To request XARACOLL Medical Information or to report a product complaint or Adverse Reaction to Innocoll:
To request XARACOLL Product Information or to report Adverse Reactions to Innocoll:
- Phone: 1-833-606-1421
- Email Us
To report a product complaint or Adverse Reaction to the FDA:
To report Adverse Reactions to the FDA:
- Phone: 1-800-FDA-1088
- www.fda.gov/medwatch
What is XARACOLL?
XARACOLL is a collagen implant that contains the drug bupivacaine, a pain medication commonly used for surgery.
XARACOLL is inserted by your surgeon during your surgery and dissolves over time releasing the pain medication bupivacaine.
XARACOLL may reduce your need for prescription opioids to manage pain following open inguinal hernia repair.
The most common adverse events in XARACOLL clinical trials included altered sense of taste (1.5% of patients) and dizziness (1.0% of patients). Talk to your doctor if you have received XARACOLL and experience these symptoms, or if you have any side effects or questions regarding side effects.
XARACOLL is used in adults to treat pain for up to 24 hours after surgery to repair a hernia in your groin. XARACOLL is placed in the body at the time of surgery.
IMPORTANT SAFETY INFORMATION
- Tell your healthcare provider if you:
- Have had an allergic reaction to cow's collagen or a medication called a local anesthetic, which is used to prevent or treat pain
- Have liver disease, because this may affect how the active ingredient (bupivacaine) in XARACOLL is eliminated from your body
- Have heart disease
- Recently had, or plan to have, surgery or anesthesia
- Are pregnant or nursing, or if you are planning to get pregnant or nurse
- Tell your healthcare provider right away if you experience symptoms with your heart, blood circulation, brain, or nerves after receiving XARACOLL
- A rare blood disorder (methemoglobinemia) that causes red blood cells to carry less oxygen has been known to happen with local anesthetics like bupivacaine, which is the active ingredient in XARACOLL. You should seek immediate medical attention if you experience the following signs or symptoms: pale, grey- or blue-colored skin; headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue
- In clinical trials with XARACOLL, the most common side effects considered related to XARACOLL were incision-site swelling, change in sense of taste, headache, tremor, blurred vision, fluid under the skin, scrotal swelling, fever, numbness around the mouth, and post-procedural discharge
- Other side effects can happen, including allergic reactions at the surgical site. Tell your healthcare provider if you have any side effects after receiving XARACOLL
XARACOLL contains the drug bupivacaine. It also contains collagen, a protein from cows.
XARACOLL is used in adults to treat pain for up to 24 hours after surgery to repair a hernia in your groin. XARACOLL is placed in the body at the time of surgery.
IMPORTANT SAFETY INFORMATION
- Tell your healthcare provider if you:
- Have had an allergic reaction to cow's collagen or a medication called a local anesthetic, which is used to prevent or treat pain
- Have liver disease, because this may affect how the active ingredient (bupivacaine) in XARACOLL is eliminated from your body
- Have heart disease