Exparel

Generic Name: bupivacaine liposome (Injection route)

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

Commonly used brand name(s)

In the U.S.

• Exparel

Available Dosage Forms:

• Suspension

Therapeutic Class: Anesthetic, Local

Chemical Class: Amino Amide

Uses For Exparel

Bupivacaine liposome injection is used to relieve pain after surgery. It belongs to the family of medicines called local anesthetics. This medicine prevents pain by blocking the signals at the nerve endings

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

Before Using Exparel

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 bupivacaine liposome 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 bupivacaine liposome injection in the elderly. However, elderly patients are more likely to have kidney or liver problems, which may require caution for patients receiving bupivacaine liposome injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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

• Bone or joint problems (e.g., chondrolysis)—May increase risk for more serious side effects.

• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Obstetrical paracervical block (numbing procedure)—Should not be used in patients having this procedure.

Proper Use of Exparel

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle injected into the surgical site (such as big toe).

This medicine should cause numbness only to the area where it is injected. You may experience temporary loss of sensation or motor skills to the area injected. 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 with other formulations of bupivacaine, even at the same dose (number of milligrams). Do not convert or change the dosing from any other formulations of bupivacaine to Exparel™.

Precautions While Using Exparel

Your doctor will check you closely while you are receiving this medicine. This is to check for any problems or unwanted effects that may be caused by this medicine.

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

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

Exparel 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

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


• blurred vision


• confusion


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


• fast, pounding, or irregular heartbeat or pulse


• fever


• pale skin


• rapid weight gain


• sweating


• tingling of the hands or feet


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight gain or loss

Less common

• Bleeding from the anus


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


• chest pain or discomfort


• fainting


• lightheadedness, dizziness, or fainting


• painful defecation


• shortness of breath


• slow or irregular heartbeat


• swelling at the surgical site

Less common or rare

• Chills


• decrease in the frequency of urination


• decrease in the urine volume


• difficult or troubled breathing


• difficulty in passing urine (dribbling)


• extra heart beat


• headache


• hives


• hoarseness


• irregular, fast or slow, or shallow breathing


• irritation


• itching


• joint pain, stiffness, or swelling


• nervousness


• not breathing


• painful urination


• pale or blue lips, fingernails, or skin


• pounding in the ears


• rash


• redness of the skin


• shakiness in the legs, arms, hands, or feet


• shortness of breath


• swelling at the incision site


• tightness in the chest


• troubled breathing or swallowing


• weakness


• wheezing

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


• muscle spasm


• nausea


• sleepiness or unusual drowsiness


• sleeplessness


• trouble sleeping


• unable to sleep


• vomiting

Less common

• Decreased appetite


• itching in the genital or other skin areas


• scaling


• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Less common or rare

• Agitation


• cold sweats


• hives or welts


• increased sweating


• muscle weakness


• pain in the neck


• paleness of the skin


• restlessness

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.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.