Bupivacaine Liposome (bue-PIV-a-kane LYE-poh-some)

Relieves pain after surgery. This medicine is a local anesthetic.

Brand Name(s):

Exparel

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle injected into the surgical site or into the nerve endings of the brachial plexus (nerves that conduct signals to the shoulder, arm, and hand).

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how bupivacaine works. Tell your doctor if you are using any of the following:
  • Acetaminophen, chloroquine, metoclopramide, primaquine, quinine, sulfasalazine
  • Cancer medicine (including cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase)
  • Medicine to treat an infection (including dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamide)
  • Medicine to treat seizures (including phenobarbital, phenytoin, sodium valproate)
  • Nitrate or nitrite medicine (including nitric oxide, nitroglycerin, nitroprusside, nitrous oxide)
• Tell your doctor if you are using other numbing medicines (including lidocaine). You should not be given any other kind of anesthetic within 4 days after receiving this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, heart or blood vessel problems, lung or breathing problems, a blood disorder, or G6PD.
• This medicine may cause the following problems:
  • Methemoglobinemia (blood disorder)
  • Heart or blood vessel problems, including changes in heart rhythm, low blood pressure, or heart attack
  • Chondrolysis (a bone or joint problem)
  • Seizures
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine should cause numbness only to the area where it is injected. It is not meant to cause you to fall asleep or become unconscious.
• It may be easier to hurt yourself while your treated body area is still numb. The effects of this medicine may last up to 5 days. Be careful to avoid injury until you have regained all the feeling and are no longer numb.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, depression, restlessness, drowsiness, ringing in your ears, blurred vision
• Chest pain that may spread to your arms, jaw, back, or neck, fast, pounding, slow, or uneven heartbeat, trouble breathing
• Joint pain, stiffness, or loss of motion of the shoulder
• Lightheadedness, dizziness, fainting
• Nausea, vomiting, chills, metallic taste in your mouth
• Pale, gray, or blue lips, nails, or skin, dark urine, headache, unusual tiredness or weakness
• Seizures, shivering, shaking, or tremors
• Unusual bleeding or bruising

If you notice these less serious side effects, talk with your doctor:

• Back pain
• Constipation
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

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