oliceridine

What is the most important information I should know about oliceridine?

What is oliceridine?

Oliceridine is an opioid medicine that is used to treat severe pain when other treatments have not provided relief.

Oliceridine may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using oliceridine?

• severe asthma or breathing problems; or
• a stomach or bowel obstruction (including paralytic ileus).

Tell your doctor if you have ever had:

• asthma, chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder;
• liver disease;
• low blood pressure;
• long QT syndrome (in you or a family member);
• drug or alcohol addiction;
• depression, mental illness;
• problems with your gallbladder or pancreas; or
• a head injury, brain tumor, or seizure.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Ask a doctor before using this medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

How is oliceridine given?

Oliceridine is given around the clock (continuous) using an infusion pump attached to a catheter placed into a vein. A healthcare provider can teach you how to properly use the infusion pump by yourself.

Never use oliceridine in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Tell your caregivers if you feel any burning, pain, or swelling around your port needle.

If you have used opioid medicine regularly and are opioid-dependent, you should not stop using oliceridine suddenly, or you could have unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose.

What happens if I miss a dose?

Since oliceridine is used for pain, you are not likely to miss a dose. The infusion pump will control how much and how often you use this medicine.

What happens if I overdose?

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

What should I avoid while using oliceridine?

What are the possible side effects of oliceridine?

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
• a slow heart rate or weak pulse;
• a light-headed feeling, like you might pass out;
• severe constipation;
• low red blood cells (anemia) --pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
• low cortisol levels --nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• low oxygen in your blood --confusion, feeling restless or short of breath, blue-colored lips or skin.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects may include:

• nausea, vomiting, constipation;
• headache, dizziness;
• itching; or
• low oxygen in your blood.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect oliceridine?

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other opioids --opioid pain medicine or prescription cough medicine;
• a sedative like Valium --diazepam, alprazolam, lorazepam, Xanax, Klonopin, Ativan, and others;
• drugs that make you sleepy or slow your breathing --a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
• drugs that affect serotonin levels in your body --a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may affect oliceridine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about oliceridine.