Oliceridine Injection

FDA Drug Safety Communication:

[Posted 4/13/2023]

• As part of its ongoing efforts to address the nation's opioid crisis, FDA is requiring several updates to the prescribing information of opioid pain medicines. The changes are being made to provide additional guidance for safe use of these drugs while also recognizing the important benefits when used appropriately. The changes apply to both immediate-release (IR) and extended-release/long-acting preparations (ER/LA).
• Updates to the IR opioids state that these drugs should not be used for an extended period unless the pain remains severe enough to require an opioid pain medicine and alternative treatment options are insufficient, and that many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine.
• Updates to the ER/LA opioids recommend that these drugs be reserved for severe and persistent pain requiring an extended period of treatment with a daily opioid pain medicine and for which alternative treatment options are inadequate.
• A new warning is being added about opioid-induced hyperalgesia (OIH) for both IR and ER/LA opioid pain medicines. This includes information describing the symptoms that differentiate OIH from opioid tolerance and withdrawal.
• Information in the boxed warning for all IR and ER/LA opioid pain medicines will be updated and reordered to elevate the importance of warnings concerning life-threatening respiratory depression, and risks associated with using opioid pain medicines in conjunction with benzodiazepines or other medicines that depress the central nervous system (CNS).
• Other changes will also be required in various other sections of the prescribing information to educate clinicians, patients, and caregivers about the risks of these drugs.

Oliceridine injection may be habit forming, especially with prolonged use. Use oliceridine injection exactly as directed. Do not use more of it, use it more often, or use it in a different way than directed by your doctor. While you are using oliceridine injection, discuss with your health care provider your pain treatment goals, length of treatment, and other ways to manage your pain. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or has had an overdose, or if you have or have ever had depression or another mental illness. There is a greater risk that you will overuse oliceridine if you have or have ever had any of these conditions. Talk to your health care provider immediately and ask for guidance if you think that you have an opioid addiction or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.

Oliceridine injection may cause serious or life-threatening breathing problems, especially during the first 24 to 48 hours of your treatment and any time your dose is increased. Your doctor will monitor you carefully during your treatment. Tell your doctor if you have or have ever had slowed breathing or asthma. Your doctor will probably tell you not to use oliceridine injection. Also tell your doctor if you have or have ever had lung disease such as chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways), a head injury, a brain tumor, or any condition that increases the amount of pressure in your brain. The risk that you will develop breathing problems may be higher if you are an older adult or are weak or malnourished due to disease. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.

Taking certain medications during your treatment with oliceridine injection may increase the risk that you will experience breathing problems or other serious, life threatening breathing problems, sedation, or coma. Tell your doctor if you are taking or plan to take any of the following medications: benzodiazepines such as alprazolam (Xanax), diazepam (Diastat, Valium, Valtoco), estazolam, flurazepam, lorazepam (Ativan, Loreev), and triazolam (Halcion); medications for anxiety, nausea, or pain; muscle relaxants; sedatives; sleeping pills; or tranquilizers. Your doctor may need to change the dosages of your medications and will monitor you carefully. If you use oliceridine injection with any of these medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.

Drinking alcohol, taking prescription or nonprescription medications that contain alcohol, or using street drugs during your treatment with oliceridine injection increases the risk that you will experience serious, life-threatening side effects. Do not drink alcohol, take prescription or nonprescription medications that contain alcohol, or use street drugs during your treatment.

Do not allow anyone else to use your medication. Oliceridine injection may harm or cause death to other people who use your medication, especially children.

Tell your doctor if you are pregnant or plan to become pregnant. If you using oliceridine injection regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth. Tell your baby's doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.

Talk to your doctor about the risks of using oliceridine injection.

Oliceridine injection is used as short-term treatment to relieve acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed) that cannot be controlled by the use of alternative pain medications. Oliceridine is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.

Oliceridine injection comes as a solution (liquid) to inject intravenously (into a vein). It is usually injected every 1 to 3 hours as needed for up to 2 days. Use oliceridine injection exactly as directed.

Your doctor may adjust your dose of oliceridine injection during your treatment, depending on how well your pain is controlled and on the side effects that you experience. Talk to your doctor about how you are feeling during your treatment with oliceridine injection.

If you have used oliceridine injection for longer than a few days, do not stop using it suddenly. If you suddenly stop using oliceridine injection, you may experience withdrawal symptoms including restlessness; teary eyes; runny nose; yawning; sweating; chills; muscle, back or joint pain; widening of the pupils; irritability; anxiety; weakness; stomach cramps; difficulty falling asleep or staying asleep; nausea; loss of appetite; vomiting; diarrhea; fast breathing; or fast heartbeat. Your doctor will probably decrease your dose gradually.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using oliceridine injection,

• tell your doctor and pharmacist if you are allergic to oliceridine, any other medications, or any of the ingredients in oliceridine injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or had a blockage in your stomach or intestines or paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to use oliceridine injection.
• tell your doctor if you have or have ever had a head injury, a brain tumor, or any condition that caused damage to your brain; any condition that increases the pressure in your brain; a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death); Addison's disease (condition in which the adrenal gland produces less hormone than normal); seizures; or gallbladder, pancreas, or liver disease.
• tell your doctor if you are breast-feeding.
• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of using oliceridine injection.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using oliceridine injection.
• you should know that oliceridine injection may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• you should know that oliceridine injection may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start using oliceridine injection. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

Unless your doctor tells you otherwise, continue your normal diet.

Oliceridine injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• dizziness
• headache
• constipation
• lightheadedness
• drowsiness
• flushing
• itching
• back pain
• fever
• mood changes

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• seizures
• agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
• nausea, vomiting, loss of appetite, weakness, or dizziness
• inability to get or keep an erection
• decreased sexual desire
• irregular menstruation
• rash; hives; swelling of the eyes, face, lips, tongue, mouth, or throat; difficulty breathing or swallowing
• fainting

Oliceridine injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Your healthcare provider will tell you how to store your medication. Store your medication only as directed. Make sure you understand how to store your medication properly.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

While using oliceridine injection, you should talk to your doctor about having a rescue medication called naloxone readily available (e.g., home, office). Naloxone is used to reverse the life-threatening effects of an overdose. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood. Your doctor may also prescribe you naloxone if you are living in a household where there are small children or someone who has abused street or prescription drugs. You should make sure that you and your family members, caregivers, or the people who spend time with you know how to recognize an overdose, how to use naloxone, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and your family members how to use the medication. Ask your pharmacist for the instructions or visit the manufacturer's website to get the instructions. If symptoms of an overdose occur, a friend or family member should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. Your symptoms may return within a few minutes after you receive naloxone. If your symptoms return, the person should give you another dose of naloxone. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• slow or shallow breathing
• difficulty breathing
• extreme sleepiness
• unable to respond or wake up
• loose, floppy muscles
• cold, clammy skin
• slow heartbeat
• fainting

Keep all appointments with your doctor and the laboratory.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using oliceridine injection.

This prescription is not refillable. If you continue to have pain after you finish oliceridine injection, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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