Pronunciation:

bue-PIV-a-kane LYE-poh-some

Brand Names:

• Exparel

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Anesthetic, Local

Chemical—

Amino Amide

Uses of This Medicine:

Bupivacaine liposome injection is used to relieve pain after surgery. It is a local anesthetic that prevents pain by blocking signals at the nerve endings directly at the surgical area (local analgesia) or by blocking nerve endings (regional analgesia) of the brachial plexus (nerves that conduct signals to the shoulder, arm, and hand), sciatic nerve (nerve that starts from the lower back, then through the hips and buttock, and then to the back of each thigh), or adductor canal (nerve in the thigh).

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

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of bupivacaine liposome injection for local analgesia in children younger than 6 years of age and for regional analgesia in children. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bupivacaine liposome injection in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution for patients receiving bupivacaine liposome injection.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Other 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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Chloroprocaine
• Cocaine
• Fospropofol
• Hyaluronidase
• Levobupivacaine
• Lidocaine
• Mepivacaine
• Prilocaine
• Procaine
• Propofol
• Propranolol
• St John's Wort
• Verapamil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alacepril
• Benazepril
• Captopril
• Cilazapril
• Delapril
• Enalaprilat
• Enalapril Maleate
• Fosinopril
• Imidapril
• Lisinopril
• Moexipril
• Pentopril
• Perindopril
• Quinapril
• Ramipril
• Spirapril
• Temocapril
• Trandolapril
• Zofenopril

Other interactions—

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:

• Glucose-6-phosphate dehydrogenase deficiency (G6PD) or
• Heart problems or
• Lung or breathing problems or
• Methemoglobinemia (blood disorder), hereditary or idiopathic (unknown cause)—Use with caution. May increase risk of having methemoglobinemia.

• Heart or blood vessel problems—May increase risk for more serious side effects.

• Kidney disease or
• Liver disease, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

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

This medicine should cause numbness only to the area where it is injected. You may experience temporary loss of sensation or movement to the injected area for up to 5 days. This type of numbing procedure is called local anesthesia. It is not meant to cause you to fall asleep or become unconscious.

Bupivacaine liposome injection (Exparel®) works differently than other forms of bupivacaine, even at the same dose. You should not receive another type of bupivacaine injection or another anesthetic within 4 days (96 hours) after the injection of Exparel®.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely after you receive this medicine to see if the medicine is working properly. Blood tests may be needed to check for any unwanted effects.

This medicine should not be given to women during labor (obstetrical paracervical block anesthesia).

This medicine may cause a rare, but serious blood problem called methemoglobinemia. The risk may be increased in elderly patients or patients with certain inborn defects. It is more likely to occur in patients receiving too much of the medicine, but can also occur with small amounts. Check with your doctor right away if you or your child has the following symptoms after receiving this medicine: pale, gray, or blue-colored skin, lips, or nails, confusion, headache, lightheadedness, fast heartbeat, or unusual tiredness or weakness.

Tell your doctor or nurse right away if you have the following symptoms with this medicine: anxiety, blurred vision, depression, drowsiness, lightheadedness, nausea or vomiting, numbness and tingling of the mouth or lips, restlessness, ringing in the ears, speech problems, or tremors.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat after receiving this medicine.

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 may also increase your risk of having serious heart and blood vessel problems (eg, heart attack, heart rhythm changes, or low blood pressure). Check with your doctor if you have chest pain or discomfort, pain or discomfort in the arms, jaw, back, or neck, dizziness, fainting, pounding, slow heartbeat, trouble breathing, or unusual tiredness or weakness.

Check with your doctor if you have joint pain, stiffness, or loss of motion of the shoulder. This may be symptoms of a serious bone or joint problem called chondrolysis.

Check with your doctor before receiving this medicine with other medicines that affect the central nervous system (CNS). The use of other medicines that affect the CNS with bupivacaine liposome injection may worsen the side effects of this medicine, including dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, or muscle relaxants.

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

Side Effects of This Medicine:

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

Blurred vision

chills

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast, pounding, or irregular heartbeat or pulse

fever

sweating

Less common

Bloating or swelling of the face, arms, hands, lower legs, or feet

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain or discomfort

collection of blood under the skin

decrease in frequency of urination

decrease in urine volume

deep, dark purple bruise

difficulty in passing urine (dribbling)

dry mouth

headache

increased thirst

irregular heartbeat

itching, pain, redness, or swelling

loss of appetite

mood changes

muscle pain, cramp, spasm, or twitching

nausea

nervousness

painful urination

pale skin

pounding in the ears

rapid weight gain

seizures

slow or fast heartbeat

tingling of the hands or feet

trouble breathing

unusual bleeding or bruising

unusual weight gain or loss

vomiting

Incidence not known

Loss of consciousness

no blood pressure or pulse

stopping of the heart

weakness of the muscles in your face

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

Motor dysfunction

trouble sleeping

Less common

Anxiety

belching

change in taste

constipation

decreased appetite

falls

feeling hot

heartburn

hiccups

indigestion

itching in the genitals or other skin areas

loss of taste

scaling

seeing double

sensory loss

stomach discomfort, upset, or pain

swelling at the surgical site

Rare

Increased sweating

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.