale skin, pain, or redness at the injection site
  • passing gas
  • restlessness
  • stomach discomfort, upset, or pain
  • trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.