Exparel

Exparel is used to relieve pain after surgery. It is a local anesthetic that prevents pain by blocking signals at nerve endings.

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

This product is available as a single use vial containing 20 ml of the suspension.

Before using Exparel, 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 population: 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 population: 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 and Breastfeeding:Category C: There are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

• Drug Interactions: 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.

1. Fospropofol
2. Hyaluronidase
3. Propofol
4. Propranolol
5. St John's Wort
6. 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.

1. Alacepril
2. Benazepril
3. Captopril
4. Cilazapril
5. Delapril
6. Enalaprilat
7. Enalapril Maleate
8. Fosinopril
9. Imidapril
10. Lisinopril
11. Moexipril
12. Pentopril
13. Perindopril
14. Quinapril
15. Ramipril
16. Spirapril
17. Temocapril
18. Trandolapril
19. 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:

1. Chondrolysis (a bone or joint problem): May increase risk for more serious side effects.
2. Kidney disease or Liver disease: Use with caution.The effects may be increased because of slower removal of the medicine from the body.

Proper usage of Exparel requires strict adherence to your doctor’s orders.

A nurse or other trained health professional will give you this medicine in a hospital.

This medicine is given through a needle and is injected into the tissue at the surgical site (such as the foot).

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. 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 during the first 4 days (96 hours) after the injection of Exparel.

In using Exparel, you must be careful and take some precautions as advised by your doctor.

Your doctor will check you closely after you receive this medicine. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

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
• 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.

As with many medications, there are several potential side effects associated with Exparel.

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
• Dizzines
• 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
• 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 or itching
• Joint pain or 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.